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The Department of Health and Human Services Office of Inspector General (“OIG”) recently issued a favorable advisory opinion regarding whether a proposed patient assistance program (“PAP”) would run afoul of Federal antifraud statutes.

Under the proposed PAP, a nonprofit organization would subsidize certain cost-sharing obligations for low-income Medicare enrollees who have diabetes and reside in a specified rural area. Although the PAP displayed the potential for the generation of prohibited remuneration and did not fall under a safe harbor for either the Federal Anti-kickback Statute (AKS) or the beneficiary inducement provisions of the Civil Monetary Penalties statute (CMP), OIG stated that it would not impose administrative sanctions on the requesting entity.

While this advisory opinion is only applicable to the specific program at issue and can only be relied upon by the requestor, there are some potential considerations that could be applied more broadly to other arrangements.Continue Reading HHS OIG won’t enforce antifraud statutes against patient assistance program

The Department of Health and Human Services Office of Inspector General (OIG) recently issued two advisory opinions related to proposed arrangements offering financial assistance to individuals who receive gene therapy treatments. These arrangements were specifically targeted to patients who may suffer from infertility as a result of the treatments’ required chemotherapy-based fully myeloablative conditioning (Conditioning).

While proposed arrangements for travel support (as discussed below and in a June 14, 2024 advisory opinion) appear to receive approval from OIG, other proposed financialsupports for infertility services have received unfavorable opinions primarily because of a lack of data available to OIG regarding whether the proposed assistance would improve the ability of patients to access the gene treatment therapies.

These unfavorable decisions effectively chill arrangements to provide additional financial support to individuals who are enrolled in federal and state health care programs and require gene therapy treatments, though OIG has indicated that it may issue favorable decisions in the future if it receives additional data.  Continue Reading OIG Issues Opinions On Arrangements Involving Gene Therapy Treatments

The Department of Health and Human Services Office of Inspector General (OIG) kicked off the new year with four new advisory opinions covering retiring physicians, preferred hospital organization discounts for Medigap patients, and gift cards for the referral of potential physician practice customers of a non-clinical consulting company. While OIG published the favorable opinions last week, it issued them on December 28, 2023 to cap off a busy 2023 season.

Two opinions, Opinion 23-13 and Opinion 23-14, are substantially similar to each other and to two other opinions  issued earlier in the year (Opinion 23-09 and Opinion 23-10). All four opinions approve the use of discounts by a preferred hospital organization (PHO) within a “preferred hospital” network as part of Medicare Supplemental Health Insurance (Medigap) policies.

Specifically, the opinions approved of an insurance company contracting with the PHO to provide discounts on the otherwise-applicable Medicare inpatient deductibles for its policyholders and, in turn, the insurer providing a premium credit of $100 off the next renewal premium to those policyholders who used a network hospital for an inpatient stay. This flurry of PHO Medigap discount opinions likely reflects the fact that an OIG advisory opinion is binding only on its requestor, leading different PHOs to seek approval for the same proposal.

The other two opinions include Opinion 23-12, a favorable review of a one-time, voluntary redemption offer to physician partners reaching age 67 to have their partnership units repurchased by a partnership over a 2-year period, contingent upon the physician partners’ agreement to retire from the practice of medicine,  and Opinion 23-15, a favorable review of a consulting company’s gift card offer to physician practices for the referral of potential new customers.Continue Reading OIG Publishes First Advisory Opinions of the Year

On April 24, 2023, the Department of Health and Human Services’ Office of Inspector General (“OIG”) issued a modification to advisory opinion 20-04, from July 2020, where the OIG opined favorably on the proposal to purchase or receive donations of unpaid medical debt owed by qualifying patients from certain types of health care providers, including hospitals, and then forgive that debt.  Now, the OIG has been asked to modify certain conditions related to the public disclosure of hospitals’ donation or sale of medical debt. The requestor of the modification is a charitable organization that locates, buys, and forgives individual patents’ medical debt.Continue Reading OIG Approves Charity’s Modifications to Plan to Purchase and Forgive Medical Debt

On March 24, 2023, the Department of Health and Human Services’ Office of Inspector General (“OIG”) issued an advisory opinion in response to a proposal by a laboratory test kit company to provide prepaid gift cards to individuals, including federal health care program beneficiaries, to encourage use of its colorectal cancer screening test. The company specifically requested the opinion to determine whether the proposed gift card arrangement would constitute grounds for sanctions under federal Anti-Kickback Statute (“AKS”) and other sections of the Social Security Act. The OIG concluded that while proposed arrangement would generate prohibited remuneration under the AKS if the requisite intent were present, it would not impose administrative sanctions if the company implemented the gift card arrangement.

