Posted by Scott D. Stein and Allison W. Reimann
In a February 25, 2013 opinion, a federal district court in Massachusetts dismissed a complaint against twenty-four drug manufacturers, distributors, and labelers, holding that the court lacked subject matter jurisdiction because the facts on which the relator’s claims were based were “publicly disclosed” in drug reimbursement data files and similar documents.
The case concerned the requirement that drug manufacturers file a list of “covered outpatient drugs” they market with the Centers for Medicare and Medicaid Services (“CMS”) and inform CMS whether any of these drugs (or drugs that are identical, related or similar) were subject to review under the Drug Efficacy Study Implementation (“DESI”) program. The relator alleged that the defendants fraudulently misrepresented that their products were covered outpatient drugs eligible for Medicaid reimbursement by listing with CMS unapproved drugs, false DESI codes, and non-drug products. The relator claimed that the federal government thus had erroneously reimbursed over $500 million for the defendants’ products.
The defendants moved to dismiss on public disclosure grounds because both the “true” facts and the facts that the defendants allegedly misrepresented all were publicly disclosed. First, the defendants argued that the allegedly misrepresented facts were disclosed in two places: (1) lists of covered outpatient drugs and associated DESI codes that are published quarterly by CMS (which would show any false statements that the defendants’ products were covered outpatient drugs); and (2) lists of the products and the amounts that the federal government reimbursed to states, also published by CMS (which would show that state Medicaid programs relied on such misrepresentations). Second, the defendants asserted that the “true” facts would be disclosed by three other sources: (1) FDA’s Orange Book (which lists all FDA-approved drugs, making any unapproved drugs listed by defendants conspicuous by their absence); (2) Federal Register notices (which notify the public of FDA’s DESI determinations); and (3) FDA’s National Drug Code Directory (which provides information necessary to show that two drugs are identical, related, or similar).
The court agreed that, read together, these sources created a plausible inference of fraud sufficient to trigger the public disclosure bar – even if substantial expertise would be required to identify the alleged discrepancies. The court explained that “the only question is whether the material facts exposing the alleged fraud are already in the public domain, not whether they are difficult to recognize.” Slip. Op. at 8. The court also rejected the relator’s contention that CMS data lists could not be considered “administrative reports” for purposes of the public disclosure bar, reasoning that the agency engages in at least minimal preparation and synthesis in compiling the data into a usable format for the public.
This case is significant in that it affirmatively holds that information contained in government data files, such as CMS’s state drug utilization data, can qualify as a public disclosure, even where understanding and interpreting the data requires specialized expertise. This holding could be significant in a number of pricing-related contexts where pricing to federal health care programs and other customers may be in the public domain. The decision confirms that relators cannot bring whistleblower actions where their contribution consists of nothing more than drawing inferences from publicly available information.
Posted by Scott Stein and Jessica Rothenberg
A recent opinion by a federal district court in California addressed a competitor’s effort to leverage the outcome of pharmaceutical patent litigation into an FCA suit. The case arose out of Hatch-Waxman litigation between Aventis, manufacturer of Lovenox (enoxaparin) and Amphastar, a generic competitor. After Amphastar filed an Abbreviated New Drug Application with the FDA seeking approval to manufacture a generic form of enoxaparin, Aventis filed a patent infringement suit against Amphastar, which counterclaimed antitrust violations. Ultimately, Aventis’s patents were found unenforceable, and Amphastar’s antitrust counterclaim was dismissed.
Amphastar then filed a qui tam action, claiming that Aventis had made false representations while prosecuting its patents, improperly listed its patents in the FDA’s Orange Book, engaged in baseless litigation against Amphastar in order to delay approval of its ANDA, made false representations and material omissions to the FDA, and thereby attempted to manipulate the approval or marketing of enoxaparin. After the government declined to intervene and the complaint was unsealed, Aventis moved to dismiss the FCA claims on several grounds.
Aventis first argued that the suit was barred because the complaint was based on information publicly disclosed in the prior litigation and regulatory proceedings. The court agreed that the disclosures in the preceding antitrust litigation, FDA submissions public court filings, and judicial decisions predating the present complaint all constituted public disclosures, and that Amphastar’s FCA claims were based on those public disclosures. However, the court found that Amphastar qualified as an original source because it had direct and independent knowledge of the alleged fraud and had a hand in the public disclosure of the allegations.
Aventis separately argued that the complaint should be dismissed for failure to state a claim because it was based on certain conduct (petitioning the FDA) protected under the Noerr-Pennington doctrine. The court rejected this argument, finding that Amphastar was seeking to impose liability on Aventis for the act of overcharging the government, and not for the act of petitioning the government, making the Noerr-Pennington doctrine inapplicable.
However, the Court agreed with Aventis that the complaint failed to plead an FCA violation with the particularity required by Rule 9(b). Although Amphastar sufficiently alleged that Aventis had engaged in certain misconduct, that Aventis had acted with knowledge and intent to deceive, and that the false statements were material, the court concluded that Amphastar failed to allege “the particular details of a scheme to submit false claims and details leading to a strong inference that those claims were submitted.” Accordingly, the complaint was dismissed with leave to replead. A copy of the court’s opinion in Amphastar Pharmaceuticals Inc. v. Aventis Pharma SA, et al., Case No. EDCV-09-0023 MJG (C.D. Cal.) can be found here.
