1 SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) [X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED: SEPTEMBER 30, 1999 OR [ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934. FOR THE TRANSITION PERIOD FROM ____________________TO__________________ COMMISSION FILE NUMBER: 1-3720 FRESENIUS MEDICAL CARE HOLDINGS, INC. ------------------------------------------------------ (EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER) New York 13-3461988 - ---------------------------------------------- ------------------------ (State or Other Jurisdiction of Incorporation) (I.R.S. Employer ID No.) Two Ledgemont Center, 95 Hayden Avenue, Lexington, MA 02420 - ----------------------------------------------------- ---------- (Address of Principal Executive Office) (Zip Code) Registrant's Telephone Number, Including Area Code: 781-402-9000 ---------------------------------------------------------------- __________________________________________________________________________ (Former Name, Former Address and Former Fiscal Year, if Changed Since Last Report) Indicated by check whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes [X] No [ ] 2 APPLICABLE ONLY TO CORPORATE ISSUERS: Indicate the number of shares outstanding of each of the issuer's classes of common stock, as of the latest practicable date: As of the date hereof, 90,000,000 shares of common stock, par value $1.00 per share, are outstanding, all of which are held by Fresenius Medical Care AG. 2 3 FRESENIUS MEDICAL CARE HOLDINGS, INC. AND CONSOLIDATED SUBSIDIARIES TABLE OF CONTENTS PART I: FINANCIAL INFORMATION ITEM 1: FINANCIAL STATEMENTS PAGE Unaudited Consolidated Statements of Operations ..................................................4 Unaudited Consolidated Statements of Comprehensive Income.........................................5 Unaudited Consolidated Balance Sheets.............................................................6 Unaudited Consolidated Statements of Cash Flows...................................................7 Notes to Unaudited Consolidated Financial Statements..............................................9 ITEM 2: MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS...............................................................26 ITEM 3: QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.......................................................................................35 PART II: OTHER INFORMATION ITEM 1: Legal Proceedings................................................................................36 ITEM 6: Exhibits and Reports on Form 8-K.................................................................48 3 4 PART I FINANCIAL INFORMATION ITEM 1. FINANCIAL STATEMENTS FRESENIUS MEDICAL CARE HOLDINGS, INC. AND SUBSIDIARIES UNAUDITED, CONSOLIDATED STATEMENTS OF OPERATIONS (DOLLARS IN THOUSANDS, EXCEPT PER SHARE DATA) THREE MONTHS ENDED NINE MONTHS ENDED SEPTEMBER 30, SEPTEMBER 30, ---------------------------- ---------------------------- 1999 1998 1999 1998 ---- ---- ---- ---- NET REVENUES Health care services .................................... $ 587,314 $ 541,052 $ 1,714,051 $ 1,550,689 Medical supplies ........................................ 124,536 114,600 368,405 353,291 ----------- ----------- ----------- ----------- 711,850 655,652 2,082,456 1,903,980 ----------- ----------- ----------- ----------- EXPENSES Cost of health care services ............................ 392,763 355,887 1,145,943 1,021,727 Cost of medical supplies ................................ 84,963 77,216 253,763 242,121 General and administrative expenses ..................... 71,328 62,500 204,880 186,816 Provision for doubtful accounts ......................... 5,669 16,308 25,398 50,187 Depreciation and amortization ........................... 53,931 54,298 162,019 161,494 Research and development ................................ 1,067 1,294 3,104 3,102 Interest expense, net and related financing cost including $23,250 and $21,730 for the three months and $64,795 and $59,315 for the nine months ended, respectively of interest with affiliates .............. 49,524 54,880 152,154 155,059 Special charge for settlement of investigations and related costs ......................................... 590,000 -- 590,000 -- ----------- ----------- ----------- ----------- 1,249,245 622,383 2,537,261 1,820,506 ----------- ----------- ----------- ----------- INCOME (LOSS) FROM CONTINUING OPERATIONS BEFORE INCOME TAXES AND CUMULATIVE EFFECT OF CHANGE IN ACCOUNTING FOR START UP COSTS .......................... (537,395) 33,269 (454,805) 83,474 PROVISION (BENEFIT) FOR INCOME TAXES ....................... (150,190) 18,965 (106,631) 46,554 ----------- ----------- ----------- ----------- INCOME (LOSS) FROM CONTINUING OPERATIONS BEFORE CUMULATIVE EFFECT OF CHANGE IN ACCOUNTING FOR START UP COSTS ......................................... $ (387,205) $ 14,304 $ (348,174) $ 36,920 ----------- ----------- ----------- ----------- DISCONTINUED OPERATIONS Loss from discontinued operations, net of income taxes... -- -- -- (8,669) Loss on disposal of discontinued operations, net of income tax benefit ................................. -- -- -- (97,228) ----------- ----------- ----------- ----------- Loss from discontinued operations ....................... $ -- $ -- $ -- $ (105,897) ----------- ----------- ----------- ----------- CUMULATIVE EFFECT OF CHANGES IN ACCOUNTING FOR START UP COSTS, NET OF TAX BENEFIT .................. -- -- -- (4,890) ----------- ----------- ----------- ----------- NET INCOME (LOSS) .......................................... $ (387,205) $ 14,304 $ (348,174) $ (73,867) =========== =========== =========== =========== Basic and fully dilutive earnings (loss) per share Continuing operations ................................... $ (4.30) $ 0.16 $ (3.87) $ 0.41 Discontinued operations ................................. -- -- -- (1.18) Cumulative effect of accounting change .................. -- -- -- (0.05) Net Income (loss) ....................................... $ (4.30) $ 0.16 $ (3.87) $ (0.82) See accompanying Notes to Unaudited, Consolidated Financial Statements. 4 5 FRESENIUS MEDICAL CARE HOLDINGS, INC. AND CONSOLIDATED SUBSIDIARIES UNAUDITED, CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (DOLLARS IN THOUSANDS) THREE MONTHS ENDED NINE MONTHS ENDED SEPTEMBER 30, SEPTEMBER 30, ------------------------ ------------------------ 1999 1998 1999 1998 ---- ---- ---- ---- NET INCOME (LOSS) ............................ $(387,205) $ 14,304 $(348,174) $ (73,867) Other comprehensive income Foreign currency translation adjustments... (138) 226 (611) 1,921 --------- --------- --------- --------- Total other comprehensive income .......... (138) 226 (611) 1,921 --------- --------- --------- --------- COMPREHENSIVE INCOME (LOSS) .................. $(387,343) $ 14,530 $(348,785) $ (71,946) ========= ========= ========= ========= 5 6 FRESENIUS MEDICAL CARE HOLDINGS, INC. AND CONSOLIDATED SUBSIDIARIES CONSOLIDATED BALANCE SHEETS (DOLLARS IN THOUSANDS) SEPTEMBER 30, DECEMBER 31, 1999 1998 ------------- ------------ ASSETS (UNAUDITED) Current Assets: Cash and cash equivalents .............................. $ 27,120 $ 6,579 Accounts receivable, less allowances of $59,550 and $49,209 ............................................. 281,095 254,783 Inventories ............................................ 172,167 169,789 Deferred income taxes .................................. 285,746 139,653 Other current assets ................................... 122,249 93,912 Net assets of discontinued operations .................. 154,573 149,949 ----------- ----------- Total Current Assets ................................ 1,042,950 814,665 ----------- ----------- Properties and equipment, net ............................. 424,198 429,639 ----------- ----------- Other Assets: Excess of cost over the fair value of net assets acquired and other intangible assets, net of accumulated amortization of $390,335 and $289,167 ... 3,285,913 3,317,424 Other assets and deferred charges ...................... 49,814 51,675 ----------- ----------- Total Other Assets .................................. 3,335,727 3,369,099 ----------- ----------- Total Assets .............................................. $ 4,802,875 $ 4,613,403 =========== =========== LIABILITIES AND EQUITY Current Liabilities: Current portion of long-term debt and capitalized lease obligations ......................................... $ 139,262 $ 43,348 Current portion of borrowing from affiliates ........... 20,146 32,716 Short-term borrowings from affiliates .................. 310,321 154,471 Accounts payable ....................................... 119,889 107,482 Accrued liabilities .................................... 856,354 306,333 Net accounts payable to affiliates ..................... 21,004 17,966 Accrued income taxes ................................... 49,916 12,411 ----------- ----------- Total Current Liabilities ........................... 1,516,892 674,727 Long-term debt ............................................ 710,715 1,010,880 Non-current borrowings from affiliates .................... 790,440 801,813 Capitalized lease obligations ............................. 1,293 2,666 Deferred income taxes ..................................... 139,490 144,605 Other liabilities ......................................... 43,880 29,278 ----------- ----------- Total Liabilities ...................................... 3,202,710 2,663,969 ----------- ----------- Equity: Preferred stock, $100 par value ........................ 7,412 7,412 Preferred stock, $.10 par value ........................ 8,906 8,906 Common stock, $1 par value; 300,000,000 shares authorized; outstanding 90,000,000 ..................... 90,000 90,000 Paid in capital ........................................... 1,942,141 1,942,235 Retained deficit .......................................... (448,720) (100,156) Accumulated comprehensive income .......................... 426 1,037 ----------- ----------- Total Equity ........................................... 1,600,165 1,949,434 ----------- ----------- Total Liabilities and Equity .............................. $ 4,802,875 $ 4,613,403 =========== =========== See accompanying Notes to Unaudited, Consolidated Financial Statements. 6 7 FRESENIUS MEDICAL CARE HOLDINGS, INC. AND CONSOLIDATED SUBSIDIARIES UNAUDITED, CONSOLIDATED STATEMENTS OF CASH FLOWS (DOLLARS IN THOUSANDS) NINE MONTHS ENDED SEPTEMBER 30, ------------------------ 1999 1998 ---- ---- Cash Flows from Operating Activities: Net loss ..................................................................... $(348,174) $ (73,867) Adjustments to reconcile net earnings to net cash from operating activities: Depreciation and amortization ............................................. 162,019 161,494 Loss from discontinued operations ......................................... -- 8,669 Loss on disposition of businesses ......................................... -- 97,228 Cumulative effect of change in accounting ................................. -- 4,890 Provision for doubtful accounts ........................................... 25,398 50,187 Benefit of deferred income taxes .......................................... (151,208) (40,633) Loss on disposal of properties and equipment .............................. 363 91 Changes in operating assets and liabilities, net of effects of purchase acquisitions and foreign exchange: Increase in accounts receivable .............................................. (81,110) (109,205) Increase in inventories ...................................................... (1,739) (34,060) Increase in other current assets ............................................. (28,322) (8,532) Decrease (increase) in other assets and deferred charges ..................... 1,832 (21,970) Increase (decrease) in accounts payable ...................................... 12,407 (12,394) Increase in accrued income taxes ............................................. 37,505 94,058 Increase (decrease) in accrued liabilities ................................... 550,021 (36,567) Increase in other long-term liabilities ...................................... 14,602 5,284 Net changes due to/from affiliates ........................................... 3,038 (8,346) Other, net ................................................................... (7,261) 24,032 --------- --------- Net cash provided by operating activities of continued operations ............... 189,371 100,359 --------- --------- Net cash used in operating activities of discontinued operations ................ (4,624) (13,878) --------- --------- Net cash provided by operating activities ....................................... 184,747 86,481 --------- --------- Cash Flows from Investing Activities: Capital expenditures ......................................................... (54,096) (50,794) Payments for acquisitions, net of cash acquired .............................. (64,744) (160,246) Proceeds from disposition of businesses ...................................... -- 82,500 --------- --------- Net cash used in investing activities of continued operations ................... (118,840) (128,540) --------- --------- Net cash used in investing activities of discontinued operations ................ -- (8,925) --------- --------- Net cash used in investing activities ........................................... (118,840) (137,465) --------- --------- Cash Flows from Financing Activities: Increase in borrowings from affiliates ....................................... 131,907 442,835 Cash dividends paid .......................................................... (390) (390) Proceeds on issuance of debt ................................................. 37 16,086 Proceeds from receivable financing facility .................................. 29,400 125,000 Payments on debt and capitalized leases ...................................... (205,682) (536,122) Other net .................................................................... (94) (616) --------- --------- Net cash (used in) provided by financing activities of continued operations .... (44,822) 46,793 --------- --------- Net cash used in financing activities of discontinued operations ................ -- (2,107) --------- --------- Net cash (used in) provided by financing activities ............................ (44,822) 44,686 --------- --------- Effects of changes in foreign exchange rates .................................... (544) 2,041 --------- --------- Change in cash and cash equivalents ............................................. 20,541 (4,257) --------- --------- Cash and cash equivalents at beginning of period ................................ 6,579 13,054 --------- --------- Cash and cash equivalents at end of period ...................................... $ 27,120 $ 8,797 ========= ========= See accompanying Notes to Unaudited, Consolidated Financial Statements 7 8 FRESENIUS MEDICAL CARE HOLDINGS, INC. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF CASH FLOWS (DOLLARS IN THOUSANDS) NINE MONTHS ENDED SEPTEMBER 30, ----------------------- 1999 1998 ---- ---- Supplemental disclosures of cash flow information: Cash paid during the period for: Interest .................................................... $ 88,355 $ 102,940 Income taxes paid/(received), net ........................... 7,968 (7,532) Details for Acquisitions: Assets acquired ................................................ 64,765 162,621 Liabilities assumed ............................................ 21 2,375 --------- --------- Payments for acquisitions, net of cash acquired ................ $ 64,744 $ 160,246 ========= ========= See accompanying Notes to Unaudited Consolidated Financial Statements 8 9 FRESENIUS MEDICAL CARE HOLDINGS, INC. AND CONSOLIDATED SUBSIDIARIES NOTES TO UNAUDITED, CONSOLIDATED INTERIM FINANCIAL STATEMENTS (DOLLARS IN THOUSANDS) NOTE 1. THE COMPANY, AND BASIS OF PRESENTATION THE COMPANY Fresenius Medical Care Holdings, Inc., a New York corporation (the "Company"), formerly known as W.R. Grace & Co. ("Grace New York"), is a subsidiary of Fresenius Medical Care AG, a German corporation ("FMC" or "Fresenius Medical Care"). The Company conducts its operations through three principal subsidiaries, National Medical Care, Inc., a Delaware corporation ("NMC"), Fresenius USA, Inc., a Massachusetts corporation ("FUSA"), and SRC Holding Company, Inc., a Delaware corporation. The consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries, NMC and FUSA and those financial statements where the Company controls professional corporations in accordance with Emerging Issues Task Force Issue 97-2. The Company is primarily engaged in (i) providing kidney dialysis services, clinical laboratory testing and renal diagnostic services, and (ii) manufacturing and distributing products and equipment for dialysis treatment. The Company's healthcare operations were acquired by FMC, effective September 30, 1996, as a result of the culmination of the following transactions: (1) NMC, which was a subsidiary of W. R. Grace & Co. -- Conn. ("Grace Chemicals"), a wholly-owned subsidiary of Grace New York, borrowed $2,300,000 and paid a cash dividend of approximately $2,100,000 to Grace Chemicals; (2) the stock of NMC was transferred to Grace New York, so that NMC and Grace Chemicals became subsidiaries of Grace New York; (3) the stock of Grace Chemicals was transferred to a newly formed Delaware subsidiary of Grace New York ("New Grace") and the shares of New Grace were spun-off to the Grace New York shareholders in a pro rata distribution; (4) Grace New York was recapitalized such that each Grace New York shareholder received one share of Class D Preferred Stock of Grace New York for each share of Grace New York common stock held; and (5) Grace New York, with NMC as its sole business, merged with a wholly-owned subsidiary of FMC, and Fresenius AG's worldwide dialysis business (including its controlling interest in FUSA) ("FWD") was contributed as separate subsidiaries of FMC with the result that 44.8% of the ordinary shares of FMC were exchanged for the common stock held by Grace New York common shareholders in the merger transaction and the balance of the ordinary shares of FMC were received by Fresenius AG and the shareholders of FUSA, in consideration of the contribution of FWD to FMC. BASIS OF PRESENTATION BASIS OF CONSOLIDATION The consolidated financial statements in this report at September 30, 1999 and 1998 and for the three and nine month interim periods then ended are unaudited and should be read in conjunction with the consolidated financial statements in the Company's 1998 report on Form 10-K. Such interim financial statements reflect all adjustments that, in the opinion of management, are necessary for a fair presentation of the results of the interim periods presented. Certain amounts in the prior periods' consolidated financial statements have been reclassified to conform to the current periods' basis of presentation. The results of operations for the three and nine month periods ended September 30, 1999 are not necessarily indicative of the results of operations for the fiscal year ending December 31, 1999. NEW STANDARDS In June 1998, the Financial Accounting Standards Board issued Statement of Financial Accounting Standards ("SFAS") No. 133, Accounting for Derivative Instruments and Hedging Activities, which establishes accounting and reporting standards for derivative instruments, including certain derivative instruments embedded in other contracts (collectively referred to as "derivatives") and for hedging activities. This statement requires that an entity recognize all derivatives as either assets or liabilities in the balance sheet and measure those instruments at fair value. The statement also sets forth the criteria for determining whether a derivative may 9 10 be specifically designated as a hedge of a particular exposure with the intent of measuring the effectiveness of that hedge in the statement of operations. In June 1999, the Financial Accounting Standards Board issued SFAS No. 137, Accounting for Derivative Instruments and Hedging Activities, which amended the effective date of SFAS No. 133. The amended SFAS No. 133 is effective for all fiscal quarters of fiscal years beginning after June 15, 2000. NOTE 2. INVENTORIES SEPTEMBER 30, DECEMBER 31, 1999 1998 ------------- ------------ Inventories: Raw materials............................................... $ 40,243 $ 35,199 Manufactured goods in process............................... 17,666 18,802 Manufactured and purchased inventory available for sale..... 82,026 86,615 ------------- ------------- 139,935 140,616 Health care supplies....................................... 32,232 29,173 ------------- ------------- Total......................................................... $ 172,167 $ 169,789 ============= ============= NOTE 3. DEBT SEPTEMBER 30, DECEMBER 31, Long-term debt to outside parties consists of: 1999 1998 ------------- ------------ NMC Credit Facility............................................... $ 833,100 $ 1,032,700 Third-party debt, primarily bank borrowings at variable interest rates (3% - 9%) with various maturities...... 14,408 16,215 ------------ ------------- 847,508 1,048,915 Less amounts classified as current................................ 136,793 38,035 ------------- ------------- $ 710,715 $ 1,010,880 ============= ============= SEPTEMBER 30, DECEMBER 31, Non-current borrowings from affiliates consists of: 1999 1998 ------------- ------------ Fresenius Medical Care Finance SA borrowings at interest rates approximating 6 - 6.5%....................... 20,146 47,665 Fresenius Medical Care Trust Finance S.a.r.l. at interest rates of 8.43% and 9.25%....................................... 786,524 786,524 Other............................................................. 3,916 340 ------------- ------------- 810,586 834,529 Less amounts classified as current................................ 20,146 32,716 ------------- ------------- Total............................................................. $ 790,440 $ 801,813 ============= ============= SEPTEMBER 30, DECEMBER 31, Short-term borrowings from affiliates consists of: 1999 1998 ------------- ------------ Fresenius Medical Care AG borrowings at interest rates approximating 6 - 7%........................ $ 40,321 $ 94,471 Fresenius AG borrowing at interest rates approximating 6 - 7%.......................................... 270,000 60,000 ------------- ------------- Total............................................................. $ 310,321 $ 154,471 ============= ============= 10 11 NOTE 4. SPECIAL CHARGE FOR SETTLEMENT OF INVESTIGATIONS AND RELATED COSTS Since 1995, NMC and its subsidiaries have been the subject of criminal and civil investigations (the "OIG Investigations") by the Office of Inspector General ("OIG") of the United States Department of Health and Human Services, the United States Attorney for the District of Massachusetts (the "U.S. Attorney's Office") and other authorities concerning possible violations of federal laws, including the anti-kickback statutes and the False Claims Act. NMC has reached a preliminary agreement (the "Preliminary Agreement") with the United States Government to resolve the matters covered in the OIG Investigation and NMC's administrative appeals of an estimated $150 million of outstanding Medicare receivables for IDPN therapy rendered on and before December 31, 1998 (collectively, the "Settlement"). Consummation of the Settlement is subject to negotiation of certain material currently unresolved terms of the Settlement, completion and execution of definitive Settlement documents, satisfaction of certain conditions, and court approval. (See Note 6 - "Commitments and Contingencies - Legal Proceedings"). As a result of the Preliminary Agreement, the Company has recorded a special pre-tax charge of $590 million ($412 million, net of income taxes) which includes (i) a charge of approximately $485 million for tentative civil and criminal settlement payment obligations to the government; (ii) a reserve of approximately $80 million for the resolution of the Company's IDPN accounts receivable; and (iii) a reserve for other related costs of $25 million. NOTE 5. DISCONTINUED OPERATIONS Effective June 1, 1998, the Company classified its non-renal diagnostic services business ("Non-Renal Diagnostic Services") and homecare business ("Homecare") as discontinued operations. The Company disposed of its Non-Renal Diagnostic Services division and its Homecare division on June 26, 1998 and July 29, 1998, respectively. In connection with the sale of Homecare, the Company retained the assets and the operations associated with the delivery of IDPN and records, for accounting purposes, its activity as part of discontinued operations. The Company recorded a net after tax loss of $97 million on the sale of these businesses. The net loss on the disposal of these businesses and their results of operations have been accounted for as discontinued operations. The remaining assets and liabilities of these discontinued operations at the balance sheet date have been classified in the consolidated balance sheet as Net Assets of Discontinued Operations. Included in net assets of discontinued operations is approximately $150 million of IDPN receivables. These assets have not been sold and will remain classified as discontinued operations until they have been settled. See Note 4 - "Special Charge for Settlement of Investigations and Related Costs" and Note 6 - "Commitments and Contingencies - Legal Proceedings." Operating results and net assets of discontinued operations are presented below: Discontinued Operations - Results of Operations The revenues and results of operations of the discontinued operations of Non-Renal Diagnostic Services and Homecare divisions were as follows: THREE MONTHS ENDED NINE MONTHS ENDED SEPTEMBER 30, SEPTEMBER 30, --------------------------- -------------------------- 1999 1998 1999 1998 ---- ---- ---- ---- NET REVENUES .................................... $ -- $ -- $ -- $ 120,940 --------- ------------ ------------ --------- Loss from operations before income tax benefit... (14,212) Income tax benefit .............................. (5,543) --------- ------------ ------------ --------- Loss from operations ............................ -- -- -- (8,669) ========= ============ ============ ========= Loss on disposal before income tax benefit ...... (140,000) Income tax benefit .............................. (42,772) --------- ------------ ------------ --------- Loss on disposal operations ..................... -- -- -- (97,228) ========= ============ ============ ========= Total loss on discontinued operations ........... $ -- $ -- $ -- (105,897) ========= ============ ============ ========= 11 12 Discontinued Operations - Consolidated Balance Sheet The net assets, excluding intercompany assets, of the discontinued operations of the Non Renal Diagnostic Services and Homecare divisions, included in the consolidated balance sheet at September 30, 1999 are as follows: TOTAL Current assets........................... $ 169,099 Properties & equipment, net.............. 222 Other assets............................. 595 ----------- Total Assets.......................... $ 169,916 =========== Current liabilities...................... 15,096 Other liabilities........................ 247 ----------- Total Liabilities..................... 15,343 =========== Net Assets............................ $ 154,573 =========== 12 13 NOTE 6. COMMITMENTS AND CONTINGENCIES Contingent Non-NMC Liabilities of Grace New York (Now Known as Fresenius Medical Care Holdings, Inc.) In connection with the Merger, Grace Chemicals has agreed to indemnify the Company and NMC against all liabilities of the Company and its successors, whether relating to events occurring before or after the Merger, other than liabilities arising from or relating to NMC operations. After the Merger the Company will remain contingently liable for certain liabilities with respect to pre-Merger matters that are not related to NMC operations. The Company believes that in view of the nature of the non-NMC liabilities and the expected impact of the Merger on Grace Chemicals' financial position, the risk of significant loss from non-NMC liabilities is remote. Were events to violate the tax-free nature of the Merger, the resulting tax liability would be the obligation of the Company. Subject to representations by Grace Chemicals, the Company, and Fresenius AG, Grace Chemicals has agreed to indemnify the Company for such a tax liability. If the Company was not able to collect on the indemnity, the tax liability would have a material adverse effect on the Company's business, the financial condition of the Company and the results of operations. LEGAL PROCEEDINGS OIG INVESTIGATION Since 1995, NMC and its subsidiaries have been the subject of criminal and civil investigations (the "OIG Investigation") by the Office of Inspector General ("OIG") of the United States Department of Health and Human Services, the United States Attorney for the District of Massachusetts (the "U.S. Attorney's Office") and other authorities concerning possible violations of federal laws, including the anti-kickback statutes and the False Claims Act. NMC has reached a preliminary agreement (the "Preliminary Agreement") with the United States Government (the "Government") to resolve the matters covered in the OIG Investigation and NMC's administrative appeals of an estimated $150 million of outstanding Medicare receivables for IDPN therapy rendered on and before December 31, 1998 (collectively, the "Settlement"). Consummation of the Settlement is subject to negotiation of certain material currently unresolved terms of the Settlement, completion and execution of definitive Settlement documents, satisfaction of certain conditions, and court approval. If the Settlement is consummated, the net Settlement payment to the Government is estimated to be approximately $415 million (the "Net Settlement Amount"). The Net Settlement Amount is the result of an estimated payment to the Government of approximately $485 million (the "Settlement Amount"), less an estimated payment by the Government to the Company of approximately $70 million for the above-mentioned IDPN receivable claims. The Company and the Government have not yet agreed upon the payment terms of the Settlement Amount. The net cash outflow resulting from the Preliminary Agreement is anticipated to be approximately $260 million. This amount reflects receipt of the IDPN accounts receivable payment from the Government and the tax effect of the special charge but does not consider any payment terms in the final Net Settlement Amount. The cash savings of the tax benefit are expected to be realized over time in relation to the cash outflows of the settlement payment obligations to the Government and expenditures for other related costs. As a result of the Preliminary Agreement, the Company has recorded a special pre-tax charge against its consolidated earnings for the three month period ended September 30, 1999 totaling $590 million ($412 million after tax). This special pre-tax charge includes the $485 million estimated payment to the Government, an $80 million reserve of the remaining IDPN receivables described above, and $25 million for other related costs. If the Settlement is not consummated and the Company and the Government eventually litigate the issues, the Company currently believes that the special charge reasonably estimates the costs and expenses arising from this litigation. If the Settlement is consummated, the Company anticipates that NMC's subsidiaries, Lifechem, Inc. ("Lifechem"), NMC Homecare, Inc. and NMC Medical Products, Inc. will plead guilty to violations of federal law. As a consequence of their guilty pleas, these subsidiaries will be excluded from further participation in federally funded health care programs, including Medicare, Medicaid and TriCare. The Company believes that these exclusions will not materially interrupt its provision of, or receipt of payment for, the products and services formerly provided by the excluded subsidiaries because the Company intends to continue to provide such products and services through other subsidiaries which are qualified to participate in federal health care programs. 13 14 The Settlement is not expected to extend to any current or former employees of NMC or its subsidiaries who have been, or may be, indicted in connection with the OIG Investigation. The Company believes that it will have sufficient cash flows from continued operations and borrowing capacity under its revolving credit facility to pay the Net Settlement Amount. The Company also believes that following such payments, it will have sufficient funds available for both its day to day operations and its anticipated growth. After giving effect to the special charge, the Company continues to be in compliance with the financial covenants in its senior credit facility. The Company believes that the final terms of the Settlement could cause the Company to be out of compliance with the financial covenants, effective at the end of the financial quarter in which a Settlement is consummated. The Company is in discussions regarding the Settlement with the agent for the lenders under its senior credit facility, and the agent has informed the lenders that it is working with the Company to prepare an amendment to certain financial covenants in the senior credit facility that will enable the Company to continue in compliance with the financial covenants upon consummation of the Settlement. For a further discussion see Part I, Item 2, "Management Discussion and Analysis of Financial Condition and Results of Operations - Liquidity and Capital Resources." No assurance can be given that the Settlement will be consummated or that the costs related to the Settlement or any litigated resolution of the OIG Investigation will not exceed the amount of the above-described pre-tax charge against earnings or that additional costs, claims and damages will not result from the Settlement. If the Settlement is not consummated, the U.S. Attorney's Office is expected to institute criminal and civil legal proceedings against, and seek substantial civil and criminal financial damages and penalties from, NMC and its subsidiaries. If the Government were successful in pursuing claims arising from the OIG Investigation, NMC and one or more of its subsidiaries would be subject to civil damages and criminal penalties, including substantial fines, suspension of payments and exclusion from the Medicare, Medicaid and TriCare programs, as well as other federally-funded health care benefit programs. Such federal programs provide over 60% of NMC's consolidated revenues. The occurrence of any of these events could have a material adverse effect on the Company's business, financial condition and results of operations. See "Management's Discussion and Analysis of Financial Condition and Results of Operations - Contingencies." In addition, as discussed below, the Company has become aware that it and one or more of its subsidiaries is the subject of qui tam or "whistleblower" actions with respect to some or all of the issues raised by the OIG Investigation, which whistleblower actions are filed under seal as a matter of law in the first instance, thereby preventing disclosure to the Company and to the public except by court order. In the process of unsealing federal whistleblower complaints, it is not unusual for courts to allow the Government to inform the Company and its counsel of a complaint prior to the time the Company may be legally permitted to disclose it to the public. NMC may be the subject of other "whistleblower" actions not known to the Company. Fresenius Medical Care and the Company have guaranteed NMC's obligations relating to or arising out of the OIG Investigation and the qui tam proceedings, and indemnified Grace Chemicals for any such liabilities. The following is a description of the OIG Investigation. In October 1995, NMC received five investigative subpoenas from the OIG in connection with the OIG Investigation. The subpoenas have resulted in extensive document production relating to various aspects of NMC's business. The Company has continued to receive additional subpoenas directed to NMC or the Company to obtain supplemental information and documents relating to the subject matter of the OIG Investigation, or to clarify the scope of the original subpoenas. The Company has cooperated with the OIG Investigation in providing supplemental information and documents. As indicated above, the Government continues, from time to time, to seek supplementing and/or clarifying information from the Company. The Company understands that the Government has utilized a grand jury to investigate these matters. The Company expects that this process will continue while the Government completes its evaluation of the documentation and issues or until the Settlement is consummated. The OIG Investigation covers the following areas: (a) NMC's dialysis services business ("Dialysis Services"), principally relating to its Medical Director contracts and compensation; (b) NMC's treatment of credit balances resulting from overpayments received under the Medicare, Medicaid, TriCare and other Government and commercial payors, NMC's billing for home dialysis services, and its payment of supplemental medical insurance premiums on behalf of indigent patients; (c) Lifechem's laboratory business, including testing procedures, marketing, customer relationships, competition, overpayments totaling approximately $4.9 million that were received by Lifechem from the Medicare program with respect to laboratory services rendered between 1989 and 1993, a 1997 review of dialysis facilities' standing orders, and the provision of discounts on products from NMC's products division, grants, equipment and entertainment to Lifechem customers; and (d) Homecare and, in particular, information concerning IDPN utilization, documentation of claims and billing practices including various services, equipment and supplies and payments made to third parties as compensation for administering IDPN therapy. 14 15 The Government has indicated that the areas identified above are not exclusive, and that it may pursue additional areas. The penalties applicable under the anti-kickback statutes, the False Claims Act and other federal and state statutes and regulations applicable to NMC's business could be substantial. While NMC asserts that it is able to offer legal and/or factual defenses with respect to many of the claims the Government has identified, it is expected that the Government will assert that NMC has violated multiple statutory and regulatory provisions. Also, as discussed below, qui tam actions alleging that NMC submitted false claims to the Government have been filed under seal by former or current NMC employees or other individuals who may have familiarity with one or more of the issues under investigation. As noted, under the False Claims Act, any such private plaintiff could pursue an action against NMC in the name of the U.S. at his or her own expense if the Government declines to do so. Under the terms of the Merger, any potential resulting monetary liability has been retained by NMC, and the Company has indemnified Grace Chemicals against all potential liability arising from or relating to the OIG Investigation. The Company has provided the U.S. Government with a guarantee of payment of the obligations, if any, arising from the OIG Investigation. In support of this guarantee, the Company has delivered to the U.S. Government a standby letter of credit in the amount of $150 million. MEDICAL DIRECTOR COMPENSATION The Government is investigating whether Dialysis Services' compensation arrangements with its Medical Directors constitute payments to induce referrals, which would be illegal under the anti-kickback statutes, rather than payment for services rendered. Dialysis Services compensated the substantial majority of its Medical Directors on the basis of a percentage of the earnings of the dialysis center for which the Medical Director was responsible from the inception of NMC's predecessor in 1972 until January 1, 1995, the effective date of Stark II. Under the arrangements in effect prior to January 1, 1995, the compensation paid to Medical Directors was adjusted to include "add backs," which represented a portion of the profit earned by the Company on products purchased by the Medical Director's facility from NMC Medical Products, Inc. and (until January 1, 1992) a portion of the profit earned by Lifechem on laboratory services provided to patients at the Medical Director's facility. These adjustments were designed to allocate a profit factor to each dialysis center relating to the profits that could have been realized by the center if it had provided the items and services directly rather than through a subsidiary of NMC. The percentage of profits paid to any specific Medical Director was reached through negotiation, and was typically a provision of a multi-year consulting agreement. Under Stark II, if Designated Health Services are involved, Medical Director compensation must not exceed fair market value and may not take into account the volume or value of referrals or other business generated between the parties. Since January 1, 1995, Dialysis Services has compensated its Medical Directors on a fixed compensation arrangement intended to comply with the requirements of Stark II. In renegotiating its Medical Director compensation arrangements in connection with Stark II, Dialysis Services took and continues to take account of the compensation levels paid to its Medical Directors in prior years. Certain Government representatives have expressed the view in meetings with counsel for NMC that arrangements where the Medical Director was or is paid amounts in excess of the "fair market value" of the services rendered may evidence illegal payments to induce referrals, and that hourly compensation is a relevant measure for evaluating the "fair market value" of the services. The Company's dialysis services division ("DSD" or Dialysis Services") does not compensate its Medical Directors on an hourly basis and has asserted to the Government that hourly compensation is not a determinative measure of fair market value. Although the Company believes that the compensation paid to its Medical Directors is generally reflective of fair market value, there can be no assurances that the Government will agree with this position or that the Company ultimately will be able to defend its position successfully. Because of the wide variation in local market factors and in the profit percentage contractually negotiated between Dialysis Services and its Medical Directors prior to January 1, 1995, there is a wide variation in the amounts that have been paid to Medical Directors. As a result, the compensation that Dialysis Services has paid and is continuing to pay to a material number of its Medical Directors could be viewed by the Government as being in excess of "fair market value," both in absolute terms and in terms of hourly compensation. NMC has asserted to the Government that NMC's compensation arrangements do not constitute illegal payments to induce referrals. NMC has also asserted to the Government that OIG auditors repeatedly reviewed Dialysis Services' compensation arrangements with NMC's Medical Directors in connection with their audits of the costs claimed by Dialysis Services; that the OIG stated in its audit reports that, with the exception of certain technical issues, Dialysis Services had complied with applicable Medicare laws and regulations pertaining to the ESRD program; and that Dialysis Services reasonably relied on these audit reports in concluding that its program for compensating Medical Directors was lawful. There has been no indication that the Government will 15 16 accept NMC's assertions concerning the legality of its arrangements generally or NMC's assertion that it reasonably relied on OIG audits, or that the Government will not focus on specific arrangements that DSD has made with one or more Medical Directors and assert that those specific arrangements were or are unlawful. The Government is also investigating whether Dialysis Services' profit sharing arrangements with its Medical Directors influenced the Medical Directors to order unnecessary ancillary services and items. NMC has asserted to the Government that the rate of utilization of ancillary services and items by its Medical Directors is reasonable and that it did not provide illegal inducements to Medical Directors to order ancillary services and items and the practice of profit-sharing has been discontinued. CREDIT BALANCES In the ordinary course of business, medical service providers like Dialysis Services receive overpayments from Medicare intermediaries and other payors for services that they provide to patients. Medicare intermediaries commonly direct such providers to notify them of the overpayment and not remit such amounts to the intermediary by check or otherwise unless specifically requested to do so. In 1992, HCFA adopted a regulation requiring certain Medicare providers, including dialysis centers, to file a quarterly form listing unrecouped overpayments with the Medicare intermediary responsible for reimbursing the provider. The first such filing was required to be made as of June 30, 1992 for the period beginning with the initial date that the provider participated in the Medicare program and ending on June 30, 1992. The Government is investigating whether DSD intentionally understated the Medicare credit balance reflected on its books and records for the period ended June 30, 1992 by reversing entries out of its credit balance account and taking overpayments into income in anticipation of the institution of the new filing requirement. Dialysis Services policy was to notify Medicare intermediaries in writing of overpayments upon receipt and to maintain unrecouped Medicare overpayments as credit balances on the books and records of Dialysis Services for four years; overpayments not recouped by Medicare within four years would be reversed from the credit balance account and would be available to be taken into income. NMC asserts that Medicare overpayments that have not been recouped by Medicare within four years are not subject to recovery under applicable regulations. Accordingly, NMC's initial filing with the intermediaries disclosed the credit balance on the books and records of Dialysis Services as shown in accordance with its policy. There can be no assurance that the Government will accept NMC's position. The Government has inquired whether other divisions including Homecare, Lifechem, renal diagnostics services and non-renal diagnostic services have appropriately treated Medicare credit balances as well as credit balances of other payors. The Government is also investigating whether Dialysis Services failed to disclose Medicare overpayments that resulted from Dialysis Services' obligation to rebill commercial payors for amounts originally billed to Medicare under HCFA's initial implementation of the OBRA 93 amendments to the secondary payor provisions of the Medicare Act. Dialysis Services experienced delays in reporting a material amount of overpayments after the implementation of the OBRA 93 amendments. NMC asserts that most of these delays were the result of the substantial administrative burdens placed on Dialysis Services as a consequence of the changing and inconsistent instructions issued by HCFA with respect to the OBRA 93 amendments and were not intentional. Substantially all overpayments resulting from the rebilling effort associated with the OBRA 93 amendments have now been reported. Procedures are in place that are designed to ensure that subsequent overpayments resulting from the OBRA 93 amendments will be reported on a timely basis. SUPPLEMENTAL MEDICAL INSURANCE The Government has indicated that it is investigating the method by which NMC made Medigap payments on behalf of its indigent patients. The impact, if any, of this investigation on the Company, cannot be predicted at this time. OVERPAYMENTS FOR HOME DIALYSIS SERVICES NMC acquired Home Intensive Care, Inc. ("HIC"), an in-center and home dialysis service provider, in 1993. At the time of the acquisition, HIC was the subject of a claim by HCFA that HIC had received payments for home dialysis services in excess of the Medicare reasonable charge for services rendered prior to February 1, 1990. NMC settled the HCFA claim against HIC in 1994. The Government is investigating whether the settlement concerning the alleged overpayments made to HIC resolved all issues relating to such alleged overpayments. The Government is also investigating whether NMC's subsidiary, Home Dialysis Services, Inc. ("HDS"), 16 17 received payments similar to the payments that HIC received, and whether HDS improperly billed for home dialysis services in excess of the monthly cost cap for services rendered on or after February 1, 1990. The Government is investigating whether NMC was overpaid for services rendered. NMC asserts that the billings by HDS were proper, but there can be no assurance that the Government will accept NMC's view. LIFECHEM Overpayments. On September 22, 1995, Lifechem voluntarily disclosed certain billing problems to the Government that had resulted in Lifechem's receipt of approximately $4.9 million in overpayments from the Medicare program for laboratory services rendered between 1989 and 1993. Lifechem asserts that most of these overpayments relate to errors caused by a change in Lifechem's computer systems and that the remainder of the overpayments were the result of the incorrect practice of billing for a complete blood count with differential when only a complete blood count was ordered and performed, and of the incorrect practice of billing for a complete blood count when only a hemoglobin or hematocrit test was ordered. Lifechem asserts that the overpayments it received were not caused by fraudulent activity, but there can be no assurance that the Government will accept Lifechem's view. Lifechem made these disclosures to the Government as part of an application to be admitted to a voluntary disclosure program begun by the Government in mid-1995. At the time of the disclosures, Lifechem tendered repayment to the Government of the $4.9 million in overpayments. After the OIG Investigation was announced, the Government indicated that Lifechem had not been accepted into its voluntary disclosure program. The Government has deposited the $4.9 million check with NMC's approval. The matters disclosed in Lifechem's September 22, 1995 voluntary disclosure are a subject of the OIG Investigation. On June 7, 1996, Lifechem voluntarily disclosed an additional billing problem to the Government that had resulted in Lifechem's receipt of between $40,000 and $160,000 in overpayments for laboratory services rendered in 1991. Lifechem advised the Government that this overpayment resulted from the submission for payment of a computer billing tape that had not been subjected to a "billing rules" program designed to eliminate requests for payments for laboratory tests that are included in the Composite Rate and that were not eligible for separate reimbursement. Lifechem also advised the Government that there may have been additional instances during the period from 1990 to 1992 when other overpayments were received as a result of the submission of computer billing tapes containing similar errors and that it was in the process of determining whether such additional overpayments were received. On June 21, 1996, Lifechem advised the Government that the 1991 billing problem disclosed on June 7, 1996 resulted in an overpayment of approximately $112,000. Lifechem also advised the Government that certain records suggested instances in July 1990 and August 31 through September 11, 1990, when billing tapes may have been processed without rules processing. Lifechem continued its effort to determine whether any other overpayments occurred relating to the "billing rules" problem and, in March 1997, advised the Government that an additional overpayment of approximately $260,000 was made by Medicare. On April 6, 1999, Lifechem voluntarily disclosed an additional billing problem to the Government that resulted in Lifechem's receipt of overpayments for laboratory services rendered between 1994 and 1999. In 1994, as a result of the advice of a billing consultant, Lifechem began to bill for platelet testing performed in connection with complete blood counts. This advice was confirmed by the consultant in 1997 as part of a review performed by the consultant under the auspices of Lifechem's then outside counsel. In 1999, however, an internal inquiry resulted in a reexamination of this advice and Lifechem determined that the prior advice was incorrect. As a result, Lifechem voluntarily disclosed the overpayment and repaid to the Government the amount of $8.6 million. Capitation for routine tests and panel design. In October 1994, the OIG issued a special fraud alert in which it stated its view that the industry practice of offering to perform