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Volumn 54, Issue 3, 1999, Pages 279-323

Kickbacks, courtesies or cost-effectiveness?: Application of the medicare antikickback law to the marketing and promotional practices of drug and medical device manufacturers

Author keywords

[No Author keywords available]

Indexed keywords

BIOMEDICAL TECHNOLOGY ASSESSMENT; CLINICAL STUDY; COST EFFECTIVENESS ANALYSIS; DRUG LEGISLATION; DRUG MARKETING; EVALUATION; FEE; FORGERY; GOOD MANUFACTURING PRACTICE; HEALTH ECONOMICS; HOSPITAL; LABORATORY; LAW; LAW ENFORCEMENT; MANAGED CARE ORGANIZATION; MARKETING; MEDICAL TECHNOLOGY; MEDICARE; PATENT; PATIENT REFERRAL; PHARMACY; PRESCRIPTION; REVIEW; RISK MANAGEMENT;

EID: 0344172606     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review
Times cited : (8)

References (191)
  • 1
    • 0345054090 scopus 로고    scopus 로고
    • 56 Fed. Reg. 35,952, 35,978 (July 29, 1991) (comments of DHHS, Office of inspector General (OIG) regarding discounting practices)
    • 56 Fed. Reg. 35,952, 35,978 (July 29, 1991) (comments of DHHS, Office of inspector General (OIG) regarding discounting practices).
  • 2
    • 0344191827 scopus 로고    scopus 로고
    • note
    • Remark from a frustrated drug company employee after attending a seminar on the Medicare antikickback law.
  • 3
    • 0345054088 scopus 로고    scopus 로고
    • note
    • Pub. L. No. 92-603, 86 Stat. 1419 (1972) (codified as amended 42 U.S.C. § 1320a-7b(b) (1994)). The antikickback statute amends the Social Security Act (SSA), Ch. 531, 49 Stat. 620 (1935) (codified as amended 42 U.S.C. §§ 300 et seq.). The antikickback statute also applies to state programs funded under Titles V (Maternal and Child Health), XIX (Medicaid), and XX (Social Services Block Grants) of the Social Security Act, and (as of January 1, 1997) to all federal health care programs other than the Federal Employees Health Benefits Plan. See Health Insurance Portability and Accountability Act of 1996 (HIPAA), Pub. L. No. 104-191. § 204, 110 Stat. 1936, 1999 (amending 42 U.S.C § 1320a-7b (SSA § 1128B)). The term federal health care program means "any plan or program that provides health benefits, whether directly, through insurance, or otherwise, which is funded directly, in whole or in part, by the United States Government [other than the Federal Employees Health Benefits Plan]," 42 U.S.C. § 1320a-7b(f) (SSA § 1128B(f)), and any federally funded state health care program. For the ease of readers and because the principal programs likely to be affected will remain Medicare and Medicaid, the traditional Medicare/Medicaid nomenclature is used throughout this article. Future references to "Medicare and Medicaid" generally should be read to include these other federally-funded health care programs.
  • 4
    • 0344191800 scopus 로고    scopus 로고
    • note
    • This article will not address the potential for manufacturer liability under other federal authorities that prohibit health care "fraud and abuse," such as the crime of "health care fraud" created by HIPAA § 241 or the so-called "tark law" prohibition on physician self-referral. 42 U.S.C. § 1395nn (SSA § 1877). HIPAA creates new liabilities for any "scheme or artifice" to defraud, or obtain money by false pretenses from, a health plan (federal or not); it is potentially relevant in numerous circumstances, but perhaps most especially where payment arrangements are hidden from plans. Although the Stark law is not clear on its face, there is a good argument that it should not be read to apply to financial relationships between physicians and drug or device manufacturers who simply sell products for inventory to physicians. In a proposed regulation published in early 1998 to implement the Stark law, the Health Care Financing Administration (HCFA) appeared to take a contrary view, suggesting that manufacturer sales to physicians are "financial relationships" subject to regulation under the Stark law. See 63 Fed. Reg. 1659, 1694 (Jan. 9, 1998). HCFA officials, however, subsequently made public statements to clarify that the agency had not intended to imply that manufacturer-physician relations would be subject to Stark, See, e.g., Letter from Nancy-Ann Min DeParle, HCFA Adm'r, to Rep. Bill Thomas (R-CA), Apr. 20, 1998 ("the compensation relationship between the physician and the drug manufacturer is irrelevant [under Stark] . . . because there is no referral to the drug manufacturer [when the physician purchases drugs and provides them to patients]; instead, the physician is referring to himself."). The article also will not address the potential for manufacturer liability under the federal civil False Claims Act (FCA), Pub. L. No. 97-258, 96 Stat. 978 (1982) (codified at 31 U.S.C. §§ 3729 et seq. (1994)), which permits the government to recover damages and penalties in a civil judicial proceeding if the government proves that a defendant knowingly presented or caused to be presented a false or fraudulent claim for payment or approval, 31 U.S.C. § 3729(a)(1). Some courts have accepted the theory of some prosecutors that a claim for services provided pursuant to an unlawful referral (e.g., a referral resulting from an unlawful kickback) runs afoul of the FCA because all such services by definition are false, fraudulent, or for a service not provided as claimed. See infra note 7, While drug and device manufacturers ordinarily do not "present" Medicare or Medicaid claims for payment, it is conceivable that the government could seek to hold a manufacturer liable for "causing" a claim to be presented on behalf of a customer for whom the manufacturer provided billing services or reimbursement advice. The act also allows private persons to bring qui tam suits in the name of the government under certain circumstances, thus raising the potential for suits instituted by competitors or disgruntled employees. See 31 U.S.C. § 3730.
  • 5
    • 24544448206 scopus 로고    scopus 로고
    • § 3
    • 42 U.S.C. § 1320a-7b(b) (SSA § 1128B(b)). Many states have enacted substantially similar antikickback laws that apply regardless of whether federal payment is involved. See, e.g.. MASS. GEN. LAWS ch. 175H, § 3 (1999); MICH. COMP. LAWS § 752,1004 (1999); MINN. STAT. § 621.23 (Supp. 1999); R.I. GEN. LAWS § 40-8,2-3 (1990). This article generally will discuss only the federal law, although state officials could apply federal law principles in interpreting state antikickback laws.
    • (1999) Mass. Gen. Laws Ch.
  • 6
    • 0039501017 scopus 로고    scopus 로고
    • § 752,1004
    • 42 U.S.C. § 1320a-7b(b) (SSA § 1128B(b)). Many states have enacted substantially similar antikickback laws that apply regardless of whether federal payment is involved. See, e.g.. MASS. GEN. LAWS ch. 175H, § 3 (1999); MICH. COMP. LAWS § 752,1004 (1999); MINN. STAT. § 621.23 (Supp. 1999); R.I. GEN. LAWS § 40-8,2-3 (1990). This article generally will discuss only the federal law, although state officials could apply federal law principles in interpreting state antikickback laws.
    • (1999) Mich. Comp. Laws
  • 7
    • 0345485748 scopus 로고    scopus 로고
    • § 621.23
    • 42 U.S.C. § 1320a-7b(b) (SSA § 1128B(b)). Many states have enacted substantially similar antikickback laws that apply regardless of whether federal payment is involved. See, e.g.. MASS. GEN. LAWS ch. 175H, § 3 (1999); MICH. COMP. LAWS § 752,1004 (1999); MINN. STAT. § 621.23 (Supp. 1999); R.I. GEN. LAWS § 40-8,2-3 (1990). This article generally will discuss only the federal law, although state officials could apply federal law principles in interpreting state antikickback laws.
    • (1999) Minn. Stat. , Issue.SUPPL.
  • 8
    • 0345485746 scopus 로고
    • § 40-8,2-3 This article generally will discuss only the federal law, although state officials could apply federal law principles in interpreting state antikickback laws
    • 42 U.S.C. § 1320a-7b(b) (SSA § 1128B(b)). Many states have enacted substantially similar antikickback laws that apply regardless of whether federal payment is involved. See, e.g.. MASS. GEN. LAWS ch. 175H, § 3 (1999); MICH. COMP. LAWS § 752,1004 (1999); MINN. STAT. § 621.23 (Supp. 1999); R.I. GEN. LAWS § 40-8,2-3 (1990). This article generally will discuss only the federal law, although state officials could apply federal law principles in interpreting state antikickback laws.
    • (1990) R.I. Gen. Laws
  • 9
    • 0345485749 scopus 로고    scopus 로고
    • 42 U.S.C. § 1320a-7b(b)
    • 42 U.S.C. § 1320a-7b(b).
  • 10
    • 0344191820 scopus 로고    scopus 로고
    • note
    • In addition, in some jurisdictions a violation of the antikickback statute may provide grounds for suit by the government or a qui tam relator under the FCA. See, e.g., United States v. Kensington Hosp., 760 F. Supp. 1120 (E.D. Pa, 1991); United States ex rel. Roy v. Anthony, 914 F. Supp. 1504 (S.D. Ohio 1994); United States ex rel. Pogue v. American Healthcorp, Inc., 914 F. Supp. 1507 (M.D. Tenn. 1996). The only federal court of appeals to have addressed the issue heid that while a mere violation of antikickback law does not create a basis for suit under the FCA, such basis may exist where defendant certifies compliance with the law in a filing and payment is conditioned on such certification. United States ex rel. Thompson v. Columbia/HCA Healthcare Corp., 125 F.3d 899 (5th Cir. 1997). On remand, the district court denied the defendant's motion to dismiss and allowed the suit to proceed. United States ex rel. Thompson v. Columbia/HCA Healthcare Corp., 1998 U.S. Dist. LEXIS 14350 (No. C-95-110, S.D. Tex., Aug. 18, 1998).
  • 11
    • 0344623553 scopus 로고    scopus 로고
    • 56 Fed. Reg. at 35,954 (quoting United States v. Ruttenberg, 625 F.2d 173, 177, n.9 (7th Cir. 1980))
    • 56 Fed. Reg. at 35,954 (quoting United States v. Ruttenberg, 625 F.2d 173, 177, n.9 (7th Cir. 1980)).
  • 12
    • 0344623549 scopus 로고    scopus 로고
    • note
    • United States v. Greber, 760 F.2d 68, 72 (3d Cir.), cert. denied, 474 U.S. 988 (1985) ("If the payments were intended to induce the physician to use [defendant's] services, the statute was violated, even if the payments were also intended to compensate for professional services"); United States v, Bay State Ambulance & Hosp. Rental Serv., Inc., 874 F.2d 20, 30 (1st Cir. 1989) (noting that the "issue of the sole versus primary reason for payments is irrelevant since any amount of inducement is illegal," but approving a jury instruction that prohibited conviction if the improper purpose was "incidental" or "minor"); United States v. Kats, 871 F.2d 105, 108 (9th Cir. 1989) (approving jury instruction that guilt could be found "if you find beyond a reasonable doubt that one of the material purposes for the solicitation was to obtain money for the referral of services") (emphasis in original).
  • 13
    • 0344623534 scopus 로고
    • Inspector Gen. v. Hanlester Network, Dec. No. 1275 (DHHS Dep't App. Bd., App. Div., Sept. 19, 1991) at 57 & n.34, reprinted in [1992-1 Transfer Binder] (CCH) ¶ 39,566 n.34, on remand, Doc. C-448, Dec. No. CR 181 DHHS Dep't App. Bd., Civ. Remedies Div., Mar. 10
    • Inspector Gen. v. Hanlester Network, Dec. No. 1275 (DHHS Dep't App. Bd., App. Div., Sept. 19, 1991) at 57 & n.34, reprinted in [1992-1 Transfer Binder] Medicare &. Medicaid Guide (CCH) ¶ 39,566 at 27,763 & n.34, on remand, Doc. C-448, Dec. No. CR 181 (DHHS Dep't App. Bd., Civ. Remedies Div., Mar. 10, 1992), reprinted in [1992-2 Transfer Binder] Medicare & Medicaid Guide (CCH) ¶ 40,064, aff'd in part and rev'd in part, Dec. No. 1347 (DHHS Dep't App. Bd., App. Div., July 24, 1992), reprinted in [1992-2 Transfer Binder] Medicare & Medicaid Guide (CCH) at ¶ 40,406B, aff'd sub nom, Hanlester Network v. Sullivan, No. CV 92-4552-LHM, 1993 WL 78299 (C.D. Cal. Feb. 10, 1993), reprinted in [1993-1 Transfer Binder] Medicare & Medicaid Guide (CCH) ¶ 41,076, aff'd in part and rev'd in part sub nom. Hanlester Network v. Shalala, 51 F.3d 1390 (9th Cir. 1995).