It remains to be seen whether Amphastar can or will seek to replead a viable claim, but it will be interesting to see whether this case is an anomaly, or whether it portends a new strategy for generic manufacturers seeking to leverage victories in Hatch-Waxman litigation into FCA claims.
On August 1, the Third Circuit affirmed the dismissal of the long-running Repko litigation. Repko, the former General Counsel of Guthrie Clinic and Guthrie Healthcare System in Pennsylvania, stole two million dollars and ultimately pleaded guilty to bank fraud. The plea agreement required Repko to cooperate by “providing information concerning the unlawful activities of others.” Pursuant to that agreement, Repko provided information to the government alleging fraud by his former employer. After the Government determined that Repko’s claims were “baseless,” Repko filed a qui tam in which the government declined to intervene.
The Third Circuit held that the district court correctly determined that Repko’s allegations that Guthrie violated Stark and the Anti-Kickback Statute were based on information that was publicly disclosed on websites and in prior litigation. Moreover, the Third Circuit held, Repko could not qualify as an original source because he did not “voluntarily provide[ ] the information” he had “to the Government before filing” the qui tam, as required to qualify for original source status. See 31 U.S.C. sec. 3730(e)(4)(B) (2008). Repko “gave this information only after he pleaded guilty to bank fraud, faced a substantial sentence, and bargained for a lower sentence.” Because “the plea agreement compelled Repko’s disclosures,” the Third Circuit concluded that “he could not be regarded as an ‘original source.'” A copy of the Third Circuit’s opinion can be found here.
The Supreme Court this morning announced that the so-called “individual mandate,” the centerpiece of the Patient Protection and Affordable Care Act (PPACA), which requires most individuals to maintain a minimum level of health insurance, is a constitutional exercise of Congress’s power to tax. Separately, the Court held that a provision of PPACA that would penalize States that elected not to participate in the expansion of the Medicaid program by withdrawing their existing federal Medicaid funding is unconstitutional. However, the Court concluded that this violation can be cured by severing this provision from the rest of the law, leaving the remainder of PPACA standing.
Thus, those False Claims Act and Anti-Kickback Statute-related amendments enacted as part of PPACA, briefly listed here, remain standing: (1) the amendment to the AKS establishing that claims “resulting from” AKS violations that are submitted to the federal healthcare programs give rise to FCA liability (PPACA § 4204(f)(1)); (2) the further AKS amendment, clarifying that knowledge of and specific intent to violate the AKS are not necessary to establish a violation (PPACA § 6402(f)(2)); (3) amendments to the FCA’s “public disclosure bar” provision that convert it from a jurisdictional bar to an affirmative defense that can be raised by a defendant in a motion to dismiss but rejected by the government, precluding judicial resolution of the issue, and significantly limiting the types of disclosures that can give rise to the defense (PPACA § 10104(j)(2)); (4) requiring recipients of “overpayments” to report and return them, and making the failure to do so the basis of a “reverse false claim” cause of action under the FCA (PPACA § 6402(a)); and (5) creating additional civil monetary penalties that may be applied to conduct that violates the FCA (PPACA §§ 6402(d)(2), 6408(a)).
The opinion is available at http://www.supremecourt.gov/opinions/11pdf/11-393c3a2.pdf
One of the most significant changes that the Affordable Care Act made to the FCA was elimination of the jurisdictional nature of the public disclosure bar and vesting in the United States the right to seek to veto any motion to dismiss based on violation of the public disclosure bar. The new post-ACA public disclosure bar provides that the court “shall dismiss” an FCA claim that violates the public disclosure bar “unless opposed by the Government.” 31 U.S.C. sec. 3730(e)(4)(A).
On June 4, a federal district court in Florida denied a defendant’s motion to dismiss on public disclosure grounds, finding that the alleged disclosures were insufficient to trigger the bar. See U.S. ex rel. Sanchez v. Abuabara, No. 10-61673 (S.D. Fla.), slip op. attached. While the decision itself is unremarkable – the court concluded that the alleged disclosures failed to disclose the key elements of relator’s claim that the Defendants induced federal agencies to award the defendants a contract based on false representations regarding their financial solvency and ability to perform the work – it is nevertheless notable because it appears to be the first decision reporting on the government’s exercise of its new veto authority. In the opinion, the Court notes that “[a]t the oral argument held before this Court on June 1, 2012, . . . a representative of the United States Attorney’s Office, confirmed that the government would not oppose a subject matter jurisdiction dismissal if the Public Disclosure Bar was otherwise satisfied.”
Neither the opinion nor other information on the public docket provides further information about how the Government made its decision, or who was involved in making that decision. Indeed, DOJ has not provided any guidance as to the criteria that will guide its decision as to whether to exercise its new authority or how far “up the chain” those decisions will be made. Thus, a defendant considering moving to dismiss on public disclosure grounds under the new FCA must contend not only with the ordinary risk that the motion will be rejected by the Court on the merits, but also the risk that DOJ, through some as-yet-unspecified process based on as-yet-unspecified criteria may unilaterally seek to deprive the Court of the opportunity to decide the motion at all, either before or perhaps even after a ruling by the Court.