or performing the routine tests covered by the Composite Rate at a price below fair market value, coupled with an agreement by a dialysis center to refer all or most of its non-Composite Rate tests to the laboratory, violates the anti-kickback statutes. In response to this alert, Lifechem changed its practices with respect to testing covered by the Composite Rate to increase the amount charged to both Dialysis Services and third-party dialysis centers and reduce the number of tests provided for the fixed rate. The Government is investigating Lifechem's practices with respect to these tests. Benefits provided to dialysis centers and persons associated with dialysis centers. The Government is investigating whether Dialysis Services or any third-party dialysis center or any person associated with any such center was provided with benefits in order to induce them to use Lifechem services. Such benefits could include, for example, discounts on products or supplies, the provision of computer equipment, the provision of money for the purchase of computer equipment, the provision of research grants and the provision of entertainment to customers. NMC has identified certain instances in which benefits were provided to customers who 17 18 purchased medical products from NMC Medical Products, Inc., NMC's products company, and used Lifechem's laboratory services. The Government claims that the provision of such benefits violates, among other things, the anti-kickback statutes. In December 1998, the former Vice President of Sales responsible for NMC's laboratory and products divisions pled guilty to the payment of illegal kickbacks to obtain laboratory business for Lifechem. In February 1999, the former President of NMC Medical Products, Inc., was indicted by the Government for the payment of these same and/or similar kickbacks. Business and testing practices. As noted above, the Government has identified a number of specific categories of documents that it is requiring NMC to produce in connection with Lifechem business and testing practices. In addition to documents relating to the areas discussed above, the Government has also required Lifechem to produce documents relating to the equipment and systems used by Lifechem in performing and billing for clinical laboratory blood tests, the design of the test panels offered and requisition forms used by Lifechem, the utilization rate for certain tests performed by Lifechem, recommendations concerning diagnostic codes to be used in ordering tests for patients with given illnesses or conditions, internal and external audits and investigations relating to Lifechem's billing and testing. Subsequently, the Government served an investigative subpoena for documents concerning the Company's 1997 review of dialysis facilities' standing orders, and responsive documents were provided. The Government has served investigative subpoenas requiring NMC to update its production on the above issues and to produce contract files for twenty-three identified dialysis clinic customers. The Government is investigating each of these areas, and asserts that Lifechem and/or NMC have violated the False Claims Act and/or the anti-kickback statutes through the test ordering, paneling, requisitioning, utilization, coding, billing and auditing practices described above. In June 1999, a former Vice President of Marketing of NMC Medical Products, Inc. pled guilty to a charge of conspiracy to defraud Medicare in connection with the marketing of certain hepatitis tests. In August 1999, the former President and the then Director of Marketing of Lifechem were indicted by the Government for defrauding Medicare in connection with marketing the same hepatitis and laboratory tests. IDPN Administration kits. One of the activities of Spectra Renal Management ("SRM") is to provide IDPN therapy to dialysis patients at both NMC-owned facilities and at facilities owned by other providers. IDPN therapy was provided by Homecare prior to its divestiture. IDPN therapy is typically provided to the patient 12-13 times per month during dialysis treatment. Bills are submitted to Medicare on a monthly basis and include separate claims for reimbursement for supplies, including, among other things, nutritional solutions, administration kits and infusion pumps. In February 1991, the Medicare carrier responsible for processing Homecare's IDPN claims issued a Medicare advisory to all parenteral and enteral nutrition suppliers announcing a coding change for reimbursement of administration kits provided in connection with IDPN therapy for claims filed for items provided on or after April 1, 1991. The Medicare allowance for administration kits during this period was approximately $625 per month per patient. The advisory stated that IDPN providers were to indicate the "total number of actual days" when administration kits were "used," instead of indicating that a one-month supply of administration kits had been provided. In response, Homecare billed for administration kits on the basis of the number of days that the patient was on an IDPN treatment program during the billing period, which typically represented the entire month, as opposed to the number of days the treatment was actually administered. During the period from April 1991 to June 1992, Homecare had an average of approximately 1,200 IDPN patients on service. In May 1992, the carrier issued another Medicare advisory to all PEN suppliers in which it stated that it had come to the carrier's attention that some IDPN suppliers had not been prorating their billing for administration kits used by IDPN patients and that providers should not bill for administration kits on the basis of the number of days that the patient was on an IDPN treatment program during the billing period. The advisory stated further that the carrier would be conducting "a special study to determine whether or not overpayments have occurred as a result of incorrect billing" and that "if overpayments have resulted, providers that have incorrectly billed" would "be contacted so that refunds can be recovered." Homecare revised its billing practices in response to this advisory for claims filed for items provided on or after July 1, 1992. Homecare was not asked to refund any amounts relating to its billings for administration kits following the issuance of the second advisory. The Government asserts that NMC submitted false claims for administration kits during the period from 1988 to June 30, 1996, and that Homecare's billing for administration kits during this period violated, among other things, the False Claims Act. Infusion Pumps and IV Poles. During the time period covered by the subpoenas, Medicare regulations permitted IDPN providers to bill Medicare for infusion pumps and, until 1992, for IV poles provided to IDPN patients in connection with the administration of IDPN treatments. These regulations do not expressly specify that a particular pump and IV pole be dedicated to a specific patient, and NMC asserts that these regulations permitted Homecare to bill Medicare for an infusion pump and IV pole so 18 19 long as the patient was infused using a pump and IV pole. Despite the absence of an express regulatory specification, Homecare developed a policy to deliver to a dialysis center a dedicated infusion pump and IV pole for each patient, although the Company cannot represent that Homecare followed this policy in every instance. The Government is investigating the propriety of Homecare's billings for infusion pumps and IV poles and asserts that Homecare's billings violate the False Claims Act. As noted above, under the new policies published by HCFA with respect to IDPN therapy, the Company was not able to bill for infusion pumps after July 1, 1996. The Government discontinued reimbursement for IV poles in 1992. "Hang fees" and other payments. IDPN therapy is typically provided to the patient during dialysis by personnel employed by the dialysis center treating the patient with supplies provided and billed to Medicare by Homecare in accordance with the Medicare parenteral nutrition supplier rules. In order to compensate dialysis centers for the costs incurred in administering IDPN therapy and monitoring the patient during therapy, Homecare followed the practice common in the industry of paying a "hang fee" to the center. Dialysis centers are responsible for reporting such fees to HCFA on their cost reports. For Dialysis Services dialysis centers, the fee was $30 per administration, based upon internal Dialysis Services cost calculations. For third-party dialysis centers, the fee was negotiated with each center, typically pursuant to a written contract, and ranged from $15 to $65 per administration. The Company has identified instances in which other payments and amounts beyond that reflected in a contract were paid to these third-party centers. The Company has stopped paying "hang fees" to both Dialysis Services and third-party facilities. In July 1993, the OIG issued a management advisory alert to HCFA in which it stated that "hang fees" and other payments made by suppliers of IDPN to dialysis centers "appear to be illegal as well as unreasonably high." The Government is investigating the nature and extent of the "hang fees" and other payments made by Homecare as well as payments by Homecare to physicians whose patients have received IDPN therapy. The Government asserts that the payments by Homecare to dialysis centers violate, among other things, the anti-kickback statutes. Utilization of IDPN. Since 1984, when HCFA determined that Medicare should cover IDPN and other parenteral nutrition therapies, the Company has been an industry leader in identifying situations in which IDPN therapy is beneficial to ESRD patients. It is the policy of the Company to seek Medicare reimbursement for IDPN therapy only when it is prescribed by a patient's treating physician and when it believes that the circumstances satisfy the requirements published by HCFA and its carrier agents. Prior to 1994, HCFA and its carriers approved for payment more than 90% of the IDPN claims submitted by Homecare. After 1993, the rate of approval for Medicare reimbursement for IDPN claims submitted by Homecare for new patients, and by the infusion industry in general, fell to approximately 9%. The Company contends that the reduction in rates of approval occurred because HCFA and its carriers implemented an unauthorized change in coverage policy without giving notice to providers. While NMC continued to offer IDPN to patients pursuant to the prescription of the patients' treating physicians and to submit claims for Medicare reimbursement when it believed the requirements stated in HCFA's published regulations were satisfied, other providers responded to the drop in the approval rate for new Medicare IDPN patients by abandoning the Medicare IDPN business, cutting back on the number of Medicare patients to whom they provide IDPN, or declining to add new Medicare patients. Beginning in 1994 the number of patients to whom NMC provided IDPN increased as a result. The Government is investigating the utilization rate of IDPN therapy among NMC patients, whether NMC submitted IDPN claims to Medicare for patients who were not eligible for coverage, and whether documentation of eligibility was adequate. NMC asserts that the utilization rate of IDPN therapy among its dialysis patients, which, in 1995, averaged less than 3.5%, is the result of the factors discussed above and that it is the policy of Homecare to seek Medicare reimbursement for IDPN therapy prescribed by the patient's treating physician in accordance with the requirements published by HCFA and its carrier agents. There can be no assurance that the Government will accept the NMC's view. The Government asserts that Homecare submitted IDPN claims for individuals who were not eligible for coverage and/or with inadequate documentation of eligibility. The Company believes that it has presented to the Government substantial defenses which support NMC's interpretation of coverage rules of IDPN as HCFA and its carriers published and explained them, and which demonstrated that HCFA and its carriers improperly implemented unpublished, more restrictive criteria after 1993. Nevertheless, the Government is expected to assert in the OIG Investigation that, on a widespread basis, NMC submitted and received payments on claims for IDPN to Medicare for patients who were not eligible for coverage, and for whom the documentation of eligibility was inadequate. 19 20 In addition, the Government asserts that, in a substantial number of cases, documentation of eligibility was false or inaccurate. With respect to some claims, the Company has determined that false or inaccurate documentation was submitted, deliberately or otherwise. The Government continues to investigate the IDPN claims. As indicated above, if the Settlement is consummated, the Company anticipates receiving an estimated $70 million payment to the Company from the Government that is reflected in the Net Settlement Amount in exchange for a release of the Company's IDPN receivable claims against the Government for IDPN therapy administered on or before December 31, 1998. The Company continues to pursue appeals of certain denied claims for IDPN therapy rendered after December 31, 1998 which the Company anticipates will clarify the coverage criteria for IDPN therapy on a prospective basis. QUI TAM ACTIONS The Company is aware that it and/or certain of its subsidiaries are the subject of qui tam or "whistleblower" actions with respect to some or all of the issues raised by the OIG Investigation, which whistleblower actions are filed under seal as a matter of law in the first instance, thereby preventing disclosure to the Company and to the public except by court order. The Company and/or certain of its subsidiaries may be the subject of other "whistleblower" actions not yet known to the Company. Each of these actions is under seal and in each action, pursuant to court order the seal has been modified to permit the Company, NMC and other affiliated defendants to disclose the complaint to any relevant investors, financial institutions and/or underwriters, their successors and assigns and their respective counsel and to disclose the allegations in the complaints in their respective reports filed with the U.S. Securities and Exchange Commission (the "SEC" or the "Commission"). A qui tam action was filed in the United States District Court for the Southern District of Florida in June 1994, amended on July 8, 1996 and disclosed to the Company on July 10, 1996. It alleges, among other things, that Grace Chemicals and NMC violated the False Claims Act in connection with certain billing practices regarding IDPN and the administration of EPO and that as a result of this allegedly wrongful conduct, the United States suffered actual damages in excess of $200 million. A qui tam action was filed in the United States District Court for the Southern District of Florida in December 1994 and disclosed to the Company on April 16, 1999. It alleges, among other things, that NMC violated the False Claims Act in connection with certain billing practices regarding IDPN and the cost relating thereto. The second qui tam was filed by the same relator which filed the first qui tam and covers the same services covered by the first qui tam complaint. A qui tam action was filed in the United States District Court for the Middle District of Florida in 1995 and disclosed to the Company on or before November 7, 1996. It alleges, among other things, that NMC and certain NMC subsidiaries violated the False Claims Act in connection with the alleged retention of over-payments made under the Medicare program, the alleged submission of claims in violation of applicable cost caps and the payment of supplemental Medicare insurance premiums as an alleged inducement to patients to obtain dialysis products and services from NMC. The complaint alleges that as a result of this allegedly wrongful conduct, the United States suffered damages in excess of $10 million, including applicable fines. A qui tam action was filed in the United States District Court for the District of Massachusetts in 1994 and was disclosed to the Company in February 1999. It alleges among other things that NMC violated the False Claims Act and the anti-kickback statutes in connection with certain billing and documentation practices regarding IDPN therapy, home oxygen therapy and certain medical billings in NMC's Chicago office. A qui tam action was filed in the United States District Court for the Middle District of Tennessee on December 15, 1994, transferred to the United States District Court for the District of Massachusetts in 1995, and subsequently was disclosed to the Company in September 1999. It alleges, among other things, that Lifechem violated the False Claims Act in connection with the submission of claims for laboratory tests which already had been billed by the Company, and that Lifechem manipulated its chemistry panels to increase its Medicare and Medicaid billings. The Complaint alleges that as a result of this illegal action, the United States suffered damages in excess of $25,000,000. Sometime after 1996, the Complaint was amended to add Spectra Laboratories, Inc., the Company and FMC as defendants, and added the allegation that the defendants violated the Medicare and Medicaid Anti-Kickback Statute by providing discounted hemodialysis products to induce the purchase of laboratory services. Each of the qui tam complaints asserts that as a result of the allegedly wrongful conduct, the Government suffered damages and 20 21 that the defendants are liable to the Government for three times the amount of the alleged damages plus civil penalties of up to $10,000 per false claim. An adverse result in any of the qui tam actions could have a material adverse effect on the Company's business, financial condition or results of operations. OIG AGREEMENTS As a result of discussions with representatives of the United States in connection with the OIG Investigation, certain agreements (the "OIG Agreements") have been entered into to guarantee the payment of any obligations of NMC to the United States (an "Obligation") relating to or arising out of the OIG Investigation and the qui tam action filed in the Southern District of Florida (the "Government Claims"). For the purposes of the OIG Agreements, an Obligation is (a) a liability or obligation of NMC to the United States in respect of a Government Claim pursuant to a court order (i) which is final and nonappealable or (ii) the enforcement of which has not been stayed pending appeal or (b) a liability or obligation agreed to be an Obligation in a settlement agreement executed by Fresenius Medical Care, the Company or NMC, on the one hand, and the United States, on the other hand. As stated elsewhere herein if the Settlement is not consummated, the outcome of the OIG Investigation cannot be predicted. Pursuant to the OIG Agreements, upon consummation of the Merger, Fresenius Medical Care, the Company and NMC provided the United States with a joint and several unconditional guarantee of payment when due of all Obligations (the "Primary Guarantee"). As credit support for the Primary Guarantee, NMC delivered an irrevocable standby letter of credit in the amount of $150 million. The United States will return such letter of credit (or any renewal or replacement) for cancellation when all Obligations have been paid in full or it is determined that NMC has no liability in respect of the Government Claims. Under the terms of the Merger, any potential resulting monetary liability has been retained by NMC, and the Company has indemnified Grace Chemicals against all potential liability arising from or relating to the OIG Investigation. FMC and the Company and the United States state in the OIG Agreements that they will negotiate in good faith to attempt to arrive at a consensual resolution of the Government Claims and, in the context of such negotiations, will negotiate in good faith as to the need for any restructuring of the payment of any Obligations arising under such resolution, taking into account the ability of FMC and the Company to pay the Obligations. The OIG Agreements state that the foregoing statements shall not be construed to obligate any person to enter into any settlement of the Government Claims or to agree to a structured settlement. Moreover, the OIG Agreements state that the statements described in the first sentence of this paragraph are precatory and statements of intent only and that (a) compliance by the United States with such provisions is not a condition of or defense to the obligations of FMC and the Company under the OIG Agreements and (b) breach of such provisions by the Government cannot and will not be raised by FMC and the Company to excuse performance under the OIG Agreements. Neither the entering into of the OIG Agreements nor the providing of the Primary Guarantee and the $150 million letter of credit is an admission of liability by any party with respect to the OIG Investigation, nor does it indicate the liability which may result therefrom. The foregoing describes the material terms of the OIG Agreements, copies of which were previously filed with the Commission and copies of which may be examined without charge at the public reference facilities maintained by the Commission at Room 1024, 450 Fifth Street, N.W., Washington, D.C. 20549, and at the Regional Offices of the Commission located at Suite 1400, Citicorp Center, 500 West Madison Street, Chicago, Illinois 60661-2551 and Room 1300, 7 World Trade Center, New York, New York 10048. Copies of such material will also be made available by mail from the Public Reference Branch of the Commission at 450 Fifth Street, N.W., Washington, D.C. 20549, at prescribed rates. The foregoing description does not purport to be complete and is qualified in its entirety by reference to such agreements. An adverse determination with respect to any of the issues addressed by the subpoenas, or any of the other issues that have been or may be identified by the Government, could result in the payment of substantial fines, penalties and forfeitures, the suspension of payments or exclusion of the Company or one or more of its subsidiaries from the Medicare program and other federal programs, and changes in billing and other practices that could adversely affect the Company's revenues. Any such result could have a material adverse effect on the Company's business, financial condition and results of operations. OMNIBUS BUDGET RECONCILIATION ACT OF 1993 OBRA 93 affected the payment of benefits under Medicare and employer health plans for certain eligible ESRD patients. In July 21 22 1994, HCFA issued an instruction to Medicare claims processors to the effect that Medicare benefits for the patients affected by OBRA 93 would be subject to a new 18-month "coordination of benefits" period. This instruction had a positive impact on NMC's dialysis revenues because, during the 18-month coordination of benefits period, patients' employer health plans were responsible for payment, which was generally at rates higher than that provided under Medicare. In April 1995, HCFA issued a new instruction, reversing its original instruction in a manner that would substantially diminish the positive effect of the original instruction on NMC's dialysis business. HCFA further proposed that its new instruction be effective retroactive to August 1993, the effective date of OBRA 93. NMC ceased to recognize the incremental revenue realized under the original Program Memorandum as of July 1, 1995, but it continued to bill employer health plans as primary payors for patients affected by OBRA 93 through December 31, 1995. As of January 1, 1996, NMC commenced billing Medicare as primary payor for dual eligible ESRD patients affected by OBRA 93, and then began to rebill in compliance with the revised policy for services rendered between April 24 and December 31, 1995. On May 5, 1995, NMC filed a complaint in the U.S. District Court for the District of Columbia (National Medical Care, Inc. and Bio-Medical Applications of Colorado, Inc. d/b/a Northern Colorado Kidney Center v. Shalala, C.A. No. 95-0860 (WBB)) seeking to preclude HCFA from retroactively enforcing its April 24, 1995 implementation of the OBRA 93 provisions relating to the coordination of benefits for dual eligible ESRD patients. On May 9, 1995, NMC moved for a preliminary injunction to preclude HCFA from enforcing its new policy retroactively, that is, to billings for services provided between August 10, 1993 and April 23, 1995. On June 6, 1995, the court granted NMC's request for a preliminary injunction and in December of 1996, NMC moved for partial summary judgment seeking a declaration from the Court that HCFA's retroactive application of the April 1995 rule was legally invalid. HCFA cross-moved for summary judgment on the grounds that the April 1995 rule was validly applied prospectively. In January 1998, the court granted NMC's motion for partial summary judgment and entered a declaratory judgment in favor of NMC, holding HCFA's retroactive application of the April 1995 rule legally invalid, and based on its finding, the Court also permanently enjoined HCFA from enforcing and applying the April 1995 rule retroactively against NMC. The Court took no action on HCFA's motion for summary judgment pending completion of outstanding discovery. On October 5, 1998 NMC filed it's own motion for summary judgment requesting that the Court declare HCFA's prospective application of the April 1995 rule invalid and permanently enjoin HCFA from prospectively enforcing and applying the April 1995 rule. The Court has not yet ruled on the parties' motions. HCFA elected not to appeal from the Court's June 1995 and January 1998 orders. HCFA may, however, appeal all rulings at the conclusion of the litigation. If HCFA should successfully appeal so that the revised interpretation would be applied retroactively, Dialysis Services may be required to refund the payments received from employer health plans for services provided after August 10, 1993 under HCFA's original implementation, and to re-bill Medicare for the same services, which would result in a net loss to Dialysis Services of approximately $120 million attributable to all periods prior to December 31, 1995. Also, in such event, the Company's business, financial position and results of operations would be materially adversely affected. The Settlement would not affect these proceedings. INTRADIALYTIC PARENTERAL NUTRITION COVERAGE ISSUES SRM administers IDPN therapy to chronic dialysis