    • (1992) Medicare &. Medicaid Guide , pp. 27763
  • 14
    • 0344623534 scopus 로고
    • reprinted in [1992-2 Transfer Binder] (CCH) ¶ 40,064, aff'd in part and rev'd in part, Dec. No. 1347 DHHS Dep't App. Bd., App. Div., July 24
    • Inspector Gen. v. Hanlester Network, Dec. No. 1275 (DHHS Dep't App. Bd., App. Div., Sept. 19, 1991) at 57 & n.34, reprinted in [1992-1 Transfer Binder] Medicare &. Medicaid Guide (CCH) ¶ 39,566 at 27,763 & n.34, on remand, Doc. C-448, Dec. No. CR 181 (DHHS Dep't App. Bd., Civ. Remedies Div., Mar. 10, 1992), reprinted in [1992-2 Transfer Binder] Medicare & Medicaid Guide (CCH) ¶ 40,064, aff'd in part and rev'd in part, Dec. No. 1347 (DHHS Dep't App. Bd., App. Div., July 24, 1992), reprinted in [1992-2 Transfer Binder] Medicare & Medicaid Guide (CCH) at ¶ 40,406B, aff'd sub nom, Hanlester Network v. Sullivan, No. CV 92-4552-LHM, 1993 WL 78299 (C.D. Cal. Feb. 10, 1993), reprinted in [1993-1 Transfer Binder] Medicare & Medicaid Guide (CCH) ¶ 41,076, aff'd in part and rev'd in part sub nom. Hanlester Network v. Shalala, 51 F.3d 1390 (9th Cir. 1995).
    • (1992) Medicare & Medicaid Guide
  • 15
    • 0345485744 scopus 로고
    • reprinted in [1992-2 Transfer Binder] (CCH) at ¶ 40,406B, aff'd sub nom, Hanlester Network v. Sullivan, No. CV 92-4552-LHM, 1993 WL 78299 C.D. Cal. Feb. 10
    • Inspector Gen. v. Hanlester Network, Dec. No. 1275 (DHHS Dep't App. Bd., App. Div., Sept. 19, 1991) at 57 & n.34, reprinted in [1992-1 Transfer Binder] Medicare &. Medicaid Guide (CCH) ¶ 39,566 at 27,763 & n.34, on remand, Doc. C-448, Dec. No. CR 181 (DHHS Dep't App. Bd., Civ. Remedies Div., Mar. 10, 1992), reprinted in [1992-2 Transfer Binder] Medicare & Medicaid Guide (CCH) ¶ 40,064, aff'd in part and rev'd in part, Dec. No. 1347 (DHHS Dep't App. Bd., App. Div., July 24, 1992), reprinted in [1992-2 Transfer Binder] Medicare & Medicaid Guide (CCH) at ¶ 40,406B, aff'd sub nom, Hanlester Network v. Sullivan, No. CV 92-4552-LHM, 1993 WL 78299 (C.D. Cal. Feb. 10, 1993), reprinted in [1993-1 Transfer Binder] Medicare & Medicaid Guide (CCH) ¶ 41,076, aff'd in part and rev'd in part sub nom. Hanlester Network v. Shalala, 51 F.3d 1390 (9th Cir. 1995).
    • (1993) Medicare & Medicaid Guide
  • 16
    • 0004826315 scopus 로고
    • reprinted in [1993-1 Transfer Binder] (CCH) ¶ 41,076, aff'd in part and rev'd in part sub nom. Hanlester Network v. Shalala, 51 F.3d 1390 9th Cir.
    • Inspector Gen. v. Hanlester Network, Dec. No. 1275 (DHHS Dep't App. Bd., App. Div., Sept. 19, 1991) at 57 & n.34, reprinted in [1992-1 Transfer Binder] Medicare &. Medicaid Guide (CCH) ¶ 39,566 at 27,763 & n.34, on remand, Doc. C-448, Dec. No. CR 181 (DHHS Dep't App. Bd., Civ. Remedies Div., Mar. 10, 1992), reprinted in [1992-2 Transfer Binder] Medicare & Medicaid Guide (CCH) ¶ 40,064, aff'd in part and rev'd in part, Dec. No. 1347 (DHHS Dep't App. Bd., App. Div., July 24, 1992), reprinted in [1992-2 Transfer Binder] Medicare & Medicaid Guide (CCH) at ¶ 40,406B, aff'd sub nom, Hanlester Network v. Sullivan, No. CV 92-4552-LHM, 1993 WL 78299 (C.D. Cal. Feb. 10, 1993), reprinted in [1993-1 Transfer Binder] Medicare & Medicaid Guide (CCH) ¶ 41,076, aff'd in part and rev'd in part sub nom. Hanlester Network v. Shalala, 51 F.3d 1390 (9th Cir. 1995).
    • (1995) Medicare & Medicaid Guide
  • 17
    • 0344623532 scopus 로고
    • Hanlester, Transfer Binder (CCH) ¶ 39,566 United States v. Lipkis, 740 F.2d 1447, 1449 (9th Cir. 1985); Bay State, 874 F.2d at 29
    • Hanlester, [1992-1 Transfer Binder] Medicare & Medicaid Guide (CCH) ¶ 39,566 at 27,762-63; United States v. Lipkis, 740 F.2d 1447, 1449 (9th Cir. 1985); Bay State, 874 F.2d at 29.
    • (1992) Medicare & Medicaid Guide , pp. 27762-27763
  • 18
    • 0344623534 scopus 로고
    • Hanlester, Transfer Binder (CCH) ¶ 39,566
    • Hanlester, [1992-1 Transfer Binder] Medicare & Medicaid Guide (CCH) ¶ 39,566 at 27,740, 27,748, 27,759, 27,763.
    • (1992) Medicare & Medicaid Guide , pp. 27740
  • 19
    • 0344623534 scopus 로고
    • Ruttenberg, 625 F.2d at 177; Hanlester Transfer Binder (CCH) ¶ 39,566
    • Ruttenberg, 625 F.2d at 177; Hanlester [1992-1 Transfer Binder] Medicare & Medicaid Guide (CCH) ¶ 39,566 at 27,763.
    • (1992) Medicare & Medicaid Guide , pp. 27763
  • 20
    • 0344623534 scopus 로고
    • Hanlester, Transfer Binder (CCH) ¶ 39,566
    • Hanlester, [1992-1 Transfer Binder] Medicare & Medicaid Guide (CCH) ¶ 39,566 at 27,763. In 1995. the U.S. Court of Appeals for the Ninth Circuit held that a violation of the antikickback law cannot be found absent a showing that the defendant: (1) knew that the law prohibited giving or receiving remuneration for referrals; and (2) acted with a specific intent to violate the law. See Hanlester, 5 F.3d at 1400. Several courts in other jurisdictions, however, have declined to follow this approach. See, e.g., United States v. Starks, 157 F.3d 833, 839 (11th Cir. 1998) (finding that antikickback statute is not a highly technical regulation "that poses a danger of ensnaring persons engaged in apparently innocent conduct"); United States v. Jain, 93 F.3d 436, 440-41 (8th Cir. 1996) (distinguishing Hanlester as an administrative debarment proceeding and rejecting application of the main case on which the Hanlester court relied); United States v. Neufeld, 908 F. Supp. 491, 497 (S.D. Ohio 1995) (declining to follow Hanlester); Medical Dev. Network, Inc. v. Professional Respiratory Care/ Home Med. Equip. Serv. Inc., 673 So.2d 565, 567 (Fla. Dist. Ct. App. 1996) (the statute "is directed at punishment of those who perform sped fie acts and does not require that one engage in the prohibited conduct with the specific intent to violate the statute"), Cf. United States v. Davis, 132 F.3d 1092, 1094 (5th Cir. 1998) ("even the Hanlester court requires knowledge only that the conduct in question was unlawful, and not necessarily knowledge of which particular statute makes the conduct unlawful").
    • (1992) Medicare & Medicaid Guide , pp. 27763
  • 21
    • 0041543660 scopus 로고    scopus 로고
    • § 2B4.1 (sentencing calculations for violation of antikickback law)
    • The civil monetary penalty authority was added by section 4304 of the Balanced Budget Act of 1997, Pub. L. No. 105-33, 111 Stat. 251 (codified at 42 U.S.C. § 1320a-7a(a)(7) (SSA § 1128A(a)(7)). The antikickback law's stated criminal fine - $25,000 per violation - essentially has been rendered obsolete by the more stringent penalty provisions of the Federal sentencing law. See 18 U.S.C § 3571 (1994) (imposing criminal fines of $250,000 for individuals or $500,000 for organizations per violation, or twice the gain to the defendant or loss to another as a result of the illegal conduct); U.S. SENTENCING GUIDELINES MAN. § 2B4.1 (1998) (sentencing calculations for violation of antikickback law).
    • (1998) U.S. Sentencing Guidelines Man
  • 22
    • 0344191797 scopus 로고    scopus 로고
    • note
    • 42 U.S.C. §§ 1320a-7(b)(7), 1320a-7a(a)(7), 1320a-7b(b)(SSA §§ 1128(b)(7), 1128B(a)(7), 1128B(b)) (imposing civil exclusion or civil money penalty of up to $50,000 per act plus three times the remuneration in administrative proceeding, or criminal prosecution with potential fines and prison time of up to five years); 42 C.F.R. §§ 1001.101, 1001.951 (civil exclusion) (1999). HIPPA also added a related civil monetary penalty for offering remuneration to individuals enrolled in Medicare or a state health care program that the person offering knows or should know is likely to influence the individual to order or receive items or services from a particular provider, practitioner, or supplier, 42 U.S.C. § 1320a-7a(a)(5) (SSA § 1128A(a)(5)). Although the term "supplier" is not defined, this authority conceivably could be applied to manufacturers that offer patient coupons or other benefits.
  • 23
    • 0027128522 scopus 로고    scopus 로고
    • See 57 Fed. Reg. 3298, 3300 (Jan. 29, 1992)
    • See 57 Fed. Reg. 3298, 3300 (Jan. 29, 1992).
  • 24
    • 0345054064 scopus 로고    scopus 로고
    • note
    • See 63 Fed. Reg. 46,676 (Sept. 2, 1998). The OIG has indicated specifically that it intends this authority to apply to manufacturers and distributors. Id. at 46,678; 62 Fed. Reg. 47,182, 47,184-85 (Sept. 8, 1997) (NPRM). Because the relevant statutory provisions speak to exclusion of individuals or entities "from participation" in the Medicare and Medicaid programs, it is not clear that the statute gives the OIG the authority to make this change. Moreover, a host of practical considerations, arising out of the different roles played by manufacturers and providers in the health care delivery system - including the potential for beneficiaries to be denied Medicare or Medicaid coverage of drugs or devices for which no therapeutic equivalent exists - led many manufacturers to argue against implementation of this policy change.
  • 25
    • 0344623525 scopus 로고    scopus 로고
    • See, e.g., Polk County v. Peters, 800 F, Supp. 1451 (E.D. Tex. 1992) (citing Hospital Fraud Alert in declaring void a contract under which a physician agreed to refer patients to a hospital as part of a recruitment package)
    • See, e.g., Polk County v. Peters, 800 F, Supp. 1451 (E.D. Tex. 1992) (citing Hospital Fraud Alert in declaring void a contract under which a physician agreed to refer patients to a hospital as part of a recruitment package).
