Anti-Kickback Statute Research Articles

Medical Science Liaisons: A Guide for Advanced Practice Registered Nurses

Medical science liaisons (MSLs) are part of the field medical affairs (FMA) department of pharmaceutical companies and are scientific resources for advanced practice registered nurses (APRNs). Following strict regulations and antikickback statutes, MSLs operate differently from sales and engage in unbiased, nonpromotional scientific exchange to provide clinical resources to APRNs. They also collaborate with shareholders like professional organizations, clinical trial sites, and academic institutions. Understanding MSL engagement allows APRNs multiple avenues both externally and within the pharmaceutical industry to leverage their experience to enhance clinical practice.

Radiology quick cash? Kickbacks, compliance, and consequences

The Anti-Kickback Statute was passed by Congress in the 1970s to reduce the overuse of government-reimbursed medical services. It attempts to eliminate fraud, abuse, and waste of medical services by outlawing the incentive of personal gain when referring patients for government-funded services. Although safe harbors were written into the law to maintain transactions beneficial to society, they require strict adherence. Anti-Kickback Statute violations are subject to the whistleblower provision of the False Claims Act, and violations can yield significant civil and criminal penalties.

“Resulting From” Unclear Language: Why Congress Must Amend the Anti-Kickback Statute to Clarify Its Intent to Hold Violators Accountable and Recover Fraud-Based Payments

“Resulting From” Unclear Language: Why Congress Must Amend the Anti-Kickback Statute to Clarify Its Intent to Hold Violators Accountable and Recover Fraud-Based Payments

Giving A Buck Or Making A Buck? Donations By Pharmaceutical Manufacturers To Independent Patient Assistance Charities.

The federal Anti-Kickback Statute prohibits biopharmaceutical manufacturers from directly covering Medicare enrollees' out-of-pocket spending for the drugs they manufacture, but manufacturers may donate to independent patient assistance charities and earmark donations for a condition treated by their drugs. To assess whether this law and its associated regulations prevent manufacturers from profiting from their donations, we analyzed drug spending of more than three million Medicare Advantage enrollees in 2010 and 2017, together with data on conditions and drugs covered by these charities. We found that donations by the leading manufacturer of drugs for each condition were often likely to be profitable, even if relatively few patients were induced to use the manufacturer's drugs as a result. This was particularly true among the ten costliest conditions, where the leading manufacturer accounted for 67percent of sales in 2010 and 89percent in 2017, on average, indicating that manufacturers could effectively assist in the purchase of their own medications by contributing to condition-specific charities. We conclude that the current regulations or enforcement permit donations that violate the spirit of Medicare's Anti-Kickback Statute.

Industry Payments to Physicians Are Kickbacks. How Should Stakeholders Respond?

Payments from the pharmaceutical industry to US physicians are common. In determining which payments rise to the level of an illegal kickback under the Anti-Kickback Statute (AKS), the Department of Health and Human Services' Office of Inspector General (OIG) has stated in nonbinding guidance that influencing or "swaying" physician prescribing is key. OIG has highlighted as a compliance standard the Pharmaceutical Research and Manufacturers of America Code on Interactions with Health Professions, which stipulates that permissible payments are those that do not interfere with prescribing. However, recent evidence has shown that most payments influence physician prescribing, driving higher prescription drug costs by increasing use of brand-name and low-value drugs. This evidence implies that many payments that are currently commonplace could be subject to prosecution under AKS. Given that these payments increase costs to patients and the health care system, there is a public interest in curtailing them. This article proposes a range of actions available to stakeholders-including industry, providers, regulators, and payers-to mitigate the cost-increasing effect of industry payments to physicians.

Patient Assistance Programs and the Anti-Kickback Statute

This Viewpoint discusses how patient assistance programs help patients pay for expensive name-brand drugs, which help ensure profit, and recommends anti-kickback statutes be used to ensure the programs help those most in need.

Trading Pain for Gain: Addressing Misaligned Interests in Prescription Drug Benefit Administration