One related side note: It appears from the opinion that the parties agreed that the amended (post-ACA) version of the public disclosure bar applied to the relator’s claims because the case was filed after the ACA was enacted. However, it is not clear that the date that the ACA was enacted rather than, for example, the date that the alleged false claims were submitted, is the date that should determine which version of the ACA should apply. We expect the issue of “which version of the FCA” applies to be increasingly litigated as cases are unsealed that involved claims and complaints that straddle the pre- and post-ACA versions of the FCA.
Posted by Lauren K. Roth and Kristin Graham Koehler
The public disclosure bar is meant to prevent or cut short the life of the “parasitic” lawsuit. In short, if a relator’s allegations are substantially the same as claims have been publicly disclosed already, and the relator is not the “original source” of the information, then a court generally must dismiss the suit. But as defendants know all too well, getting to dismissal can be a long and costly process. Moreover, enticed by the prospect of sharing in settlement proceeds, relators—and relators’ counsel—have an incentive to reprocess public allegations and “see what sticks.” Last week, however, a district court in Indiana sent a strong message by penalizing such conduct and demonstrating that it, too, may be costly for relators and their lawyers.
In U.S. ex rel. Leveski v. ITT Educational Services, Inc., the court—having earlier dismissed relator’s case—granted (in part) ITT’s Motion for Attorneys Fees and Sanctions and ordered relators’ counsel to pay nearly $400,000 in fees. U.S. ex rel. Leveski v. ITT Educational Services, Inc., 1:07-cv-0867 (D. Ind. March 26, 2012). Moreover, in a 30+ page opinion, the court took Leveski and her lawyers to task for filing such a contemptible, blatantly frivolous lawsuit, which reportedly cost ITT over $13 million to litigate. “Common sense,” the court opined, “suggests that Leveski is worlds apart from the type of genuine whistleblower contemplated by the FCA.”
The facts in the case were as follows: Leveski had worked at ITT for approximately 11 years, during which time she filed an unrelated employment suit against ITT that settled. In May 2007, after Ms. Leveski had ended employment with ITT, she was contacted by an investigator for Timothy Matusheski, her would-be FCA counsel. Matusheski had learned of Leveski through a public records search for former employees of for-profit educational institutions who had sued their former employer. Soon after their introduction, Leveski became convinced that ITT had violated an incentive compensation provision of Title IV of the Higher Education Act and she filed her FCA suit. (“Matusheski plucked a prospective plaintiff out of thin air and tried to manufacture a lucrative case,” the court wrote.) She was, apparently, not alone. The court’s decision cites to four other lawsuits against for-profit educational institutions that were filed by plaintiffs who had been recruited by Matusheski. All of the suits had been dismissed. Indeed, in one instance, Matusheski—”in consultation with his client, who was fearful of the potentially devastating financial impact of an attorney’s fees award” formally apologized to the court, the Department of Justice, and the Defendant after the dismissal.
In Leveski’s case, the court dismissed her suit for lack of subject matter jurisdiction, based on a public disclosure bar analysis. In support of its subsequent Motion for Attorney’s Fees and Sanctions, ITT identified several significant events in the case and argued that it was entitled to attorney’s fees incurred from the date of those events. Ultimately, the court found the triggering event to be Leveski’s deposition, in which she had revealed an extensive lack of knowledge about the substance of her allegations, undermining any argument that she was original source of the information. Although ITT reported having incurred approximately $2.6 million in legal expenses since the deposition, the court decreased its award to $394,998.33 for two reasons: (i) ITT’s delay in deposing Leveski, and (ii) the court’s application of Rule 11’s instruction that sanctions be limited to “what suffices to deter repetition of the same conduct or comparable conduct by others similarly situated.” See Fed. R. Civ. P. 11(c)(4). “In light of these considerations, the Court finds that 15 percent of the amount of attorney’s fees actually spent [from the date of the deposition onward] is an appropriate figure.”
Ultimately, ITT recovered only a tiny fraction of the attorney’s fees that it incurred defending a wholly unmeritorious lawsuit. Nevertheless, the mere fact of the award should provide a stronger deterrent effect to specious FCA suits than the public disclosure bar alone.
On March 14, 2012, Judge Donovan W. Frank of the United States District Court for the District of Minnesota upheld a relator’s complaint against Guidant Corporation (“Guidant”) based on its manufacture of certain implantable cardiac devices (“ICDs”), which had been sold to the Department of Veterans Affairs and/or reimbursed by Medicare. The relator, James Allen, alleged that Guidant had made false statements and failed to disclose known safety concerns in its post-approval reports to the Food and Drug Administration. Allen, a patient who had received one of Guidant’s ICDs, claimed that his allegations were based on his personal experience and certain adverse event reports he had reviewed. However, the safety and disclosure allegations in question had also been litigated both in prior, multi-district products liability litigation and in an earlier criminal adulteration proceeding.
After the government moved to intervene, Guidant moved to dismiss the relator’s complaint. The district court first rejected the argument that the government’s complaint in partial intervention was sufficient to supersede Allen’s complaint in its entirety. The district court also rejected the argument that the earlier litigation and related news coverage deprived the court of jurisdiction under the pre-FERA version of the FCA because it found the relator’s personal experience with Guidant’s products qualified him as an original source. Finally, the court found that Rule 9(b) had been satisfied because Relator had provided, inter alia, the names of Guidant employees allegedly involved in the purported false statements as well as the particulars of five allegedly defective devices.