  • 26
    • 0345485725 scopus 로고    scopus 로고
    • note
    • Issued August 1994, reprinted at 59 Fed. Reg. 65,372, 65,376 (Dec. 19, 1994). Special Fraud Alerts must be distinguished from internal OIG "fraud alerts," which are used as an internal means to share information among investigators in the agency. Unlike Special Fraud Alerts, which are available publicly from a variety of sources, internal fraud alerts are available to the public only by making a request under the Freedom of Information Act. Pub. L. No. 89-487, 80 Stat. 250 (1966) (as amended 5 U.S.C. § 552 (1994)); 42 C.F.R. § 401.116.
  • 27
    • 0344623526 scopus 로고    scopus 로고
    • 59 Fed. Reg. at 65,376
    • 59 Fed. Reg. at 65,376.
  • 28
    • 0345485724 scopus 로고    scopus 로고
    • Id.
    • Id.
  • 29
    • 0344623524 scopus 로고    scopus 로고
    • Each of these programs corresponds to a specific investigation and settlement agreement discussed later in this article. See infra notes 97-99 and accompanying text
    • Each of these programs corresponds to a specific investigation and settlement agreement discussed later in this article. See infra notes 97-99 and accompanying text.
  • 30
    • 0344191793 scopus 로고    scopus 로고
    • 59 Fed. Reg. at 65,376
    • 59 Fed. Reg. at 65,376.
  • 31
    • 0345054059 scopus 로고    scopus 로고
    • Issued May 1992, reprinted at 59 Fed. Reg. at 65,375
    • Issued May 1992, reprinted at 59 Fed. Reg. at 65,375.
  • 32
    • 0345485719 scopus 로고    scopus 로고
    • Id. at 65,376
    • Id. at 65,376.
  • 33
    • 0344623521 scopus 로고    scopus 로고
    • Issued October 1994, reprinted at 59 Fed. Reg. at 65,377
    • Issued October 1994, reprinted at 59 Fed. Reg. at 65,377.
  • 34
    • 0345485716 scopus 로고
    • Nov. 23
    • Id. at 65,376. In this regard, it may be worth noting that the American Medical Association (AMA) has taken the position that because it generally is considered unethical for physicians to treat themselves or their families (exceptin emergency situations), it likewise is unethical for physicians to accept from manufacturers free products for their own use or the use of their families, See Am. Med. Ass'n, New Clarification by the Council on Ethical and Judicial Affairs of Guideline 1 from Gifts to Physicians from Industry, Nov. 23, 1993.
    • (1993) Am. Med. Ass'n, New Clarification by the Council on Ethical and Judicial Affairs of Guideline 1 from Gifts to Physicians from Industry
  • 35
    • 0344191786 scopus 로고    scopus 로고
    • Medicare & Medicaid Patient and Program Protection Act of 1987, Pub. L. No. 100-93, § 14, 101 Stat. 697-698
    • Medicare & Medicaid Patient and Program Protection Act of 1987, Pub. L. No. 100-93, § 14, 101 Stat. 697-698.
  • 36
    • 0345054048 scopus 로고    scopus 로고
    • See 56 Fed. Reg. 35,952 (July 29, 1991) (codified at 42 C.F.R. § 1001.952). Amendments to some of the safe harbor provisions were proposed in September 1993 and July 1994, but have not been finalized. See 58 Fed. Reg. 49,008 (Sept. 21, 1993), 59 Fed. Reg. 37,202 (July 21, 1994)
    • See 56 Fed. Reg. 35,952 (July 29, 1991) (codified at 42 C.F.R. § 1001.952). Amendments to some of the safe harbor provisions were proposed in September 1993 and July 1994, but have not been finalized. See 58 Fed. Reg. 49,008 (Sept. 21, 1993), 59 Fed. Reg. 37,202 (July 21, 1994).
  • 37
    • 0344623513 scopus 로고    scopus 로고
    • 54 Fed. Reg. 3088, 3089 (Jan. 23, 1989); 56 Fed. Reg. at 35,954
    • 54 Fed. Reg. 3088, 3089 (Jan. 23, 1989); 56 Fed. Reg. at 35,954.
  • 38
    • 0345054047 scopus 로고    scopus 로고
    • See supra note 8 and accompanying text
    • See supra note 8 and accompanying text.
  • 39
    • 0344191778 scopus 로고    scopus 로고
    • 56 Fed. Reg. at 35,956, 35,978
    • 56 Fed. Reg. at 35,956, 35,978,
  • 40
    • 0344191777 scopus 로고    scopus 로고
    • note
    • As noted supra note 9, the anti-kickback law is violated if even one purpose (as opposed to a primary or sole purpose) of a payment is in exchange for or to induce referred, or the order, purchasing, or recommending of items and services. See, e.g., Greber, 760 F.2d at 72.
  • 41
    • 0344623507 scopus 로고    scopus 로고
    • note
    • 42 U.S.C § 1320a-7b(b)(3)(SSA § 1128B(b)(3)). Exceptions for these payments are needed because percentage sales commissions to employees, the financial benefits entailed by price reductions on purchased products, and fees to group purchasing organizations all can be viewed as "remuneration" intended to induce the recipient to purchase or to recommend or arrange for purchases. See infra notes 58-64 and accompanying text.
  • 42
    • 0345485705 scopus 로고    scopus 로고
    • note
    • See 56 Fed. Reg. at 35,956-57. Thus, where there is an overlap, the OIG has maintained that the scope of the statutory exemptions is defined by the safe harbor provisions. See, e.g., 59 Fed. Reg. at 37,206 (all discounts that Congress intended to protect under the statute are protected under the discount safe harbor).
  • 43
    • 0344623505 scopus 로고    scopus 로고
    • note
    • 42 U.S.C. § 1320a-7b(b)(3) (SSA § 1128B(b)(3)); 42 C.F.R. § 1001.952(h). In July 1994, OIG proposed to rewrite the discount safe harbor See 59 Fed. Reg. at 37,205-06. The proposed amendments would strengthen the requirements imposed on buyers and sellers, and create obligations for a new class of entities described as "offerors" of discounts that are neither buyers nor sellers. To date, this rule has not been finalized.
  • 44
    • 0344191776 scopus 로고    scopus 로고
    • 42 U.S.C. § 1320a-7b(b)(3)(A)(SSA § 1128B(b)(3)(A))
    • 42 U.S.C. § 1320a-7b(b)(3)(A)(SSA § 1128B(b)(3)(A)).
  • 45
    • 0345054041 scopus 로고    scopus 로고
    • note
    • 42 C.F.R. § 1001.952(h). The regulations can be summarized as follows: Buyers that file cost reports (e.g., hospitals and nursing homes) must satisfy the following four requirements: (1) the discount must be earned on purchases of the same good or service bought within a single fiscal year of the buyer; (2) buyer must claim the benefit of the discount in the fiscal year earned or the immediately following year; (3) buyer must fully and accurately report the discount in the applicable cost report; and (4) buyer must provide, on request by Medicare or Medicaid officials, information provided by the seller with respect to the discount. Buyers that are health maintenance organizations (HMOs) or competitive medical plans (CMPs) (under [SSA] §§ 1876(g) or 1903(m)) need not report discounts unless required to do so under their risk contracts. All other buyers (e.g., physicians) must satisfy the following requirements: (1) the discount must be made at the time of the original sale of the good or service; (2) where the good or service is claimed separately for payment under Medicare or Medicaid, the buyer must fully and accurately report the discount on the claim; and (3) buyer must provide, on request by Medicare and Medicaid officials, information furnished by the seller with respect to the discount. Where the buyer is a qualifying HMO or CMP, the seller need not report the discount to the buyer. Where the buyer is an entity that files a cost report, the seller must comply with one of the following standards; (1) where the discount is known at the time of sale, the seller must fully and accurately report the discount on the invoice or statement submitted to the buyer, and inform the buyer of its obligations to report the discount; or (2) where the value of the discount is not known at the time of sale (as in the case of a year-end discount) the seller must fully and accurately report the existence of a discount program on the invoice or statement, [and] when the value of the discount becomes known, provide the buyer with documentation of the calculation of the discount, identifying the specific goods or services purchased to which the discount will be applied, and inform the buyer of its obligations to report the discount. Where the buyer is any other individual or entity and the item or service discounted is not separately claimed for payment, the seller need not report the discount to the buyer. If the item or service is separately claimed for payment, the seller must: fully and accurately report the discount on the invoice or statement submitted to the buyer, and inform the buyer of its obligations to report the discount. See id.
  • 46
    • 0345485704 scopus 로고    scopus 로고
    • 42 U.S.C. § 1320a-7b(b)(3)(B) (SSA § 1128(b)(3)(B)); 42 C.F.R.. § 1001.952(i). While implicated by many types of payments to employees, this safe harbor is of special importance for percentage commission sales arrangements, See infra parts III.D and IV.C.7
    • 42 U.S.C. § 1320a-7b(b)(3)(B) (SSA § 1128(b)(3)(B)); 42 C.F.R.. § 1001.952(i). While implicated by many types of payments to employees, this safe harbor is of special importance for percentage commission sales arrangements, See infra parts III.D and IV.C.7.
  • 47
    • 0345054039 scopus 로고    scopus 로고
    • note
    • The Chief Counsel to the OIG has suggested that in some circumstances the bona fide employment safe harbor may be interpreted more narrowly than its language suggests. In a 1992 letter to the IRS, the Chief Counsel noted that the statutory exception applies only to payments to employees that are for employment in "the provision of covered items or services." Letter from D. McCarty Thornton, Chief Counsel, OIG, to T.J. Sullivan, Tech. Assistant (Health Care Indus.), Off. of the Assoc. Chief Counsel (Employee Benefits and Exempt Organizations), IRS, Dec. 22, 1992. The Chief Counsel's letter notes that "payments to employees which are for the purpose of compensating such employees for the referral of patients would likely not be covered by the employee exemption." Id. n.2. In addition, a proposed, but not yet finalized, rule that would allow the OIG to challenge "sham transactions" suggests that the OIG could challenge even a bona fide employment relationship if it were "entered into or employed for the purpose of appearing to fit within a safe harbor when the substance of the transaction or device is not accurately reflected by the form." See 59 Fed. Reg. 37,202, 37,208 (July 21, 1994). To date, the OIG or the Department of Justice have not applied this interpretation of the employee exemption.
  • 48
    • 0345054035 scopus 로고    scopus 로고
    • 42 U.S.C. § 1320a-7b(b)(3)(C); 42 C.F.R. § 1001.952(j)
    • 42 U.S.C. § 1320a-7b(b)(3)(C); 42 C.F.R. § 1001.952(j).
  • 49
    • 0345054036 scopus 로고    scopus 로고
    • 42 U.S.C. § 1320a-7b(b)(3)(C)
    • 42 U.S.C. § 1320a-7b(b)(3)(C).
  • 50
    • 0344191773 scopus 로고    scopus 로고
    • The term "provider of services" also includes critical access hospitals and comprehensive outpatient rehabilitation facilities. 42 U.S.C. § 1395x(u)(SSA § 1861(u))
    • The term "provider of services" also includes critical access hospitals and comprehensive outpatient rehabilitation facilities. 42 U.S.C. § 1395x(u)(SSA § 1861(u)).
  • 51
    • 0345054037 scopus 로고    scopus 로고
    • Id. § 1320a-7b(b)(3)(C)
    • Id. § 1320a-7b(b)(3)(C).
  • 52
    • 0344191772 scopus 로고    scopus 로고
    • Pub. L. No. 104-191, § 216(a) (codified at 42 U.S.C. § 1320a-7b(b)(3)(F) (SSA § 1128B(b)(3)(F)))
    • Pub. L. No. 104-191, § 216(a) (codified at 42 U.S.C. § 1320a-7b(b)(3)(F) (SSA § 1128B(b)(3)(F))).
  • 53
    • 0344191769 scopus 로고    scopus 로고
    • Id.
    • Id.
  • 54
    • 0344191761 scopus 로고    scopus 로고
    • Government Presents "Big Picture" Plan for Managed Care/Anti-kickback Policy
    • Dec. 5 Industry still awaits release of the proposed rule
    • Id. § 216(b). Representatives from major manufacturer trade associations, including the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Health Industry Manufacturers Association (HIMA), participated in the negotiation process, which formally concluded in 1998. See generally Government Presents "Big Picture" Plan for Managed Care/Anti-kickback Policy, BNA's Medicare Rep., Dec. 5 1997, at 1164. Industry still awaits release of the proposed rule.