The company’s parent entity manufactures a non-invasive colorectal cancer screening test that has been approved by the U.S. Food and Drug Administration. The screening test is covered by Medicare Part B every three years for beneficiaries aged 45 and older, if the beneficiary meets certain criteria. It may be ordered for a patient only by a health care provider with prescribing authority. After an order is placed, the company ships its sample collection kit directly to a patient’s home. The patient then collects a stool sample and ships it back to the company in a prepaid, preaddressed package. The sample is subsequently analyzed by a laboratory for presence of colorectal cancer or other indicators of disease.Continue Reading OIG approves lab company’s gift card proposal for colorectal cancer screening kits

On February 28, 2023, the Department of Health and Human Services’ Office of Inspector General (“OIG”) issued a favorable advisory opinion regarding an arrangement through which a pharmaceutical company provides free enzyme replacement therapy (“ERT”) medication to patients who satisfy certain eligibility requirements where the patients’ insurer is delayed in making a coverage determination.

The OIG noted that, although the arrangement would generate prohibited remuneration under the federal Anti-Kickback Statute (“AKS”) if conducted with the requisite intent, it would not impose administrative sanctions. Further, the OIG opined that the arrangement would not generate prohibited remuneration under the beneficiary inducement prohibition (“Beneficiary Inducement CMP”).Continue Reading OIG allows drug company to provide free medication during coverage determination delay

After a long line of opinions scrutinizing the use of rewards programs offered by providers, the Department of Health and Human Services’ Office of Inspector General (“OIG”) issued Advisory Opinion 22-16 on August 19, 2022– a favorable opinion for the provision of gift cards to Medicare Advantage (“MA’) plan enrollees who complete educational modules as part of an online surgical treatment learning tool.

The opinion adds flexibility to existing opinions on gift cards and patient engagement programs and, while binding only on the requestor, provides insight into the OIG’s evolving view of these programs.Continue Reading OIG Approves Rewards Program for Medicare Advantage Organizations

The Department of Health and Human Services’ Office of Inspector General (“OIG”) recently issued a favorable advisory opinion to a digital health company that offers direct monetary incentives to patients as part of a technology-enabled contingency management program for patients with substance use disorders.

Contingency management, also known as motivational incentives, is a treatment approach that utilizes tangible rewards to reinforce positive behaviors (e.g., abstinence from opioids) and to motivate and sustain behavioral health efforts (e.g., treatment adherence) in patients who suffer from substance use disorders. Because these monetary incentives are an integral part of the protocol-driven and evidenced-based program, the OIG concluded that it would not impose sanctions under the federal Anti-Kickback Statute (“AKS”) or the Beneficiary Inducements Civil Monetary Penalty (“CMP”) provision, notwithstanding the involvement of federal health care program beneficiaries, providers/suppliers, and reimbursable services.

Nevertheless, the mitigating facts that motivated the OIG’s favorable treatment of the program here—namely, the clinical nature and independence of the program—could likely trigger compliance with other federal and state regulatory frameworks.
Continue Reading OIG blesses digital health substance use disorder treatment program paid for by providers and suppliers

In a March 11 advisory opinion the Department of Health and Human Services’ Office of Inspector General (“OIG”) permitted a medical device manufacturer to pay Medicare-reimbursable costs for subjects enrolled in a clinical trial sponsored by the manufacturer and involving the manufacturer’s therapy.

The OIG indicated it would not impose administrative sanctions, despite the fact…

Andrew and Quynh are law clerks at the firm and their work is supervised by licensed attorneys. Their admission to – respectively – the Washington, D.C. and California bar is pending.

On October 4, 2021, the Department of Health and Human Services Office of Inspector General (OIG) issued a favorable advisory opinion on a proposal by a chiropractic clinic operator to extend an existing discount program to federal health plan beneficiaries.

The requesting clinics initially offered various discount programs to their privately insured or self-paid patients, but not to Federal health care program beneficiaries. Many healthcare providers are hesitant to give federal beneficiaries access to certain discount programs because of concern that doing so would run afoul Federal anti-kickback and beneficiary inducement statutes. Specifically, the concern is that if the beneficiaries receive discounts, clinics would provide patients with something of value—a discount on self-paid services—in exchange for the option to seek federally reimbursed services through a specific provider.

