legislation & regulation

North Carolina and Colorado recently became the latest in a string of states that have taken over the reins of Friday Health Plans Management Services Company, Inc.’s subsidiaries in a bid to ensure consumers and providers aren’t harmed by the insurer’s implosion. The company’s downfall has implications for health insurers, too, as they may not receive the risk-adjustment funds they’re expecting if Friday can’t pay its share, an industry expert previously told AIS Health.

Insurance Commissioner Mike Causey said June 20 that Friday Health Plans of North Carolina Inc. “consented to being placed into receivership to protect North Carolina policyholders due to its reported insolvency and inability to raise additional funds from outside investors.” Technically, the action is not yet completed, as the state said it filed its receivership petition with the Wake County Superior Court and will post the order on the North Carolina Dept. of Insurance's website once it is signed.

The Pharmaceutical Research and Manufacturers of America (PhRMA) sued the Biden administration over Medicare drug price negotiation and inflation cap provisions in the Inflation Reduction Act (IRA), arguing that the policies are unconstitutional. Two patient assistance groups, the National Infusion Center Association and the Global Colon Cancer Association, joined the lawsuit, which was filed in the U.S. District Court for the Western District of Texas, per a PhRMA press release. The U.S. Chamber of Commerce, Bristol Myers Squibb, and Merck & Co. Inc. filed their own lawsuits against the drug price provisions of the law in recent weeks, and Biogen Inc.’s CEO said that his firm may do the same. The Chamber of Commerce was a major financial backer of legal efforts to overturn the Affordable Care Act during the 2010s, and it filed an amicus brief in support of the lawsuit that ultimately led to the U.S. Supreme Court’s move to strike down mandatory state Medicaid expansion.

The Senate Finance Committee recently introduced a bill that adds to a growing swell of legislation aimed at changing how PBMs conduct business. This latest measure, which is focused solely on Medicare Part D, aims to delink PBM compensation from drug list prices and utilization. Industry experts say it is meant to complement, rather than compete with, other legislation that targets a broader range of business practices and insurance markets.

The Patients Before Middlemen (PBM) Act, introduced on June 14, targets just Medicare Part D because that program is where the Senate Finance Committee’s jurisdiction lies, explains James Gelfand, president and CEO of the ERISA Industry Committee (ERIC). And based on the Senate Health, Education, Labor and Pensions (HELP) Committee’s jurisdiction, the legislation that it advanced in May — the Pharmacy Benefit Manager Reform Act — would apply just to employer-based health plans and address issues such as rebate retention and spread pricing.

In 2021, almost all commercial, Medicare Advantage and Medicaid health plans covered at least one immediate-release buprenorphine, a medication for treating opioid use disorder (OUD), according to a recent Health Affairs study. Also, since 2017, fewer health plans have been requiring prior authorization and quantity limits for those medications.

However, fewer than half of commercial formularies and one-fifth of MA formularies covered extended-release buprenorphine products in 2021. Comparatively, 82.8% of Medicaid formularies covered such medications, and the share of Medicaid formularies without prior authorization requirements increased from 6.8% in 2018 to 63.3% in 2021.

Friday Health Plans Management Services Company, Inc. — a Colorado-based insurer that offers Affordable Care Act exchange plans in seven states — is in a downward spiral. Concerned by the company’s deteriorating financial situation, state regulators are taking steps such as putting the insurer’s subsidiaries under supervision and placing them into receivership.

Georgia, for example, recently garnered headlines by announcing that Friday enrollees will need to find a different health plan. And Colorado said on June 1 that it will work with the insurer to wind down its business across the country due to ongoing capital shortfalls.

Venture-backed Friday Health Plans will cease operating after several state regulators placed it into receivership due to its rocky finances. The Colorado-based insurer operated in seven states — Colorado, Georgia, Nevada, New Mexico, North Carolina, Oklahoma and Texas — and as of December 2022 covered almost 400,000 enrollees, according to AIS’s Directory of Health Plans.

The insurtech, founded in 2015 with a focus on the Affordable Care Act exchanges, raised over $306 million in venture capital and debt funding. Yet in late 2022, it announced it would scale back from operating in seven states to five states, pulling out of Texas and New Mexico. In March 2023, it was placed into receivership in Texas and soon other states took similar actions.

In a unanimous 9-0 vote, the Supreme Court on June 1 overturned a lower court’s decision pertaining to the False Claims Act (FCA) and allegations that two large pharmacy chains overcharged the federal government for prescription medications. Experts tell AIS Health, a division of MMIT, that the ruling is significant for health insurers because the FCA disproportionately impacts the health care industry.

The Department of Justice (DOJ), for instance, said it obtained more than $2.2 billion in settlements and judgments involving fraud and false claims for the 12 months through Sept. 30, 2022. More than $1.7 billion of that total involved the health care industry.

With the Federal Trade Commission investigating major PBMs’ business practices and reform measures gaining momentum in Congress, executives of the country’s three largest PBMs have been busy assuring investors and analysts that they can withstand the heat. The recent Bernstein Strategic Decision Conference proved no exception, as CVS Health Corp.’s chief financial officer made the case there that employers and health plans — rather than PBMs — are in the driver’s seat when it comes to deciding how contracts are written.

Industry experts tell AIS Health, a division of MMIT, that while it is true that some employers may prefer the status quo, that’s certainly not the case universally. And they say the argument that employers and health plans use “sophisticated consultants” ignores the fact that those same consultants can get paid hefty sums by PBMs when they win contracts.

The traditional pharmacy benefit market is seeing a challenge to its model from patient-paid prescriptions, contended longtime industry expert Adam J. Fein, Ph.D., CEO of Drug Channels Institute, during a recent webinar. While some generics of specialty drugs are being sold via these routes, the potential exists for disruption in crowded biologic-treated classes facing a lot of competition, particularly via biosimilars.

And with some industry developments such as the Inflation Reduction Act likely to impact the uptake of high-price/high-rebate drugs, patient-paid prescriptions could become an even bigger disruption within the market than they already are.

In 2021, almost all commercial, Medicare Advantage and Medicaid health plans covered at least one immediate-release buprenorphine, a medication for treating opioid use disorder (OUD), according to a recent Health Affairs study. Also, since 2017, fewer health plans have been requiring prior authorization and quantity limits for those medications.

However, fewer than half of commercial formularies and one-fifth of MA formularies covered extended-release buprenorphine products in 2021. Comparatively, 82.8% of Medicaid formularies covered such medications, and the share of Medicaid formularies without prior authorization requirements increased from 6.8% in 2018 to 63.3% in 2021.