See Kahn, J.P., “Scalpel, Please,” Boston Globe, Feb. 1, 1996, at 57.Google Scholar

In an article attacking gag clauses as illegal and unethical, one commentator compared HMO limitations on physician speech to the actions of Romanian dictator Nicolae Ceausescu, who forbade doctors from advising patients about birth control and the use of condoms to prevent the spread of HIV See Martin, J.A. and Bjerknes, L.K., “The Legal and Ethical Implications of Gag Clauses in Physician Contracts,” American Journal of Law & Medicine, 22 (1996): At 433.Google Scholar

See Zabel, K., “AAO, AMA Plan to Fight Gags,” Ophthalmology Times, Mar. 11, 1996, at 9.Google Scholar

See Hartnett-Barry, J., “Mass. Becomes First State to Bar ‘Gag Clauses,”’ National Underwriter, Feb. 19, 1996, at 6.Google Scholar

See “HMO Regulation on Agenda for 1997 Term in State, Federal Legislatures,” Mealey's Insurance Law Weekly, Mar. 6, 1997.Google Scholar

See “1997 Could Be a Big Year for State Consumer Protections,” Managed Care Week, Feb. 24, 1997.Google Scholar

See “HHS to State Medicaid Agencies: No Gag Clauses in HMO Contracts,” Managed Care Week, Feb. 24, 1997.Google Scholar

See “Ganske-Markey Bill Gets a Presidential Boost,” Medicine & Health, Feb. 24, 1997.Google Scholar

The Patient Right to Know Act, H.R. 586, 105th Cong., 1st Sess. (1997).Google Scholar

See “Ganske-Markey Bill Gets a Presidential Boost,” Medicine & Health, Feb. 24, 1997.Google Scholar

See “AAHP Announces First Phase of ‘Patients First’ Plan, Including ‘Gag Rule’ Ban,” Mealey's Litigation Reports: Managed Care, Jan. 22, 1997.Google Scholar

See “Humana: Eliminates ‘Gag’ Clauses from Physician Contracts,” Health Line, Oct. 29, 1996, at. Others, such as Medica Health Plans, have publicly boasted that they never had such provisions in provider contracts. See Howatt, G. and Wright, F., “Medica Affirms No-Gag Policy,” Star Tribune, July 23, 1996, at 1B.Google Scholar

Adams, R.W., “Clauses Cause Doctors to Gag,” Lakeland Ledger, July 23, 1996, at D1.Google Scholar

See Pear, R., “Laws Won’t Let H.M.O.'s Tell Doctors What to Say,” New York Times, Sept. 17, 1996, at A12.Google Scholar

See Martin, and Bjerknes, , supra note 2, at 443–48.Google Scholar

Cal. Bus. & Prof. Code § 2056.1(b) (West 1996).Google Scholar

N.H. Rev. Stat. Ann. § 420-A:8-aII (1996).Google Scholar

Va. Code Ann. § 38.2-3407.10J (Michie 1996). Tennessee's Patients’ Right to Truth Act also limits its protections to discussion of treatment options. See Tenn. Code Ann. § 56-7-2349(b) (1996).Google Scholar

Delaware and Rhode Island have anti-gag laws modeled on the Massachusetts law. See 18 Del. Code Ann. tit. 3339, § 6408 (1996); and R.I. Gen. Laws § 23-17.13-3(c)(5) (1996).Google Scholar

Mass. Ann. Laws ch. 176G, § 6 (Law. Co-op. 1996).Google Scholar

Me. Rev. Stat. Ann. tit. 24-A, § 4303(3) (West 1996).Google Scholar

See id.Google Scholar

N.Y. Ins. Law § 4803(e) (McKinney 1996).Google Scholar

Colo. Rev. Stat. § 10-16-121(l)(b) (1996).Google Scholar

Id. at § 10-16-121(l)(a).Google Scholar

Wash. Rev. Code Ann. § 48.43.075(1)-(2) (West 1996).Google Scholar

See Conklin, M., “‘Gag’ Order Sparks Uproar: AMA Says Contract that Prevents Doctors from Discussing How They’re Paid is Illegal,” Rocky Mountain News, Mar. 24, 1997, at 1B.Google Scholar

See “Denver Doctors: Protest Disclosure Clause in Contract,” Health Line, Mar. 25, 1997.Google Scholar

Ind. Code Ann. § 27-8-11-4.5(a)–(b) (Michie 1996).Google Scholar

See, for example, Fla. S.B. 348 (1997); Minn. H.B. 354, § 2 (1997); Iowa S.B. 108 (1997); and N.D. H.B. 2278 (1997).Google Scholar