Over the last two decades, Pharmacy Benefit Managers (PBMs), organizations that act as middlemen between health plans and drug manufacturers, have become increasingly powerful players in the healthcare industry. PBMs promise to leverage their expertise and ability to aggregate buying power to negotiate lower drug prices and administer prescription drug benefit plans. In practice, however, PBMs are widely criticized for benefitting from, and contributing to, inefficiencies in the prescription drug market, particularly by imposing restrictions on beneficiary access to drugs in exchange for rebates paid to PBMs by manufacturers. To the extent that the rebates are retained by PBMs, or otherwise do not result in a benefit to the beneficiaries, this practice amounts to trading the pain of plan beneficiaries for the PBM’s own gain. Despite this criticism, regulatory and enforcement efforts directed against PBMs have been anemic. Existing structural and legal protections for beneficiaries are largely ineffectual. While this problem is widely acknowledged, regulators have failed to pass new laws that successfully address the challenges posed by the insertion of PBMs as middlemen into the web of prescription drug benefits and reimbursement. Regulators express frustration with the complexity of balancing the interests of beneficiaries with PBMs’ aspirational goal of cost-control, as well as with addressing the inherent conflict of interest in PBMs’ competing goals of profitability for themselves and cost containment for their clients. Lawsuits alleging PBM mistreatment of beneficiaries are sparse, and a consistent vision of what is and is not permissible to PBMs has not emerged from the case law. But the Federal Anti-Kickback Statute can—and there are indications that it increasingly will—be used to regulate manufacturer-PBM rebate arrangements. The U.S. Department of Justice recently settled a case predicated on an allegation that a pharmaceutical manufacturer, Roche, violated the Federal Anti-Kickback Statute when it paid a health insurance company, Humana, a kickback of lump sum debt forgiveness for formulary placement, conditioned on the exclusion of a competitor. Also, the federal government recently adopted a rule applicable to Medicare Part D plans that radically reconfigures the existing incentives by prohibiting manufacturers from extending rebates other than at the point of sale, and from making the rebates contingent on the plans or PBMs taking various steps with respect to encouragement of use of the drugs. These developments likely presage increased use of the Anti-Kickback Statute to attack rebating arrangements and underscore the need for PBMs to reevaluate their current practices with respect to their relationships with manufacturers to ensure that they are complying with the law. In this Article, we argue that the Federal Anti-Kickback Statute and its state law analogs, state anti-kickback statutes, can be used to effectively protect beneficiary interests against manufacturer-purchased, PBM-imposed restrictions on access to drugs. We also identify key issues that may be hampering effective enforcement, and suggest an analysis that effectively addresses these issues. We demonstrate that current law is best understood to allow manufacturers to extend discounts and rebates to plans (either directly or through PBMs) but not to PBMs, and that those rebates cannot make those payments contingent on PBMs or plans adopting specific preferences for drugs. By embracing these principles, PBMs can protect beneficiary interests, achieve enforcement certainty, and perhaps ward off the ultimate adoption of more radical restrictions.

THE NEW STARK LAW AND ANTI-KICKBACK STATUTE FINAL RULES PROVIDE NEW OPPORTUNITIES FOR VALUE BASED PROGRAMS AND VALUE BASED ARRANGEMENTS

ABSTRACT The Stark Law and the Anti-Kickback Statute represent two of the most significant areas of liability for providers and participants in the health care industry. Often times, either or both of these laws can form the basis of a False Claims Act case. The key to avoiding liability is to ensure that the relevant exception(s) under the Stark Law and the relevant safe harbors under the Anti-Kickback Statute are met. With the evolution of value-based programs and reimbursement models based one value-based outcomes such as patient care coordination and quality measures, industry participants relayed to the Centre's for Medicare and Medicaid, as well as the U.S. Department of Health and Human Services that they were unable to effectively implement some value-based programs and types of legitimate arrangements for fear of civil and/or criminal exposure. The Government listened and in December 2020, two separate Final Rules were released, opening the door for new initiatives in the healthcare industry to achieve success with value-based programs and arrangements, so long as the new safe harbors and exceptions are met. This article details an overview of some of the critical aspects of the new Final Rules, which became effective on January 19, 2021 (with a couple of provisions that are effective at a later date).

Medicolegal Sidebar: A Fast Route To A Criminal Indictment-Violating Fraud and Abuse Laws.

Medicolegal Sidebar: A Fast Route To A Criminal Indictment-Violating Fraud and Abuse Laws.

Flying too close to the sun: Navigating changes to CMS' Open Payments program.

Increasingly, physician assistants (PAs), advanced practice nurses, and physicians are financially involved with healthcare product manufacturers. Although the relationships themselves might not be illegal, when the transaction influences the healthcare provider's medical decision-making, patients can be harmed and the healthcare provider and manufacturer can face accusations of violating federal and state law. In 2019, the federal government recouped $2.6 billion from healthcare fraud and abuse by healthcare stakeholders. PAs' and NPs' behaviors violating the Anti-Kickback Statute (AKS) and False Claims Act (FCA) were partially responsible for the reported amount. To increase the transparency of the financial relationships between healthcare providers and healthcare manufacturers, the federal Centers for Medicare and Medicaid Services, under statutory obligation, created the Open Payments program, which will begin reporting PAs' and advanced practice nurses' financial relationships with manufacturers in 2022.

