legislation & regulation

Insurer and plan sponsor trade groups strongly oppose the Biden administration’s stepped-up mental health parity regulations, according to statements and public comment letters submitted in response to the latest rulemaking on the subject. Insurer groups AHIP, the Blue Cross Blue Shield Association (BCBSA) and the Alliance of Community Health Plans (ACHP) all lined up against the rulemaking, as did the ERISA Industry Committee (ERIC), a plan sponsor group.

According to the insurer and plan sponsor groups, the proposed rules, which were released in July, are unworkable. They argue that there are simply not enough providers available to meet the more stringent requirements set out in the proposed regulations. The current round of rules, if implemented, would expand the list of conditions covered by parity rules, require additional data reporting and establish stronger network adequacy standards. Both plan sponsors and carriers could be held liable for violations of most provisions in the Biden administration’s proposed regulations.

When the Affordable Care Act (ACA) became law on March 23, 2010, it established the 351(k) biosimilar pathway via the Biologics Price Competition and Innovation Act (BPCIA), which amended the Public Health Service (PHS) Act. Since then, the FDA has approved more than 40 biosimilars, with only a handful of those gaining interchangeable status. That designation, however, may not carry quite the distinction it historically has had if proposed guidance from the agency — which would replace previous guidance — on labeling for interchangeable biosimilars is finalized. Various stakeholders, including manufacturers, pharmacies, patients and providers, stand to be affected, stakeholders say.

In contrast to the EU, whose European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) clarified in September 2022 that all biosimilars approved in the EU are interchangeable, the FDA has created two levels of biosimilars: biosimilars and interchangeable biosimilars.

“Wheel of deceit.” “Sleazy, private sector scoundrels.” The transfer of personal information “from one moneygrubbing hand to another.” These are just a few of the verbal gems dropped by Sen. Ron Wyden (D-Ore.) when, during a recent hearing on Capitol Hill, he described the billion-dollar third-party Medicare marketing machine that has been under increased scrutiny by Congress, consumer advocates and researchers.

But beyond Wyden’s descriptive remarks, the Senate Finance Committee chair and other lawmakers queried stakeholders about real solutions to rein in misleading marketing practices and improve seniors’ shopping experiences. Suggestions that came up on multiple occasions included prohibiting the transfer of beneficiary information from one lead generator to another, putting additional limits on the fees brokers earn for enrolling MA members, penalizing MA insurers for the actions of third-party marketers, and increasing transparency around the full cost associated with enrolling in an MA plan.

PHILADELPHIA — Lina Khan, chair of the Federal Trade Commission, told attendees at the American College of Emergency Physicians (ACEP) Scientific Assembly on Oct. 11 that the FTC is paying close attention to so-called vertical integration in the health care industry.

“The FTC for decades, before I even arrived, had really been focused on what are known as horizontal mergers, between hospitals in particular,” she said. “But we’ve seen over the last decade that the tactics are changing. We are increasingly seeing not just the merger of alike, but also the merger of different entities within the same supply chain, what’s known as vertical integration.”

On Sept. 29, a U.S. District Court ruled in favor of patient advocates who challenged a regulation that allowed most individual and group market health plans to use copay accumulator programs. So far, it isn’t clear how CMS will respond to the ruling, likely leaving health plans and PBMs waiting eagerly for guidance from the agency. But one thing is certain: Health insurers aren’t happy about the decision.

Insurers created copay accumulator programs in response to the drug manufacturer practice of offering copay assistance programs — including coupons and copay cards — to defray high out-of-pocket costs patients might face for branded drugs. When copay accumulator programs are applied, health plan enrollees are not allowed to count any direct-to-consumer discounts toward their deductibles or out-of-pocket maximums.

CVS Health is getting into the biosimilars business, the company said in late August, and will officially enter the market on Jan. 1 in partnership with a Humira biosimilar. CVS stressed the importance of driving use of biosimilars and ensuring their supply, which sources say is a positive development. But one industry source questions whether the new company raises potential conflict-of-interest issues.

On Aug. 23, CVS revealed that it had launched the wholly owned subsidiary Cordavis to commercialize and/or co-produce biosimilars in collaboration with drug manufacturers. “Through Cordavis, CVS Health intends to develop a portfolio of products that it expects will facilitate broader access to biosimilars in the U.S. — creating more competition that drives down prices — while encouraging investment in future products,” said the company in a press release.

Resolving longstanding legal issues regarding its Medicare risk adjustment submissions, The Cigna Group has agreed to pay nearly $172.3 million and enter into a Corporate Integrity Agreement with the HHS Office of Inspector General. Cigna will pay approximately $135.3 million to resolve allegations stemming from an investigation based out of the Eastern District of Pennsylvania, according to a Sept. 30 press release from the U.S. Attorney’s Office. The insurer was accused of using a “chart review” program to identify and submit inaccurate diagnosis information in order to receive higher risk-adjusted payments from CMS while failing to delete or withdraw the “inaccurate or untruthful” diagnosis codes. The remaining $37 million will resolve allegations related to unsupported diagnoses for MA beneficiaries arising from Cigna’s home visit program. The allegations were brought in a whistleblower lawsuit transferred from the Southern District of New York, said the U.S. Attorney’s Office. Cigna in its own press release said the agreements “fully resolve” the False Claims Act lawsuit and investigation and will allow it to “maximize the company’s focus on delivering value to customers and taxpayers.” Cigna did not admit wrongdoing as part of the settlement.

House Reps. Gus Bilirakis (R-Fla.) and Earl Blumenauer (D-Ore.) have re-introduced legislation that would increase the number of people who are eligible to receive supplemental benefits as part of their Medicare Advantage plans. Jeannie Fuglesten Biniek, Ph.D., associate director of KFF’s Program on Medicare Policy, explains that the bill is “trying to expand the definition of who can qualify for extra benefits that are not primarily health related.”

The bill comes as the Medicare Payment Advisory Commission is considering standardizing a limited number of common supplemental benefits in MA — such as dental, vision and hearing benefits — with the goal of helping seniors better navigate a dizzying array of plan options.

Health insurer trade groups agree that it’s a good idea to reinstate strict limits on short-term, limited-duration insurance (STLDI) plans, according to their official comments on a proposed rule from the Biden administration. But their views diverge on the proposed regulation’s treatment of fixed indemnity insurance and other supplemental coverage.

The proposed rule in question — issued on July 7 by HHS and the Labor and Treasury departments — answered a growing chorus of calls to crack down on STLDI amid concerns that many consumers mistake them for comprehensive coverage. Meant to bridge a gap in insurance coverage, STLDI plans are exempt from the Affordable Care Act’s consumer protections, such as the ban on charging higher rates for sicker people and the requirement that plans must cover a prescribed set of “essential benefits.”

As PBMs continue to face an onslaught of regulatory scrutiny, their main trade group — the Pharmaceutical Care Management Association (PCMA) — has been arguing that attempts to alter the industry’s dominant business practices would do nothing but hand Big Pharma a victory and erode PBMs’ ability to bring down drug prices.

Now, however, a new coalition of smaller PBMs that promote a “transparent” business model has entered the scene and is aligning itself not with PCMA, but with attempts to overhaul the PBM industry.