While the court ultimately refused to dismiss this FCA case entirely, it did dismiss the relator’s claims for unjust enrichment and payment by mistake. Citing authority from courts in the First, Second, Eighth and D.C. Circuits, Judge Donovan ruled that qui tam relators lack standing to bring common law claims on behalf of the government.
On March 14, a three-judge panel of the Fourth Circuit held that a defendant’s SEC filings may trigger the FCA’s public disclosure bar. In U.S. ex rel Jones v. Collegiate Funding Services, Inc., No. 11-1103 (4th Cir. March 14, 2012), 2012 U.S. App. LEXIS 5574 (slip opinion attached), the relators alleged that CFS, a major student loan lender, violated the FCA by falsely certifying compliance with a variety of loan program requirements. The defendants successfully moved to dismiss the relators’ amended complaint on the ground that certain allegations had been publicly disclosed in various places, including the defendant’s SEC filings.
On appeal, the relators argued that SEC filings do not qualify as “administrative reports” for purposes of the FCA’s public disclosure bar. The Fourth Circuit panel affirmed the district court, holding that “the SEC filings by CFS were reasonably determined to be administrative reports because they were submitted under the SEC’s administrative regulatory requirements of the company. Forms 8-K and S-1 are mandatory filings for all publicly traded companies. While these documents were not authored by the SEC or created under their supervision, they were produced at the request of and were made public by the SEC in the course of carrying out its activities as a federal agency.”
While the opinion is unpublished, and therefore of no precedential value, its reasoning has persuasive value. As the Fourth Circuit panel explained, “the Supreme Court has noted that statutory construction of the FCA should be guided by the likelihood that a disclosure will ‘put the Government on notice of a potential fraud . . . . Congress passed the public disclosure bar to bar a subset of those suits that it deemed unmeritorious or downright harmful . . . . The statutory touchstone, once again, is whether the allegations of fraud have been [publicly disclosed].’ [citing Graham County Soil & Water Conservation Dist. v. United States ex rel. Wilson, 130 S. Ct. 1396, 176 L. Ed. 2d 225 (2010)]. Here, the SEC forms in question were requested, received, made public, and presumably included in any corporate profiles compiled by the agency. While such a report does not necessarily alert federal agencies to wrongdoing, it certainly provides easily accessible notice of the transactions between CFS and its customers from which an investigation could have begun or developed.” Therefore, the panel concluded that “the SEC filings in question . . . were properly considered by the court below in the mix of publicly available information on the basis of which, in whole or in part, the Relators’ claims are based.”
A Wisconsin court recently unsealed a qui tam complaint alleging that several pharmaceutical manufacturers violated Wisconsin’s version of the False Claims Act by publishing false “average wholesale prices” (AWPs) for their drugs, on which the State Medicaid program relied to establish drug reimbursement. This is not the first suit based on allegedly false AWPs. Indeed, AWP litigation has been raging in state and federal courts for the better part of the last decade. But what makes this case unusual is that the qui tam relator is the former Attorney General of Wisconsin, Peggy A. Lautenschlager. As Ms. Lautenschlager notes in the first paragraph of the complaint, it was under her term as Attorney General that the State of Wisconsin sued 38 other drug companies in 2004 for the same alleged conduct. These facts would appear to present obvious problems for the former Attorney General under Wisconsin’s public disclosure bar, but it will be interesting to watch this suit play out.
President Obama recently signed into law two pieces of legislation that, together, represent the most comprehensive reform that the U.S. healthcare system has seen in decades.1 In addition to providing for sweeping changes to health insurance coverage, healthcare delivery, and healthcare funding mechanisms, these laws substantially expand the government’s investigative and enforcement authority in connection with healthcare fraud and abuse. Additionally, the new laws include increased penalties for fraud and abuse in several contexts, as well as heightened disclosure and compliance obligations for providers, manufacturers, and other entities as part of government efforts to reduce fraud and to increase transparency.
This update highlights the key provisions of the new laws pertaining to anti-fraud and pro-transparency initiatives. Several of these new enforcement risks and compliance obligations take effect immediately or within one year, so affected entities will need to familiarize themselves with these provisions and plan for their implementation accordingly.
Enhanced Enforcement of Fraud and Abuse Laws
Expanded Applicability of the False Claims Act (FCA).
The PPACA extends the scope of payments subject to the FCA in two significant ways. First, it amends the Anti-Kickback Statute (AKS) to state that any claims for items or services “resulting from” a violation of the AKS also constitute a “false or fraudulent claim” under the FCA. Second, the PPACA extends the FCA to any payments made “by, through, or in connection with” any of the state-based health insurance exchanges created by the PPACA to assist individuals in finding affordable and available coverage, if such payments include any federal funds.
Additionally, the PPACA amends the FCA’s “public disclosure” bar in several ways. First, it limits the scope of relevant disclosures in government reports or investigations to those that occur at the federal level. Second, it eliminates language that previously described public disclosure as a matter implicating the court’s subject-matter jurisdiction, and authorizes the government to permit a complaint that otherwise would violate the public disclosure bar to proceed. Third, it expands the scope of individuals who qualify as an “original source” to include any person who “has knowledge that is independent of and materially adds to the publicly disclosed allegations or transactions.”
Affirmative Obligation To Report and Return Overpayments.