patients who suffer from severe gastrointestinal malfunctions. IDPN therapy was provided by Homecare prior to its divestiture. After 1993, Medicare claims processors sharply reduced the number of IDPN claims approved for payment as compared to prior periods. NMC believes that the reduction in IDPN claims represented an unauthorized policy coverage change. Accordingly, NMC and other IDPN providers pursued various administrative and legal remedies, including administrative appeals, to address this reduction. In November 1995, NMC filed a complaint in the U.S. District Court for the Middle District of Pennsylvania seeking a declaratory judgment and injunctive relief to prevent the implementation of this policy coverage change. (National Medical Care, Inc. v. Shalala, 3:CV-95-1922 (RPC)). Subsequently, the District Court affirmed a prior report of the magistrate judge dismissing NMC's complaint, without considering any substantive claims, on the grounds that the underlying cause of action should be submitted fully to the administrative review processes available under the Medicare Act. NMC decided not to appeal the Court's decision, but rather, to pursue the claims through the available administrative processes. NMC was successful in pursuing these claims through the administrative process, receiving favorable decisions from Administrative Law Judges in more than 80% of its cases. In early 1998, a group of claims which had been ruled on favorably were 22 23 remanded by the Medicare Appeals Council to a single Administrative Law Judge (the "ALJ") with extensive instructions concerning the review of these decisions. A hearing was scheduled on the remanded claims to take place in July, but later postponed until October 1998. Prior to the July hearing date, the U.S. Attorney's Office requested that the hearing be stayed pending resolution of the OIG Investigation, on the basis that proceeding could adversely effect the Government's investigation as well as the Government's efforts to confirm its belief that these claims are false. Prior to the ALJ issuing a decision on the stay request, the U.S. Attorney's Office requested that NMC agree to a stay in the proceedings in order to achieve a potential resolution of the IDPN claims subject to the OIG Investigation as well as those which are subject to the administrative appeals process. NMC agreed to this request, and together with the U.S. Attorney's Office requested a stay. The ALJ agreed to this request in order to allow the parties the opportunity to resolve both the IDPN claims which are the subject of the OIG Investigation and the IDPN claims which are the subject of the administrative proceedings. In March 1999 negotiations between NMC and the U.S. Attorney's Office failed to progress and NMC requested that the stay be lifted. In connection with the settlement discussions described above (which, if consummated, would resolve all pending IDPN coverage appeals for services rendered prior to 1999), the Government renewed its motion to stay proceedings before the ALJ. The Company opposed the stay. On November 10, 1999, the ALJ agreed to reschedule certain hearings that had been scheduled for the week of November 29, 1999, but denied the motion for a stay and scheduled further hearings to begin January 10, 2000. It is not possible to determine whether, if the Settlement is not consummated, NMC and the Government will be able to resolve issues surrounding the IDPN claims. Further proceedings on other administrative appeals related to unpaid claims remain stayed. Although NMC management believes that those unpaid IDPN claims were consistent with published Medicare coverage guidelines, if the settlement is not consummated and the Company resumes its appeals of the IDPN claims there can be no assurance that the claims on appeal will be approved for payment or, to the extent approved, collected in full. Such claims represent substantial accounts receivable of NMC, amounting to approximately $150 million as of September 30, 1999. If NMC is unable to collect its IDPN receivable, either through the administrative appeal process or through negotiation, or if IDPN coverage is reduced or eliminated, depending on the amount of the receivable that is not collected and/or the nature of the coverage change, the Company's business, financial condition and results of operations could be materially adversely affected. NMC's IDPN receivables are included in the net assets of the Company's discontinued operations. However, these receivables have not been sold and will remain classified as discontinued operations until they have been settled. See Note 5 -"Discontinued Operations." OTHER LEGAL PROCEEDINGS DISTRICT OF NEW JERSEY INVESTIGATION NMC had received multiple subpoenas from a federal grand jury in the District of New Jersey investigating, among other things, whether NMC sold defective products, the manner in which NMC handled customer complaints and certain matters relating to the development of a new dialyzer product line. NMC cooperated with this investigation and provided the grand jury with extensive documents. In February, 1996, NMC received a letter from the U.S. Attorney's Office for the District of New Jersey indicating that it was the target of a federal grand jury investigation into possible violations of criminal law in connection with its efforts to persuade the FDA to lift a January 1991 import hold issued with respect to NMC's Dublin, Ireland manufacturing facility. In June 1996, NMC received a letter from the U.S. Attorney for the District of New Jersey indicating that the U.S. Attorney had declined to prosecute NMC with respect to a submission related to NMC's effort to lift the import hold. The letter added that NMC remains a subject of a federal grand jury's investigation into other matters. NMC also produced documents in response to a June 1996 subpoena from the federal grand jury requesting certain documents in connection with NMC's imports of the FOCUS(R) dialyzer from January 1991 to November 1995. In November 1999, NMC's subsidiary, NMC Medical Products, Inc. ("NMC Medical Products") and the U.S. Attorney's Office for the District of New Jersey executed a plea agreement (the "New Jersey Agreement") pursuant to which NMC Medical Products will plead guilty to two misdemeanor violations of the Federal Food, Drug and Cosmetic Act, pay the United States Government $3.8 million and be released, together with NMC and its related entities and their present officers, directors and employees, from any further civil or criminal liability with respect to all matters investigated by the U.S. Attorney's Office for the District of New Jersey, including the matters described above, or arising out of Food and Drug Administration inspections of NMC Medical Products' facilities prior to October 20, 1995. The terms of the New Jersey Agreement are subject to court approval. The 23 24 $3.8 million to be paid pursuant to the Plea Agreement does not constitute part of the Net Settlement Amount. COMMERCIAL INSURER LITIGATION In 1997, the Company, NMC, and certain named NMC subsidiaries, were served with a civil complaint filed by Aetna Life Insurance Company in the U.S. District Court for the Southern District of New York (Aetna Life Insurance Company v. National Medical Care, Inc. et al, 97-Civ-9310). In April 1999, Aetna amended its complaint to include its affiliate, Aetna U.S. Healthcare, Inc., as an additional plaintiff, and to make certain other limited changes in its pleading. Based in large part on information contained in prior securities filings, the lawsuit alleges inappropriate billing practices for nutritional therapy, diagnostic and clinical laboratory tests and misrepresentations. The amended complaint seeks unspecified damages and costs. This matter is at a relatively early stage in the litigation process, with substantial discovery just beginning, and its outcome and impact on the Company cannot be predicted at this time. However, the Company, NMC and its subsidiaries believe that they have substantial defenses to the claims asserted, and intend to continue to vigorously defend the lawsuit. Other private payors have contacted the Company and may assert that NMC received excess payments and similarly, may join the lawsuit or file their own lawsuits seeking reimbursement and other damages from NMC. An adverse result could have a material adverse effect on the Company's business, financial condition or results of operations. In May 1999, the Company filed counterclaims against Aetna Life Insurance Company and Aetna U.S. Healthcare, Inc. based on inappropriate claim denials and delays in claim payments. The Company is also investigating similar counterclaims against other private payors that have contacted the Company. The Settlement would not resolve these proceedings and claims. ADMINISTRATIVE APPEALS The Company regularly pursues various administrative appeals relating to reimbursement issues in connection with its dialysis facilities. One such appeal consists of a challenge to the Medicare regulation which capped reimbursement for the bad debts incurred by dialysis facilities. In 1998, the United States Court of Appeals for the District of Columbia ruled in favor of the Company in connection with the bad debt issue, holding that the Secretary of Health & Human Services had not adequately justified the bad debt regulation, and ruling that the Government's order adopting the rule was arbitrary and capricious. The Court of Appeals remanded the matter to the Secretary to provide a more adequate explanation of the bad debt cap or to abandon it. Subsequently, the Court modified its holding to continue the bad debt regulation in effect pending remand. Accordingly, the Company has revised its estimate of recoveries for the previously disallowed bad debt expense associated with the regulation. The Company has reached a preliminary agreement with the Department of Health and Human Services with respect to certain material terms to resolve this matter which, if approved by the Department of Justice, will require payment to the Company of approximately $20 million. STATE OF FLORIDA In October 1999, NMC received an Antitrust Civil Investigative Demand ("CID") from the Attorney General of the State of Florida ("Florida AG"). The CID was issued by the Florida AG in the course of an investigation to determine whether there is, has been, or may be a violation of federal and Florida laws resulting from the possible monopolization of, or the entering into agreements in restraint of, trade relating to the provision of dialysis products and services in Florida. The Company is cooperating with the Florida AG's investigation by providing documents and other information to the Florida AG. The impact of this investigation on the Company, if any, cannot be determined at this time. 24 25 NOTE 7. INDUSTRY SEGMENTS INFORMATION The Company adopted SFAS No. 131, Disclosure about Segments of an Enterprise and Related Information during the fourth quarter of 1998. SFAS No. 131 established the standards for reporting information about operating statements in annual financial statements and requires selected information about operating segments in interim financial reports issued to stockholders. The Company's reportable segments are Dialysis Services and Dialysis Products. For purposes of segment reporting, the Dialysis Services Division and Spectra Renal Management are combined and reported as Dialysis Services. These divisions are aggregated because of their similar economic classifications. These include the fact that they are both health care service providers whose services are provided to a common patient population, and both receive a significant portion of their net revenue from Medicare and other government and non-government third party payors. The Dialysis Products segment reflects the activity of the Dialysis Products Division only. The table below provides information for the three and nine months ended September 30, 1999 and 1998 pertaining to the Company's two industry segments. LESS DIALYSIS DIALYSIS INTERSEGMENT SERVICES PRODUCTS SALES TOTAL -------- -------- ------------ ----- NET REVENUES Three Months Ended 9/30/99 $ 590,778 $ 180,176 $ 59,104 $ 711,850 Three Months Ended 9/30/98 544,318 164,977 53,643 655,652 Nine Months Ended 9/30/99 $1,724,749 $ 526,017 $ 168,310 $2,082,456 Nine Months Ended 9/30/98 1,563,266 493,876 153,162 1,903,980 OPERATING EARNINGS Three Months Ended 9/30/99 $ 100,684 $ 31,176 -- $ 131,860 Three Months Ended 9/30/98 88,284 28,960 -- 117,244 Nine Months Ended 9/30/99 $ 284,150 $ 90,851 -- $ 375,001 Nine Months Ended 9/30/98 246,410 75,132 -- 321,542 TOTAL ASSETS 9/30/99 $1,921,546 $ 649,797 -- $2,571,343 12/31/98 1,817,751 644,112 -- 2,461,863 The table below provides the reconciliations of reportable segment operating earnings to the Company's consolidated totals. THREE MONTHS ENDED NINE MONTHS ENDED SEGMENT RECONCILIATION SEPTEMBER 30, SEPTEMBER 30, ---------------------- ------------------------ ------------------------ 1999 1998 1999 1998 ----- ---- ---- ---- INCOME FROM CONTINUING OPERATIONS BEFORE INCOME TAXES AND CUMULATIVE EFFECT OF CHANGE IN ACCOUNTING FOR START UP COSTS: Total operating earnings for reportable segments .... $ 131,860 $ 117,244 $ 375,001 $ 321,542 Corporate G&A (including foreign exchange) .......... (28,664) (27,801) (84,548) (79,907) Research and development expense .................... (1,067) (1,294) (3,104) (3,102) Net interest expense ................................ (49,524) (54,880) (152,154) (155,059) Special charge for settlement of investigations and related costs .................................... (590,000) -- (590,000) -- --------- --------- --------- --------- Income (loss) from continuing operations before income taxes and cumulative effect of change in accounting for start up costs .................... $(537,395) $ 33,269 $(454,805) $ 83,474 ========= ========= ========= ========= 25 26 ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS The following is a discussion of the financial condition and results of operations of the Company. The discussion should be read in conjunction with the financial statements included elsewhere in this document. This section contains certain forward-looking statements that are subject to various risks and uncertainties. Such statements include, without limitation, discussions concerning the outlook of the Company, government reimbursement, future plans and management's expectations regarding future performance. Actual results could differ materially from those contained in these forward-looking statements due to certain factors including, without limitation, changes in business, economic and competitive conditions, regulatory reforms, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, the realization of anticipated tax deductions, and the availability of financing. These and other risks and uncertainties, which are more fully described elsewhere in this Item 2 and in the Company's reports filed from time to time with the Commission, could cause the Company's results to differ materially from the results that have been or may be projected by or on behalf of the Company. OVERVIEW The Company is primarily engaged in (a) providing kidney dialysis services, clinical laboratory testing and renal diagnostic services and (b) manufacturing and distributing products and equipment for dialysis treatment. Throughout the Company's history, a significant portion of the Company's growth has resulted from the development of new dialysis centers and the acquisition of existing dialysis centers, as well as from the acquisition and development of complementary businesses in the health care field. The Company derives a significant portion of its health care services net revenues from Medicare, Medicaid and other government health care programs (approximately 60% in 1998). The reimbursement rates under these programs, including the Composite Rate, the reimbursement rate for EPO, and the reimbursement rate for other dialysis and non-dialysis related services and products, as well as other material aspects of these programs, have in the past and may in the future be changed as a result of deficit reduction and health care reform measures. The discussion of the Company's financial condition and results of operations included herein reflects the Preliminary Agreement and the resulting special charge. If the Settlement is not consummated and the Company and the Government eventually litigate the issues that are the subject of the OIG Investigation, the Company currently believes that the special charge reasonably estimates the costs and expenses that would arise from this litigation. No assurance, however, can be given that the Settlement will be consummated or that the costs related to the Settlement or any litigated resolution of the OIG Investigation will not exceed the amount of the special charge or that additional costs, claims and damages will not result from the Settlement. The Company's business, financial position and results of operations also could be materially adversely affected by an adverse outcome in the OIG Investigation, any whistleblower action, the pending challenge by the Company of changes effected by Medicare in approving reimbursement claims relating to the administration of IDPN or the adoption in 1996 of a new coverage policy that has changed IDPN coverage prospectively. The Company's business, financial position and results of operations could be materially adversely affected by an adverse outcome in the pending litigation concerning the implementation of certain provisions of OBRA 93 relating to the coordination of benefits between Medicare and employer health plans in the case of certain dual eligible ESRD patients. The Company also derives a significant portion of its net revenues from reimbursement by non-government payors. Historically, reimbursement rates paid by these payors generally have been higher than Medicare and other government program rates. However, non-government payors are imposing cost containment measures that are creating significant downward pressure on reimbursement levels that the Company receives for its services and products. 26 27 RESULTS OF OPERATIONS The following table summarizes certain operating results of the Company by principal business unit for the periods indicated. Intercompany eliminations primarily reflect sales of medical supplies by Dialysis Products to Dialysis Services. 1998 information has been reorganized to distinguish between continued and discontinued operations (dollars in millions). THREE MONTHS ENDED NINE MONTHS ENDED SEPTEMBER 30, SEPTEMBER 30, ----------------------- ----------------------- 1999 1998 1999 1998 ---- ---- ---- ---- NET REVENUES Dialysis services ................................ $ 591 $ 544 $ 1,725 $ 1,563 Dialysis products ................................ 180 165 526 494 Intercompany eliminations ........................ (59) (53) (169) (153) ------- ------- ------- ------- Total net revenues .................................. $ 712 $ 656 $ 2,082 $ 1,904 ======= ======= ======= ======= Operating earnings: Dialysis services ................................ $ 101 $ 88 $ 284 $ 246 Dialysis products ................................ 31 29 91 75 ------- ------- ------- ------- Total operating earnings ............................ 132 117 375 321 ------- ------- ------- ------- Other expenses: General corporate ................................ $ 28 $ 28 $ 85 $ 80 Research and development ......................... 1 1 3 3 Interest expense, net ............................ 50 55 152 155 Special charge for settlement of investigations and related costs ............................ 590 -- 590 -- ------- ------- ------- ------- Total other expenses ................................ 669 84 830 238 ------- ------- ------- ------- Earnings before income taxes and cumulative effect of change in accounting for start up costs ....... (537) 33 (455) 83 Provision (benefit) for income taxes ............... (150) 19 (107) 46 ------- ------- ------- ------- Net earnings from continuing operations before cumulative effect of change in accounting for start up costs ................................... $ (387) $ 14 $ (348) $ 37 ------- ------- ------- ------- Discontinued operations: Net revenues ..................................... $ -- $ -- $ -- $ 121 ======= ======= ======= ======= Loss on discontinued operations Loss before income taxes ...................... -- -- -- (14) Benefit for income taxes ..................... -- -- -- (5) ------- ------- ------- ------- Loss from operations .......................... -- -- -- (9) ------- ------- ------- ------- Loss on disposal of discontinued operations Loss before income taxes ...................... -- -- -- (140) Benefit for income taxes ..................... -- -- -- (43) ------- ------- ------- ------- Loss from operations .......................... -- -- -- (97) ------- ------- ------- ------- Total loss on discontinued operations ........... $ -- $ -- $ -- $ (106) Cumulative effect of change in accounting for start up costs, net of tax benefit ............... -- -- -- (5) ------- ------- ------- ------- Net income (loss) ................................... $ (387) $ 14 $ (348) $ (74) ======= ======= ======= ======= 27 28 THREE MONTHS ENDED SEPTEMBER 30, 1999 COMPARED TO THREE MONTHS ENDED SEPTEMBER 30, 1998 Net revenues from continuing operations for the third quarter of 1999 increased by 9% ($56 million) over the comparable period in 1998. Net earnings from continuing operations for the third quarter of 1999 decreased by ($401 million) over the comparable period in 1998 as a result of the special charge for settlement of investigations and related costs ($412 million, after income taxes), partially offset by the increased operating earnings ($11 million). DIALYSIS SERVICES Dialysis Services net revenues for the third quarter of 1999 increased by 9% ($47 million) over the comparable period in 1998, primarily as a result of a 7% increase in the number of treatments provided, the beneficial impact of the extension of the Medicare Secondary Payor (MSP) provision, higher EPO utilization relative to the comparable 1998 period and increased laboratory testing revenues. The treatment increase was a result of base business growth and the impact of 1998 and 1999 acquisitions. The laboratory testing revenue increase was primarily due to higher testing volume. Dialysis Services operating earnings for the third quarter of 1999 increased by 15% ($13 million) over the comparable period of 1998 primarily due to the increase in treatment volume, the beneficial impact of the extension of the MSP provision and the decrease in the provision for doubtful accounts. The provision for doubtful accounts decreased ($11 million) due to additional bad debt cost report recoveries for the years 1985 and 1988 through 1997, partially offset by additional provisions. These recoveries are the result of the Company's successful challenge of the Medicare regulation which capped reimbursement for the bad debts incurred by dialysis facilities in those years. Accordingly, the Company has revised its estimate of recoveries for the previously disallowed bad debt expense associated with this regulation. DIALYSIS PRODUCTS Dialysis Products net revenues for the third quarter of 1999 increased by 9% ($15 million) over the comparable period of 1998. This is due to increased sales of dialyzers ($4 million), machines ($6 million), concentrates ($4 million) and other products ($5 million), offset by decreased sales of peritoneal products ($4 million). Dialysis Products operating earnings for the third quarter of 1999 increased by 7% ($2 million) over the comparable period of 1998. This is primarily due to revenue growth, changes in product mix, and improvements in manufacturing efficiencies from increased production volume, partially offset by increased freight and distribution costs. SPECIAL CHARGE FOR SETTLEMENT OF INVESTIGATIONS AND RELATED COSTS Since 1995, NMC and its subsidiaries have been the subject of criminal and civil investigations (the "OIG Investigations") by the Office of Inspector General ("OIG") of the United States Department of Health and Human Services, the United States Attorney for the District of Massachusetts (the "U.S. Attorney's Office") and other authorities concerning possible violations of federal laws, including the anti-kickback statutes and the False Claims Act. NMC has reached a preliminary agreement (the "Preliminary Agreement") with the United States Government to resolve the matters covered in the OIG Investigation and NMC's administrative appeals of an estimated $150 million of outstanding Medicare receivables for IDPN therapy rendered on and before December 31, 1998 (collectively, the "Settlement"). Consummation of the Settlement is subject to negotiation of certain material currently unresolved terms of the Settlement, completion and execution of definitive Settlement documents, satisfaction of certain conditions, and court approval. (See Note 4 - "Special Charge for Settlement of Investigations and Related Costs" and Note 6 - "Commitments and Contingencies - Legal Proceedings"). As a result of the Preliminary Agreement, the Company has recorded a special pre-tax charge of $590 million ($412 million, net of income taxes) which includes (i) a charge of approximately $485 million for settlement payment obligations to the government; (ii) a reserve of approximately $80 million for the resolution of the Company's IDPN accounts receivable; and (iii) a reserve for other related costs of $25 million. 