    • (1997) BNA's Medicare Rep. , pp. 1164
  • 55
    • 0344623499 scopus 로고    scopus 로고
    • 42 C.F.R. § 1001.952(d)
    • 42 C.F.R. § 1001.952(d).
  • 56
    • 0345485700 scopus 로고    scopus 로고
    • note
    • Safe harbor amendments proposed in July 1994 also would require the agreement to cover all services that the agent provides to the principal for the period of the agreement, and would require that the aggregate services not exceed those that reasonably are necessary to accomplish the legitimate business purpose of the services. See 59 Fed. Reg. at 37,205, 37,207. To date, these proposed changes have not been finalized.
  • 57
    • 0344191768 scopus 로고    scopus 로고
    • See 56 Fed. Reg. at 35,972 (laboratory's lease of space from physician, which laboratory does not use, is a disguised kickback)
    • See 56 Fed. Reg. at 35,972 (laboratory's lease of space from physician, which laboratory does not use, is a disguised kickback).
  • 58
    • 0344623498 scopus 로고    scopus 로고
    • 42 C.F.R. §§ 1001.952(b), (c)
    • 42 C.F.R. §§ 1001.952(b), (c).
  • 59
    • 0344191759 scopus 로고    scopus 로고
    • Id. § 1001.952(d)
    • Id. § 1001.952(d).
  • 60
    • 0345054026 scopus 로고    scopus 로고
    • note
    • Pub. L. No. 104-191, § 205 (adding 42 U.S.C. § 1320a-7d(b)(SSA § 1128D(b)). The OIG has issued a final rule addressing the advisory opinion process, 63 Fed. Reg. 38,311 (July 16, 1998). The rule addresses only the procedures involved in obtaining advisory opinions, however, and does not address "the substance or content of advisory opinions which may be issued in the future." Id. at 38,322.
  • 61
    • 0031577951 scopus 로고    scopus 로고
    • See 62 Fed. Reg. 7350 (Feb. 19, 1997) (codified at 42 C.F.R. pt. 1008)
    • See 62 Fed. Reg. 7350 (Feb. 19, 1997) (codified at 42 C.F.R. pt. 1008).
  • 62
    • 0345054020 scopus 로고    scopus 로고
    • 42 C.F.R. § 1008.36
    • 42 C.F.R. § 1008.36.
  • 63
    • 0344191752 scopus 로고    scopus 로고
    • note
    • For example, the first two advisory opinions, issued in June and July 1997, approved charity care programs that received contributions from companies that might benefit from referrals. The fourth advisory opinion, issued in September 1997, indirectly addressed a charity care issue, but concluded that a waiver of coinsurance program by an ambulatory surgical center that was not limited to cases of demonstrable financial need created risks under the antikickback law. The fifth advisory opinion, issued in October 1997, approved a radiologist-hospital joint venture to operate a radiology center where it was clear that neither the radiologists nor hospital physicians would be a significant source of referrals to the center.
  • 64
    • 0344623477 scopus 로고    scopus 로고
    • note
    • See, e.g., 56 Fed. Reg. at 35,974. This view probably is a technically correct, if overly literal, reading of the law. By nature, a payment to a sales representative is remuneration to a person in exchange for that person arranging for or recommending the purchase of the manufacturer's product. The OIG recognizes that this activity may not be abusive if undertaken appropriately by persons not in a position to actually purchase or prescribe the product, but it is difficult to argue that the law technically does not prohibit all such activity. Because it is not even remotely plausible that Congress believed it was outlawing all commission-based independent contractor sales/marketing arrangements when it enacted the law's 1977 amendments, this is an obvious deficiency in the law itself, which should be corrected either by regulation or statutory amendment. See infra notes 61, 143-56.
  • 65
    • 0344191746 scopus 로고    scopus 로고
    • OIG Advis. Op. No. 98-10 (Aug. 31, 1998), reprinted
    • OIG Advis. Op. No. 98-10 (Aug. 31, 1998), reprinted at 2 Health Care Fraud Rep. (BNA) 680 (1998).
    • (1998) Health Care Fraud Rep. (BNA) , vol.2 , pp. 680
  • 66
    • 0344191750 scopus 로고    scopus 로고
    • note
    • Id. at 3. Under the prospective payment system used by Medicare, hospital patients are grouped into categories (DRGs) by diagnosis. Hospitals are paid a lump sum to care for each patient, which varies according to the DRG to which the patient is assigned. For an explanation of how Medicare calculates prospective payment for hospitals under the DRG payment system, see generally 42 C.F.R. part 412, subpart D.
  • 67
    • 0344623470 scopus 로고
    • Sept. 22
    • See 56 Fed. Reg. at 35,981 (rejecting commentator arguments that independent contractors should be protected under the employee exception to the antikickback law). See generally 123 CONG. REC. 30,280 (Sept. 22, 1977); H. CONF. REP. NO. 95-673, 95th Cong., 1st Sess., at 6-10 (1977); H.R. REP. NO 95-393, pt. 1, 95th Cong., 1st Sess., at 8-11 (1977) (discussing such arrangements in legislative history of antikickback law). Interestingly, the OIG'S basis for rejecting the legislative history suggesting that Congress intended for independent contractors to be protected under the employment exception was that the relevant remarks were made in commenting on the House version of the bill (which referred to "employees") rather than the compromise Conference version (which took the Senate's language and referred to "bona fide employees"). Because one easily might argue that there is no legal distinction between "employees" and "bona fide" (meaning "real") employees, it is unclear whether the OIG's interpretation would survive if subjected to litigation.
    • (1977) Cong. Rec. , vol.123 , pp. 30280
  • 68
    • 0345054008 scopus 로고
    • See 56 Fed. Reg. at 35,981 (rejecting commentator arguments that independent contractors should be protected under the employee exception to the antikickback law). See generally 123 CONG. REC. 30,280 (Sept. 22, 1977); H. CONF. REP. NO. 95-673, 95th Cong., 1st Sess., at 6-10 (1977); H.R. REP. NO 95-393, pt. 1, 95th Cong., 1st Sess., at 8-11 (1977) (discussing such arrangements in legislative history of antikickback law). Interestingly, the OIG'S basis for rejecting the legislative history suggesting that Congress intended for independent contractors to be protected under the employment exception was that the relevant remarks were made in commenting on the House version of the bill (which referred to "employees") rather than the compromise Conference version (which took the Senate's language and referred to "bona fide employees"). Because one easily might argue that there is no legal distinction between "employees" and "bona fide" (meaning "real") employees, it is unclear whether the OIG's interpretation would survive if subjected to litigation.
    • (1977) H. Conf. Rep. No. 95-673, 95th Cong., 1st Sess. , pp. 6-10
  • 69
    • 0344974436 scopus 로고
    • 95th Cong., 1st Sess.
    • See 56 Fed. Reg. at 35,981 (rejecting commentator arguments that independent contractors should be protected under the employee exception to the antikickback law). See generally 123 CONG. REC. 30,280 (Sept. 22, 1977); H. CONF. REP. NO. 95-673, 95th Cong., 1st Sess., at 6-10 (1977); H.R. REP. NO 95-393, pt. 1, 95th Cong., 1st Sess., at 8-11 (1977) (discussing such arrangements in legislative history of antikickback law). Interestingly, the OIG'S basis for rejecting the legislative history suggesting that Congress intended for independent contractors to be protected under the employment exception was that the relevant remarks were made in commenting on the House version of the bill (which referred to "employees") rather than the compromise Conference version (which took the Senate's language and referred to "bona fide employees"). Because one easily might argue that there is no legal distinction between "employees" and "bona fide" (meaning "real") employees, it is unclear whether the OIG's interpretation would survive if subjected to litigation.
    • (1977) H.R. Rep. No 95-393 , Issue.1 PART , pp. 8-11
  • 70
    • 0345485669 scopus 로고    scopus 로고
    • OIG Advis. Op. No. 99-3 (Mar. 16, 1999), reprinted
    • OIG Advis. Op. No. 99-3 (Mar. 16, 1999), reprinted at 3 Health Care Fraud Rep. (BNA) 273 (1999).
    • (1999) Health Care Fraud Rep. (BNA) , vol.3 , pp. 273
  • 72
    • 0344623458 scopus 로고    scopus 로고
    • OIG Advis. Op. No. 98-1 (Mar. 19, 1998), reprinted
    • OIG Advis. Op. No. 98-1 (Mar. 19, 1998), reprinted at 2 Health Care Fraud Rep. (BNA) 255 (1998).
    • (1998) Health Care Fraud Rep. (BNA) , vol.2 , pp. 255
  • 74
    • 0345054000 scopus 로고    scopus 로고
    • Id.
    • Id.
  • 75
    • 0344191742 scopus 로고    scopus 로고
    • Id.
    • Id.
  • 76
    • 0345485661 scopus 로고    scopus 로고
    • note
    • See, e.g., United States v. Tapert, 625 F.2d 111 (6th Cir.), cert. denied sub nom. Freedlander v. United States, 449 U.S. 952 (1980) (volume dependent payments to physicians from laboratories); United States v. Ruttenberg, 625 F.2d 173 (7th Cir. 1980) (monthly fees "for the opportunity to provide drugs and pharmaceutical services" from suppliers to nursing home owners); United States v. Hancock, 604 F.2d 999 (7th Cir.), cert. denied, 444 U.S. 991 (1979) (percentage payments to chiropractors from laboratory).
  • 77
    • 0345053997 scopus 로고
    • Advertising, Marketing and Promotional Practices of the Pharmaceutical Industry: Hearings before the Senate Committee on Labor and Human Resources
    • See generally Advertising, Marketing and Promotional Practices of the Pharmaceutical Industry: Hearings Before the Senate Committee on Labor and Human Resources, 101st Cong., 2d Sess. (1990).
    • (1990) 101st Cong., 2d Sess.
  • 78
    • 0026437456 scopus 로고
    • Guidelines on Gifts to Physicians from Industry: An Update
    • including interpretive commentary in the form of questions and answers
    • See AMA Council on Ethical and Judicial Affairs, Guidelines on Gifts to Physicians from Industry: An Update, 47 FOOD & DRUG L.J. 445 (1992) (including interpretive commentary in the form of questions and answers). The AMA Guidelines originally were issued in December 1990, and first published in 236 JAMA 501 (1991). The Guidelines state: 1. Any gifts accepted by physicians individually should primarily entail a benefit to patients and should not be of substantial value. Accordingly, textbooks, modest meals, and other gifts are appropriate if they serve a genuine educational function. Cash payments should not be accepted. 2. Individual gifts of minimal value are permissible as long as the gifts are related to the physician's work (e.g., pens and notepads). 3. Subsidies to underwrite the costs of continuing medical education conferences or professional meetings can contribute to the improvement of patient care and therefore are permissible. Since the giving of a subsidy directly to a physician by a company's sales representative may create a relationship which could influence the use of the company's products, any subsidy should be accepted by the conference's sponsor who in turn can use the money to reduce the conference's registration fee. Payments to defray the costs of a conference should not be accepted directly from the company by the-physicians attending the conference. 4. Subsidies from industry should not be accepted directly or indirectly to pay for the costs of travel, lodging or other personal expenses of physicians attending conferences or meetings, nor should subsidies be accepted to compensate for the physicians' time. Subsidies for hospitality should not be accepted outside of modest meals or social events held as part of a conference or meeting. It is appropriate for facuhy at conferences or meetings to accept reimbursement for reasonable travel, lodging and meal expenses. It is also appropriate for consultants who provide genuine services to receive reasonable compensation and to accept reimbursement for reasonable travel, lodging and meal expenses. Token consulting or advisory arrangements cannot be used to justify compensating physicians for their time or their travel, lodging and other out-of-pocket expenses. 5. Scholarships or other special funds to permit medical students, residents and fellows to altend carefully selected educational conferences may be permissible as long as the selection of students, residents or fellows who will receive the funds is made by the academic or training institution. 6. No gifts should be accepted if the re are strings attached. For example, physicians should not accept gifts if they are given in relation to the physicians' prescribing practices. In addition, when companies underwrite medical conferences or lectures other than their own, responsibility for and control over the selection of content, faculty, educational methods and materials should belong to the organizers of the conferences or lectures. AMA GUIDELINES ON GIFTS TO PHYSICIANS FROM INDUSTRY (Dec. 1990).