The PPACA imposes on recipients of overpayments an affirmative obligation to report and return the overpayment on the later of (a) 60 days after the overpayment is “identified,” or (b) the date any corresponding cost report is due, if applicable. Any overpayment retained after the applicable deadline is an “obligation” under the civil FCA statute, and therefore subject to a repayment obligation. For purposes of this requirement, the PPACA defines the term “overpayment” as “any funds that a person receives or retains under title XVIII or XIX [of the Social Security Act] to which the person, after applicable reconciliation, is not entitled under such title.”
The PPACA requires that any “person” receiving an overpayment must “report and return the overpayment to the Secretary, the State, an intermediary, a carrier, or a contractor, as appropriate, at the correct address”, and must notify the returnee “in writing of the reason for the overpayment.” The term “person” includes a provider of services, supplier, Medicaid managed care organization, Medicare Advantage organization, or Part D prescription drug plan sponsor; it does not include a beneficiary.
Lowered Intent Standard Under the Anti-Kickback Statute (AKS).
The PPACA amends the AKS to overrule court decisions holding that, in order to be criminally liable under the AKS, an individual must have actual knowledge of and the specific intent to violate the AKS. Specifically, the PPACA amends section 1128B of the Social Security Act (which includes the AKS) to state that “[w]ith respect to violations of this section, a person need not have actual knowledge of this section or specific intent to commit a violation of this section.”
Stronger Tools for Criminal Enforcement.
In addition to establishing a lowered intent requirement under the AKS, the PPACA amends the federal healthcare fraud statute (18 U.S.C. § 1347) to state explicitly that, “[w]ith respect to violations of this section, a person need not have actual knowledge of this section or specific intent to commit a violation of this section.” It also amends the definition of a “federal healthcare fraud offense” (18 U.S.C. § 24(a)) to include violations of the AKS—and also to include violations of section 301 of the Food, Drug, and Cosmetic Act (21 U.S.C. § 331) (FDCA) or section 501 of the Employee Retirement Income Security Act of 1974 (29 U.S.C. § 1131). As a result, an FDCA violation potentially can trigger certain enforcement-related authorities under title 18, including the use of administrative subpoenas under section 3486 and criminal forfeiture authorities under section 982, as well as providing a new basis to be prosecuted for money laundering under section 1956 or obstruction of justice under section 1518.
Additionally, the PPACA includes substantial enhancements to federal sentences for violations of healthcare fraud under the advisory U.S. Sentencing Guidelines. In particular, the law requires the U.S. Sentencing Commission to amend the federal sentencing guidelines to provide that, when a court is calculating the amount of intended loss by the defendant in an action for healthcare fraud, the “aggregate dollar amount of fraudulent bills” submitted to a government healthcare program “shall constitute prima facie evidence” of the loss amount. The PPACA also sets forth new offense-level multipliers for government losses related to federal healthcare offenses.
Expanded Administrative Remedies
New Civil Monetary Penalties (CMPs).
The PPACA also includes several provisions creating new or increased CMPs, including the following:
- A $50,000 penalty for any false statement, misrepresentation, or omission in applications, bids, or contracts to participate as a provider or supplier under any federal healthcare program. The $50,000 penalty would apply to each violation, plus up to three times the damages for such claims.
- A $10,000 penalty for any excluded individual or entity who orders or prescribes a covered item or service under a federal healthcare program during the period of exclusion, or who “knows or should know that a claim” for such item or service will be made under a federal healthcare program.
- A $10,000 penalty for any person who knows of an overpayment and does not report and return the amount due.
- A $15,000 penalty for any failure to grant timely access to the Department of Health and Human Services (HHS) Office of the Inspector General (OIG) “for the purposes of audits, investigations, evaluations, or other statutory functions of” the OIG. The $15,000 penalty can be assessed for each day of delayed access.
- A $50,000 penalty (per violation) for conduct that is also actionable under the FCA.
New CMPs are also created under provisions of the PPACA and Reconciliation Act that establish the Medicare Part D “coverage gap discount program” starting in 2011. Under this program, manufacturers must sign an agreement with the Secretary and provide 50% discounts on covered drugs provided to beneficiaries who are in the coverage gap. As part of their participation in the coverage gap discount program, manufacturers are subject to audits by the Secretary to ensure that they are satisfying the terms of their agreements, and are subject to CMPs if they fail to provide beneficiaries with the discounts required. The penalty amount can be up to 125% of the total amount the manufacturer was obligated to provide in coverage gap discounts.
The PPACA amends section 1128(b)(2) of the Social Security Act (SSA) to authorize permissive exclusion for, among other things, obstructing an investigation or audit. Under pre-PPACA law, this provision permitted exclusion only for obstructing certain criminal investigations.
The PPACA also extends permissive exclusion authority under SSA section 1128(b) to “[a]ny individual or entity that knowingly makes or causes to be made any false statement, omission, or misrepresentation of a material fact in any application, agreement, bid, or contract to participate or enroll as a provider of services or supplier under a Federal healthcare program”, including Medicare Advantage organizations under Part C, prescription drug plan sponsors under Part D, Medicaid managed care organizations, and other “entities that apply to participate as providers of services or suppliers in such managed care organizations and such plans.”