28 29 OTHER EXPENSES The Company's other expenses for the third quarter of 1999 decreased by 6% ($5 million) over the comparable period of 1998 entirely due to decreased interest expense associated with the Company's reduction in funded debt. INCOME TAXES The Company has recorded an income tax benefit of $150 million for the third quarter of 1999 as compared to an income tax provision of $19 million in the third quarter of 1998. The income tax benefit in 1999 is lower than the statutory tax rate primarily due to the tax effect of the special charge for the Settlement and related costs. The provision for income taxes in 1998 is higher than the statutory tax rate primarily due to the non-deductible merger goodwill. NINE MONTHS ENDED SEPTEMBER 30, 1999 COMPARED TO NINE MONTHS ENDED SEPTEMBER 30, 1998 Net revenues from continuing operations for the first nine months of 1999 increased by 9% ($178 million) over the comparable period in 1998. Net earnings from continuing operations for the first nine months of 1999 decreased by ($385 million) over the comparable period in 1998 as a result of the special charge for settlement of investigations and related costs (net of tax $412 million) and increases to general corporate expenses, partially offset by increased operating earnings. DIALYSIS SERVICES Dialysis Services net revenues for the first nine months of 1999 increased by 10% ($162 million) over the comparable period in 1998, primarily as a result of a 8% increase in the number of treatments provided, the beneficial impact of the extension of the Medicare Secondary Payor (MSP) provision, and higher EPO utilization relative to the comparable 1998 period, partially offset by decreased laboratory testing revenues. The treatment increase was a result of base business growth and the impact of 1998 and 1999 acquisitions. The laboratory testing revenue decrease was primarily due to lower testing volume during the first nine months of 1999, as competitors consolidate lab activity. Dialysis Services operating earnings for the first nine months of 1999 increased by 15% ($38 million) over the comparable period of 1998 primarily due to the increase in treatment volume, the beneficial impact of the extension of the MSP provision, higher EPO utilization, and the decrease in the provision for doubtful, partially offset by decreased operating earnings in laboratory testing. The provision for doubtful accounts decreased due to revisions of estimates for bad debt cost report recoveries. These recoveries include the result of the Company's successful challenge of the Medicare regulation which capped reimbursement for the bad debts incurred by dialysis facilities in those years. Accordingly, the Company has revised its estimate of recoveries for the previously disallowed bad debt expense associated with this regulation in the third quarter. DIALYSIS PRODUCTS Dialysis Products net revenues for the first nine months of 1999 increased by 7% ($32 million) over the comparable period of 1998. This is due to increased sales of dialyzers ($18 million), machines ($18 million), concentrates ($5 million) and other products ($12 million), partially offset by decreased sales of bloodlines ($3 million) and peritoneal products ($18 million). Dialysis Products operating earnings for the first nine months of 1999 increased by 21% ($16 million) over the comparable period of 1998. This is primarily due to revenue growth, changes in product mix, and improvements in manufacturing efficiencies from increased production volume. SPECIAL CHARGE FOR SETTLEMENT OF INVESTIGATIONS AND RELATED COSTS Since 1995, NMC and its subsidiaries have been the subject of criminal and civil investigations (the "OIG Investigations") by the Office of Inspector General ("OIG") of the United States Department of Health and Human Services, the United States Attorney for the District of Massachusetts (the "U.S. Attorney's Office") and other authorities concerning possible violations of federal laws, including the anti-kickback statutes and the False Claims Act. 29 30 NMC has reached a preliminary agreement (the "Preliminary Agreement") with the United States Government to resolve the matters covered in the OIG Investigation and NMC's administrative appeals of an estimated $150 million of outstanding Medicare receivables for IDPN therapy rendered on and before December 31, 1998 (collectively, the "Settlement"). Consummation of the Settlement is subject to negotiation of certain material currently unresolved terms of the Settlement, completion and execution of definitive Settlement documents, satisfaction of certain conditions, and court approval. (See Note 4 - "Special Charge for Settlement of Investigations and Related Costs" and Note 6 - "Commitments and Contingencies - Legal Proceedings"). As a result of the Preliminary Agreement, the Company has recorded a special pre-tax charge of $590 million ($412 million, net of income taxes) which includes (i) a charge of approximately $485 million for settlement payment obligations to the government; (ii) a reserve of approximately $80 million for the resolution of the Company's IDPN accounts receivable; and (iii) a reserve for other related costs of $25 million. OTHER EXPENSES The Company's other expenses for the first nine months of 1999 increased by 1% ($2 million) over the comparable period of 1998. General corporate expenses increased by $5 million due to increases in casualty and insurance expenses. Interest expense decreased by $3 million primarily due to the reduction of the Company's funded debt. INCOME TAXES The Company has recorded an income tax benefit of $107 million for the third quarter of 1999 as compared to an income tax provision of $46 million in the third quarter of 1998. The income tax benefit in 1999 is lower than the statutory tax rate primarily due to the tax effect of the special charge for the Settlement and related costs. The provision for income taxes in 1998 is higher than the statutory tax rate primarily due to the non-deductible merger goodwill. DISCONTINUED OPERATIONS On June 1, 1998, the Company classified its Non-Renal Diagnostic Services and Homecare businesses as discontinued operations. The Company sold both its Non-Renal Diagnostic Services business and its Homecare business on June 26, 1998 and July 29, 1998, respectively. In connection with the sale of Homecare, the Company retained the assets and the operations associated with the delivery of IDPN and, for accounting purposes, records its activities as part of discontinued operations. A net after tax loss of $97 million was recorded in 1998 on the sale of these businesses. The discontinued operations revenues for its Non- Renal Diagnostic Services and Homecare divisions for the first nine months of 1998 was $121 million with a net after tax loss of $105 million. 30 31 LIQUIDITY AND CAPITAL RESOURCES LIQUIDITY AND CAPITAL RESOURCES The Company's cash requirements have historically been funded by cash generated from operations. Cash generated from continued operations was $189 million and $100 million for the first nine months of 1999 and 1998, respectively. This increase is primarily due to the Company's improved operating profit levels as well as working capital improvements. NMC has reached a Preliminary Agreement with the United States Government to resolve the matters covered in the Settlement. Consummation of the Settlement is subject to negotiation of certain material currently unresolved terms of the Settlement, completion and execution of definitive Settlement documents, satisfaction of certain conditions, and court approval. The Company has recorded a special pre-tax charge against its consolidated earnings totaling $590 million ($412 million after tax). It is anticipated that the Settlement of the Investigation if consummated, will require payments totaling approximately $485 million. As part of the Settlement, the Company also expects to resolve the Company's administrative appeals outstanding accounts receivable from Medicare for IDPN therapy rendered on or before December 31, 1998. The net cash obligations of the Company, related to the special charge is anticipated to approximate $260 million. This amount reflects the special charge of $590 million reduced for the resolution of the Company's IDPN receivable claims (approximately $150 million), and the estimated cash savings for the tax effect of the special charge ($178 million). The Company and the Government have not yet agreed upon the payment terms of the Settlement Amount. The net cash effect, described above, does not consider any payment terms in the final Net Settlement Amount. The cash savings of the tax benefit are expected to be realized over time in relation to the cash outflows of the settlement payment obligations to the Government and expenditures for other related costs. The Company believes that it will have sufficient cash flows from continued operations and borrowing capacity under its revolving credit facility to pay the entire settlement amount as it becomes due. The Company also believes that following such payments, it will have sufficient funds available for both its day to day operations and its anticipated growth. After giving effect to the special charge, the Company continues to be in compliance with the financial covenants in its senior credit facility. The Company believes that the final terms of the Settlement could cause the Company to be out of compliance with the financial covenants, effective at the end of the financial quarter in which a Settlement is consummated. The company is in discussions regarding the Settlement with the agent for the lenders under its senior credit facility, and the agent has informed the lenders that it is working with the Company to prepare an amendment to certain financial covenants in the senior credit facility that will enable the Company to continue in compliance with the financial covenants upon consummation of the Settlement. If cash flows from operations or availability under existing banking arrangements fall below expectations, or if the company is unsuccessful in amending existing banking agreements, the Company may be required to consider other alternatives to maintain sufficient liquidity. The Company made acquisitions totaling $65 million and $160 million for the first nine months of 1999 and 1998, respectively. The Company made capital expenditures for internal expansion, improvements, new furnishings and equipment of $54 million and $51 million for the first nine months of 1999 and 1998, respectively. The Company intends to continue to enhance its presence in the U.S. by focusing its expansion on the acquisition of individual or small groups of clinics, expansion of existing clinics, and opening of new clinics. During the first nine months of 1999, the Company funded its acquisitions and capital expenditures primarily through cashflows from operations. In addition, the Company reduced its total borrowings by approximately $45 million. During the first nine months of 1998, the Company funded its acquisitions and capital expenditures primarily through proceeds from external short and long-term debt, proceeds from a receivable financing facility, and proceeds from the sale of the Non-Renal Diagnostics and Homecare divisions. Additionally in 1998, acquisitions were also funded through the issuance of investment securities by Fresenius Medical Care Finance, S.A., a Luxembourg subsidiary of FMC ("FMC Finance"). In exchange for such financing, an intercompany account was established between FMC Finance and the Company with payables due to FMC Finance of $42 million at September 30, 1998. 31 32 Effective July 1, 1995, the Company ceased to recognize the incremental revenue provided under HCFA's initial instruction under OBRA 93, although the Company continued to bill private third-party payors for these amounts through December 31, 1995. The Company began billing Medicare as the primary payor for the dual eligible ESRD patients affected by OBRA 93 effective January 1, 1996. If HCFA's revised instruction under OBRA 93 is permanently enjoined on a prospective basis, or if such revised instruction is sustained but given an effective date of later than September 30, 1995, the Company may be able to rebill such services to third-party payors and, as a result, the Company's future results of operations and financial position would be favorably affected by the incremental revenue that the Company would recognize. For further discussion see Notes to Consolidated Financial Statements Note 5, "Commitments and Contingencies - Omnibus Budget Reconciliation Act of 1993." CONTINGENCIES The Company is the subject of investigations by several federal agencies and authorities, including the OIG Investigation. As a result of the Preliminary Agreement in respect of the OIG Investigation, the Company has recorded a special pre-tax charge against its consolidated earnings for the three month period ended September 30, 1999 totaling $590 million ($412 million after tax). No assurance can be given that the Settlement will be consummated or that the costs related to the Settlement or any litigated resolution of the OIG Investigation will not exceed the amount of the above-described pre-tax charge against earnings or that additional costs, claims and damages will not result from the Settlement. If the Settlement is not consummated, the U.S. Attorney's Office is expected to institute criminal and civil legal proceedings against, and seek substantial civil and criminal financial damages and penalties from, NMC and its subsidiaries. If the Government is successful in pursuing claims arising from the OIG Investigation, NMC and one or more of its subsidiaries would be subject to civil damages and criminal penalties, including substantial fines, suspension of payments and exclusion from the Medicare, Medicaid and TriCare programs, as well as other federally-funded health care benefit programs. Such federal programs provide over 60% of NMC's consolidated revenues. The occurrence of any of these events could have a material adverse effect on the Company's business, financial condition and results of operations. The Company is also a plaintiff in litigation against the federal government with respect to the implementation of OBRA 93 and coverage for IDPN therapy, is seeking to change a proposed revision to IDPN coverage policies, and is a defendant in significant commercial insurance litigation. An adverse outcome in any of these matters, could have a material adverse effect on the Company's business, financial condition and results of operations. Because of the significant complexities and uncertainties associated with the above referenced governmental investigations and proceedings, except for the above-described pre-tax charge against earnings, neither an estimate of the possible loss or range of loss the Company may incur in respect of such matters nor a reserve based on any such estimate can be reasonably made. See Item 1 - Notes to Unaudited Consolidated Financial Statements - Note 6 "Commitments and Contingencies." The Company believes that its existing credit facilities, cash generated from operations and other current sources of financing are sufficient to meet its foreseeable needs. If cash flows from operations or availability under existing banking arrangements fall below expectations, or if the Company is unsuccessful in amending its existing banking agreements, the Company may be required to consider other alternatives to maintain sufficient liquidity. There can be no assurance that the Company will be able to do so on satisfactory terms, if at all. See Part I, Item 1I "Management's Discussion and Analysis of Financial Condition and Results of Operations - Liquidity and Capital Resources." IMPACT OF INFLATION A substantial portion of the Company's net revenue is subject to reimbursement rates which are regulated by the federal government and do not automatically adjust for inflation. Non-governmental payors also are exerting downward pressure on reimbursement levels. Increased operating costs that are subject to inflation, such as labor and supply costs, without a compensating increase in reimbursement rates, may adversely affect the Company's business and results of operations. YEAR 2000 ISSUES The "Year 2000 problem" is the result of computer programs using two digits rather than four to define the applicable years. Such software may recognize a date using "00" as the year 1900 rather than the year 2000. These programs are present in software applications running on desktop computers and network servers. These programs are also present in microchips and microcontrollers incorporated into equipment. Certain of the Company's computer hardware and software, building infrastructure components (e.g., alarm systems, HVAC systems, etc.) and medical devices that are date sensitive may contain programs with the Year 2000 problem. If uncorrected, the problem could result in computer system and program failures or equipment and medical device malfunctions or miscalculations that could result in a disruption of business operations or affect patient treatment. If the Company, its significant customers, reimbursement sources or suppliers fail to make necessary modifications and conversions on a timely basis, the Year 2000 problem could have a material adverse effect on the Company's operations and financial results. The Company believes that its competitors face a similar risk. The Company has been working on identifying and addressing potential Year 2000 risks since March 1997. In an effort to more comprehensively monitor and assess its progress in addressing Year 2000 issues, the Company established a Year 2000 Steering Committee in August 1998. The committee is comprised of senior company executives who meet regularly and provide status updates to the Company's management committee on a regular basis. Regarding information technology ("IT") systems, the Company has inventoried substantially all IT systems (e.g., clinical, supply chain management, financial, etc.) and has assessed Year 2000 compliance for those systems. The Company has developed specific plans and timetables to remediate or replace critical non-compliant systems and is in the process of completing these changes. The Company believes it has resolved such issues for a significant number of IT systems and anticipates that substantially all of the 32 33 remaining changes will be completed prior to the end of 1999. Regarding non-IT equipment that may be dependent upon embedded software (e.g., medical, manufacturing/distribution, etc.), the Company has inventoried and assessed Year 2000 compliance for substantially all of this equipment. The Company has developed specific plans to remediate or replace substantially all non-compliant non-IT equipment and is in the process of completing these changes. The Company believes it has resolved such issues for a significant number of non-IT systems and anticipates that substantially all of the remaining changes will be completed prior to the end of 1999. Although there can be no assurance that the Company will successfully complete implementation of its remediation efforts for IT systems and non-IT equipment by the dates critical for Year 2000 compliance, the Company's Year 2000 program is currently progressing in accordance with the Company's completion timetables. The Company relies heavily on third parties in operating its business. In addition to its reliance on systems and non-IT equipment vendors to verify Year 2000 compliance of their products, the Company also depends on 1) fiscal intermediaries which process claims and make payments for their Medicare and Medicaid programs, 2) insurance companies, HMOs, and other private payors, 3) utilities which provide electricity, water, natural gas, and telephone services, and 4) vendors of medical supplies and pharmaceuticals used in patient care. The Company has successfully tested and placed into production Year 2000 formats for its systemic interfaces with the Medicare fiscal intermediaries. The Company continues to work with Medicare, Medicaid, and significant private payors to ensure that these payors will be able to process and make any remittances for billed services. The Company has contacted substantially all significant vendors and service providers to seek assurances from these third parties that the services and products they provide will not be interrupted or malfunction due to the Year 2000 problem. Although no method exists for achieving certainty that any third party's organization will be Year 2000 compliant, the Company's goal is to obtain as much detailed information as possible about its significant vendors and service providers and to identify those companies which appear to pose a significant risk of failure to perform their obligations to the Company as a result of the Year 2000 problem. Failure of significant third parties to resolve their Year 2000 issues could have a material adverse effect on the Company's results of operations and ability to provide health care services and manufacture products. Costs related to the Year 2000 issue are funded through operating cash flows. The Company expects to spend a total of approximately $6.5 million in remediation and replacement efforts, including new software and hardware, costs to modify existing software, and consultant fees. The Company does not separately track the internal costs incurred for the Year 2000 remediation effort; such costs are principally related to the compensation costs for certain members of the Company's IT Department. The Company estimates remaining costs to be approximately $500,000, substantially all of which relate to non-critical Year 2000 efforts. IT expenditures for Year 2000 are covered as part of the normal IT budget (the Year 2000 efforts are taking priority over other discretionary IT projects). Non-IT expenditures for Year 2000 are similarly being covered as part of the normal non-IT budget. The Company presently believes that the incremental cost of achieving Year 2000 compliant systems and equipment will not be material to the Company's financial condition, liquidity, or results of operation. Time and cost estimates are based on currently available information. Developments that could affect estimates include, but are not limited to: 1) the availability and cost of trained personnel, 2) the ability to locate and correct all relevant computer code and systems, and 3) remediation success of the Company's customers and suppliers. Based on its assessments to date, the Company believes it will not experience any material disruption as a result of Year 2000 issues in its internally manufactured medical devices, its internal manufacturing and distribution processes, and its internal information processing. However, if certain critical third party providers, such as those supplying electricity or water, experience difficulties resulting in disruption of service to the Company, a shutdown of the Company's operations at individual facilities could occur for the duration of the disruption. The Year 2000 Steering Committee has reviewed and updated its existing, standard contingency plans with the potential Year 2000 issues in mind. At this point in time, the Company has not identified any risk areas that appear to have a reasonable likelihood to cause a material disruption to the Company's operations. Additional contingency plans will be developed on a case-by-case basis 33 34 if new risks are identified. Despite these efforts, judgments regarding contingency plans such as to what extent they should be developed are themselves subject to many variables and uncertainties. There can be no assurance that the Company will correctly anticipate the level, impact, or duration of non-compliance by third party vendors or suppliers that provide inadequate information in respect to their Year 2000 status. As a result, there can be no assurance that any contingency plan developed by the Company will be sufficient to mitigate the impact of non-compliance by third party vendors and service providers, and some material adverse effect to the Company could result regardless of such contingency plans. 34 35 ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK The Company is exposed to market risks due to changes in interest rates and foreign currency rates. The Company uses derivative financial instruments, including interest rate swaps and foreign exchange contracts, as part of its market risk management strategy. These instruments are used as a means of hedging exposure to interest rate and foreign currency fluctuations in connection with debt obligations and purchase commitments. The Company does not hold or issue derivative instruments for trading or speculative purposes. Hedge accounting is applied if the derivative reduces the risk of the underlying hedged item and is designated at inception as a hedge. Additionally, changes in the value of the derivative must result in payoffs that are highly correlated to the changes in value of the hedged item. Derivatives are measured for effectiveness both at inception and on an ongoing basis. The Company enters into foreign exchange contracts that are designated, and effective as hedges for firmly committed purchases. Also, since the Company carries a substantial amount of floating rate debt, the Company uses interest rate swaps to synthetically change certain variable-rate debt obligations to fixed-rate obligations, as well as options to mitigate the impact of interest rate fluctuations. Gains and losses on foreign exchange contracts accounted for as hedges are deferred as other current assets or liabilities. The deferred gains and losses are recognized as adjustments to the underlying hedged transaction when the future sales or purchases are recognized. Interest rate swap payments and receipts are recorded as part of interest expense. The fair value of the swap contracts is not recognized in the financial statements. Cash flows from derivatives are recognized in the consolidated statement of cash flows in the same category as the item being hedged. If a derivative instrument ceases to meet the criteria for deferral, any subsequent gains or losses are recognized in operations. If a firm commitment does not occur, the foreign exchange contract is terminated and any gain or loss is recognized in operations. If a hedging instrument is sold or terminated prior to maturity, gains or losses continue to be deferred until the hedged item is recognized. Should a swap be terminated while the underlying obligation remains outstanding, the gain or loss is capitalized as part of the underlying obligation and amortized into interest expense over the remaining term of the obligation. The Company's hedging strategy vis-a-vis the above-mentioned market risks has not changed significantly from 1998 to 1999. For additional information, see also the Company's 1998 Annual Report on Form 10-K "Notes to Consolidated Financial Statements - Note 2. Summary of Significant Accounting Policies - Derivative Financial Instruments and Notes to Consolidated Financial Statements - - Note 15. Financial Instruments." 