    • (1992) Food & Drug L.J. , vol.47 , pp. 445
  • 79
    • 0344191738 scopus 로고
    • The AMA Guidelines originally were issued in December 1990, and first published
    • See AMA Council on Ethical and Judicial Affairs, Guidelines on Gifts to Physicians from Industry: An Update, 47 FOOD & DRUG L.J. 445 (1992) (including interpretive commentary in the form of questions and answers). The AMA Guidelines originally were issued in December 1990, and first published in 236 JAMA 501 (1991). The Guidelines state: 1. Any gifts accepted by physicians individually should primarily entail a benefit to patients and should not be of substantial value. Accordingly, textbooks, modest meals, and other gifts are appropriate if they serve a genuine educational function. Cash payments should not be accepted. 2. Individual gifts of minimal value are permissible as long as the gifts are related to the physician's work (e.g., pens and notepads). 3. Subsidies to underwrite the costs of continuing medical education conferences or professional meetings can contribute to the improvement of patient care and therefore are permissible. Since the giving of a subsidy directly to a physician by a company's sales representative may create a relationship which could influence the use of the company's products, any subsidy should be accepted by the conference's sponsor who in turn can use the money to reduce the conference's registration fee. Payments to defray the costs of a conference should not be accepted directly from the company by the-physicians attending the conference. 4. Subsidies from industry should not be accepted directly or indirectly to pay for the costs of travel, lodging or other personal expenses of physicians attending conferences or meetings, nor should subsidies be accepted to compensate for the physicians' time. Subsidies for hospitality should not be accepted outside of modest meals or social events held as part of a conference or meeting. It is appropriate for facuhy at conferences or meetings to accept reimbursement for reasonable travel, lodging and meal expenses. It is also appropriate for consultants who provide genuine services to receive reasonable compensation and to accept reimbursement for reasonable travel, lodging and meal expenses. Token consulting or advisory arrangements cannot be used to justify compensating physicians for their time or their travel, lodging and other out-of-pocket expenses. 5. Scholarships or other special funds to permit medical students, residents and fellows to altend carefully selected educational conferences may be permissible as long as the selection of students, residents or fellows who will receive the funds is made by the academic or training institution. 6. No gifts should be accepted if the re are strings attached. For example, physicians should not accept gifts if they are given in relation to the physicians' prescribing practices. In addition, when companies underwrite medical conferences or lectures other than their own, responsibility for and control over the selection of content, faculty, educational methods and materials should belong to the organizers of the conferences or lectures. AMA GUIDELINES ON GIFTS TO PHYSICIANS FROM INDUSTRY (Dec. 1990).
    • (1991) JAMA , vol.236 , pp. 501
  • 80
    • 0005250770 scopus 로고
    • Dec.
    • See AMA Council on Ethical and Judicial Affairs, Guidelines on Gifts to Physicians from Industry: An Update, 47 FOOD & DRUG L.J. 445 (1992) (including interpretive commentary in the form of questions and answers). The AMA Guidelines originally were issued in December 1990, and first published in 236 JAMA 501 (1991). The Guidelines state: 1. Any gifts accepted by physicians individually should primarily entail a benefit to patients and should not be of substantial value. Accordingly, textbooks, modest meals, and other gifts are appropriate if they serve a genuine educational function. Cash payments should not be accepted. 2. Individual gifts of minimal value are permissible as long as the gifts are related to the physician's work (e.g., pens and notepads). 3. Subsidies to underwrite the costs of continuing medical education conferences or professional meetings can contribute to the improvement of patient care and therefore are permissible. Since the giving of a subsidy directly to a physician by a company's sales representative may create a relationship which could influence the use of the company's products, any subsidy should be accepted by the conference's sponsor who in turn can use the money to reduce the conference's registration fee. Payments to defray the costs of a conference should not be accepted directly from the company by the-physicians attending the conference. 4. Subsidies from industry should not be accepted directly or indirectly to pay for the costs of travel, lodging or other personal expenses of physicians attending conferences or meetings, nor should subsidies be accepted to compensate for the physicians' time. Subsidies for hospitality should not be accepted outside of modest meals or social events held as part of a conference or meeting. It is appropriate for facuhy at conferences or meetings to accept reimbursement for reasonable travel, lodging and meal expenses. It is also appropriate for consultants who provide genuine services to receive reasonable compensation and to accept reimbursement for reasonable travel, lodging and meal expenses. Token consulting or advisory arrangements cannot be used to justify compensating physicians for their time or their travel, lodging and other out-of-pocket expenses. 5. Scholarships or other special funds to permit medical students, residents and fellows to altend carefully selected educational conferences may be permissible as long as the selection of students, residents or fellows who will receive the funds is made by the academic or training institution. 6. No gifts should be accepted if the re are strings attached. For example, physicians should not accept gifts if they are given in relation to the physicians' prescribing practices. In addition, when companies underwrite medical conferences or lectures other than their own, responsibility for and control over the selection of content, faculty, educational methods and materials should belong to the organizers of the conferences or lectures. AMA GUIDELINES ON GIFTS TO PHYSICIANS FROM INDUSTRY (Dec. 1990).
    • (1990) Ama Guidelines on Gifts to Physicians from industry
  • 83
    • 0345485658 scopus 로고    scopus 로고
    • supra note 70
    • The Commentary to the Guidelines indicates that gifts not worth more than about $100 to the receiving physician will not be deemed of "substantial value." See AMA Guidelines: An Update, supra note 70, at 451-52.
    • AMA Guidelines: An Update , pp. 451-452
  • 84
    • 0344623452 scopus 로고    scopus 로고
    • note
    • The Commentary to the Guidelines indicates that this means the major educational, scientific, or policymaking meetings of national, regional, or specialty medical associations, rather than conferences or symposia designed specifically for students, residents, or fellows. Am. Med. Ass'n, Clarification, Oct. 1, 1993.
  • 85
    • 0024826182 scopus 로고
    • Doctors. Drug Companies and Gifts
    • See Mary Margaret Chen, M.D., Tom H. Murray, Ph.D., & Charles S. Landefeld, M.D., Doctors. Drug Companies and Gifts, 262 JAMA 3448 (1989).
    • (1989) JAMA , vol.262 , pp. 3448
    • Chen, M.M.1    Murray, T.H.2    Landefeld, C.S.3
  • 86
    • 0345053990 scopus 로고    scopus 로고
    • Id. passim
    • Id. passim.
  • 89
    • 24544447731 scopus 로고
    • Caremark Cited in an Indictment over Payments
    • Aug. 5, See infra notes 95-96 and accompanying text
    • See, e.g., Caremark Cited in an Indictment Over Payments, WALL ST. J., Aug. 5, 1994, at A2. See infra notes 95-96 and accompanying text.
    • (1994) Wall St. J.
  • 90
    • 0345485657 scopus 로고
    • FBI Increases Health Care Fraud Criminal Investigations over 30%
    • Feb. 4
    • FBI Increases Health Care Fraud Criminal Investigations Over 30%, F-D-C Rep., Health News Daily, Feb. 4, 1992, at 3.
    • (1992) F-D-C Rep., Health News Daily , pp. 3
  • 92
    • 0344623446 scopus 로고    scopus 로고
    • Id. at 7
    • Id. at 7.
  • 93
    • 0345485655 scopus 로고    scopus 로고
    • Pub. L. No. 104-191, § 201(b), 110 Stat. 1936, 1993-96(adding 42 U.S.C. § 1395i(k) (SSA § 1817))
    • Pub. L. No. 104-191, § 201(b), 110 Stat. 1936, 1993-96(adding 42 U.S.C. § 1395i(k) (SSA § 1817)).
  • 94
    • 0345485651 scopus 로고    scopus 로고
    • Justice Department Health Care Fraud Cases under Review Totaled over 4,000 in 1997
    • Aug. 13
    • Justice Department Health Care Fraud Cases Under Review Totaled Over 4,000 in 1997, F-D-C Rep., Health News Daily, Aug. 13, 1998, at 5.
    • (1998) F-D-C Rep., Health News Daily , pp. 5
  • 95
    • 0032498680 scopus 로고    scopus 로고
    • G-Men; Federal Resources are Stacking up to Tackle Health Care Fraud
    • Mar. 9
    • G-Men; Federal Resources are Stacking up to Tackle Health Care Fraud, MODERN HEALTHCARE, Mar. 9, 1998, at 32.
    • (1998) Modern Healthcare , pp. 32
  • 96
    • 0344623444 scopus 로고    scopus 로고
    • Crackdown on Health Care Fraud Nets $480 Million in Fiscal 1998, Report Says
    • Mar. 5
    • Crackdown on Health Care Fraud Nets $480 Million in Fiscal 1998, Report Says, BNA's Medicare Rep., Mar. 5, 1999, at 270.
    • (1999) BNA's Medicare Rep. , pp. 270
  • 97
    • 0344191730 scopus 로고    scopus 로고
    • supra note 84
    • G-Men, supra note 84, at 32.
    • G-Men , pp. 32
  • 98
    • 0345485648 scopus 로고    scopus 로고
    • Id. at 33
    • Id. at 33.
  • 100
    • 0344623442 scopus 로고    scopus 로고
    • See supra note 18 and accompanying text
    • See supra note 18 and accompanying text.
  • 101
    • 0345485643 scopus 로고
    • DHHS Fact Sheet Concerning DHHS' Operation Restore Trust
    • reprinted (CCH) Transfer Binder, ¶ 43,213
    • See, e.g., DHHS Fact Sheet Concerning DHHS' Operation Restore Trust, reprinted in Medicare & Medicaid Guide (CCH) [1995-1 Transfer Binder], ¶ 43,213.
    • (1995) Medicare & Medicaid Guide
  • 102
    • 4243696665 scopus 로고    scopus 로고
    • Fraud and Abuse: Operation Restore Trust First Year Brings $42.3 Million to Government
    • May 14
    • Fraud and Abuse: Operation Restore Trust First Year Brings $42.3 Million to Government, BNA Health Care Daily, May 14, 1996, at d2.
    • (1996) BNA Health Care Daily
  • 103
    • 24544439090 scopus 로고    scopus 로고
    • Fraud and Abuse: Expanded Operation Restore Trust to Target More Providers in More States
    • Mar. 25
    • See, e.g., Fraud and Abuse: Expanded Operation Restore Trust to Target More Providers in More States, BNA Health Care Daily, Mar. 25, 1997, at d6.
    • (1997) BNA Health Care Daily
  • 104
    • 24544445684 scopus 로고    scopus 로고
    • Probe in Texas of Columbia Comes to Head
    • Dec. 23
    • See, e.g., Probe in Texas of Columbia Comes to Head, WALL ST. J., Dec. 23, 1997, at A3; For Biggest Hospital Operator, a Debate Over the Ties That Bind, N. Y. TIMES, Apr. 6, 1997, at A1.
    • (1997) Wall St. J.
  • 105
    • 24544468986 scopus 로고    scopus 로고
    • For Biggest Hospital Operator, a Debate over the Ties That Bind
    • Apr. 6
    • See, e.g., Probe in Texas of Columbia Comes to Head, WALL ST. J., Dec. 23, 1997, at A3; For Biggest Hospital Operator, a Debate Over the Ties That Bind, N. Y. TIMES, Apr. 6, 1997, at A1.