To enhance Medicaid integrity, PPACA requires states to terminate individuals or entities from their Medicaid programs if the individual or entity has been terminated from Medicare or from the Medicaid program of another state. Further, the PPACA requires Medicaid agencies to exclude individuals or entities from Medicaid participation for a specified period of time if the entity or individual “owns, controls, or manages an entity that (or if such entity is owned, controlled, or managed by an individual that)” is suspended, excluded, or terminated, or is “affiliated with” an individual or entity that has been excluded, suspended, or terminated.
Suspension and Withholding of Payments.
Substantially expanding the authority of the Secretary of the Department of Health and Human Services (HHS), the PPACA permits the Secretary to “suspend payments to a [Medicare] provider of services or supplier . . . pending an investigation of a credible allegation of fraud against the provider of services or supplier, unless the Secretary determines there is good cause not to suspend such payments.” The Secretary is required to consult with the HHS Office of Inspector General (OIG) in determining whether there is a “credible allegation of fraud” against a provider of services or supplier, and to issue implementing regulations to carry out this provision.
Further, the Reconciliation Act allows the Secretary to withhold payments to new suppliers of durable medical equipment (DME) for up to 90 days if the Secretary determines the supplier is operating in an area with significant levels or risks of fraud and abuse among DME suppliers. The Reconciliation Act refers to this 90-day withholding period as an “enhanced oversight” period.
Revocation of Enrollment.
Effective as of January 1, 2010, the PPACA allows the Secretary to revoke enrollment for up to one year for any home health provider or DME supplier that fails to maintain documents substantiating claims for items or services, or that fails to provide the Secretary with access to such documentation upon request. This provision applies to orders, certifications, and referrals made by physicians, home health providers, and DME suppliers.
Enhanced Authority and Access for the OIG and Department of Justice (DOJ).
The PPACA requires the HHS Secretary to maintain an “Integrated Data Repository” with claims and payment data for all major federal healthcare programs, including Medicare Parts A, B, C, and D; Medicaid; the Children’s Health Insurance Program (CHIP); and any health-related programs administered by the Departments of Veterans Affairs and Defense, the Social Security Administration, and the Indian Health Service. Further, this section expressly provides that the OIG and DOJ shall have access to this data “[f]or purposes of conducting law enforcement and oversight activities”, to the extent that such access is consistent with regulations promulgated under the Health Insurance Portability and Accountability Act of 1996.
In addition, the PPACA specifies that the OIG’s authority to obtain information extends to any person or entity who “directly or indirectly provides, orders, manufactures, distributes, arranges for, prescribes, supplies, or receives medical or other items or services payable by any Federal healthcare program (as defined in [SSA] section 1128B(f)) regardless of how the item or service is paid for, or to whom such payment is made.” In connection with this authority, the OIG is authorized to access any documents necessary to validate claims, including medical records and any other “records necessary for evaluation of the economy, efficiency, and effectiveness of” federal healthcare programs.
The PPACA also expands the government’s subpoena power by allowing for physical access by DOJ to any institution, and its books and records, where the institution “is the subject of an investigation under [the Civil Rights of Institutionalized Persons Act (42 U.S.C. § 1997 et seq.)] to determine whether there are conditions which deprive persons residing in or confined to the institution of any rights, privileges, or immunities secured or protected by the Constitution or laws of the United States.”
340B Integrity Amendments
The PPACA adds a new subsection (d) to section 340B of the Public Health Service Act (42 U.S.C. § 256b). The new subsection includes important provisions regarding manufacturer compliance (including new CMPs), covered entity compliance, and the administrative dispute resolution process. These amendments to the 340B program take effect as of January 1, 2010, and apply to drugs purchased on or after that date.
The manufacturer compliance provisions are designed to prevent overcharges and other violations of the discounted pricing requirements in section 340B through various regulatory mechanisms, such as the publication of more precise guidelines by the HHS Secretary. The provisions also authorize the Secretary to conduct spot checks of manufacturers and wholesalers, and to establish procedures for manufacturers to issue refunds to covered entities in the event of an overcharge.
The 340B integrity amendments impose sanctions in the form of CMPs on any manufacturer with an agreement under 340B that “knowingly and intentionally charges a covered entity a price that” exceeds the applicable 340B ceiling price. The CMPs would be assessed “according to standards established in regulations to be promulgated by the Secretary not later than 180 days after the date of enactment” and would be capped at $5,000 per instance of overcharging a covered entity.
Covered Entity Compliance.
The provisions regarding covered entity compliance call for clarification of covered entity requirements through “more detailed guidance” from the agencies that administer the program. This section also sets forth sanctions, in the form of interest payments to manufacturers, where covered entities knowingly and intentionally violate their 340B program requirements. Further, if the Secretary determines that a covered entity’s violations are “systematic and egregious as well as knowing and intentional,” the Secretary may remove the covered entity from the 340B drug discount program and may prohibit re-entry “for a reasonable period of time”- also to be determined by the Secretary.
Dispute Resolution and “Must Offer” Language.
The PPACA also provides for the replacement of the informal and involuntary alternative dispute resolution (ADR) process established under prior guidance from the Health Resources and Services Administration (HRSA), the agency responsible for administering the 340B program, by authorizing new regulations providing for a binding ADR process to adjudicate and make final determinations regarding complaints about non-compliance by covered entities or manufacturers. Covered entities would be afforded at least some discovery during these administrative proceedings. Notably, manufacturers would still be required to conduct the rather time-consuming and cumbersome audit process under the existing HRSA guidance before proceeding with the ADR process.