35 36 PART II OTHER INFORMATION ITEM 1. LEGAL PROCEEDINGS OIG INVESTIGATION Since 1995, NMC and its subsidiaries have been the subject of criminal and civil investigations (the "OIG Investigation") by the Office of Inspector General ("OIG") of the United States Department of Health and Human Services, the United States Attorney for the District of Massachusetts (the "U.S. Attorney's Office") and other authorities concerning possible violations of federal laws, including the anti-kickback statutes and the False Claims Act. NMC has reached a preliminary agreement (the "Preliminary Agreement") with the United States Government (the "Government") to resolve the matters covered in the OIG Investigation and NMC's administrative appeals of an estimated $150 million of outstanding Medicare receivables for IDPN therapy rendered on and before December 31, 1998 (collectively, the "Settlement"). Consummation of the Settlement is subject to negotiation of certain material currently unresolved terms of the Settlement, completion and execution of definitive Settlement documents, satisfaction of certain conditions, and court approval. If the Settlement is consummated, the net Settlement payment to the Government is estimated to be approximately $415 million (the "Net Settlement Amount"). The Net Settlement Amount is the result of an estimated payment million to the Government of approximately $485 million, less an estimated payment by the Government to the Company of approximately $70 million for the above-mentioned IDPN receivable claims. The Company and the Government have not yet agreed upon the payment terms of the Net Settlement Amount. The net cash outflow resulting from the Preliminary Agreement is anticipated to be approximately $260 million. This amount reflects receipt of the IDPN accounts receivable payment from the Government and the tax effect of the special charge but does not consider any payment terms in the final Net Settlement Amount. The cash savings of the tax benefit are expected to be realized in relation to the cash outflows of the settlement obligation to the Government and expenditures for other related costs. As a result of the Preliminary Agreement, the Company has recorded a special pre-tax charge against its consolidated earnings for the three month period ended September 30, 1999 totaling $590 million ($412 million after tax). This special pre-tax charge includes the $485 million estimated payment to the Government, an $80 million reserve of the remaining IDPN receivables described above, and $25 million for other related costs. If the Settlement is not consummated and the Company and the Government eventually litigate the issues, the Company currently believes that the special charge reasonably estimates the costs and expenses arising from this litigation. If the Settlement is consummated, the Company anticipates that NMC's subsidiaries, Lifechem, Inc. ("Lifechem"), NMC Homecare, Inc. and NMC Medical Products, Inc. will plead guilty to violations of federal law. As a consequence of their guilty pleas, these subsidiaries will be excluded from further participation in federally funded health care programs, including Medicare, Medicaid and TriCare. The Company believes that these exclusions will not materially interrupt its provision of, or receipt of payment for, the products and services formerly provided by the excluded subsidiaries because the Company intends to continue to provide such products and services through other subsidiaries which are qualified to participate in federal health care programs. The Settlement is not expected to extend to any current or former employees of NMC or its subsidiaries who have been, or may be, indicted in connection with the OIG Investigation. The Company believes that it will have sufficient cash flows from continued operations and borrowing capacity under its revolving credit facility to pay the Net Settlement Amount. The Company also believes that following such payments, it will have sufficient funds available for both its day to day operations and its anticipated growth. After giving effect to the special charge, the Company continues to be in compliance with the financial covenants in its senior credit facility. The Company believes that the final terms of the Settlement could cause the Company to be out of compliance with the financial covenants, effective at the end of the financial quarter in which a Settlement is consummated. The Company is in discussions regarding the Settlement with the agent for the lenders under its senior credit facility, and the agent has informed the lenders that it is working with the Company to prepare an amendment to certain financial covenants in the senior credit facility that will enable the Company to continue in compliance with the financial covenants upon consummation of the Settlement. For a further discussion see Part I, Item 2, "Management Discussion and Analysis of Financial Condition and Results of Operations - Liquidity and Capital Resources." 36 37 No assurance can be given that the Settlement will be consummated or that the costs related to the Settlement or any litigated resolution of the OIG Investigation will not exceed the amount of the above-described pre-tax charge against earnings or that additional costs, claims and damages will not result from the Settlement. If the Settlement is not consummated, the U.S. Attorney's Office is expected to institute criminal and civil legal proceedings against, and seek substantial civil and criminal financial damages and penalties from, NMC and its subsidiaries. If the Government were successful in pursuing claims arising from the OIG Investigation, NMC and one or more of its subsidiaries would be subject to civil damages and criminal penalties, including substantial fines, suspension of payments and exclusion from the Medicare, Medicaid and TriCare programs, as well as other federally-funded health care benefit programs. Such federal programs provide over 60% of NMC's consolidated revenues. The occurrence of any of these events could have a material adverse effect on the Company's business, financial condition and results of operations. See "Management's Discussion and Analysis of Financial Condition and Results of Operations - Contingencies." In addition, as discussed below, the Company has become aware that it and one or more of its subsidiaries is the subject of qui tam or "whistleblower" actions with respect to some or all of the issues raised by the OIG Investigation, which whistleblower actions are filed under seal as a matter of law in the first instance, thereby preventing disclosure to the Company and to the public except by court order. In the process of unsealing federal whistleblower complaints, it is not unusual for courts to allow the Government to inform the Company and its counsel of a complaint prior to the time the Company may be legally permitted to disclose it to the public. NMC may be the subject of other "whistleblower" actions not known to the Company. Fresenius Medical Care and the Company have guaranteed NMC's obligations relating to or arising out of the OIG Investigation and the qui tam proceedings, and indemnified Grace Chemicals for any such liabilities. The following is a description of the OIG Investigation. In October 1995, NMC received five investigative subpoenas from the OIG in connection with the OIG Investigation. The subpoenas have resulted in extensive document production relating to various aspects of NMC's business. The Company has continued to receive additional subpoenas directed to NMC or the Company to obtain supplemental information and documents relating to the subject matter of the OIG Investigation, or to clarify the scope of the original subpoenas. The Company has cooperated with the OIG Investigation in providing supplemental information and documents. As indicated above, the Government continues, from time to time, to seek supplementing and/or clarifying information from the Company. The Company understands that the Government has utilized a grand jury to investigate these matters. The Company expects that this process will continue while the Government completes its evaluation of the documentation and issues or until the Settlement is consummated. The OIG Investigation covers the following areas: (a) NMC's dialysis services business ("Dialysis Services"), principally relating to its Medical Director contracts and compensation; (b) NMC's treatment of credit balances resulting from overpayments received under the Medicare, Medicaid, Tri-Care and other Government and commercial payors, NMC's billing for home dialysis services, and its payment of supplemental medical insurance premiums on behalf of indigent patients; (c) Lifechem's laboratory business, including testing procedures, marketing, customer relationships, competition, overpayments totaling approximately $4.9 million that were received by Lifechem from the Medicare program with respect to laboratory services rendered between 1989 and 1993, a 1997 review of dialysis facilities' standing orders, and the provision of discounts on products from NMC's products division, grants, equipment and entertainment to Lifechem customers; and (d) Homecare and, in particular, information concerning IDPN utilization, documentation of claims and billing practices including various services, equipment and supplies and payments made to third parties as compensation for administering IDPN therapy. The Government has indicated that the areas identified above are not exclusive, and that it may pursue additional areas. The penalties applicable under the anti-kickback statutes, the False Claims Act and other federal and state statutes and regulations applicable to NMC's business could be substantial. While NMC asserts that it is able to offer legal and/or factual defenses with respect to many of the claims the Government has identified, it is expected that the Government will assert that NMC has violated multiple statutory and regulatory provisions. Also, as discussed below, qui tam actions alleging that NMC submitted false claims to the Government have been filed under seal by former or current NMC employees or other individuals who may have familiarity with one or more of the issues under investigation. As noted, under the False Claims Act, any such private plaintiff could pursue an action against NMC in the name of the U.S. at his or her own expense if the Government declines to do so. Under the terms of the Merger, any potential resulting monetary liability has been retained by NMC, and the Company has 37 38 indemnified Grace Chemicals against all potential liability arising from or relating to the OIG Investigation. The Company has provided the U.S. Government with a guarantee of payment of the obligations, if any, arising from the OIG Investigation. In support of this guarantee, the Company has delivered to the U.S. Government a standby letter of credit in the amount of $150 million. MEDICAL DIRECTOR COMPENSATION The Government is investigating whether Dialysis Services' compensation arrangements with its Medical Directors constitute payments to induce referrals, which would be illegal under the anti-kickback statutes, rather than payment for services rendered. Dialysis Services compensated the substantial majority of its Medical Directors on the basis of a percentage of the earnings of the dialysis center for which the Medical Director was responsible from the inception of NMC's predecessor in 1972 until January 1, 1995, the effective date of Stark II. Under the arrangements in effect prior to January 1, 1995, the compensation paid to Medical Directors was adjusted to include "add backs," which represented a portion of the profit earned by the Company on products purchased by the Medical Director's facility from NMC Medical Products, Inc. and (until January 1, 1992) a portion of the profit earned by Lifechem on laboratory services provided to patients at the Medical Director's facility. These adjustments were designed to allocate a profit factor to each dialysis center relating to the profits that could have been realized by the center if it had provided the items and services directly rather than through a subsidiary of NMC. The percentage of profits paid to any specific Medical Director was reached through negotiation, and was typically a provision of a multi-year consulting agreement. Under Stark II, if Designated Health Services are involved, Medical Director compensation must not exceed fair market value and may not take into account the volume or value of referrals or other business generated between the parties. Since January 1, 1995, Dialysis Services has compensated its Medical Directors on a fixed compensation arrangement intended to comply with the requirements of Stark II. In renegotiating its Medical Director compensation arrangements in connection with Stark II, Dialysis Services took and continues to take account of the compensation levels paid to its Medical Directors in prior years. Certain Government representatives have expressed the view in meetings with counsel for NMC that arrangements where the Medical Director was or is paid amounts in excess of the "fair market value" of the services rendered may evidence illegal payments to induce referrals, and that hourly compensation is a relevant measure for evaluating the "fair market value" of the services. The Company's dialysis services division ("DSD" or "Dialysis Services") does not compensate its Medical Directors on an hourly basis and has asserted to the Government that hourly compensation is not a determinative measure of fair market value. Although the Company believes that the compensation paid to its Medical Directors is generally reflective of fair market value, there can be no assurances that the Government will agree with this position or that the Company ultimately will be able to defend its position successfully. Because of the wide variation in local market factors and in the profit percentage contractually negotiated between Dialysis Services and its Medical Directors prior to January 1, 1995, there is a wide variation in the amounts that have been paid to Medical Directors. As a result, the compensation that Dialysis Services has paid and is continuing to pay to a material number of its Medical Directors could be viewed by the Government as being in excess of "fair market value," both in absolute terms and in terms of hourly compensation. NMC has asserted to the Government that NMC's compensation arrangements do not constitute illegal payments to induce referrals. NMC has also asserted to the Government that OIG auditors repeatedly reviewed Dialysis Services' compensation arrangements with NMC's Medical Directors in connection with their audits of the costs claimed by Dialysis Services; that the OIG stated in its audit reports that, with the exception of certain technical issues, Dialysis Services had complied with applicable Medicare laws and regulations pertaining to the ESRD program; and that Dialysis Services reasonably relied on these audit reports in concluding that its program for compensating Medical Directors was lawful. There has been no indication that the Government will accept NMC's assertions concerning the legality of its arrangements generally or NMC's assertion that it reasonably relied on OIG audits, or that the Government will not focus on specific arrangements that DSD has made with one or more Medical Directors and assert that those specific arrangements were or are unlawful. The Government is also investigating whether Dialysis Services' profit sharing arrangements with its Medical Directors influenced the Medical Directors to order unnecessary ancillary services and items. NMC has asserted to the Government that the rate of utilization of ancillary services and items by its Medical Directors is reasonable and that it did not provide illegal inducements to Medical Directors to order ancillary services and items and the practice of profit-sharing has been discontinued. CREDIT BALANCES 38 39 In the ordinary course of business, medical service providers like Dialysis Services receive overpayments from Medicare intermediaries and other payors for services that they provide to patients. Medicare intermediaries commonly direct such providers to notify them of the overpayment and not remit such amounts to the intermediary by check or otherwise unless specifically requested to do so. In 1992, HCFA adopted a regulation requiring certain Medicare providers, including dialysis centers, to file a quarterly form listing unrecouped overpayments with the Medicare intermediary responsible for reimbursing the provider. The first such filing was required to be made as of June 30, 1992 for the period beginning with the initial date that the provider participated in the Medicare program and ending on June 30, 1992. The Government is investigating whether DSD intentionally understated the Medicare credit balance reflected on its books and records for the period ended June 30, 1992 by reversing entries out of its credit balance account and taking overpayments into income in anticipation of the institution of the new filing requirement. Dialysis Services policy was to notify Medicare intermediaries in writing of overpayments upon receipt and to maintain unrecouped Medicare overpayments as credit balances on the books and records of Dialysis Services for four years; overpayments not recouped by Medicare within four years would be reversed from the credit balance account and would be available to be taken into income. NMC asserts that Medicare overpayments that have not been recouped by Medicare within four years are not subject to recovery under applicable regulations. Accordingly, NMC's initial filing with the intermediaries disclosed the credit balance on the books and records of Dialysis Services as shown in accordance with its policy. There can be no assurance that the Government will accept NMC's position. The Government has inquired whether other divisions including Homecare, Lifechem, renal diagnostic services and non-renal diagnostic services have appropriately treated Medicare credit balances as well as credit balances of other payors. The Government is also investigating whether Dialysis Services failed to disclose Medicare overpayments that resulted from Dialysis Services' obligation to rebill commercial payors for amounts originally billed to Medicare under HCFA's initial implementation of the OBRA 93 amendments to the secondary payor provisions of the Medicare Act. Dialysis Services experienced delays in reporting a material amount of overpayments after the implementation of the OBRA 93 amendments. NMC asserts that most of these delays were the result of the substantial administrative burdens placed on Dialysis Services as a consequence of the changing and inconsistent instructions issued by HCFA with respect to the OBRA 93 amendments and were not intentional. Substantially all overpayments resulting from the rebilling effort associated with the OBRA 93 amendments have now been reported. Procedures are in place that are designed to ensure that subsequent overpayments resulting from the OBRA 93 amendments will be reported on a timely basis. SUPPLEMENTAL MEDICAL INSURANCE The Government has indicated that it is investigating the method by which NMC made Medigap payments on behalf of its indigent patients. The impact, if any, of this investigation on the Company, cannot be predicted at this time. OVERPAYMENTS FOR HOME DIALYSIS SERVICES NMC acquired Home Intensive Care, Inc. ("HIC"), an in-center and home dialysis service provider, in 1993. At the time of the acquisition, HIC was the subject of a claim by HCFA that HIC had received payments for home dialysis services in excess of the Medicare reasonable charge for services rendered prior to February 1, 1990. NMC settled the HCFA claim against HIC in 1994. The Government is investigating whether the settlement concerning the alleged overpayments made to HIC resolved all issues relating to such alleged overpayments. The Government is also investigating whether NMC's subsidiary, Home Dialysis Services, Inc. ("HDS"), received payments similar to the payments that HIC received, and whether HDS improperly billed for home dialysis services in excess of the monthly cost cap for services rendered on or after February 1, 1990. The Government is investigating whether NMC was overpaid for services rendered. NMC asserts that the billings by HDS were proper, but there can be no assurance that the Government will accept NMC's view. LIFECHEM Overpayments. On September 22, 1995, Lifechem voluntarily disclosed certain billing problems to the Government that had resulted in Lifechem's receipt of approximately $4.9 million in overpayments from the Medicare program for laboratory services rendered between 1989 and 1993. Lifechem asserts that most of these overpayments relate to errors caused by a change in Lifechem's computer systems and that the remainder of the overpayments were the result of the incorrect practice of billing for a complete blood count with differential when only a complete blood count was ordered and performed, and of the incorrect practice of billing for a 39 40 complete blood count when only a hemoglobin or hematocrit test was ordered. Lifechem asserts that the overpayments it received were not caused by fraudulent activity, but there can be no assurance that the Government will accept Lifechem's view. Lifechem made these disclosures to the Government as part of an application to be admitted to a voluntary disclosure program begun by the Government in mid-1995. At the time of the disclosures, Lifechem tendered repayment to the Government of the $4.9 million in overpayments. After the OIG Investigation was announced, the Government indicated that Lifechem had not been accepted into its voluntary disclosure program. The Government has deposited the $4.9 million check with NMC's approval. The matters disclosed in Lifechem's September 22, 1995 voluntary disclosure are a subject of the OIG Investigation. On June 7, 1996, Lifechem voluntarily disclosed an additional billing problem to the Government that had resulted in Lifechem's receipt of between $40,000 and $160,000 in overpayments for laboratory services rendered in 1991. Lifechem advised the Government that this overpayment resulted from the submission for payment of a computer billing tape that had not been subjected to a "billing rules" program designed to eliminate requests for payments for laboratory tests that are included in the Composite Rate and that were not eligible for separate reimbursement. Lifechem also advised the Government that there may have been additional instances during the period from 1990 to 1992 when other overpayments were received as a result of the submission of computer billing tapes containing similar errors and that it was in the process of determining whether such additional overpayments were received. On June 21, 1996, Lifechem advised the Government that the 1991 billing problem disclosed on June 7, 1996 resulted in an overpayment of approximately $112,000. Lifechem also advised the Government that certain records suggested instances in July 1990 and August 31 through September 11, 1990, when billing tapes may have been processed without rules processing. Lifechem continued its effort to determine whether any other overpayments occurred relating to the "billing rules" problem and, in March 1997, advised the Government that an additional overpayment of approximately $260,000 was made by Medicare. On April 6, 1999, Lifechem voluntarily disclosed an additional billing problem to the Government that resulted in Lifechem's receipt of overpayments for laboratory services rendered between 1994 and 1999. In 1994, as a result of the advice of a billing consultant, Lifechem began to bill for platelet testing performed in connection with complete blood counts. This advice was confirmed by the consultant in 1997 as part of a review performed by the consultant under the auspices of Lifechem's then outside counsel. In 1999, however, an internal inquiry resulted in a reexamination of this advice and Lifechem determined that the prior advice was incorrect. As a result, Lifechem voluntarily disclosed the overpayment and repaid to the Government the amount of $8.6 million. Capitation for routine tests and panel design. In October 1994, the OIG issued a special fraud alert in which it stated its view that the industry practice of offering to perform or performing the routine tests covered by the Composite Rate at a price below fair market value, coupled with an agreement by a dialysis center to refer all or most of its non-Composite Rate tests to the laboratory, violates the anti-kickback statutes. In response to this alert, Lifechem changed its practices with respect to testing covered by the Composite Rate to increase the amount charged to both Dialysis Services and third-party dialysis centers and reduce the number of tests provided for the fixed rate. The Government is investigating Lifechem's practices with respect to these tests. Benefits provided to dialysis centers and persons associated with dialysis centers. The Government is investigating whether Dialysis Services or any third-party dialysis center or any person associated with any such center was provided with benefits in order to induce them to use Lifechem services. Such benefits could include, for example, discounts on products or supplies, the provision of computer equipment, the provision of money for the purchase of computer equipment, the provision of research grants and the provision of entertainment to customers. NMC has identified certain instances in which benefits were provided to customers who purchased medical products from NMC Medical Products, Inc., NMC's products company, and used Lifechem's laboratory services. The Government claims that the provision of such benefits violates, among other things, the anti-kickback statutes. In December 1998, the former Vice President of Sales responsible for NMC's laboratory and products divisions pled guilty to the payment of illegal kickbacks to obtain laboratory business for Lifechem. In February 1999, the former President of NMC Medical Products, Inc., was indicted by the Government for the payment of these same and/or similar kickbacks. Business and testing practices. As noted above, the Government has identified a number of specific categories of documents that it is requiring NMC to produce in connection with Lifechem business and testing practices. In addition to documents relating to the areas discussed above, the Government has also required Lifechem to produce documents relating to the equipment and systems used by Lifechem in performing and billing for clinical laboratory blood tests, the design of the test panels offered and requisition forms used by Lifechem, the utilization rate for certain tests performed by Lifechem, recommendations concerning diagnostic codes to be used in ordering tests for patients with given illnesses or conditions, internal and external audits and investigations relating to 40 41 Lifechem's billing and testing. Subsequently, the Government served an investigative subpoena for documents