    • (1997) N. Y. Times
  • 106
    • 0345485638 scopus 로고    scopus 로고
    • Battle Escalates over Feds False Claims Tactics
    • Nov. 24
    • With regard to PATH, see, e.g., Battle Escalates over Feds False Claims Tactics, NAT'L INTELL. REP., Nov. 24, 1997, at 6; Inspector General's "PATH" Initiative is Aimed at Uncovering Faulty Billing for Teaching Physicians Under Medicare, WASHINGTON FAX, Oct. 30, 1996, at 1; In Crackdown on Health Care Fraud, U.S. Focuses on Training Hospitals and Clinics. N. Y. TIMES, Dec. 22, 1995, at A32; University Agrees to Pay in Settlement on Medicare, N. Y. TIMES, Dec. 13, 1995, at A 18. With regard to LabScam, see, e.g., SmithKline to Pay $325 Million to Settle Federal Claims of Lab-Billing Fraud, WALL ST. J., Feb. 25, 1997, at B6.
    • (1997) Nat'l Intell. Rep. , pp. 6
  • 107
    • 0345053972 scopus 로고    scopus 로고
    • Inspector General's "PATH" Initiative is Aimed at Uncovering Faulty Billing for Teaching Physicians under Medicare
    • Oct. 30
    • With regard to PATH, see, e.g., Battle Escalates over Feds False Claims Tactics, NAT'L INTELL. REP., Nov. 24, 1997, at 6; Inspector General's "PATH" Initiative is Aimed at Uncovering Faulty Billing for Teaching Physicians Under Medicare, WASHINGTON FAX, Oct. 30, 1996, at 1; In Crackdown on Health Care Fraud, U.S. Focuses on Training Hospitals and Clinics. N. Y. TIMES, Dec. 22, 1995, at A32; University Agrees to Pay in Settlement on Medicare, N. Y. TIMES, Dec. 13, 1995, at A 18. With regard to LabScam, see, e.g., SmithKline to Pay $325 Million to Settle Federal Claims of Lab-Billing Fraud, WALL ST. J., Feb. 25, 1997, at B6.
    • (1996) Washington Fax , pp. 1
  • 108
    • 0010643363 scopus 로고
    • In Crackdown on Health Care Fraud, U.S. Focuses on Training Hospitals and Clinics
    • Dec. 22
    • With regard to PATH, see, e.g., Battle Escalates over Feds False Claims Tactics, NAT'L INTELL. REP., Nov. 24, 1997, at 6; Inspector General's "PATH" Initiative is Aimed at Uncovering Faulty Billing for Teaching Physicians Under Medicare, WASHINGTON FAX, Oct. 30, 1996, at 1; In Crackdown on Health Care Fraud, U.S. Focuses on Training Hospitals and Clinics. N. Y. TIMES, Dec. 22, 1995, at A32; University Agrees to Pay in Settlement on Medicare, N. Y. TIMES, Dec. 13, 1995, at A 18. With regard to LabScam, see, e.g., SmithKline to Pay $325 Million to Settle Federal Claims of Lab-Billing Fraud, WALL ST. J., Feb. 25, 1997, at B6.
    • (1995) N. Y. Times
  • 109
    • 24544438183 scopus 로고
    • University Agrees to Pay in Settlement on Medicare
    • Dec. 13
    • With regard to PATH, see, e.g., Battle Escalates over Feds False Claims Tactics, NAT'L INTELL. REP., Nov. 24, 1997, at 6; Inspector General's "PATH" Initiative is Aimed at Uncovering Faulty Billing for Teaching Physicians Under Medicare, WASHINGTON FAX, Oct. 30, 1996, at 1; In Crackdown on Health Care Fraud, U.S. Focuses on Training Hospitals and Clinics. N. Y. TIMES, Dec. 22, 1995, at A32; University Agrees to Pay in Settlement on Medicare, N. Y. TIMES, Dec. 13, 1995, at A 18. With regard to LabScam, see, e.g., SmithKline to Pay $325 Million to Settle Federal Claims of Lab-Billing Fraud, WALL ST. J., Feb. 25, 1997, at B6.
    • (1995) N. Y. Times
  • 110
    • 0344034385 scopus 로고    scopus 로고
    • SmithKline to Pay $325 Million to Settle Federal Claims of Lab-Billing Fraud
    • Feb. 25
    • With regard to PATH, see, e.g., Battle Escalates over Feds False Claims Tactics, NAT'L INTELL. REP., Nov. 24, 1997, at 6; Inspector General's "PATH" Initiative is Aimed at Uncovering Faulty Billing for Teaching Physicians Under Medicare, WASHINGTON FAX, Oct. 30, 1996, at 1; In Crackdown on Health Care Fraud, U.S. Focuses on Training Hospitals and Clinics. N. Y. TIMES, Dec. 22, 1995, at A32; University Agrees to Pay in Settlement on Medicare, N. Y. TIMES, Dec. 13, 1995, at A 18. With regard to LabScam, see, e.g., SmithKline to Pay $325 Million to Settle Federal Claims of Lab-Billing Fraud, WALL ST. J., Feb. 25, 1997, at B6.
    • (1997) Wall St. J.
  • 111
    • 24544444335 scopus 로고
    • Judge Acquits 3 Caremark Execs of Paying Kickbacks to Doctor
    • Oct. 4, The physician who had received these payments, however, was convicted on two counts of violating the antikickback law
    • See United States v. Caremark, No. Cr. 4-94-95 (D. Minn.), Information, Plea Agreement, Joint Stipulation of Facts in Support of Plea Agreement, and Corporate Integrity Agreement (undated). The Caremark settlement agreement explicitly did not cover employees. Three Caremark employees, indicted on allegations related to payments to one particular physician, were acquitted following a jury trial, as was an employee of the manufacturer of the drug distributed by Caremark. See. e.g., Judge Acquits 3 Caremark Execs of Paying Kickbacks to Doctor, CHI. TRIB., Oct. 4, 1995, at B4. The physician who had received these payments, however, was convicted on two counts of violating the antikickback law. See, e.g., Jury Convicts Pediatrician in Kickback Trial. S.F. CHRON., Oct. 20, 1995, at B2.
    • (1995) Chi. Trib.
  • 112
    • 4243696666 scopus 로고
    • Jury Convicts Pediatrician in Kickback Trial
    • Oct. 20
    • See United States v. Caremark, No. Cr. 4-94-95 (D. Minn.), Information, Plea Agreement, Joint Stipulation of Facts in Support of Plea Agreement, and Corporate Integrity Agreement (undated). The Caremark settlement agreement explicitly did not cover employees. Three Caremark employees, indicted on allegations related to payments to one particular physician, were acquitted following a jury trial, as was an employee of the manufacturer of the drug distributed by Caremark. See. e.g., Judge Acquits 3 Caremark Execs of Paying Kickbacks to Doctor, CHI. TRIB., Oct. 4, 1995, at B4. The physician who had received these payments, however, was convicted on two counts of violating the antikickback law. See, e.g., Jury Convicts Pediatrician in Kickback Trial. S.F. CHRON., Oct. 20, 1995, at B2.
    • (1995) S.F. Chron.
  • 113
    • 24544431655 scopus 로고    scopus 로고
    • Genentech Settlement of Changes in Drug Investigation
    • Apr. 9
    • See Genentech Settlement of Changes in Drug Investigation, WALL ST. J., Apr. 9, 1999, at B16: Genentech Settlement Agreed, SCRIP, Apr. 16, 1999, at 10; Genentech's $50 Million U.S. Fine, SCRIP, Apr. 21, 1999, at 14. According to the Wall Street Journal article, the kickback allegations appear not be part of the plea or settlement agreement.
    • (1999) Wall St. J.
  • 114
    • 0345053967 scopus 로고    scopus 로고
    • Genentech Settlement Agreed
    • Apr. 16
    • See Genentech Settlement of Changes in Drug Investigation, WALL ST. J., Apr. 9, 1999, at B16: Genentech Settlement Agreed, SCRIP, Apr. 16, 1999, at 10; Genentech's $50 Million U.S. Fine, SCRIP, Apr. 21, 1999, at 14. According to the Wall Street Journal article, the kickback allegations appear not be part of the plea or settlement agreement.
    • (1999) SCRIP , pp. 10
  • 115
    • 0345053966 scopus 로고    scopus 로고
    • Genentech's $50 Million U.S. Fine
    • Apr. 21
    • See Genentech Settlement of Changes in Drug Investigation, WALL ST. J., Apr. 9, 1999, at B16: Genentech Settlement Agreed, SCRIP, Apr. 16, 1999, at 10; Genentech's $50 Million U.S. Fine, SCRIP, Apr. 21, 1999, at 14. According to the Wall Street Journal article, the kickback allegations appear not be part of the plea or settlement agreement.
    • (1999) SCRIP , pp. 14
  • 116
    • 0344623435 scopus 로고    scopus 로고
    • article, the kickback allegations appear not be part of the plea or settlement agreement
    • See Genentech Settlement of Changes in Drug Investigation, WALL ST. J., Apr. 9, 1999, at B16: Genentech Settlement Agreed, SCRIP, Apr. 16, 1999, at 10; Genentech's $50 Million U.S. Fine, SCRIP, Apr. 21, 1999, at 14. According to the Wall Street Journal article, the kickback allegations appear not be part of the plea or settlement agreement.
    • Wall Street Journal
  • 117
    • 24544464703 scopus 로고
    • Roche Holdings Unit Will Pay $450,000 to Settle Fraud Claim
    • Sept. 6
    • See Off. of Inspector Gen., Fact Sheet on Settlement Agreement with Hoffmann-La Roche, Inc., New Jersey, Sept. 2, 1994; Roche Holdings Unit Will Pay $450,000 To Settle Fraud Claim, WALL ST. J., Sept. 6, 1994, at B6; Hoffmann-La Roche to Pay DHHS $450,000 Settlement, WASH. POST. Sept. 3, 1994, at C1.
    • (1994) Wall St. J.
  • 118
    • 24544470533 scopus 로고
    • Hoffmann-La Roche to Pay DHHS $450,000 Settlement
    • Sept. 3
    • See Off. of Inspector Gen., Fact Sheet on Settlement Agreement with Hoffmann-La Roche, Inc., New Jersey, Sept. 2, 1994; Roche Holdings Unit Will Pay $450,000 To Settle Fraud Claim, WALL ST. J., Sept. 6, 1994, at B6; Hoffmann-La Roche to Pay DHHS $450,000 Settlement, WASH. POST. Sept. 3, 1994, at C1.
    • (1994) Wash. Post.
  • 119
    • 0344623433 scopus 로고    scopus 로고
    • See Settlement Agreement between United States and Ayerst Laboratories, Inc., July 29, 1993
    • See Settlement Agreement between United States and Ayerst Laboratories, Inc., July 29, 1993.
  • 120
    • 0345053964 scopus 로고    scopus 로고
    • note
    • See Letters from Michael B. McCulley, Gen. Att'y, Johnson & Johnson, to Robert A. Simon, Assistant Inspector Gen., (Feb. 7 & 10, 1992). Under the terms of the settlement. Johnson & Johnson agreed to discontinue the aspect of the program that involved frequent flyer miles to prescribing physicians, to channel all rebates through the purchasing pharmacist, and to remind the pharmacist of his or her obligation to reflect price reductions on claims for payment. The latter two requirements appear designed to ensure that Medicare and Medicaid receive any benefits of price reductions. See also infra note 114 (new Medicare civil money penalty for inducements to patients).
  • 121
    • 0345485626 scopus 로고    scopus 로고
    • note
    • See Commonwealth of Mass., Off. of the Att'y Gen., Drug Company Pays $200,000 to Settle Kickback Claims (June 30, 1994); Settlement Agreement Between Miles Inc. and the Commonwealth of Massachusetts, Dep't of the Att'y Gen. (June 30, 1994); In re Upjohn Company, C7-94-7856, Order Approving Assurance of Discontinuance (Ramsey Cty. (Mass.) Dist. Ct., Aug. 1, 1994). As noted above, these practices also appear to constitute "suspect" practices under the Drug Marketing Fraud Alert. See supra notes 20-23 and accompanying text.
  • 122
    • 0344623432 scopus 로고    scopus 로고
    • See supra note 5
    • See supra note 5.
