HHS-OIG Declines Sanctions On Gift Card Incentive For At-Home …

Wednesday, April 5, 2023

The Office of Inspector General of the U.S. Department of Health and Human Services (HHS-OIG) issued Advisory Opinion No.

23-03 on March 29 regarding a proposal related to the manufacturer’s desire to issue a gift card to users of its product. The opinion addresses concerns about an at-home lab test manufacturer who wished to provide individuals a gift card for up to £75 to encourage them to use and return the manufacturer’s at-home colorectal cancer screening test.

Despite implicating both the beneficiary inducement civil monetary penalty (CMP) rules and the federal Anti-Kickback Statute (AKS), the agency determined it would not impose sanctions on the manufacturer.

The manufacturer has a proprietary, non-invasive colorectal cancer screening test that has been approved by the U.S.

Food and Drug Administration (FDA). Medicare covers the test once every three years for Medicare beneficiaries aged 45 or older who meet certain criteria. Medicare reimburses the lab approximately £500 per test.

The U.S. Preventive Services Task Force (USPSTF) recommends adults ages 45 to 75 use the test once every three years. Additionally, the American Cancer Society recommends the test for individuals at average risk of developing colorectal cancer.

After a patient receives a prescription for the test, the lab ships the test sample collection kit to the patient’s home.

The patient collects their own stool sample and ships the kit back to the lab, which analyzes the stool sample for a result that may indicate the presence of colorectal cancer.

The manufacturer typically contacts a patient at the outset to request the timely return of the kit. If the lab does not receive the kit promptly, the manufacturer contacts the patient again. The manufacturer’s data shows that more than 30 percent of patients fail to return their kit.

For that reason, the manufacturer desires to provide patients a gift card to promote compliance with the kit return timeline.

Under the proposal, the manufacturer would send the patient one final reminder letter to return the kit. This letter would state that, if the patient returns the kit within a certain time frame, the manufacturer would send the patient a prepaid gift card for up to £75. The manufacturer noted:

  • The gift card would only be mailed to patients who return the kit by the deadline in the letter

  • The gift card may not be used for items or services provided by the manufacturer

  • Each patient would be limited to one gift card every 36 months, which aligns with Medicare’s coverage for the test

  • The manufacturer would have protocols in place to ensure each patient only received one gift card every 36 months

  • Besides the letter, the manufacturer would not engage in any promotion of the gift card

  • The manufacturer would not promote the gift card model to prescribers

Beneficiary Inducement CMP

HHS-OIG determined the gift card model would implicate the beneficiary inducement CMP rules; however, since the proposal involves an incentive related to the promotion of preventive care services, it meets the Preventive Care Exception.

Under the Preventive Care Exception, the gift card would be permissible because: 

  • The manufacturer would offer and provide the gift cards to individuals eligible for Medicare to promote a specific, clinical service described in the USPSTF’s Guide to Clinical Preventive Services

  • The gift card would not be convertible to cash or be of a value disproportionately large in relationship to the value of the service

  • The test would not be tied to the provision of any additional needed services

Anti-Kickback Statute

HHS-OIG reached a slightly different conclusion as related to the Anti-Kickback Statute. Although HHS-OIG determined the gift card would likely be remuneration under AKS, the agency declined to impose sanctions because:

  • The gift cards are unlikely to lead to improperly increased costs or overutilization of federally reimbursable services. Patients only receive the gift card once every 36 months, in line with Medicare’s reimbursement and USPSTF’s recommendation.

    The manufacturer would not promote or incentivize providers to engage in the program, so it is unlikely to influence a prescriber. And, the test is reimbursed by Medicare at a fixed rate, preventing the manufacturer from increasing the cost of the test and passing the cost of the gift cards on to the federal health care programs.

  • The arrangement would promote patient compliance with a screening test that has been recommended by USPSTF and the American Cancer Society. Only patients among the 30 percent who do not return the kit would be eligible for the gift card, thereby promoting compliance with the prescription.

  • The arrangement has several other safeguards that reduce the risk of fraud and abuse.

    For instance, the manufacturer will ensure that a patient only receives one gift card every 36 months and the manufacturer will not advertise the gift cards to patients or prescribers.