concerning the Company's 1997 review of dialysis facilities' standing orders, and responsive documents were provided. The Government has served investigative subpoenas requiring NMC to update its production on the above issues and to produce contract files for twenty-three identified dialysis clinic customers. The Government is investigating each of these areas, and claims that Lifechem and/or NMC have violated the False Claims Act and/or the anti-kickback statutes through the test ordering, paneling, requisitioning, utilization, coding, billing and auditing practices described above. In June 1999, a former Vice President of Marketing of NMC Medical Products, Inc. pled guilty to a charge of conspiracy to defraud Medicare in connection with the marketing of certain hepatitis tests. In August 1999, the former President and the then Director of Marketing of Lifechem were indicted by the Government for defrauding Medicare in connection with marketing the same hepatitis and laboratory tests. IDPN Administration kits. One of the activities of Spectra Renal Management ("SRM") is to provide IDPN therapy to dialysis patients at both NMC-owned facilities and at facilities owned by other providers. IDPN therapy was provided by Homecare prior to its divestiture. IDPN therapy is typically provided to the patient 12-13 times per month during dialysis treatment. Bills are submitted to Medicare on a monthly basis and include separate claims for reimbursement for supplies, including, among other things, nutritional solutions, administration kits and infusion pumps. In February 1991, the Medicare carrier responsible for processing Homecare's IDPN claims issued a Medicare advisory to all parenteral and enteral nutrition suppliers announcing a coding change for reimbursement of administration kits provided in connection with IDPN therapy for claims filed for items provided on or after April 1, 1991. The Medicare allowance for administration kits during this period was approximately $625 per month per patient. The advisory stated that IDPN providers were to indicate the "total number of actual days" when administration kits were "used," instead of indicating that a one-month supply of administration kits had been provided. In response, Homecare billed for administration kits on the basis of the number of days that the patient was on an IDPN treatment program during the billing period, which typically represented the entire month, as opposed to the number of days the treatment was actually administered. During the period from April 1991 to June 1992, Homecare had an average of approximately 1,200 IDPN patients on service. In May 1992, the carrier issued another Medicare advisory to all PEN suppliers in which it stated that it had come to the carrier's attention that some IDPN suppliers had not been prorating their billing for administration kits used by IDPN patients and that providers should not bill for administration kits on the basis of the number of days that the patient was on an IDPN treatment program during the billing period. The advisory stated further that the carrier would be conducting "a special study to determine whether or not overpayments have occurred as a result of incorrect billing" and that "if overpayments have resulted, providers that have incorrectly billed" would "be contacted so that refunds can be recovered." Homecare revised its billing practices in response to this advisory for claims filed for items provided on or after July 1, 1992. Homecare was not asked to refund any amounts relating to its billings for administration kits following the issuance of the second advisory. The Government asserts that NMC submitted false claims for administration kits during the period from 1988 to June 30, 1996, and that Homecare's billing for administration kits during this period violated, among other things, the False Claims Act. Infusion Pumps and IV Poles. During the time period covered by the subpoenas, Medicare regulations permitted IDPN providers to bill Medicare for infusion pumps and, until 1992, for IV poles provided to IDPN patients in connection with the administration of IDPN treatments. These regulations do not expressly specify that a particular pump and IV pole be dedicated to a specific patient, and NMC asserts that these regulations permitted Homecare to bill Medicare for an infusion pump and IV pole so long as the patient was infused using a pump and IV pole. Despite the absence of an express regulatory specification, Homecare developed a policy to deliver to a dialysis center a dedicated infusion pump and IV pole for each patient, although the Company cannot represent that Homecare followed this policy in every instance. The Government is investigating the propriety of Homecare's billings for infusion pumps and IV poles and asserts that Homecare's billings violate the False Claims Act. As noted above, under the new policies published by HCFA with respect to IDPN therapy, the Company was not able to bill for infusion pumps after July 1, 1996. The Government discontinued reimbursement for IV poles in 1992. "Hang fees" and other payments. IDPN therapy is typically provided to the patient during dialysis by personnel employed by the dialysis center treating the patient with supplies provided and billed to Medicare by Homecare in accordance with the Medicare parenteral nutrition supplier rules. In order to compensate dialysis centers for the costs incurred in administering IDPN therapy and monitoring the patient during therapy, Homecare followed the practice common in the industry of paying a "hang fee" to the center. 41 42 Dialysis centers are responsible for reporting such fees to HCFA on their cost reports. For Dialysis Services dialysis centers, the fee was $30 per administration, based upon internal Dialysis Services cost calculations. For third-party dialysis centers, the fee was negotiated with each center, typically pursuant to a written contract, and ranged from $15 to $65 per administration. The Company has identified instances in which other payments and amounts beyond that reflected in a contract were paid to these third-party centers. The Company has stopped paying "hang fees" to both Dialysis Services and third-party facilities. In July 1993, the OIG issued a management advisory alert to HCFA in which it stated that "hang fees" and other payments made by suppliers of IDPN to dialysis centers "appear to be illegal as well as unreasonably high." The Government is investigating the nature and extent of the "hang fees" and other payments made by Homecare as well as payments by Homecare to physicians whose patients have received IDPN therapy. The Government asserts that the payments by Homecare to dialysis centers violate, among other things, the anti-kickback statutes. Utilization of IDPN. Since 1984, when HCFA determined that Medicare should cover IDPN and other parenteral nutrition therapies, the Company has been an industry leader in identifying situations in which IDPN therapy is beneficial to ESRD patients. It is the policy of the Company to seek Medicare reimbursement for IDPN therapy only when it is prescribed by a patient's treating physician and when it believes that the circumstances satisfy the requirements published by HCFA and its carrier agents. Prior to 1994, HCFA and its carriers approved for payment more than 90% of the IDPN claims submitted by Homecare. After 1993, the rate of approval for Medicare reimbursement for IDPN claims submitted by Homecare for new patients, and by the infusion industry in general, fell to approximately 9%. The Company contends that the reduction in rates of approval occurred because HCFA and its carriers implemented an unauthorized change in coverage policy without giving notice to providers. While NMC continued to offer IDPN to patients pursuant to the prescription of the patients' treating physicians and to submit claims for Medicare reimbursement when it believed the requirements stated in HCFA's published regulations were satisfied, other providers responded to the drop in the approval rate for new Medicare IDPN patients by abandoning the Medicare IDPN business, cutting back on the number of Medicare patients to whom they provide IDPN, or declining to add new Medicare patients. Beginning in 1994 the number of patients to whom NMC provided IDPN increased as a result. The Government is investigating the utilization rate of IDPN therapy among NMC patients, whether NMC submitted IDPN claims to Medicare for patients who were not eligible for coverage, and whether documentation of eligibility was adequate. NMC asserts that the utilization rate of IDPN therapy among its dialysis patients, which, in 1995, averaged less than 3.5%, is the result of the factors discussed above and that it is the policy of Homecare to seek Medicare reimbursement for IDPN therapy prescribed by the patient's treating physician in accordance with the requirements published by HCFA and its carrier agents. There can be no assurance that the Government will accept the NMC's view. The Government asserts that Homecare submitted IDPN claims for individuals who were not eligible for coverage and/or with inadequate documentation of eligibility. The Company believes that it has presented to the Government substantial defenses which support NMC's interpretation of coverage rules of IDPN as HCFA and its carriers published and explained them, and which demonstrated that HCFA and its carriers improperly implemented unpublished, more restrictive criteria after 1993. Nevertheless, the Government is expected to assert in the OIG Investigation that, on a widespread basis, NMC submitted and received payments on claims for IDPN to Medicare for patients who were not eligible for coverage, and for whom the documentation of eligibility was inadequate. In addition, the Government asserts that, in a substantial number of cases, documentation of eligibility was false or inaccurate. With respect to some claims, the Company has determined that false or inaccurate documentation was submitted, deliberately or otherwise. The Government continues to investigate the IDPN claims. As indicated above, if the Settlement is consummated, the Company anticipates receiving an estimated $70 million payment to the Company from the Government that is reflected in the Net Settlement Amount in exchange for a release of the Company's IDPN receivable claims against the Government for IDPN therapy administered on or before December 31, 1998. The Company continues to pursue appeals of certain denied claims for IDPN therapy rendered after December 31, 1998 which it anticipates will clarify the coverage criteria for IDPN therapy on a prospective basis. QUI TAM ACTIONS The Company is aware that it and/or certain of its subsidiaries are the subject of qui tam or "whistleblower" actions with 42 43 respect to some or all of the issues raised by the OIG Investigation, which whistleblower actions are filed under seal as a matter of law in the first instance, thereby preventing disclosure to the Company and to the public except by court order. The Company and/or certain of its subsidiaries may be the subject of other "whistleblower" actions not yet known to the Company. Each of these actions is under seal and in each action, pursuant to court order the seal has been modified to permit the Company, NMC and other affiliated defendants to disclose the complaint to any relevant investors, financial institutions and/or underwriters, their successors and assigns and their respective counsel and to disclose the allegations in the complaints in their respective reports filed with the U.S. Securities and Exchange Commission (the "SEC" or the "Commission"). A qui tam action was filed in the United States District Court for the Southern District of Florida in June 1994, amended on July 8, 1996 and disclosed to the Company on July 10, 1996. It alleges, among other things, that Grace Chemicals and NMC violated the False Claims Act in connection with certain billing practices regarding IDPN and the administration of EPO and that as a result of this allegedly wrongful conduct, the United States suffered actual damages in excess of $200 million. A qui tam action was filed in the United States District Court for the Southern District of Florida in December 1994 and disclosed to the Company on April 16, 1999. It alleges, among other things, that NMC violated the False Claims Act in connection with certain billing practices regarding IDPN and the cost relating thereto. The second qui tam was filed by the same relator which filed the first qui tam and covers the same services covered by the first qui tam complaint. A qui tam action was filed in the United States District Court for the Middle District of Florida in 1995 and disclosed to the Company on or before November 7, 1996. It alleges, among other things, that NMC and certain NMC subsidiaries violated the False Claims Act in connection with the alleged retention of over-payments made under the Medicare program, the alleged submission of claims in violation of applicable cost caps and the payment of supplemental Medicare insurance premiums as an alleged inducement to patients to obtain dialysis products and services from NMC. The complaint alleges that as a result of this allegedly wrongful conduct, the United States suffered damages in excess of $10 million, including applicable fines. A qui tam action was filed in the United States District Court for the District of Massachusetts in 1994 and was disclosed to the Company in February 1999. It alleges among other things that NMC violated the False Claims Act and the federal anti-kickback statutes in connection with certain billing and documentation practices regarding IDPN therapy, home oxygen therapy and certain medical billings in NMC's Chicago office. A qui tam action was filed in the United States District Court for the Middle District of Tennessee on December 15, 1994, transferred to the United States District Court for the District of Massachusetts in 1995, and subsequently was disclosed to the Company in September 1999. It alleges, among other things, that Lifechem violated the False Claims Act in connection with the submission of claims for laboratory tests which already had been billed by the Company, and that Lifechem manipulated its chemistry panels to increase its Medicare and Medicaid billings. The Complaint alleges that as a result of this illegal action, the United States suffered damages in excess of $25,000,000. Sometime after 1996, the Complaint was amended to add Spectra Laboratories, Inc., the Company and FMC as defendants, and added the allegation that the defendants violated the Medicare and Medicaid Anti-Kickback Statute by providing discounted hemodialysis products to induce the purchase of laboratory services. Each of the qui tam complaints asserts that as a result of the allegedly wrongful conduct, the Government suffered damages and that the defendants are liable to the Government for three times the amount of the alleged damages plus civil penalties of up to $10,000 per false claim. An adverse result in any of the qui tam actions could have a material adverse effect on the Company's business, financial condition or results of operations. OIG AGREEMENTS As a result of discussions with representatives of the United States in connection with the OIG Investigation, certain agreements (the "OIG Agreements") have been entered into to guarantee the payment of any obligations of NMC to the United States (an "Obligation") relating to or arising out of the OIG Investigation and the qui tam action filed in the Southern District of Florida (the "Government Claims"). For the purposes of the OIG Agreements, an Obligation is (a) a liability or obligation of NMC to the United States in respect of a Government Claim pursuant to a court order (i) which is final and nonappealable or (ii) the enforcement of which has not been stayed pending appeal or (b) a liability or obligation agreed to be an Obligation in a settlement agreement executed by Fresenius Medical Care, the Company or NMC, on the one hand, and the United States, on the other hand. As stated elsewhere herein if the Settlement is not consummated, the outcome of the OIG Investigation cannot be predicted. 43 44 Pursuant to the OIG Agreements, upon consummation of the Merger, Fresenius Medical Care, the Company and NMC provided the United States with a joint and several unconditional guarantee of payment when due of all Obligations (the "Primary Guarantee"). As credit support for the Primary Guarantee, NMC delivered an irrevocable standby letter of credit in the amount of $150 million. The United States will return such letter of credit (or any renewal or replacement) for cancellation when all Obligations have been paid in full or it is determined that NMC has no liability in respect of the Government Claims. Under the terms of the Merger, any potential resulting monetary liability has been retained by NMC, and the Company has indemnified Grace Chemicals against all potential liability arising from or relating to the OIG Investigation. FMC and the Company and the United States state in the OIG Agreements that they will negotiate in good faith to attempt to arrive at a consensual resolution of the Government Claims and, in the context of such negotiations, will negotiate in good faith as to the need for any restructuring of the payment of any Obligations arising under such resolution, taking into account the ability of FMC and the Company to pay the Obligations. The OIG Agreements state that the foregoing statements shall not be construed to obligate any person to enter into any settlement of the Government Claims or to agree to a structured settlement. Moreover, the OIG Agreements state that the statements described in the first sentence of this paragraph are precatory and statements of intent only and that (a) compliance by the United States with such provisions is not a condition of or defense to the obligations of FMC and the Company under the OIG Agreements and (b) breach of such provisions by the Government cannot and will not be raised by FMC and the Company to excuse performance under the OIG Agreements. Neither the entering into of the OIG Agreements nor the providing of the Primary Guarantee and the $150 million letter of credit is an admission of liability by any party with respect to the OIG Investigation, nor does it indicate the liability which may result therefrom. The foregoing describes the material terms of the OIG Agreements, copies of which were previously filed with the Commission and copies of which may be examined without charge at the public reference facilities maintained by the Commission at Room 1024, 450 Fifth Street, N.W., Washington, D.C. 20549, and at the Regional Offices of the Commission located at Suite 1400, Citicorp Center, 500 West Madison Street, Chicago, Illinois 60661-2551 and Room 1300, 7 World Trade Center, New York, New York 10048. Copies of such material will also be made available by mail from the Public Reference Branch of the Commission at 450 Fifth Street, N.W., Washington, D.C. 20549, at prescribed rates. The foregoing description does not purport to be complete and is qualified in its entirety by reference to such agreements. An adverse determination with respect to any of the issues addressed by the subpoenas, or any of the other issues that have been or may be identified by the Government, could result in the payment of substantial fines, penalties and forfeitures, the suspension of payments or exclusion of the Company or one or more of its subsidiaries from the Medicare program and other federal programs, and changes in billing and other practices that could adversely affect the Company's revenues. Any such result could have a material adverse effect on the Company's business, financial condition and results of operations. OTHER LEGAL PROCEEDINGS DISTRICT OF NEW JERSEY INVESTIGATION NMC had received multiple subpoenas from a federal grand jury in the District of New Jersey investigating, among other things, whether NMC sold defective products, the manner in which NMC handled customer complaints and certain matters relating to the development of a new dialyzer product line. NMC cooperated with this investigation and provided the grand jury with extensive documents. In February, 1996, NMC received a letter from the U.S. Attorney's Office for the District of New Jersey indicating that it was the target of a federal grand jury investigation into possible violations of criminal law in connection with its efforts to persuade the FDA to lift a January 1991 import hold issued with respect to NMC's Dublin, Ireland manufacturing facility. In June 1996, NMC received a letter from the U.S. Attorney for the District of New Jersey indicating that the U.S. Attorney had declined to prosecute NMC with respect to a submission related to NMC's effort to lift the import hold. The letter added that NMC remains a subject of a federal grand jury's investigation into other matters. NMC also produced documents in response to a June 1996 subpoena from the federal grand jury requesting certain documents in connection with NMC's imports of the FOCUS(R) dialyzer from January 1991 to November 1995. In November 1999, NMC's subsidiary, NMC Medical Products, Inc. ("NMC Medical Products") and the U.S. Attorney's Office for the District of New Jersey executed a plea agreement (the "New Jersey Agreement") pursuant to which NMC Medical Products will plead guilty to two misdemeanor violations of the Federal Food, Drug and Cosmetic Act, pay the United States Government $3.8 million and be released, together with NMC and its related entities and their present officers, directors and employees, from any further civil or criminal liability with respect to all matters investigated by the U.S. Attorney's Office for the District of New Jersey, including the matters described above, or arising out of Food and Drug Administration inspections of NMC Medical Products' facilities prior to October 20, 1995. The terms of the New Jersey Agreement are subject to court approval. The $3.8 million to b paid pursuant to the Plea Agreement does not constitute part of the Settlement Amount. COMMERCIAL INSURER LITIGATION 44 45 In 1997, the Company, NMC, and certain named NMC subsidiaries, were served with a civil complaint filed by Aetna Life Insurance Company in the U.S. District Court for the Southern District of New York (Aetna Life Insurance Company v. National Medical Care, Inc. et al, 97-Civ-9310). In April 1999, Aetna amended its complaint to include its affiliate, Aetna U.S. Healthcare, Inc., as an additional plaintiff, and to make certain other limited changes in its pleading. Based in large part on information contained in prior securities filings, the lawsuit alleges inappropriate billing practices for nutritional therapy, diagnostic and clinical laboratory tests and misrepresentations. The amended complaint seeks unspecified damages and costs. This matter is at a relatively early stage in the litigation process, with substantial discovery just beginning, and its outcome and impact on the Company cannot be predicted at this time. However, the Company, NMC and its subsidiaries believe that they have substantial defenses to the claims asserted, and intend to continue to vigorously defend the lawsuit. Other private payors have contacted the Company and may assert that NMC received excess payments and similarly, may join the lawsuit or file their own lawsuits seeking reimbursement and other damages from NMC. An adverse result could have a material adverse effect on the Company's business, financial condition or results of operations. In May 1999, the Company filed counterclaims against Aetna Life Insurance Company and Aetna U.S. Healthcare, Inc. based on inappropriate claim denials and delays in claim payments. The Company is also investigating similar counterclaims against other private payors that have contacted the Company. The Settlement would not resolve these proceedings and claims. OBRA 93 OBRA 93 affected the payment of benefits under Medicare and employer health plans for certain eligible ESRD patients. In July 1994, HCFA issued an instruction to Medicare claims processors to the effect that Medicare benefits for the patients affected by OBRA 93 would be subject to a new 18-month "coordination of benefits" period. This instruction had a positive impact on NMC's dialysis revenues because, during the 18-month coordination of benefits period, patients' employer health plans were responsible for payment, which was generally at rates higher than those provided under Medicare. In April 1995, HCFA issued a new instruction, reversing its original instruction in a manner that would substantially diminish the positive effect of the original instruction on NMC's dialysis business. HCFA further proposed that its new instruction be effective retroactive to August 1993, the effective date of OBRA 93. NMC ceased to recognize the incremental revenue realized under the original Program Memorandum as of July 1, 1995, but it continued to bill employer health plans as primary payors for patients affected by OBRA 93 through December 31, 1995. As of January 1, 1996, NMC commenced billing Medicare as primary payor for dual eligible ESRD patients affected by OBRA 93, and then began to rebill in compliance with the revised policy for services rendered between April 24 and December 31, 1995. On May 5, 1995, NMC filed a complaint in the U.S. District Court for the District of Columbia (National Medical Care, Inc. and Bio-Medical Applications of Colorado, Inc. d/b/a Northern Colorado Kidney Center v. Shalala, C.A. No. 95-0860 (WBB)) seeking to preclude HCFA from retroactively enforcing its April 24, 1995 implementation of the OBRA 93 provisions relating to the coordination of benefits for dual eligible ESRD patients. On May 9, 1995, NMC moved for a preliminary injunction to preclude HCFA from enforcing its new policy retroactively, that is, to billings for services provided between August 10, 1993 and April 23, 1995. On June 6, 1995, the court granted NMC's request for a preliminary injunction and in December of 1996, NMC moved for partial summary judgment seeking a declaration from the Court that HCFA's retroactive application of the April 1995 rule was legally invalid. HCFA cross-moved for summary judgment on the grounds that the April 1995 rule was validly applied prospectively. In January 1998, the court granted NMC's motion for partial summary judgment and entered a declaratory judgment in favor of NMC, holding HCFA's retroactive application of the April 1995 rule legally invalid, and based on its finding, the Court also permanently