Additionally, the PPACA includes language requiring manufacturers to “offer” covered outpatient drugs to 340B covered entities if such drug “is made available to any other purchaser at any price.” The Administration has indicated that the intent of this language is simply to codify existing HRSA guidance requiring manufacturers to treat 340B covered entities in a non-discriminatory manner as compared to entities that do not participate in the 340B program. It remains to be seen, however, exactly how the language will be interpreted and enforced moving forward.
&llt;P>Transparency: New Reporting and Disclosure Obligations
Physician Payments “Sunshine” Provisions.
Reflecting heightened public attention in recent months to financial relationships between physicians and industry, the PPACA requires drug, device, biological, and medical supply manufacturers to submit annual, electronic reports to HHS disclosing any “payment or other transfer of value” made to a physician and/or teaching hospital. It also requires applicable manufacturers and group purchasing organizations (GPOs) to submit annual, electronic reports regarding any ownership or investment interest (other than publicly traded securities and mutual funds) held by a physician, or immediate family member of a physician, in the applicable manufacturer or GPO.
This provision of the PPACA codifies many aspects of what had previously been introduced as a stand-alone bill sponsored by Senators Charles Grassley (R-IA) and Herb Kohl (D-WI), known as the “Physician Payments Sunshine Act” (S. 301). As enacted, the provision defines an applicable “manufacturer of a covered drug, device, biological, or medical device supply” as:
any entity which is engaged in the production, preparation, propagation, compounding, or conversion of a covered drug, device, biological, or medical supply (or any entity under common ownership with such entity which provides assistance or support to such entity with respect to the production, preparation, propagation, compounding, conversion, marketing, promotion, sale, or distribution of a covered drug, device, biological, or medical supply).
The first required “transparency reports” are due March 31, 2013, and must cover all payments or other transfers of value made, and all ownership and investment interested existing, during calendar year 2012.
These reports must include, for each payment or transfer of value:
- the name and business address of the covered recipient;
- the amount of the payment or other transfer of value;
- a description of the form of the payment or other transfer of value (e.g., cash or cash equivalent; in-kind items or services; stock, stock options, or other ownership or investment interests);
- the dates on which the payment or transfer of value was made; and
- a description of the nature of the payment or transfer of value (e.g., consulting fees, compensation for non-consulting services, grant, gift, entertainment, education, research, etc).
For payments or other transfers of value related to marketing, education, or research specific to a particular covered drug, device, biological, or medical supply, the report also must include the name of the covered product. Additionally, the statute permits the Secretary to determine additional appropriate categories of information to be required in the reports.
Importantly, several types of transactions are excluded from the statute’s definition of a covered “payment or other transfer of value”, including (among others):
- A transfer of anything valued under $10, unless the aggregate amount transferred to, requested by, or designated on behalf of the covered recipient by the applicable manufacturer in the calendar year exceeds $100. (For calendar years after 2012, these dollar amounts will be indexed to the consumer price index for all urban consumers.)
- Product samples that are not intended to be sold and are intended for patient use.
- Educational materials that directly benefit patients or are intended for patient use.
- Short-term loans for a covered device, unless the trial period exceeds 90 days.
- Discounts (including rebates).
- In-kind items used for the provision of charity care.
With respect to manufacturers’ and GPOs’ required annual disclosures of ownership or investment interests (other than publicly traded securities and mutual funds) held by a physician, or immediate family member of a physician, these reports must include:
- the dollar amount invested by each physician (or family member) holding such an ownership or investment interest;
- the value and terms of each such ownership or investment interest;
- any payment or other transfer of value provided to a physician holding an ownership or investment interest; and
- any other information regarding the ownership or investment interest that the HHS Secretary deems appropriate.
Any information reported under this provision must be made publicly available by no later than September 30, 2013, and on June 30 of each calendar year thereafter. Public availability must be provided through a searchable Internet website and in a format that is clear, understandable, and “able to be easily aggregated and downloaded.” Publicly available reports also must contain background information on industry-physician relationships. The Secretary must establish procedures for the submission of information and for public availability by no later than October 1, 2011, and must consult the HHS Office of Inspector General, as well as “affected industry, consumers, consumer advocates, and other interested parties in order to ensure that the information made available to the public under [this section] is presented in the appropriate overall context.”
The public availability process must afford applicable manufacturers and GPOs with a 45-day “review period” before the information becomes available to the public, so long as the 45-day period for review and submission of corrections does not prevent the information from being posted for public access by the dates specified above. An exception would allow “delayed publication” for payments made pursuant to product research or development agreements or in connection with a clinical investigation regarding a new drug, device, biological, or medical supply. In these cases, reports must be made available after the earlier of the following: (1) the FDA approval date of the product; or (2) four calendar years after the date the payment/transfer was made.
Manufacturers and GPOs that fail to comply with the Act’s reporting requirements are subject to civil monetary penalties (CMPs) ranging from $1,000 to $10,000 per unintentional violation, and up to $10,000 to $100,000 per knowing violation. The maximum annual fines would be $150,000 and $1 million, respectively. (The statute defines the term “knowingly” by way of cross-reference to the definition in the False Claims Act provided at 31 U.S.C. § 3729(b).)