Ill. H.B. 333 (1997).Google Scholar

Id. at § 15(d).Google Scholar

Id. at § 20(b).Google Scholar

See generally Iowa S.B. 108 (1997); and N.D. S.B. 2278 (1997).Google Scholar

Ala. H.B. 314 (1997).Google Scholar

Me. Rev. Stat. Ann. tit. 24-A, § 4303(3) (West 1996).Google Scholar

Ala. H.B. 314, § 3(c).Google Scholar

N.Y. A.B. 8602 (1997).Google Scholar

Id. at § 5.Google Scholar

See, for example, R.I. Gen. Laws § 23-17.13-3 (1996); and Me. Rev. Stat. Ann. tit. 24-A, § 4303 (West 1996).Google Scholar

See, for example, Cal. Bus. & Prof. Code § 2056.1(c) (West 1996).Google Scholar

See Tenn. Code Ann. § 56-7-2349 (1996).Google Scholar

Id. at § 56-7-2349(c).Google Scholar

See Ill. H.B. 333, § 30(a)–(b) (1997).Google Scholar

See N.D. S.B. 2278, § 4 (1997).CrossRefGoogle Scholar

See Ill. H.B. 333, § 25.Google Scholar

See Me. Rev. Stat. Ann. tit. 24-A, § 4(c)(2) (West 1996).Google Scholar

Fla. S.B. 348, § 2 (1997).Google Scholar

See Precious, T., “Lawmakers Target HMOs’ Gag Rules,” Times Union, Jan. 30, 1996, at B2.Google Scholar

See Adams, , supra note 13.Google Scholar

See Hartnett-Barry, , supra note 4.Google Scholar

See Adams, , supra note 13.Google Scholar

See Conklin, , supra note 29.Google Scholar

See N.H. Rev. Stat. Ann. § 420-A:8-aII (Michie 1996).Google Scholar

See N.Y. A.B. 8602, § 5 (1997).Google Scholar

See Cal. Bus. & Prof. Code § 2056.1(b) (West 1996).Google Scholar

See Colo. Rev. Stat. § 10-16-121(2)(a) (1996).Google Scholar

See id. at § 10-16-121(2)(b).Google Scholar

See Ill. H.B. 333, § 15(d) (1997).Google Scholar

See id.Google Scholar

See N.Y. A.B. 8602, § 5 (1997).Google Scholar

See Colo. Rev. Stat. § 10-16-121(1)(a) (1996).Google Scholar

See Tenn. Code Ann. § 56-7-2349(c) (1996).Google Scholar

See O’Leary, H.E., “Regulating Health Care Costs Through Fraud Enforcement,” Defense Counsel Journal, 61 (1995): At 211 (“Since 1980, a system of enforcement and adjudication … has evolved.”).Google Scholar

There are coordinated criminal and civil enforcement teams for health care fraud in each of the ninety-four U.S. attorneys’ offices, and approximately 450 full-time positions at the Federal Bureau of Investigation and the Office of the Inspector General (OIG) devoted to investigating health care fraud. “IG Estimates 500 Each Year Will Seek Advisory Opinions on Anti-Kickback Law,” Health Care Daily (BNA), at D-7 (Apr. 3, 1997); and O’Leary, , supra note 1.Google Scholar

42 U.S.C. § 1320a–7b (1994).Google Scholar

42 U.S.C. § 1395nn(a)(1) (1994).Google Scholar

Pub. L. No. 104-191, 110 Stat. 1936 (1996) (codified as amended in scattered sections of U.S.C.A.) (hereinafter HIPAA).Google Scholar

42 U.S.C. § 1320a–7b(b).Google Scholar

See id. There are fourteen situations under which program exclusion is permissive (§ 1320a–7(b)) and two under which exclusion is mandatory (§ 1320a–7(a)).Google Scholar

Compare Hanlester Network v. Shalala, 51 F.3d 1390 (9th Cir. 1995) (finding the scienter requirement of Anti-Kickback Statute to require that the violator must (a) know that the statute prohibits the activity, and (b) act with specific intent to break the law) with U.S. v. Jain, 93 F.3d 436 (8th Cir. 1996) (upholding trial court's jury instructions defining “the word ‘willfully’ [to] mean … unjustifiably and wrongfully, known to be such by the defendant…”).Google Scholar

Medicare and Medicaid Patient and Program Protection Act of 1987, Pub. L. No. 100-93, 1987 U.S.C.C.A.N. (101 Stat.) 680.Google Scholar

Medicare and State Health Care Programs: Fraud and Abuse; Issuance of Advisory Opinions by the OIG, 62 Fed. Reg. 7350-01 (1997). Safe harbor provisions are codified at 42 C.F.R. § 1001.952 (1996), 42 U.S.C. § 1320a–7b(b)(3) (1994).Google Scholar