Key Takeaways

HHS-OIG relied heavily on the public health benefits of the test to reach its conclusion. Colorectal cancer is the third most commonly diagnosed cancer in the United States and can often be effectively treated if identified early with regular screenings. The manufacturer’s test, which is non-invasive and completed at home, in conjunction with the gift card can encourage compliance with screening recommendations.

This upstream prevention can help decrease cancer incidence and care costs down the line. 

HHS-OIG also heavily emphasized the safeguards the manufacturer put in place.

Providers considering a similar gift card model should consider implementing protocols that would limit how many patients are eligible, reduce duplication of gift cards, and avoid promotion or marketing of the model.

art-gallery listed on couponmatrix.ukpost-office-insurance listed on couponmatrix.ukrobert-dyas listed on couponmatrix.ukthe-jewellery-channel listed on couponmatrix.ukvoidu listed on couponmatrix.ukwoven listed on couponmatrix.uk
art-gallery listed on couponmatrix.ukLooking to fill your home with inspirational, affordable art? ArtGallery.co.uk is the place to find it. Browse through thousands of works of art from independent artists and find the perfect piece to frame your fireplace or liven up your back room. Shop with an Art Gallery discount code from us and enjoy unique creations for the fraction of the price. From dramatic surrealist paintings to delicate botanical watercolours, Art Gallery stocks a piece of art to suit every taste.
post-office-insurance listed on couponmatrix.ukWhen checking out the Post Office’s huge range of insurance policies, you may be surprised to find that there’s barely an aspect of your life that you can’t get coverage for! Whether you want to ensure your pet is protected, are jetting off on your travels, or want to be safe on the roads, with your Post Office Insurance promo code, you can save on some of the top protection available. In operation for over 370 years, the Post Office is a name you can trust.
robert-dyas listed on couponmatrix.ukIf you're looking for a one-stop shop for all of your kitchen and garden needs, look no further than Robert Dyas. It stocks the best appliances and home essentials - and with a Robert Dyas discount code from us, finding that perfect bargain is easy. Whether you are looking for an incredible discount on garden furniture or that once in a lifetime deal on electrical kitchen products, you'll want to check out these amazing deals and benefit from those savings.
the-jewellery-channel listed on couponmatrix.ukTune in to The Jewellery Channel’s online marketplace and live TV channel to indulge your inner magpie and stock up on baubles for prices that won’t bust your budget. Don’t forget to use a TJC discount code from us when you browse glittering rings, twinkling earrings and show-stopping necklaces to complement any look, and you could spoil yourself or that certain special someone while keeping your bank balance firmly in the black.
voidu listed on couponmatrix.ukVoidu is a well-known digital game store that offers PC game keys at discounted prices. They offer a wide variety of games from popular publishers such as Ubisoft, Bethesda, and Square Enix. Be it an RPG or a first-person shooter, make the most of a Voidu discount code and enjoy your favourite games without breaking the bank. With a library that includes over 4,000 titles to enjoy, rest assured you’ll never be stuck for choice when gaming with Voidu. We work hard to find the best Voidu discounts and voucher codes for our members. We search high and low for the latest Voidu deals so you can save big on the biggtest gaming releases. Be sure to browse the catalogue during the next Voidu sale to secure as much as 50% off games that’ll give you endless hours of content. In the meantime, check Groupon for the best bargains for your PC games library. Voidu offers a wide variety of titles from a multitude of publishers, so it's easy to find a great deal on everything from AAA releases to the latest indie hit. If you fancy taking a trip through the world of Norse mythology for example, you can rip and tear for less by using our newest Voidu vouchers to knock the cost God of War. Whether you’re new to the platform or are an absolute PC gaming god, you’ll find plenty to please at Voidu.
woven listed on couponmatrix.ukThere’s an art to crafting your ideal home, yet with Woven and their inventory of immaculate handwoven fabrics your vision can become reality. As experts in the trade of designing rugs, bedding and cushions that are both beautiful and long-lasting, no avid homeowner will regret adding Woven to their home with the help of a Woven discount code. Made with the perfect balance of style, comfort and practicality, you’ll quickly come to understand the luxury that Woven entails.