legislation & regulation

Demand for Medication Abortion May Rise if Roe Falls

The use of medication abortion — which involves two drugs, mifepristone and misoprostol — has grown significantly since its approval and now accounts for 54% of all pregnancy terminations before nine weeks of gestation in the U.S. If the Supreme Court overturns Roe v. Wade, medication abortion usage is likely to increase as patients in states that ban the procedure are likely to attempt to obtain courses of medication abortion from states that allow it. Only 18 states and the District of Columbia allow both advanced practice clinicians and medical doctors to dispense abortion pills. Six states have passed laws banning any use of telehealth for medication abortion, according to a recent Kaiser Family Foundation analysis. Insurance coverage for both surgical and medical abortion is heavily regulated across the nation. A 2019 study from the Government Accountability Office found that 14 states’ Medicaid programs do not cover mifepristone even in the cases of rape, incest and life endangerment.

News Briefs: UnitedHealthcare to Restrict Aduhelm Access

UnitedHealthcare will restrict access to Aduhelm (aducanumab) across all of its books of business, arguing that “Aduhelm is unproven and not medically necessary for the treatment of Alzheimer’s disease due to insufficient evidence of efficacy,” according to company documents obtained by Stat News. The decision from the insurance branch of UnitedHealth Group, the largest private carrier in the country, follows a controversial move by CMS to restrict access to the drug mainly to patients who are participating in clinical trials. In a National Coverage Determination, CMS said the Medicare program will cover Biogen Inc.’s Aduhelm only for patients enrolled in randomized, controlled clinical trials conducted either through the FDA or the National Institutes of Health. For Medicare patients to be prescribed Aduhelm, they also must have a clinical diagnosis of mild cognitive impairment due to Alzheimer’s disease or mild dementia with a confirmed presence of plaque on the brain.

Some Insurers May Not Be Ready for Price Transparency Mandates

Insurer price transparency rules are finally starting to come into effect after years of litigation and administrative delays, but it’s not clear whether insurers will be compliant when deadlines arrive. Health care insiders tell AIS Health, a division of MMIT, that larger carriers have an advantage in implementation and smaller insurers may have a more difficult time keeping up.

Federal enforcement of payer price transparency rules by HHS and the departments of Labor and Treasury will begin on July 1 of this year. That deadline, during which plans will need to “make public machine-readable files disclosing in-network rates and out-of-network allowed amounts and billed charges,” per a government document, is the first of many health plan transparency requirements that will come into effect over the next two years.


CMS Finalizes MA Rule Provisions, Delays Pharmacy DIR Change

Just a month shy of the bid deadline for the 2023 plan year, CMS on April 29 finalized most provisions of a sweeping Medicare Advantage and Part D rule that was proposed in January. Those provisions included restoring detailed medical loss ratio (MLR) reporting requirements, requiring MA Special Needs Plans to incorporate certain questions on social risk factors into health risk assessments, and finalizing a pathway to allow for star ratings to reflect a Dual Eligible SNP’s local performance. But one Part D provision regarding pharmacy direct and indirect remuneration (DIR) was notably delayed, allowing plans, pharmacies and pharmacy benefit managers time to renegotiate pharmacy pacts.

“Generally speaking, the rule wasn’t surprising. CMS largely did what they proposed. I think the major concession that plans and PBMs were concerned about was the start date of the pharmacy DIR change, and they had that addressed. But by and large this rule was consistent with CMS’s goals of raising the bar for what it means to be a SNP and for reducing costs at point of sale for seniors” starting in 2024, says Tom Kornfield, senior consultant with Avalere.

OIG Report on Prior Authorization Denials Puts Pressure on CMS

As Medicare Advantage insurers face increasing scrutiny from lawmakers over coding practices and a pending pay boost of 8.5% next year, a new HHS Office of Inspector General report on rates of prior authorization and payment denials in MA doesn’t do much to help their case. Although it was based on just a weeklong sample of denial cases, the report adds to a growing body of evidence that the prior authorization process in MA is ripe for improvement and in need of either more guidance from CMS and/or stronger oversight.