False Claims Act Overview and Implications for Neurologists.

The US Department of Health and Human Services Office of the Inspector General identifies the five most important federal fraud and abuse laws that are most applicable to physicians: the False Claims Act, the Anti-Kickback Statute, the Physician Self-Referral Law (Stark Law), the Exclusion Authorities, and the Civil Monetary Penalties LawThe False Claims Act is the US government's primary tool for combating fraud perpetrated through the filing of false claims for federal government reimbursement. Neurologists and companies serving the needs of neurologic patients have not been immune from False Claims Act-related legal action. This article provides an overview of the False Claims Act, uses real-life neurologic cases to illustrate the range of False Claims Act violations and recoveries, and offers some practical compliance suggestions.

Development of AGA’s Policy Agenda During the COVID-19 Pandemic

Development of AGA’s Policy Agenda During the COVID-19 Pandemic

Value-based Healthcare: The Politics of Value-based Care and its Impact on Orthopaedic Surgery.

Value-based Healthcare: The Politics of Value-based Care and its Impact on Orthopaedic Surgery.

Recommendations to protect patients and health care practices from Medicare and Medicaid fraud

Fraud is defined as knowingly submitting, or causing to be submitted, false claims or making misrepresentations of a fact to obtain a federal health care payment for which no entitlement would otherwise exist. In today’s health care environment, Medicare and Medicaid fraud is not uncommon. The negative impact of fraud is vast because it diverts resources meant to care for patients in need to the benefit of fraudsters. Fraud increases the overall costs for vital health care services and can potentially be harmful to Medicare and Medicaid beneficiaries. The objectives of this commentary are to describe the types and trends of Medicare and Medicaid fraud that are committed, and provide recommendations to protect patients and health care practices. Specifically, this article identifies types of Medicare and Medicaid fraud at beneficiary (patient) and provider level, and it can be intentional or unintentional. This article also describes the 3 primary laws that prohibit fraud and gives fraud case examples relevant to each law, including the False Claims Act, Anti-Kickback Statute, and the Stark Law. We also discuss currently trending and emerging areas, including opioid and pharmacogenetic testing; both have experienced heavier and higher-profile instances of fraud in today’s health care landscape. Last, the article summarizes detection methods and recommendations for health care providers and patients to protect themselves against fraud. Recommended strategies to combat fraud are discussed at policy, practice, and grassroots levels. Health care practitioners, including pharmacists, can use these strategies to protect themselves and their patients from becoming victims of fraud or unknowingly committing fraud.

Stark Law and Anti-Kickback Statute Modernization, Why Now?

Stark Law and Anti-Kickback Statute Modernization, Why Now?

The Great American Health Care System and the Dire Need for Change

The Great American Health Care System and the Dire Need for Change

The corporatization of dermatopathology

The corporatization of dermatopathology has long preceded that of dermatology and has been driven by federal legislation and economic influences. Although the Clinical Laboratory Improvement Amendments and the Stark Law limited physician-owned laboratories, loopholes via the Safe Harbor Exemptions outlined in the Anti-Kickback Statute allowed corporate laboratories to flourish through relationships built by health information technology donations. The rise of corporatization has had widespread effects on the fields of dermatopathology and dermatology, resulting in reduced numbers of dermatology-trained dermatopathologists and decreased caseloads in academic institutions, potentially compromising dermatology residency education. Although there have been efforts to counteract these effects, more global changes will be required to alter the direction of this subspecialty.

Regulatory, Policy, and Operational Considerations for Outcomes-Based Risk-Sharing Agreements in the U.S. Market: Opportunities for Reform.