  • 123
    • 0345485625 scopus 로고    scopus 로고
    • § 151.461 The statute also imposes annual reporting requirements on wholesale drug distributors, id. § 151.47, a term that the Minnesota Pharmacy Board interprets to include any manufacturer that distributes prescription drugs in Minnesota to persons other than a consumer or a patient. See id. § 151.449a
    • See MINN. STAT. ANN. § 151.461 (Supp. 1999). The statute also imposes annual reporting requirements on wholesale drug distributors, id. § 151.47, a term that the Minnesota Pharmacy Board interprets to include any manufacturer that distributes prescription drugs in Minnesota to persons other than a consumer or a patient. See id. § 151.449a).
    • (1999) Minn. Stat. Ann. , Issue.SUPPL.
  • 124
    • 0344191717 scopus 로고    scopus 로고
    • See Commonwealth of Mass., Off. of the Att'y Gen., N.J. Pharmaceutical Corporation Settles With Attorney General: 21,000 Nitroglycerin Patches to Be Distributed Free of Charge (May 21, 1993); Settlement Agreement Between Commonwealth of Massachusetts and Schering Corporation (May 20, 1993)
    • See Commonwealth of Mass., Off. of the Att'y Gen., N.J. Pharmaceutical Corporation Settles With Attorney General: 21,000 Nitroglycerin Patches to Be Distributed Free of Charge (May 21, 1993); Settlement Agreement Between Commonwealth of Massachusetts and Schering Corporation (May 20, 1993).
  • 125
    • 0344623430 scopus 로고    scopus 로고
    • See Settlement Agreement Between Commonwealth of Massachusetts and Novo
    • b 1.5 Delivery System Promotion to Medicaid Patients ( Mar 19, 1997).
  • 126
    • 0344623429 scopus 로고    scopus 로고
    • See Settlement Agreement Between Mallinckrodt Chemical, Inc. and the Commonwealth of Massachusetts, (Jan. 23, 1998)
    • See Settlement Agreement Between Mallinckrodt Chemical, Inc. and the Commonwealth of Massachusetts, (Jan. 23, 1998).
  • 127
    • 0344623428 scopus 로고    scopus 로고
    • note
    • For the purposes of this article, "gifts and business courtesies" are defined as straightforward economic benefits to customers that plainly are designed to create goodwill that will make it more likely the customer will want to purchase the giver's product.
  • 128
    • 0344191714 scopus 로고
    • Inspector General v. Hanlester Network, DHHS Dep't App. Bd., App. Div., Sept. 19, at 48 n.34, reprinted (CCH) ¶ 39,566
    • There is, of course, a contrary argument that the intent to build goodwill with customers and physicians should not be deemed to rise to the level of an unlawful inducement to purchase the manufacturer's product. This argument arguably was rejected by the DHHS Departmental Appeals Board (DAB) in Hanlester. In deciding that drug samples and recruitment lunches did not constitute remuneration, the DAB focused on the de minimis nature of those benefits, suggesting that only if the benefit were small enough would they avoid the antikickback law. The Board apparently assumed that if the benefit were large enough to "influence the physician's reason and judgment," it would have involved the impermissible intent of inducing the physician to purchase or order the drug. See Inspector General v. Hanlester Network, (DHHS Dep't App. Bd., App. Div., Sept. 19, 1991) at 48 n.34, reprinted in Medicare & Medicaid Guide (CCH) ¶ 39,566 at 27,763 n.34.
    • (1991) Medicare & Medicaid Guide , Issue.34 , pp. 27763
  • 129
    • 0345485624 scopus 로고    scopus 로고
    • note
    • Id. ("de minimis or very remote forms of remuneration, such as drug samples or recruitment lunches, may not be subject to prosecution.... If the remuneration offered is unlikely to affect physician referral decisions, it is probably not intended to induce referrals, absent clear evidence to the contrary") (emphasis in original).
  • 131
    • 0345485623 scopus 로고    scopus 로고
    • 63 Fed. Reg. 1659, 1725 (Jan. 9, 1998)
    • 63 Fed. Reg. 1659, 1725 (Jan. 9, 1998).
  • 132
    • 0344191711 scopus 로고    scopus 로고
    • See, e.g., Settlement Agreement between Commonwealth of Massachusetts and The Rugby Group, Inc., Civ. Action No. 94-2731 (May 15, 1994) (Rugby paid $200,000 in settlement of allegations that the company provided numerous pharmacists with vacation packages at selected resort locations with purchase of the company's products)
    • See, e.g., Settlement Agreement between Commonwealth of Massachusetts and The Rugby Group, Inc., Civ. Action No. 94-2731 (May 15, 1994) (Rugby paid $200,000 in settlement of allegations that the company provided numerous pharmacists with vacation packages at selected resort locations with purchase of the company's products).
  • 133
    • 0344191713 scopus 로고    scopus 로고
    • Food & Drug Law institute Conference
    • May 20, 1997, Washington, D.C., reported May 26, at T&G-15
    • Remarks by Kevin McAnaney at Food & Drug Law institute Conference, May 20, 1997, Washington, D.C., reported in F-D-C Rep. ("The Pink Sheet") May 26, 1997, at T&G-15.
    • (1997) F-D-C Rep. ("The Pink Sheet")
    • McAnaney, K.1
  • 135
    • 0345485621 scopus 로고    scopus 로고
    • note
    • See supra note 99 and accompanying text. Patient coupons also present difficulties with reporting and passing along price reductions to Medicare and Medicaid, thus preventing many of them from qualifying for the discount safe harbor. See supra note 37 and accompanying text. For these reasons, many manu facturer coupon programs exclude Medicare and Medicaid patients, a practice that can result in difficulties with state regulators. See, e.g., supra note 103 and accompanying text. Congress also has adopted a civil monetary penalty law amendment that specifically forbids remuneration to Medicare beneficiaries to induce them to order covered items or services from a particular provider, practitioner, or supplier 42 U.S.C. § 1320a-7a(a)(5). On its face, however, this provision would not seem to apply to patient coupon programs offered by manufacturers, which Medicare does not treat as providers, practitioners, or suppliers. Patient coupon programs also may implicate state and federal insurance fraud or other laws to the extent that they reduce or eliminate cost-sharing or coinsurance requirements.
  • 136
    • 0345485622 scopus 로고    scopus 로고
    • New Partnership for Patient Programs
    • Mar.
    • See supra note 57. See New Partnership for Patient Programs, PHARM. EXEC., Mar. 1997, at 78.
    • (1997) Pharm. Exec. , pp. 78
  • 137
    • 24544481531 scopus 로고
    • Study Finds Music Soothes Surgeons, Medicine
    • Sept. 21
    • See, e.g., Study Finds Music Soothes Surgeons, Medicine, L.A. TIMES, Sept. 21, 1994, at A20.
    • (1994) L.A. Times
  • 139
    • 0344191709 scopus 로고    scopus 로고
    • As noted above, however, providing reimbursement advice to customers may increase the chances that a manufacturer will be subject to liability under the FCA. See supra note 4
    • As noted above, however, providing reimbursement advice to customers may increase the chances that a manufacturer will be subject to liability under the FCA. See supra note 4.
  • 140
    • 0345485620 scopus 로고    scopus 로고
    • note
    • See, e.g., 54 Fed. Reg. at 3091. The analysis in this section applies to payments for services to the manufacturer, not to general or unrestricted grants that allow customers to pursue research of interest to the customer or for any other purpose. Such payments are more properly characterized as gifts, and should be analyzed under the preceding section.
  • 141
    • 0345485618 scopus 로고    scopus 로고
    • See, e.g., 56 Fed. Reg. at 35,972
    • See, e.g., 56 Fed. Reg. at 35,972.
  • 142
    • 0344191707 scopus 로고    scopus 로고
    • See, e.g., id. at 35.953 (payment varies with volume of referrals); 54 Fed. Reg. at 3090 (payment not for fair market value of services)
    • See, e.g., id. at 35.953 (payment varies with volume of referrals); 54 Fed. Reg. at 3090 (payment not for fair market value of services).
  • 143
    • 0344191706 scopus 로고    scopus 로고
    • 42 C.F.R. § 1001.952(d); see also id. § 1001.952(i) (employee safe harbor)
    • 42 C.F.R. § 1001.952(d); see also id. § 1001.952(i) (employee safe harbor).
  • 144
    • 0344191705 scopus 로고    scopus 로고
    • Id.
    • Id.
  • 145
    • 0344191703 scopus 로고    scopus 로고
    • note
    • In addition, if compensation for a post-approval clinical study were structured on a per patient basis, it also would not be possible to satisfy the requirement that aggregate payment be set in advance and be unrelated to the volume or value of business generated between the parties, because treating more patients could lead to more compensation. If compensation is reasonable, as discussed below, however, the failure to meet this criterion arguably would not be abusive. This criterion arguably could be satisfied if a single amount for all study patients was agreed to in advance, although it might be advisable to consider some mechanism to reduce the overall payment if patients drop out of the study.
  • 146
    • 0344623422 scopus 로고    scopus 로고
    • See. e.g., 56 Fed. Reg. at 35,954
    • See. e.g., 56 Fed. Reg. at 35,954.
  • 147
    • 0344623426 scopus 로고    scopus 로고
    • Id.; see also supra note 8 and accompanying text
    • Id.; see also supra note 8 and accompanying text.
  • 148
    • 0345053957 scopus 로고    scopus 로고
    • See supra notes 77-78 and accompanying text
    • See supra notes 77-78 and accompanying text.
  • 149
    • 0345485613 scopus 로고    scopus 로고
    • But see supra note 41
    • But see supra note 41.
  • 150
    • 33645630721 scopus 로고
    • Some insight, at least, into the OIG's view of studies that are more than likely to be used for promotional purposes, can be found in an April OIG report, supra note 77
    • Some insight, at least, into the OIG's view of studies that are more than likely to be used for promotional purposes, can be found in an April 1991 OIG report, PROMOTION OF PRESCRIPTION DRUGS THROUGH PAYMENTS AND GIFTS, supra note 77.
    • (1991) Promotion of Prescription Drugs Through Payments and Gifts
  • 151
    • 0345053954 scopus 로고    scopus 로고
    • 42 C.F.R. § 1001.952(d)
    • 42 C.F.R. § 1001.952(d).
  • 152
    • 0344623421 scopus 로고    scopus 로고
    • Pub. L. No. 101-508, 104 Stat. 1388 (1990) (codified at 42 U.S.C. § 1396r-8 (SSA § 1927) (1994))
    • Pub. L. No. 101-508, 104 Stat. 1388 (1990) (codified at 42 U.S.C. § 1396r-8 (SSA § 1927) (1994)).
  • 153
    • 0345485611 scopus 로고    scopus 로고
    • note
    • See, e.g., 61 Fed. Reg. 46,166, 46,176 (Aug. 30, 1996) (reweighting DRGs based on charge data received for Medicare beneficiaries). Currently, HCFA does not rely on acquisition cost data, but keeping this information accurate still is viewed as important by the OIG because HCFA may wish to rely on this kind of data at some time in the future.
  • 154
    • 0345053955 scopus 로고    scopus 로고
    • OIG Advis. Op. No. 99-3, supra note 62, at 3-4
    • See OIG Advis. Op. No. 99-3, supra note 62, at 3-4, 3 Health Care Fraud Rep. at 274-75.
    • Health Care Fraud Rep. , vol.3 , pp. 274-275
  • 156
    • 0344623420 scopus 로고    scopus 로고
    • Id.
    • Id.
  • 157
    • 0344623417 scopus 로고    scopus 로고
    • For example, under federal law, states are required to establish standards for pharmacist counseling of Medicaid beneficiaries. 42 U.S.C. § 1396r-8(g)(2)(A)(ii) (SSA § 1927(g)(2)(A)(ii)); 42 C.F.R. § 456.705(c)
    • For example, under federal law, states are required to establish standards for pharmacist counseling of Medicaid beneficiaries. 42 U.S.C. § 1396r-8(g)(2)(A)(ii) (SSA § 1927(g)(2)(A)(ii)); 42 C.F.R. § 456.705(c).