enjoined HCFA from enforcing and applying the April 1995 rule retroactively against NMC. The Court took no action on HCFA's motion for summary judgment pending completion of the outstanding discovery. On October 5, 1998, NMC filed it's own motion for summary judgment requesting that the Court declare HCFA's prospective application of the April 1995 rule invalid and permanently enjoin HCFA from prospectively enforcing and applying the April 1995 rule. The Court has not yet ruled on the parties' motions. HCFA elected not to appeal the Court's June 1995 and January 1998 orders. HCFA may, however, appeal all rulings at the conclusion of the litigation. If HCFA should successfully appeal so that the revised interpretation would be applied retroactively NMC may be required to refund the payments received from employer health plans for services provided after August 10, 1993 under HCFA's original implementation, and to re-bill Medicare for the same services, which would result in a net loss to NMC of approximately $120 million attributable to all periods prior to December 31, 1995. Also, in such event, the Company's business, 45 46 financial position and results of operations would be materially adversely affected. The Settlement would not resolve these proceedings and claims. IDPN COVERAGE ISSUES SRM administers IDPN therapy to chronic dialysis patients who suffer from severe gastrointestinal malfunctions. IDPN therapy was provided by Homecare prior to its divestiture. After 1993, Medicare claims processors sharply reduced the number of IDPN claims approved for payment as compared to prior periods. NMC believes that the reduction in IDPN claims represented an unauthorized policy coverage change. Accordingly, NMC and other IDPN providers pursued various administrative and legal remedies, including administrative appeals, to address this reduction. In November 1995, NMC filed a complaint in the U.S. District Court for the Middle District of Pennsylvania seeking a declaratory judgment and injunctive relief to prevent the implementation of this policy coverage change. (National Medical Care, Inc. v. Shalala, 3:CV-95-1922 (RPC)). Subsequently, the District Court affirmed a prior report of the magistrate judge dismissing NMC's complaint, without considering any substantive claims, on the grounds that the underlying cause of action should be submitted fully to the administrative review processes available under the Medicare Act. NMC decided not to appeal the Court's decision, but rather, to pursue the claims through the available administrative processes. NMC was successful in pursuing these claims through the administrative process, receiving favorable decisions from Administrative Law Judges in more than 80% of its cases. In early 1998, a group of claims which had been ruled on favorably were remanded by the Medicare Appeals Council to a single Administrative Law Judge (the "ALJ") with extensive instructions concerning the review of these decisions. A hearing was scheduled on the remanded claims to take place in July, but later postponed until October 1998. Prior to the July hearing date, the United States Attorney for the District of Massachusetts requested that the hearing be stayed pending resolution of the OIG Investigation, on the basis that proceeding could adversely affect the Government's investigation as well as the Government's efforts to confirm it belief that these claims are false. Prior to the ALJ's issuing a decision on the stay request, the U.S. Attorney's Office requested that NMC agree to a stay in the proceedings in order to achieve a potential resolution of the IDPN claims subject to the OIG Investigation as well as those which are subject to the administrative appeals process. NMC agreed to this request, and together with the U.S. Attorney's Office requested a stay. The ALJ agreed to this request in order to allow the parties the opportunity to resolve both the IDPN claims which are the subject of the OIG Investigation and the IDPN claims which are the subject of the administrative proceedings. In March 1999 negotiations between NMC and the U.S. Attorney's Office failed to progress and NMC requested that the stay be lifted. In connection with the settlement discussions described above (which, if consummated, would resolve all pending IDPN coverage appeals for services rendered prior to 1999), the Government renewed its motion to stay proceedings before the ALJ. The Company opposed the stay. On November 10, 1999, the ALJ agreed to reschedule certain hearings that had been scheduled for the week of November 29, 1999, but denied the motion for a stay and scheduled further hearings to begin January 10, 2000. It is not possible to determine whether, if the Settlement is not consummated, NMC and the Government will be able to resolve issues surrounding the IDPN claims. Further proceedings on other administrative appeals related to unpaid claims remain stayed. Although NMC management believes that those unpaid IDPN claims were consistent with published Medicare coverage guidelines, if the Settlement is not consummated and the Company resumes its appeals of the IDPN claims, there can be no assurance that the claims on appeal will be approved for payment in full or, to the extent approved, collected in full. Such claims represent substantial accounts receivable of NMC, amounting to approximately $150 million as of September 30, 1999. If NMC is unable to collect its IDPN receivable, either through the administrative appeal process or through negotiation, or if IDPN coverage is reduced or eliminated, depending on the amount of the receivable that is not collected and/or the nature of the coverage change, NMC's business, financial condition and results of operations could be materially adversely affected. NMC's IDPN receivables are included in the net assets of the Company's discontinued operations. However, these receivables have not been sold and will remain classified as discontinued operations until they have been settled. See Notes to Consolidated Financial Statements, Note 5 - "Discontinued Operations." 46 47 ADMINISTRATIVE APPEALS The Company regularly pursues various administrative appeals relating to reimbursement issues in connection with its dialysis facilities. One such appeal consists of a challenge to the Medicare regulation which capped reimbursement for the bad debts incurred by dialysis facilities. In 1998, the United States Court of Appeals for the District of Columbia ruled in favor of the Company in connection with the bad debt issue, holding that the Secretary of Health & Human Services had not adequately justified the bad debt regulation, and ruling that the government's order adopting the rule was arbitrary and capricious. The Court of Appeals remanded the matter to the Secretary to provide a more adequate explanation of the bad debt cap or to abandon it. Subsequently, the Court modified its holding to continue the bad debt regulation in effect pending remand. Accordingly, the Company has revised its estimate of recoveries for the previously disallowed bad debt expense associated with the regulation. The Company has reached a preliminary agreement with the Department of Health and Human Services with respect to certain material terms to resolve this matter which, if approved by the Department of Justice, will require payment to the Company of $20.9 million. SPECTRA CORPORATE INTEGRITY AGREEMENT Spectra was acquired by the Company in June 1997. Prior to Spectra's acquisition by the Company, Spectra settled an investigation by the Government and entered into a Corporate Integrity Agreement (the "Spectra Agreement"). In February 1999 the Government advised Spectra that it may be in breach of the Spectra Agreement and on March 15, 1999 issued a subpoena to Spectra requesting certain documents related to the Spectra Agreement. The Government recently advised the Company that the Government's review of Spectra's operations and documents did not disclose any breach of the Spectra Agreement. STATE OF FLORIDA In October 1999, NMC received an Antitrust Civil Investigative Demand ("CID") from the Attorney General of the State of Florida ("Florida AG"). The CID was issued by the Florida AG in the course of an investigation to determine whether there is, has been, or may be a violation of federal and Florida laws resulting from the possible monopolization of, or the entering into agreements in restraint of, trade relating to the provision of dialysis products and services in Florida. The Company is cooperating with the Florida AG's investigation by providing documents and other information to the Florida AG. The impact of this investigation on the Company, if any, cannot be determined at this time. OTHER LITIGATION AND POTENTIAL EXPOSURES In recent years, physicians, hospitals and other participants in the health care industry have become subject to an increasing number of lawsuits alleging professional negligence, malpractice, product liability, workers' compensation or related claims, many of which involve large claims and significant defense costs. The Company and NMC and their subsidiaries have been, and the Company can be expected to continue from time to time to be, subject to such suits due to the nature of the Company's business. Although the Company maintains insurance at a level which it believes to be prudent, there can be no assurance that the coverage limits will be adequate or that all asserted claims will be covered by insurance. In addition, there can be no assurance that liability insurance will continue to be available at acceptable costs. A successful claim against the Company or any of its subsidiaries in excess of insurance coverage could have a material adverse effect upon the Company and the results of its operations. Any claims, regardless of their merit or eventual outcome, also may have a material adverse effect on the reputation and business of the Company. The Company, NMC and their subsidiaries operate a large number and wide variety of facilities throughout the U.S. In such a decentralized system it is often difficult to maintain the desired level of oversight and control over the thousands of individuals employed by many affiliate companies. The Company relies upon its management structure, regulatory and legal resources, and the effective operation of its compliance program to direct, manage and monitor the activities of these employees. However, on occasion, the Company, NMC and their subsidiaries have identified instances where employees, deliberately or inadvertently, have submitted inadequate or false billings while employed by an affiliated company. The illegal actions of such persons may subject NMC to liability under the False Claims Act, among other laws, and the Company cannot predict whether such law enforcement authorities may use such information to initiate further investigations of the business practices disclosed or any other business activities of the Company. In addition, the Company asserts claims and suits arising in the ordinary course of business, the ultimate resolution of which would not, in the opinion of the Company, have a material adverse effect on its financial condition. 47 48 ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K (a) Exhibits Exhibit 2.1 Agreement and Plan of Reorganization dated as of February 4, 1996 between W. R. Grace & Co. and Fresenius AG (incorporated herein by reference to Appendix A to the Joint Proxy Statement-Prospectus of Fresenius Medical Care AG, W. R. Grace & Co. and Fresenius USA, Inc. dated August 2, 1996 and filed with the Commission on August 5, 1996). Exhibit 2.2 Distribution Agreement by and among W. R. Grace & Co., W. R. Grace & Co.-Conn. and Fresenius AG dated as of February 4, 1996 (incorporated herein by reference to Exhibit A to Appendix A to the Joint Proxy Statement-Prospectus of Fresenius Medical Care AG, W. R. Grace & Co. and Fresenius USA, Inc. dated August 2, 1996 and filed with the Commission on August 5, 1996). Exhibit 2.3 Contribution Agreement by and among Fresenius AG, Sterilpharma GmbH and W. R. Grace & Co.-Conn. dated February 4, 1996 (incorporated herein by reference to Exhibit E to Appendix A to the Joint Proxy-Statement Prospectus of Fresenius Medical Care AG, W. R. Grace & Co. and Fresenius USA, Inc. dated August 2, 1996 and filed with the Commission on August 5, 1996). Exhibit 3.1 Certificate of Incorporation of Fresenius Medical Care Holdings, Inc. (f/k/a W. R. Grace & Co.) under Section 402 of the New York Business Corporation Law dated March 23, 1988 (incorporated herein by reference to the Form 8-K of the Company filed on May 9, 1988). Exhibit 3.2 Certificate of Amendment of the Certificate of Incorporation of Fresenius Medical Care Holdings, Inc. (f/k/a W. R. Grace & Co.) under Section 805 of the New York Business Corporation Law dated May 25, 1988 (changing the name to W. R. Grace & Co., incorporated herein by reference to the Form 8-K of the Company filed on May 9, 1988). Exhibit 3.3 Certificate of Amendment of the Certificate of Incorporation of Fresenius Medical Care Holdings, Inc. (f/k/a W. R. Grace & Co.) under Section 805 of the New York Business Corporation Law dated September 27, 1996 (incorporated herein by reference to the Form 8-K of the Company filed with the Commission on October 15, 1996). Exhibit 3.4 Certificate of Amendment of the Certificate of Incorporation of Fresenius Medical Care Holdings, Inc. (f/k/a W. R. Grace & Co.) under Section 805 of the New York Business Corporation Law dated September 27, 1996 (changing the name to Fresenius National Medical Care Holdings, Inc., incorporated herein by reference to the Form 8-K of the Company filed with the Commission on October 15, 1996). Exhibit 3.5 Certificate of Amendment of the Certificate of Incorporation of Fresenius Medical Care Holdings, Inc. under Section 805 of the New York Business Corporation Law dated June 12, 1997 (changing name to Fresenius Medical Care Holdings, Inc., incorporated herein by reference to the Form 10-Q of the Company filed with the Commission on August 14, 1997). Exhibit 3.6 Amended and Restated By-laws of Fresenius Medical Care Holdings, Inc. (incorporated herein by reference to the Form 10-Q of the Company filed with the Commission on August 14, 1997). Exhibit 4.1 Credit Agreement dated as of September 27, 1996 among National Medical Care, Inc. and Certain Subsidiaries and Affiliates, as Borrowers, Certain Subsidiaries and Affiliates, as Guarantors, the Lenders named therein, Nationsbank, N.A., as paying agent and the Bank of Nova Scotia, The Chase Manhattan Bank, Dresdner Bank AG and Nationsbank, N.A., as Managing Agents (incorporated herein by reference to the Form 6-K of Fresenius Medical Care AG filed with the Commission on October 15, 1996). Exhibit 4.2 Amendment dated as of November 26, 1996 (amendment to the Credit Agreement dated as of September 27, 1996, 48 49 incorporated herein by reference to the Form 8-K of Registrant filed with the Commission on December 16, 1996). Exhibit 4.3 Amendment No. 2 dated December 12, 1996 (second amendment to the Credit Agreement dated as of September 27, 1996, incorporated herein by reference to the Form 10-K of Registrant filed with the Commission on March 31, 1997). Exhibit 4.4 Amendment No. 3 dated June 13, 1997 to the Credit Agreement dated as of September 27, 1996 , among National Medical Care, Inc. and Certain Subsidiaries and Affiliates , as Borrowers, Certain Subsidiaries and Affiliates, as Guarantors, the Lenders named therein, NationsBank, N.A., as paying agent and the Bank of Nova Scotia, the Chase Manhattan Bank, N.A., Dresdner Bank AG and NationsBank, N.A. as Managing Agents, as previously amended (incorporated herein by reference to the Form 10-Q of the Registrant filed with the Commission on November 14, 1997). Exhibit 4.5 Amendment No. 4, dated August 26, 1997 to the Credit Agreement dated as of September 27, 1996, among National Medical Care, Inc. and Certain Subsidiaries and Affiliates, as Borrowers, Certain Subsidiaries and Affiliates, as Guarantors, the Lenders named therein, NationsBank, N.A., as paying agent and the Bank of Nova Scotia, the Chase Manhattan Bank, N.A., Dresdner Bank AG and NationsBank, N.A. as Managing Agents, as previously amended (incorporated herein by reference to the Form 10-Q of Registrant filed with Commission on November 14, 1997). Exhibit 4.6 Amendment No. 5 dated December 12, 1997 to the Credit Agreement dated as of September 27, 1996, among National Medical Care, Inc. and Certain Subsidiaries and Affiliates, as Borrowers, Certain Subsidiaries and Affiliates, as Guarantors, the Lenders named therein, NationsBank, N.A., as paying agent and the Bank of Nova Scotia, the Chase Manhattan Bank, N.A., Dresdner Bank AG and NationsBank, N.A. as Managing Agents, as previously amended (incorporated herein by reference to the Form 10-K of Registrant filed with Commission on March 23, 1998). Exhibit 4.7 Form of Consent to Modification of Amendment No. 5 dated December 12, 1997 to the Credit Agreement dated as of September 27, 1996 among National Medical Care, Inc. and Certain Subsidiaries and Affiliates, as Borrowers, Certain Subsidiaries and Affiliates, as Guarantors, the Lenders named therein, NationsBank, N.A., as paying agent and the Bank of Nova Scotia, the Chase Manhattan Bank, N.A., Dresdner Bank AG and NationsBank, N.A. as Managing Agents (incorporated herein by reference to the Form 10-K of Registrant filed with Commission on March 23, 1998). Exhibit 4.8 Amendment No. 6 dated effective September 30, 1998 to the Credit Agreement dated as of September 27, 1996, among National Medical Care, Inc. and Certain Subsidiaries and Affiliates, as Borrowers, Certain Subsidiaries and Affiliates, as Guarantors, the Lenders named therein, NationsBank, N.A., as paying agent and the Bank of Nova Scotia, the Chase Manhattan Bank, N.A., Dresdner Bank AG and NationsBank, N.A. as Managing Agents, as previously amended (incorporated herein by reference to the Form 10-Q of Registrant filed with Commission on November 12, 1998). Exhibit 4.9 Amendment No. 7 dated as of December 31, 1998 to the Credit Agreement dated as of September 27, 1996 among National Medical Care, Inc. and Certain Subsidiaries and Affiliates, as Borrowers, Certain Subsidiaries and Affiliates Guarantors , the Lendors named therein, Nations Bank, N.A. as paying agent and the Bank of Nova Scotia, the Chase Manhattan Bank, Dresdner Bank A. G. and Nations Bank, N.A. as Managing Agents (incorporated herein by reference to the Form 10-K of registrant filed with Commission on March 9, 1999). Exhibit 4.10 Fresenius Medical Care AG 1998 Stock Incentive Plan as amended effective as of August 3, 1998 (incorporated herein by reference to the Form 10-Q of Registrant filed with Commission on May 14, 1998). Exhibit 4.11 Senior Subordinated Indenture dated November 27, 1996, among Fresenius Medical Care AG, State Street Bank and Trust Company, as successor to Fleet National Bank, as Trustee and the Subsidiary Guarantors named therein (incorporated herein by reference to the Form 10-K of Registrant filed with the Commission on March 31, 1997). 49 50 Exhibit 4.12 Senior Subordinated Indenture dated as of February 19, 1998, among Fresenius Medical Care AG, State Street Bank and Trust Company as Trustee and Fresenius Medical Care Holdings, Inc., and Fresenius Medical Care AG, as Guarantors with respect to the issuance of 7 7/8% Senior Subordinated Notes due 2008 (incorporated herein by reference to the Form 10-K of Registrant filed with Commission on March 23, 1998). Exhibit 4.13 Senior Subordinated Indenture dated as of February 19, 1998 among FMC Trust Finance S.a.r.l. Luxemborg, as Insurer, State Street Bank and Trust Company as Trustee and Fresenius Medical Care Holdings, Inc., and Fresenius Medical Care AG, as Guarantors with respect to the issuance of 7 3/8% Senior Subordinated Notes due 2008 (incorporated herein by reference to the Form 10-K of Registrant filed with Commission on March 23, 1998). Exhibit 10.1 Employee Benefits and Compensation Agreement dated September 27, 1996 by and among W. R. Grace & Co., National Medical Care, Inc., and W. R. Grace & Co.-- Conn. (incorporated herein by reference to the Registration Statement on Form F-1 of Fresenius Medical Care AG, as amended (Registration No. 333-05922), dated November 22, 1996 and the exhibits thereto). Exhibit 10.2 Purchase Agreement, effective January 1, 1995, between Baxter Health Care Corporation and National Medical Care, Inc., including the addendum thereto (incorporated by reference to the Form SE of Fresenius Medical Care dated July 29, 1996 and the exhibits thereto). Exhibit 10.3 Agreement, dated November 25, 1992 between Bergen Brunswig Drug Company and National Medical Care, Inc., including the addendum thereto (incorporated by reference to the Form SE of Fresenius Medical Care dated July 29, 1996 and the exhibits thereto). Exhibit 10.4* Product Purchase Agreement, effective January 1, 1999, between Amgen, Inc. and National Medical Care, Inc., including addendum thereto (incorporated by reference to the Form 10-Q of the Registrant filed with the Commission on May 14, 1999). Exhibit 10.5 Primary Guarantee dated July 31, 1996 (incorporated by reference to the Registrant's Registration Statement on Form S-4 (Registration No. 333-09497) dated August 2, 1996 and the exhibits thereto). Exhibit 10.6 Secondary Guarantee dated July 31, 1996 (incorporated by reference to the Registrant's Registration Statement on Form S-4 (Registration No. 333-09497) dated August 2, 1996 and the exhibits thereto). Exhibit 10.7 Receivables Purchase Agreement dated August 28, 1997 between National Medical Care, Inc. and NMC Funding Corporation (incorporated herein by reference to the Form 10-Q of the Registrant filed with the Commission on November 14, 1997). Exhibit 10.8 Amendment dated as of September 28, 1998 to the Receivables Purchase Agreement dated as of August 28, 1997, by and between NMC Funding Corporation, as Purchaser and National Medical Care, Inc., as Seller (incorporated herein by reference to the Form 10-Q of Registrant filed with Commission on November 12, 1998). Exhibit 10.9 Transfer and Administration Agreement dated August 28, 1997 among NMC Funding Corporation, National Medical Care, Inc., Enterprise Funding Corporation, the Bank Investors listed therein and NationsBank, N.A., as agent (incorporated herein by reference to the Form 10-Q of the Registrant filed with the Commission on November 14, 1997). Exhibit 10.10 Amendment No. 1 dated as of February 27, 1998 to Transfer and Administration Agreement dated as of August 28, 1997 among NMC Funding Corporation, National Medical Care, Inc., Enterprise Funding Corporation, the Bank Investors listed herein and NationsBank, N.A., as agent (incorporated herein by reference to the Form 10-K of Registrant filed with Commission on March 23, 1998). Exhibit 10.11 Amendment No. 2 dated as of August 25, 1998 to Transfer and Administration Agreement dated us of August 28, 1997 among NMC Funding Corporation as Transferor, National Medical Care, Inc., as Collection Agent, Enterprise Funding Corporation, and Nations Bank, N.A. as agent for Enterprise Funding Corporation and the Bank Investors 50 51 (incorporated herein by reference to the Form 10-Q of Registrant filed with Commission on November 12, 1998). Exhibit 10.12 Amendment No. 3 dated as of September 28, 1998 to Transfer and Administration Agreement dated as of August 28, 1997 among NMC Funding Corporation as Transferor, National Medical Care, Inc., as Collection Agent, Enterprise Funding Corporation, and Nations Bank, N.A. as agent for Enterprise Funding Corporation and the Bank Investors (incorporated herein by reference to the Form 10-Q of Registrant filed with Commission on November 12, 1998). Exhibit 10.13 Employment agreement dated January 1, 1992 by and between Ben J. Lipps and Fresenius USA, Inc. (incorporated herein by reference to the Annual Report on Form 10-K of Fresenius USA, Inc., for the year ended December 31, 1992). Exhibit 10.14 Modification to FUSA Employment Agreement effective as of January 1, 1998 by and between Ben J. Lipps and Fresenius Medical Care AG (incorporated herein by reference to the Form 10-Q of Registrant filed with Commission on May 14, 1998). Exhibit 10.15 Employment Agreement dated July 1, 1997 by and between Jerry A. Schneider and the Company (incorporated herein by reference to the Form 10-Q of Registrant filed with Commission on May 14, 1998). Exhibit 10.16 Addendum to Employment Agreement dated as of September 18, 1997 by and between Jerry A. Schneider and the Company (incorporated herein by reference to the Form 10-Q of Registrant filed with Commission on May 14, 1998). Exhibit 10.17 Separation Agreement dated as of July 21, 1998 by and between Geoffrey W. Swett and National Medical Care, Inc., (incorporated herein by reference to the Form 10-Q of Registrant filed with Commission on November 12, 1998). Exhibit 10.18 Employment Agreement dated October 23, 1998 by and between Roger G. Stoll and National Medical Care, Inc. (incorporated herein by reference to the Form 10-K of Registrant filed with Commission on March 9, 1999). Exhibit 10.19 Employment Agreement dated November 11, 1998 by and between William F. Grieco and National Medical Care, Inc., (incorporated herein by reference to the Form 10-K of Registrant filed with Commission on March 9, 1999). Exhibit 10.20 Separation Agreement dated as of September 30, 1999 by and among William F. Grieco and Fresenius Medical Care Holdings, Inc. and Fresenius Medical Care AG (incorporated herein by reference to the Form 10-K of Registrant filed with Commission on August 3, 1999). Exhibit 10.21 Subordinated Loan Note dated as of May 18, 1999, among National Medical Care, Inc. and Certain Subsidiaries with Fresenius AG as lender (filed herein). Exhibit 11 Statement re: Computation of Per Share Earnings. Exhibit 27 Financial Data Schedule (b) Reports on Form 8-K On November 2, 1999, FMCH filed a report on Form 8-K showing preliminary results from operations of FMC, the parent corporation of the registrant, for the three months ended September 30, 1999. *Confidential treatment has been granted as to certain portions of this Exhibit. 51 52 SIGNATURES Pursuant to the requirement of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized. Fresenius Medical Care Holdings, Inc. DATE: November 22, 1999 /s/ Ben J. Lipps ------------------- ---------------- NAME: Ben J. Lipps TITLE: President (Chief Executive Officer) DATE: November 22, 1999 /s/ Jerry A. Schneider ------------------ ---------------------- NAME: Jerry Schneider TITLE: Chief Financial Officer 52