Although interest in outcomes-based risk-sharing agreements (OBRSAs) and other value-based contracts (VBCs) continues to grow, the number of VBCs in the United States is still limited. A better understanding of the evolving and fluid context of policies, regulations, and operational factors affecting their uptake in the United States is needed in order to lower or obviate barriers and advance OBRSAs. To (a) identify and recognize priorities among policies, regulations, and other factors that are most likely to influence the feasibility, design, and execution of OBRSAs and (b) suggest opportunities for reform and other modifications that may advance OBRSAs in the United States. Across 18 months during 2017-2018, we reviewed health policy literature, examined stakeholder group communications, and conducted semistructured interviews with representatives of 12 diverse stakeholder organizations. Across these, and incorporating real-time contextual changes, we identified priorities for enabling and improving OBRSAs. Regulatory and policy priorities most often cited by manufacturers were Medicaid best price rule, Medicare Part B average sales pricing, FDA restrictions on communications, and the Anti-Kickback Statute. While recognizing these, health plans were more concerned about operational barriers, particularly associated with data collection and analysis, selection of outcomes that are feasible to assess, bandwidth for managing OBRSAs, and implementation costs relative to return on investment. Most recognized limitations on access to personal health information, target population turnover, and insufficient information sharing of OBRSA experiences. Noteworthy were asymmetries of administrative burden and cost management: individual manufacturers may pursue OBRSAs for 1 or a few products per year, while health plans are approached by multiple manufacturers about OBRSAs for their respective products; manufacturers focus on drugs, while health plans must manage broader costs of care. While all stakeholders express interest in OBRSAs, health plans tend to consider them as a narrower priority than manufacturers. Solving operational barriers, in addition to addressing policy and regulatory barriers, is essential for aligning efforts to advance OBRSAs. Doing so depends on collaboration to improve decisions about when and how to pursue OBRSAs, with attention to data management, modeling and piloting OBRSAs, and information sharing. These findings pertain to companies operating in the United States and some likely extend to certain value-based arrangements in other countries. This analysis was funded by Merck Sharp & Dohme (MSD), a subsidiary of Merck, as a component of the Learning Laboratory for Advancing Value-Based Healthcare, which is a multiyear collaboration of MSD and Optum, a health services, technology, and data company. The manuscript underwent an internal review by the sponsor. The Lewin Group (Lewin) is a subsidiary of OptumServe. OptumServe is wholly owned by UnitedHealth Group (UHG). Neither OptumServe nor UHG or its subsidiaries review the work products of Lewin. Lewin operates with editorial independence and provides its clients with health care and human services policy research and consulting services. Goodman and Villarivera are employees of Lewin; Gregor is an employee of Optum; and van Bavel is an employee of MSD. Goodman and Villarivera report fees from UHG, unrelated to this study. A poster presentation based on this manuscript was accepted and presented at the ISPOR Europe 2018 Conference in Barcelona, Spain, on November 13, 2018.

Financial Eligibility Criteria and Medication Coverage for Independent Charity Patient Assistance Programs

Although independent charity patient assistance programs improve patient access to costly prescription drugs, recent federal investigations have raised questions about their potential to increase pharmaceutical spending and to violate the federal Anti-Kickback Statute. Little is known about the design of the programs, patient eligibility, or drug coverage. To examine the eligibility criteria of the independent charity patient assistance programs and the drugs covered by them. Descriptive cross-sectional study of the 6 largest independent charities offering patient assistance programs for patients including, but not limited to, Medicare beneficiaries in 2018. These charities offered 274 different disease-specific patient assistance programs. Drugs were identified for subgroup analysis that had any use reported on the Medicare Part D spending dashboard and any off-patent brand-name drugs that incurred more than $10 000 in Medicare spending per beneficiary in 2016. Support by independent charity patient assistance programs. The primary outcomes were the characteristics of patient assistance programs, including assistance type, insurance coverage (vs uninsured), and income eligibility. The secondary outcomes were the cost of the drugs covered by the patient assistance programs and the coverage of expensive off-patent brand-name drugs vs substitutable generic drugs. Among the 6 independent charity foundations included in the analysis, their total revenue in 2017 ranged from $24 million to $532 million, and expenditures on patient assistance programs ranged from $24 million to $353 million, representing on average, 86% of their revenue. Of the 274 patient assistance programs offered by these organizations, 168 (61%) provided only co-payment assistance, and the most common therapeutic area covered was cancer or cancer treatment-related symptoms (113 patient assistance programs; 41%). A total of 267 programs (97%) required insurance coverage as an eligibility criterion (ie, excluded uninsured patients). The most common income eligibility limit was 500% of the federal poverty level. The median annual cost of the drugs per beneficiary covered by the programs was $1157 (interquartile range, $247-$5609) compared with $367 (interquartile range, $100-$1500) for the noncovered drugs. Off-patent brand-name drugs (cost: >$10 000) were covered by a mean of 3.1 (SD, 2.0) patient assistance programs, whereas their generic equivalents were covered by a mean of 1.2 (SD, 1.0) patient assistance programs. In 2018, among 274 patient assistance programs operated by the 6 independent charity foundations, the majority did not provide coverage for uninsured patients. Medications that were covered by the patient assistance programs were generally more expensive than those that were not covered.

HHS’s Proposed Drug Rebates Rule Would Raise Premiums; Benefits Unclear

HHS’s Proposed Drug Rebates Rule Would Raise Premiums; Benefits Unclear