Policy & Politics

PHE Unwinding Delay Gives States, MCOs Time to Ease Transitions

With radio silence from HHS on May 16 — when states at the very latest had expected to hear whether the COVID-19 public health emergency would end in July — HHS at press time appeared to be gearing up for another extension of the PHE. This will give states, insurers and other stakeholders more time to prepare for the inevitable resumption of Medicaid eligibility redeterminations, which could cause millions of adults and children to lose health insurance coverage.

The PHE has been extended multiple times since the start of the pandemic and remains a moving target. As a condition of receiving enhanced federal funds during the PHE, states have been required to ensure continuous Medicaid and CHIP coverage for most enrollees by pausing eligibility redeterminations. And the Biden administration has promised to provide states 60 days’ notice before any possible termination or expiration. But without such notification, sources estimate the next end date could be Oct. 13. Bloomberg on May 16 reported that the PHE would be extended past mid-July, “according to a person familiar with the matter.”

Medicaid Plans Get Ready for Yearlong Postpartum Care

State Medicaid programs now have the option of applying to CMS to expand postpartum coverage for parents who have just given birth to 12 months, up from the default 60 days of coverage. Medicaid MCOs in states that have opted into the expanded coverage tell AIS Health, a division of MMIT, that they are taking steps to get ready for the new coverage and anticipate better outcomes for both new parents and new children as a result of the program.

Maternal mortality rates in the United States are disturbingly high compared to other developed countries — in 2018, 17 women per 100,000 live births died, compared to three in the Netherlands, Norway and New Zealand, per the Commonwealth Fund — and the U.S. is the only developed country to see that rate increase in recent years. Most of those deaths were preventable.

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Drug Price Controls Appear Central to Democratic Priorities

Democratic lawmakers are expected to make a strong push to revive a variety of drug pricing proposals, such as those that would grant CMS the ability to negotiate the price of certain drugs and place a cap on Medicare beneficiaries’ out-of-pocket spending.

House Majority Leader Chuck Schumer (D-N.Y.) has indicated he is targeting the current congressional work period that runs through Memorial Day as the time to make good on drug pricing plans that Democrats have long favored, noted Matt Kazan, managing director of policy with consultancy Avalere Health, during an April 27 webinar.

The convergence of several factors, including looming mid-term elections and the scheduled end of the COVID-19 public health emergency (PHE) could spur Democrats to make a last-ditch effort to resuscitate the Build Back Better Act (BBBA) and the drug pricing controls contained within it — especially since the end of the PHE could significantly impact Medicaid and Affordable Care Act (ACA) exchange enrollment.

States Pass More PBM Laws, Including Copay Accumulator Bans

PBMs have drawn more attention than ever from state officials responding to the steep cost of prescription drugs. As federal efforts to manage the rising cost of medications have stalled, state lawmakers across the country have considered hundreds of bills that affect PBMs, ranging from prescription drug affordability boards to banning copay accumulators.

The National Academy for State Health Policy (NASHP), a think tank and policy group, identified 118 bills introduced to state legislatures across the country that would change PBM regulations during 2022 sessions. In addition, NASHP found state legislators nationwide have introduced 44 bills that would reform drug coupons, including bans on copay accumulators and maximizers. That follows more than 100 laws passed since 2017 by state legislatures, according to a June 2021 NASHP blog post.

News Briefs: Express Scripts Wins Anthem Lawsuit

The long-running lawsuit between Anthem, Inc. and Express Scripts — over whether the PBM now owned by Cigna Corp. overcharged Anthem for prescription drugs — has finally concluded. Anthem first sued Express Scripts in 2016, alleging primarily that the PBM failed to honor its contractual agreement to provide “competitive benchmark pricing” for prescription drugs and thus owed the insurer $14.8 billion in damages. Ultimately, Judge Edgardo Ramos dismissed most of Anthem’s claims, finding that the companies’ contract did not “obligate Express Scripts to provide competitive benchmark pricing, but merely to negotiate in good faith in the event that Anthem’s market analysis shows non-competitive pricing.”

After Aduhelm, Congress May Revamp Accelerated Approvals

The FDA’s accelerated approval of Alzheimer’s drug Aduhelm (aducanumab) last year was extremely controversial, prompting harsh criticism and calls for reform of the accelerated approval process itself. Congress has taken up the issue and is considering one bill from each major party that would revamp the process in the hope of addressing concerns that the pathway has allowed flawed drugs to stay on the market without being revisited.

Medical research and health care policy experts have raised a number of critiques of the current accelerated approval framework. Two critiques stand out: The first concerns the quality of data used in measuring the effectiveness of accelerated approval drugs. After a drug is granted accelerated approval, the FDA mandates that the drug be evaluated using confirmatory clinical trials. Experts have criticized the quality of data collected for accelerated approval drugs; in particular, the measurements used to gain approval for Aduhelm were heavily criticized by clinicians.

Millions Will Lose Medicaid Coverage After PHE Ends; Only Half of States Have Plans in Place

More than 14 million Medicaid enrollees could lose their coverage within six months when the COVID-19 public health emergency (PHE) ends, a Commonwealth Fund report projected. Meanwhile, Kaiser Family Foundation’s 50-state survey found that many states have not made key decisions on how to promote continuity of coverage. While the PHE is set to expire on April 16, HHS has said it would give at least 60 days’ notice before ending it, suggesting another extension is coming.

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As Major Drug Price Reforms Stall, Focus Shifts to Insulin Costs

The Senate Finance Committee held a hearing on March 16 in which politicians and experts discussed drug price inflation and the proposal for Medicare to negotiate prices for some high-cost medications. But the efforts in those areas still seem uncertain and most are unlikely to move forward anytime soon as they were part of the Build Back Better Act (BBBA) bill that stalled out in December, one health policy expert tells AIS Health.

Health insurers and PBMs, though generally supportive of lowering drug prices, have in the past been critical of some of legislators’ reform proposals — including a narrower focus on lowering insulin out-of-pocket costs that has emerged in recent months.

After Aduhelm, Congress May Revamp Accelerated Approvals

The FDA’s accelerated approval of Alzheimer’s drug Aduhelm (aducanumab) last year was extremely controversial, prompting harsh criticism and calls for reform of the accelerated approval process itself. Congress has taken up the issue and is considering one bill from each major party that would revamp the process in the hope of addressing concerns that the pathway has allowed flawed drugs to stay on the market without being revisited.

Medical research and health care policy experts have raised a number of critiques of the current accelerated approval framework. Two critiques stand out: The first concerns the quality of data used in measuring the effectiveness of accelerated approval drugs. After a drug is granted accelerated approval, the FDA mandates that the drug be evaluated using confirmatory clinical trials. Experts have criticized the quality of data collected for accelerated approval drugs; in particular, the measurements used to gain approval for Aduhelm were heavily criticized by clinicians.

Inflation Rebates Would Cost Manufacturers Millions, Studies Say

Drug manufacturers would be on the hook to pay the federal government hundreds of millions of dollars in rebates per year should the Build Back Better Act (BBBA) — and a key inflation-based penalty provision within it — become the law of the land. The breadth of the penalties, however, hinges on various factors, including the current runaway rate of inflation.

While the BBBA, passed by the House in November 2021, remains stalled, lawmakers have expressed a renewed sense of interest in picking up the pieces following President Joe Biden’s March 1 State of the Union address.

A previous holdout to the Democrats’ wide-ranging spending plan, Sen. Joe Manchin (D-W.V.) recently issued an informal counteroffer to Biden’s speech, calling for prescription drug spending to remain central to any legislation that moves ahead.