Finally, this provision of the PPACA preempts any state laws that mandate disclosure of payments or other transfers of value governed by the federal law. However, states are not prohibited from enacting or enforcing disclosure laws that are more stringent than the federal standard set forth in this provision. Because many states have demonstrated an interest to legislate in this area, the provision’s “partial preemption” approach presents the possibility that manufacturers and GPOs will face a patchwork of federal and state financial disclosure requirements moving forward.
Pharmacy Benefit Managers Transparency Requirements.
The PPACA also imposes reporting requirements on pharmacy benefit managers (PBMs), or health benefits plans that provide PBM services, that contract with health plans under Medicare or a health insurance exchange. Such entities must report to the Secretary information regarding:
- the generic dispensing rate;
- the total number of prescriptions dispensed;
- the aggregate amount and type of rebates, discounts, or price concessions negotiated by the PBM (excluding bona fide service fees—such as distribution service fees, inventory management fees, product stocking allowances, and fees associated with administrative services agreements and patient care programs—but including a specification of which are attributable to patient utilization under the plan and which are passed through to the plan sponsor); and
- the aggregate difference between amounts that health benefits plans pay to PBMs versus amounts that PBMs pay to retail pharmacies and mail order pharmacies.
Information disclosed to the Secretary under this section will be confidential except for limited, specified circumstances, such as to permit review by the U.S. Comptroller General or Director of the Congressional Budget Office. Even in connection with these permitted disclosures, the Secretary may not disclose the identity of a specific PBM or plan, or the prices charged for drugs.
Increased Funding for Anti-Fraud Efforts
Funding Boosts for the Health Care Fraud and Abuse Control Fund (HCFAC Fund).
The PPACA adds an extra $10 million to the HCFAC Fund for each fiscal year from 2011 through 2020—a total of $100 million in additional appropriations. Additionally, the Reconciliation Act appropriates another $95 million in FY 2011, $55 million in FY 2012, $30 million in each of fiscal years 2013 and 2014, and $20 million in each of fiscal years 2015 and 2016, to be used to combat fraud in Medicaid programs. Together, the bills increase HCFAC funding by $350 million over the coming decade. Moreover, the PPACA permanently applies the consumer price index for all urban consumers (CPI-U) to HCFAC Fund, and the Reconciliation Act does the same with respect to funding for the Medicaid Integrity Program.
Additional Compliance Obligations and Integrity Provisions
Required Compliance Programs.
Notably, the PPACA requires providers and suppliers to adopt compliance programs. More specifically, the statute requires the Secretary to develop a compliance program that providers and suppliers “within a particular industry sector or category shall, as a condition of enrollment,” complete. The provision does not specify which industry sectors or categories will be affected, and it leaves to the Secretary, in consultation with the OIG, the task of specifying the required “core elements” of these compliance programs and the timeline for their implementation.
RAC Expansion and Audits.
The PPACA expands the Medicare Recovery Audit Contractor program to require all states to establish one or more RAC contracts by December 31, 2010, for purposes of identifying overpayments and underpayments provided by state Medicaid plans and/or plan waivers. This provision also expands the RAC program to Medicare Parts C and D and includes “special rules” requiring, among other specifications, that Medicare Advantage plans and Part D plans to have an anti-fraud plan in effect and that such plans review the effectiveness of their respective anti-fraud plans.
Data Collection and Provider Screening / Reporting Requirements.
The PPACA requires HHS to maintain a national fraud and abuse data collection program for final adverse actions and to provide the data collected to the National Practitioner Data Bank (NPDB). It also contains provisions that impose new screening requirements for providers and suppliers participating in Medicare, Medicaid, and CHIP, as well as extensive disclosure requirements, demonstration projects, and enforcement tools designed to improve the quality of care in Medicare skilled nursing facilities and Medicaid nursing facilities. It also requires the HHS Secretary to establish a national program for conducting background checks on “direct patient access employees” of long-term care facilities and providers.
Additionally, the Reconciliation Act establishes new requirements for community mental health centers aimed at preventing fraud and abuse, and it modifies previously applicable restrictions on Medicare administrative contractors’ ability to conduct prepayment medical record reviews in cases of suspected fraud and abuse.
As you and your organization work to address and implement these important new changes to healthcare law, and to review your organization’s policies and procedures to ensure compliance, we would be happy to answer any questions you may have about these, or other, aspects of the newly enacted legislation. Please contact the Sidley lawyer with whom you usually work, or any of the lawyers listed on this alert, if you have any questions or wish to discuss further.
If you have any questions regarding this update, please contact Jim Stansel (+1.202.736.8092, email@example.com), Hae-Won Min Liao (+1.415.772.1227, firstname.lastname@example.org), William Sarraille (+1.202.736.8195, email@example.com), Scott D. Stein (+1.312.853.7520, firstname.lastname@example.org), Stephanie Hales (+1.202.736.8349, email@example.com) or the Sidley lawyer with whom you usually work.
1 On March 23, 2010, the President signed the Patient Protection and Affordable Care Act (H.R. 3590) (PPACA), Pub. L. No. 111-148. On March 30, 2010, the President signed the Health Care and Education Reconciliation Act of 2010 (H.R. 4872) (Reconciliation Act), Pub. L. No. 111-152, a smaller bill that effectuated a series of changes to the PPACA.