The blogosphere has lately been abuzz with an important question for pharma: Can copay coupons be used for enrollees in the new health benefit exchanges that launched this month?

The short answer is ?probably not.?

The longer answer is that this is still a muddy area, but attorneys, health plan executives, and some representatives of the pharmaceutical industry are concerned that using the coupons to offset the cost of copays in the federally subsidized exchange plans would violate federal anti-kickback laws.

Copay coupons are not permitted in Medicare, Medicaid and Tricare. According to the Centers for Medicare & Medicaid Services, the anti-kickback statute ?makes it a criminal offense to knowingly and willfully offer, pay, solicit, or receive any remuneration to induce or reward referrals of items or services reimbursable by a Federal health care program.?

Although the state health benefits exchanges are offering commercial plans, not Medicare or Medicaid (with some exceptions on the latter), they include federal subsidies for people making up to 400 percent of the federal poverty level. It's estimated that up to 80 percent of enrollees will qualify for subsidies. That puts the exchange plans in a grey area between commercial and government plans.

Neither CMS nor the Department of Health and Human Services has made a definitive ruling on whether copay coupons are allowed for exchange enrollees, but experts have been weighing in. RxObserver recently published an interview with a Washington attorney and former HHS official who said the use of copay coupons would likely violate federal anti-kickback laws. Kevin G. McAnaney, former chief of the Industry Guidance Branch, Office of Counsel to the HHS Inspector General, said that the law likely precludes anyone in exchange health plans ? whether subsidized or not ? from using the coupons.

On the other hand, the Academy of Managed Care Pharmacy, the national association of pharmacists and health care practitioners, believes the copays will be permitted for commercial plans in the exchange. In an email, AMCP Director of Regulatory Affairs Mary Jo Carde said the exchanges ?are not considered federal health care programs in the same manner as Medicare and Medicaid because individuals receive the subsidies, not the plans. Further, the plans are governed like private market plans.? She agreed with a Pharmaceutical Executive blog making that case, written by Mark McAndrew. However, McAndrew cautioned that Alternative Benefit Plans, which will be available for some Medicaid-eligible enrollees through health exchanges, will be considered federal health care programs and will be subject to the anti-kickback statute.

In our interactions with health plans at HealthLeaders-InterStudy, some MCO execs say they are advising against the coupons. Health plans have never been enthusiastic about coupons, saying they tempt members with more expensive options by subsidizing copays, and that they operate outside their data-heavy care-coordination efforts.

AMCP's official position is that coupons should be used sparingly to give the neediest access to drugs. But the organization cautions that coupons can distort the incentives MCOs use to encourage members to use lower-cost drugs ? and eventually force MCOs to raise premiums, since the insurer is ultimately responsible for reimbursing the pharmacy for the higher-cost drugs.

In the absence of an official ruling from CMS or the Department of Health and Human Services, pharma coupons inhabit the grey area of ACA unknowns. But for now, both pharmaceutical companies and MCOs seem to be erring on the side of caution.

Follow Sheri Sellmeyer on Twitter @SheriSellmeyerHLI

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