HIPAA § 205, 42 U.S.C. § 1320a–7d.Google Scholar

42 U.S.C. § 1395nn(a)(1).Google Scholar

See id. at § 1395nn(g)(3).Google Scholar

HIPAA § 242, 18 U.S.C.A. § 1347.Google Scholar

See id. at § 242(a), 18 U.S.C.A. § 1347. Violations resulting in serious bodily injury are punishable by fines under Tide 18 and/or imprisonment of up to twenty years.Google Scholar

See id. at § 241(a), 18 U.S.C.A. § 24.Google Scholar

“AAMC Releases Guidance Manual on Teaching Physician Medicare Billing,” Health Care Daily (BNA), at D-11 (Aug. 22, 1996) (quoting the Association of American Medical Colleges's resource manual).Google Scholar

See, for example, U.S. v. Healthcare Partners, No. 395-CV-01946RNC, 1996 WL 193753, at *6 (D. Conn. Feb. 15, 1996) (requiring the defendant to establish a compliance program as part of settlement); U.S. v. Health Choice of Northwest Missouri, No. 95-6171-CVSJ6, 1996 WL 773322, at *6–7 (W.D. Mo. Oct. 22, 1996) (requiring the defendants to maintain a compliance program as part of settlement); U.S. v. Ass’n of Family Practice Residency Directors, No. 96-575-CV-W-2, 1996 WL 557841, at *2–3 (W.D. Mo. Aug. 15, 1996) (ordering the defendant to maintain an antitrust compliance program as part of settlement); and U.S. v. Woman's Hospital Foundation, No. 96-389-BM2, 1996 WL 634211, at *6–7 (M.D. La. Sept. 11, 1996) (requiring the defendant to establish a compliance program as part of settlement).Google Scholar

“HHS Issues Model Plan for Clinical Laboratories,” Health Care Daily (BNA), at D-3 (Feb. 25, 1997). See also “New Fraud, Abuse Laws ‘Real Sleeper’, Show Need for Good Compliance Plans,” Health Care Daily (BNA), at D-2 (Aug. 27, 1996). At an August 1996 conference on compliance programs for health care companies sponsored by the American Compliance Institute, Ilene Nagel, former commissioner of the U.S. Sentencing Commission from 1985–94, explained that convicted companies that already have a compliance program prior to the violation and report the violation to the U.S. Attorney's Office as soon as possible are awarded “substantial credit” under the sentencing guidelines.Google Scholar

62 Fed. Reg. 9435-01 (1997).Google Scholar

See id. at 9435.Google Scholar

See id.Google Scholar

Id. at 9436.Google Scholar

See id.Google Scholar

This provision has been strongly opposed by the Clinton administration due to the fear that it will be difficult for OIG and DOJ to prosecute those who request advisory opinions and then later violate the Anti-Kickback Statute. “Administration to Propose Repeal of Some HIPAA Fraud, Abuse Provisions,” Health Care Daily (BNA), at D-3 (Mar. 7, 1997).Google Scholar

HIPAA § 205, 42 U.S.C.A. § 1320a–7d.Google Scholar

“IG Estimates 500 Each Year Will Seek Advisory Opinions on Anti-Kickback Law,” Health Care Daily (BNA), at D-7 (Apr. 3, 1997). This estimate is based on an average of six calls per day received by OIG over the past several years on topics that could be addressed by advisory opinions. It takes approximately two to forty hours to complete just one advisory opinion.Google Scholar

62 Fed. Reg. 7350-01 (Feb. 19, 1997). This rule, established in accordance with section 205 of HIPAA, creates a new part 1008 in 42 C.F.R. chapter V.Google Scholar

“Health Care Fraud is High Priority for Justice, Attorney General Claims,” Health Care Daily (BNA), at D-6 (June 11, 1996).Google Scholar

Short, L.A. and Dimond, K.L., “Operation Restore Trust,” Health Law Trends, Nov. 1990, 177, at 192–93 (supplement to Corporate Compliance: How to Be a Good Citizen Corporation Through Self-Policing, PLI/Corp. No. 943A).Google Scholar

See id.Google Scholar

United States Sentencing Commission, Guidelines Manual (Nov. 1995): Ch. 8.Google Scholar

31 U.S.C. § 3729.Google Scholar

See id. at § 3729(a)(7)(A)–(C).Google Scholar

“Insurance Law Should Increase Use of the Voluntary Disclosure Program,” Health Care Daily (BNA), at D-3 (Oct. 18, 1996).Google Scholar

“DOJ Interested in Looking at More ‘Quality of Care’ Cases as Focus Shifts,” Health Care Daily (BNA), at D-3 (Oct. 4, 1996).Google Scholar