Receiving widespread coverage at press time, starting with a New York Times article summarizing it as “saying that insurers deny tens of thousands of authorization requests annually,” OIG on April 28 released a report titled, “Some Medicare Advantage Organization Denials of Prior Authorization Requests Raise Concerns About Beneficiary Access to Medically Necessary Care.” The report immediately drew praise from providers, such as the American Medical Association (AMA), which issued a statement agreeing with federal investigators’ recommendations on reining in inappropriate denials. But AMA argued that more needs to be done, such as passing a bipartisan bill that aims to establish new electronic prior authorization (PA) requirements on MA insurers.

News Briefs: CMS Finalizes Rule Mandating Standard ACA Exchange Plans

CMS on April 28 finalized the 2023 Notice of Benefit and Payment Parameters for Affordable Care Act exchange plans, cementing its proposal to require insurers to offer standardized plans on HealthCare.gov. In a provision opposed by the insurance industry at large, the Biden administration will require issuers offering Qualified Health Plans (QHPs) on the federal exchange to offer standardized plan options at every network type, at every metal level and throughout every service area where non-standardized options are offered, starting in 2023. Those plans also will be differentially displayed on HealthCare.gov “to help consumers make more informed choices about their coverage.” Another major provision included in the annual omnibus rule governing the ACA exchanges is the addition of new network adequacy standards that require QHPs to “ensure that certain classes of providers are available within required time and distance parameters.”


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.

Amid ‘Family Glitch’ Fix, Enhanced ACA Subsidy Expiration Looms

While the Biden administration has proposed a long-awaited fix for the Affordable Care Act’s “family glitch” — potentially making coverage more affordable for thousands — the looming expiration of major ACA subsidy expansion threatens to overshadow that progress.

Health insurers that spoke to AIS Health, a division of MMIT, seem concerned about the potential drawback of generous financial help for exchange enrollees, but are not necessarily ready to hit the panic button yet.

“We have the unfortunate benefit, I’d characterize it, as having been through in the past other situations where there was uncertainty about the future of the market,” says Bill Tuthill, vice president of market strategy and federal markets for Highmark Inc. Perhaps the most frightening times occurred when all or major parts of the ACA were in danger of being struck down by the Supreme Court — but that threat didn’t pan out, Tuthill tells AIS Health, a division of MMIT.


MAOs Anticipate All-In Pay Increase of 8.5%, Await Final Rule

Perhaps the biggest headline from the largely uneventful 2023 final rate notice for Medicare Advantage and Part D plans is that they will, on average, receive a slightly higher-than-anticipated pay bump next year. Also, risk scores will not be reduced by any more than the statutory minimum adjustment of 5.9%. However, MAOs are still waiting on the final version of an MA and Part D rule containing some provisions that could impact 2023 bids, and sources at press time suggested its release was imminent.

With the April 4 release of the 2023 Rate Announcement, CMS finalized most aspects of its rate proposal for next year but increased the effective growth rate from 4.75% to 4.88%, bringing the expected average change in revenue to 8.50% — one of the highest updates in recent history. CMS maintained an estimated risk score coding trend of 3.5% and a fee-for-service normalization factor — which is used to offset the trend in risk scores and keep the FFS risk score at the same average level over time — of -0.81%. CMS also said it would continue to apply an across-the-board adjustment of 5.9% to offset the effects of higher levels of coding intensity in MA relative to FFS Medicare. That coding intensity adjustment generated much discussion in comment letters on the Advance Notice.

HHS Seeks Funding to Promote Mental Health Parity, Free Visits

The Biden administration’s proposed budget includes an ambitious mental health care agenda that would step up enforcement of mental health parity, change medical necessity standards and require expanded mental health benefits. Though the budget is only a proposal and must pass Congress, where it will be heavily modified, the document arrives at a moment when legislators in both parties have made expanding access for behavioral health care a central element of their responses to the COVID-19 pandemic and opioid misuse epidemic.

The administration’s proposed 2023 HHS budget in brief includes several notable behavioral health proposals that would impact commercial insurers. That list of proposed policies includes stepped-up behavioral health parity enforcement, more funding for Medicare and Medicaid behavioral health benefits and a requirement that all health plans — including commercial group plans backed by employers — provide three behavioral health visits per member every year without charging any cost sharing.