  • 158
    • 0345053951 scopus 로고    scopus 로고
    • Mar. 24
    • See supra notes 131-36 and accompanying text. An OIG attorney recently called into question even this commonplace practice, however, noting that her office had "concerns" with market share rebates given to pharmacies. F-D-C Rep., Health News Daily, Mar. 24, 1999, at 2 (reporting remarks of OIG Attorney Vicki Robinson at American Society of Consultant Pharmacists Conference, Mar. 23, 1999, Washington, D.C.).
    • (1999) F-D-C Rep., Health News Daily , pp. 2
  • 159
    • 0344191700 scopus 로고    scopus 로고
    • reporting remarks of OIG Attorney Vicki Robinson Mar. 23, Washington, D.C.
    • See supra notes 131-36 and accompanying text. An OIG attorney recently called into question even this commonplace practice, however, noting that her office had "concerns" with market share rebates given to pharmacies. F-D-C Rep., Health News Daily, Mar. 24, 1999, at 2 (reporting remarks of OIG Attorney Vicki Robinson at American Society of Consultant Pharmacists Conference, Mar. 23, 1999, Washington, D.C.).
    • (1999) American Society of Consultant Pharmacists Conference
  • 160
    • 0345053950 scopus 로고    scopus 로고
    • Foundation Health: Calls off Controversial Drug Deal
    • Oct. 15, As one consumer advocate commented "[t]here was nothing to justify this deal. I think this will spark legislation to prohibit this type of unseemly kickback that benefits neither the patient, the doctor or the health care system." Id.
    • This concern may have motivated one HMO and a drug manufacturer to back away from just such an arrangement in 1998. See Foundation Health: Calls Off Controversial Drug Deal, CONGRESS DAILY, Oct. 15, 1998. As one consumer advocate commented "[t]here was nothing to justify this deal. I think this will spark legislation to prohibit this type of unseemly kickback that benefits neither the patient, the doctor or the health care system." Id.
    • (1998) Congress Daily
  • 161
    • 0344191696 scopus 로고    scopus 로고
    • Federal Prosecutors May Scrutinize Manufacturer/PBM Company Contacts
    • Dec. 21, (remarks of Assistant U.S. Attorney James Sheehan)
    • See Federal Prosecutors May Scrutinize Manufacturer/PBM Company Contacts, F-D-C Rep., Health News Daily, Dec. 21, 1998, at 1 (remarks of Assistant U.S. Attorney James Sheehan). See also supra note 137. Cf. Remarks of James Sheehan at American Society of Consulting Pharmacists 28th Annual Meeting, at 6-7 (Nov. 12-15, 1997, Philadelphia, PA).
    • (1998) F-D-C Rep., Health News Daily , pp. 1
  • 162
    • 0345053949 scopus 로고    scopus 로고
    • Nov. 12-15, Philadelphia, PA
    • See Federal Prosecutors May Scrutinize Manufacturer/PBM Company Contacts, F-D-C Rep., Health News Daily, Dec. 21, 1998, at 1 (remarks of Assistant U.S. Attorney James Sheehan). See also supra note 137. Cf. Remarks of James Sheehan at American Society of Consulting Pharmacists 28th Annual Meeting, at 6-7 (Nov. 12-15, 1997, Philadelphia, PA).
    • (1997) American Society of Consulting Pharmacists 28th Annual Meeting , pp. 6-7
    • Sheehan, J.1
  • 163
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    • Id.
    • Id.
  • 164
    • 0345053948 scopus 로고    scopus 로고
    • note
    • Of course, to the extent that the PBM actually passes through discounts to the ultimate payers (e.g. health plans), those payments probably could be structured either to meet discount safe harbor requirements, or to present no reasonable basis for an enforcement proceeding.
  • 165
    • 24544454075 scopus 로고
    • Merck's Medco to Change Procedures on Prescriptions, Settling with 17 States
    • Oct. 26
    • See In re Merck & Co., Inc. and Medco Containment Servs., Inc., No. C6 95 10614, Agreement (Oct. 25, 1995); Merck's Medco to Change Procedures On Prescriptions, Settling With 17 States, WALL ST. J., Oct. 26, 1995, at B8; Merck Subdivision Settles Charges It Broke Fraud Laws, WASH. TIMES, Oct. 26, 1995, at B10.
    • (1995) Wall St. J.
  • 166
    • 4243696663 scopus 로고
    • Merck Subdivision Settles Charges It Broke Fraud Laws
    • Oct. 26
    • See In re Merck & Co., Inc. and Medco Containment Servs., Inc., No. C6 95 10614, Agreement (Oct. 25, 1995); Merck's Medco to Change Procedures On Prescriptions, Settling With 17 States, WALL ST. J., Oct. 26, 1995, at B8; Merck Subdivision Settles Charges It Broke Fraud Laws, WASH. TIMES, Oct. 26, 1995, at B10.
    • (1995) Wash. Times
  • 167
    • 0344191695 scopus 로고    scopus 로고
    • Sec supra notes 59-64 and accompanying text
    • Sec supra notes 59-64 and accompanying text.
  • 168
    • 0344623410 scopus 로고    scopus 로고
    • See supra notes 5, 59-64 and accompanying text
    • See supra notes 5, 59-64 and accompanying text.
  • 169
    • 0344191692 scopus 로고    scopus 로고
    • See supra note 40 and accompanying text. But see supra note 41
    • See supra note 40 and accompanying text. But see supra note 41.
  • 170
    • 0345053942 scopus 로고    scopus 로고
    • As noted above, this position is debatable in light of the law's legislative history. See supra note 61
    • As noted above, this position is debatable in light of the law's legislative history. See supra note 61.
  • 171
    • 0345485601 scopus 로고    scopus 로고
    • See supra notes 50-51 and accompanying text
    • See supra notes 50-51 and accompanying text.
  • 172
    • 0344191689 scopus 로고    scopus 로고
    • note
    • See supra notes 59-64 and accompanying text. While not necessarily relevant to the OIG's enforcement priorities, at least two courts have taken the position that commissions to independent sales representatives represent per se violations of the law. See Nursing Home Consultants, Inc. v. Quantum Health Serv. Inc., 926 F. Supp. 835, 844 (E.D. Ark. 1996); Medical Dev. Network, 673 So.2d 565. These cases are distinguishable because they were private contract disputes between the parties, and may have involved some degree of marketing directly to patients, A more troubling decision recently was reached by a California appellate court, which interpreted that state's Medicaid antikickback law as & per se prohibition on commission sales. People v. Duz-Mor Diagnostic Lab., 68 Cal. App. 4th 654 (2d App. Dist. 1998). Again, there is a possibly relevant distinction, in that the California law does not have a "knowingly and willfully" requirement.
  • 173
    • 0344191690 scopus 로고    scopus 로고
    • See supra note 61 and accompanying text
    • See supra note 61 and accompanying text.
  • 174
    • 0345485599 scopus 로고    scopus 로고
    • Id.
    • Id.
  • 175
    • 0344191687 scopus 로고    scopus 로고
    • 56 Fed. Reg. at 35,974
    • 56 Fed. Reg. at 35,974.
  • 176
    • 0345053941 scopus 로고    scopus 로고
    • Id.
    • Id.
  • 177
    • 0345053939 scopus 로고    scopus 로고
    • See supra note 60 and accompanying text
    • See supra note 60 and accompanying text.
  • 178
    • 0344623407 scopus 로고    scopus 로고
    • note
    • These concerns should not preclude companies from hiring physicians on a reasonable fixed-fee basis (e.g., per diem or per hour rate) to perform consulting services, including participating in speakers' bureaus or other educational activities on behalf of a product. While such arrangements clearly implicate the law, they generally should not be found to violate the law if theamount paid to the physician is appropriate compensation for his or her time and effort (and not dependent on sales), especially if the presentations are made to medical professionals orpayors and not directly to patients. See supra notes 119-28 and accompanying text.
  • 179
    • 0345053940 scopus 로고    scopus 로고
    • note
    • For example, a fixed amount per month could be paid to the other company, which then could create incentives for its own employees under the umbrella of the employment safe harbor.
  • 180
    • 0344623405 scopus 로고    scopus 로고
    • note
    • Obviously, these criteria provide little comfort to manufacturers whose primary selling strategy is to "detail" prescribing physicians on the use of outpatient products. For this reason, a new safe harbor or a statutory amendment would be necessary to truly protect legitimate and appropriate commission sales activity. See infra Part VI.B.2.
  • 181
    • 0344191685 scopus 로고    scopus 로고
    • See, e.g., Balanced Budget Act of 1997, Pub. L. No. 105-33, § 4001 (establishing Medicare+Choice program)
    • See, e.g., Balanced Budget Act of 1997, Pub. L. No. 105-33, § 4001 (establishing Medicare+Choice program).
  • 182
    • 0345485598 scopus 로고    scopus 로고
    • See, e.g., 56 Fed. Reg. at 35,961
    • See, e.g., 56 Fed. Reg. at 35,961.
  • 183
    • 0345053936 scopus 로고    scopus 로고
    • See supra notes 47-49 and accompanying text
    • See supra notes 47-49 and accompanying text.
  • 184
    • 0345485593 scopus 로고    scopus 로고
    • Managed Care: Placebo or Wonder Drug for Health Care Fraud & Abuse?
    • See, e.g., Sharon L. Davies & Timothy Stoltzfus Jost, Managed Care: Placebo or Wonder Drug for Health Care Fraud & Abuse?, 31 GA. L. REV. 373, 391-93 (1997).
    • (1997) Ga. L. Rev. , vol.31 , pp. 373
    • Davies, S.L.1    Jost, T.S.2
  • 185
    • 0344623403 scopus 로고    scopus 로고
    • note
    • See supra notes 138-42 and accompanying text. Of course, discount arrangements with risk-basis HMOs may satisfy the requirements of the discount safe harbor. 42 C.F.R. § 1001.952(h). Another safe harbor, for price reductions to health plans by contract health care providers, may not be available, because manufacturers may not meet the definition of a "contract health care provider." 42 C.F.R. § 1001.952.
  • 186
    • 0345053935 scopus 로고    scopus 로고
    • See supra note 9 and accompanying text
    • See supra note 9 and accompanying text.
  • 187
    • 0344623399 scopus 로고    scopus 로고
    • note
    • For example, since 1994, the OIG has had the authority to impose a variety of penalties on Medicare and Medicaid MCOs that, inter alia, fail to provide medically necessary care to enrollees. See 42 U.S.C. §§ 1395mm(I)(6)(A), 1396b(m)(5)(A); 42 C.F.R. § 417.500(a). These authorities have been augmented by additional requirements imposed on MCOs by the new Medicare+Choice regulations. See 63 Fed. Reg. 34,968 (June 26, 1998) (interim final rule with comment period); see also 63 Fed. Reg. 52,022 (Sept. 29, 1998) (containing similar requirements in proposed rule allowing states greater flexibility to require Medicaid recipients to enroll in MCOs).
  • 188
    • 0345485590 scopus 로고    scopus 로고
    • See Davies & Jost, supra note 160, at 390-92
    • See Davies & Jost, supra note 160, at 390-92.
  • 189
    • 0032608387 scopus 로고    scopus 로고
    • The Role of the States in Combating Managed Care Fraud & Abuse
    • See id. at 388; see also Joan H. Krause, The Role of the States in Combating Managed Care Fraud & Abuse, 8 ANNALS HEALTH L, 179 (1999).
    • (1999) Annals Health L , vol.8 , pp. 179
    • Krause, J.H.1
  • 190
    • 0344191679 scopus 로고    scopus 로고
    • See HIPAA, Pub. L. No. 104-191, § 205, 110 Stat. 2000-01 (adding 42 U.S.C. § 1320a-7d(a)(SSA § 1128D))
    • See HIPAA, Pub. L. No. 104-191, § 205, 110 Stat. 2000-01 (adding 42 U.S.C. § 1320a-7d(a)(SSA § 1128D)).
  • 191
    • 0032498007 scopus 로고    scopus 로고
    • 63 Fed. Reg. 1659, 1724-25 (Jan. 9, 1998) (proposing amendment to 42 C.F.R. § 411.357(d))
    • 63 Fed. Reg. 1659, 1724-25 (Jan. 9, 1998) (proposing amendment to 42 C.F.R. § 411.357(d)).


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.