To address these concerns, the chiropractic clinic operator requested an advisory opinion from OIG on a new discount model that would extend discount programs to Federal health care program beneficiaries. While OIG found that the proposed discount program could result in prohibited compensation to patients, it also stated that it would not pursue an enforcement action based on the nature of the requesting clinics’ specific discount model.

Although only the requesting chiropractic clinic operator may rely on this opinion, OIG’s analysis implies that equalizing discount rates across federally reimbursable and non-reimbursable chiropractic services reduces legal risk under anti-kickback and beneficiary inducement statutes. Providers offering similar discount programs should take note to inform their compliance strategies.
Continue Reading HHS-OIG approves uniform chiropractic discount program for federal beneficiaries

The Office of Inspector General (OIG) of the Department of Health Human Services (HHS) has issued a request for information (RFI) on ways to amend or add new safe harbors to the Anti-Kickback Statute and exceptions to the beneficiary inducement provisions of the Civil Monetary Penalty statute, in order to foster arrangements that promote care…

The Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) has published a final rule amending the safe harbors to the Anti-Kickback Statute (AKS) and the Civil Monetary Penalty (CMP) rules to protect certain payment practices and business arrangements from criminal prosecution or civil sanctions under the AKS (Final Rule).  The Final Rule finalizes all of the anti-kickback statute safe harbors proposed in an October 3, 2014 proposed rule, with certain modifications, and all of the beneficiary inducement CMP exceptions proposed in the Proposed Rule.

With regard to the AKS, the Final Rule finalizes:

  • A technical correction to the existing safe harbor for referral services;
  • Protection for certain cost-sharing waivers, including: pharmacy waivers of cost-sharing for financially needy Medicare Part D beneficiaries, and waivers of cost-sharing for emergency ambulance services furnished by state- or municipality-owned ambulance services;
  • Protection for certain remuneration between Medicare Advantage organizations and federally qualified health centers;
  • Protection for discounts by manufacturers on drugs furnished to beneficiaries under the Medicare Coverage Gap Discount Program; and
  • Protection for free or discounted local transportation services that meet specified criteria.

In the Final Rule, the OIG also amends the definition of “remuneration” in the CMP regulations at 42 CFR 1003 by adding certain statutory exceptions for:
Continue Reading OIG Issues CMP, Anti-kickback Safe Harbor Final Rules

The Office of Inspector General (OIG) has increased the value of permissible gifts that may be made to Medicare beneficiaries without running afoul of the civil monetary penalty (CMP) provision prohibiting beneficiary inducements (Social Security Act § 1128A(a)(5)).  The statute provides for CMPs of up to $10,000 for offers or transfers to a Medicare or…

The OIG has issued a policy statement clarifying the conditions under which hospitals may discount or waive Medicare beneficiary copayment amounts for self-administered drugs (SADs) received in outpatient settings without running afoul of OIG fraud authorities. In particular, the OIG addressed questions that have arisen from a 2003 CMS statement that a hospital’s decision not to bill a beneficiary for SADs that are not covered by the Medicare Part B program (Noncovered SADs) potentially implicates the prohibition on inducements to beneficiaries (section 1128A(a)(5) of the Social Security Act) or the anti-kickback statute (section 1128B(b) of the Act).
Continue Reading OIG Policy Statement Outlines Conditions Under Which Hospitals May Waive Beneficiary Copayments for Outpatient Self-Administered Drugs

The Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) has published a major proposed rule that would amend the safe harbors to the Anti-Kickback Statute (AKS) and the Civil Monetary Penalty rules to protect certain payment practices and business arrangements from criminal prosecution or civil sanctions under the AKS. Reed Smith has prepared a Client Alert analyzing the proposed rule, highlighting areas where the OIG is seeking public comment. Overall, the OIG appears to recognize that new health care delivery mechanisms demand a more flexible approach to fraud and abuse enforcement than has been the case in the past, as discussed in our analysis.
Continue Reading Reed Smith Client Alert: Analysis of HHS OIG Proposed Rule to Amend the Anti-Kickback Safe Harbors, CMP Rules on Beneficiary Inducements & Gainsharing Regulations

The OIG has just released a major proposed rule to amend the safe harbors to the Anti-Kickback Statute (AKS) and the Civil Monetary Penalty (CMP) rule to protect certain payment practices and business arrangements from criminal prosecution or civil sanctions under the anti-kickback statute.  In particular, with regard to the AKS, the OIG proposes:

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