legislation & regulation

Medicare Part D Coverage for Humira Biosimilars Has Inspector General’s Attention

The HHS Office of Inspector General will evaluate the extent and quality of Medicare Part D plan coverage for biosimilars to AbbVie Inc.’s Humira (adalimumab) and expects to issue a report on the study in 2025, according to a recent update to the OIG’s work plan.

The study could provide fodder for reforms to pharmacy benefit manager rebating practices and for changes in Part D coverage policy that could help boost the uptake of biosimilars. Stakeholders and policy makers have viewed adalimumab biosimilars as a test case for the viability of the biosimilar model.

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News Briefs: CDC Makes More RSV Immunizations Available to Infants

The CDC announced on Nov. 16 that it had made available more than 77,000 additional doses of Beyfortus (nirsevimab-alip), a monoclonal antibody intended to protect infants from severe respiratory syncytial virus (RSV) disease. Since the FDA approved Beyfortus in July, there have been supply issues and insurance coverage limitations for RSV medications. Sanofi, which manufactures Beyfortus alongside AstraZeneca, noted last month that it had seen “an unprecedented” level of demand for the medication and that it was working with the CDC to distribute more doses through the agency’s Vaccines for Children program.

CMS has delayed its plan to cover Medicare patients’ full cost of preexposure prophylaxis (PrEP) using FDA-approved antiretroviral drugs to prevent HIV infection in high-risk patients, according to KFF. CMS had announced the proposal in July and expected to make it official on Oct. 10, but KFF said the delay has occurred while CMS “is still working out details on how to transition coverage for patients already taking the drugs.” The drugs can cost more than $20,000 per year in the U.S.

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Proposed Regs Tweak Rx Drug Coverage in Exchanges, MA

Deep within two new proposed health insurance regulations are provisions that would alter how Medicare Advantage and Affordable Care Act exchanges cover prescription drugs — and some of them are garnering praise from patient advocates.

For example, the HIV+Hepatitis Policy Institute welcomed two of the proposals in the 2025 Notice of Benefit and Payment Parameters (NBPP), the annual regulation governing the ACA marketplaces, which CMS released on Nov. 15.

One of those provisions would codify existing policies surrounding how health plans treat prescription drugs that aren’t part of a given state’s essential health benefits (EHB) benchmark plan. Under the ACA, individual market plans must cover items and services in 10 core benefit categories, including prescription drugs, and each state is responsible for defining which drugs make the must-cover list.

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Bright, Friday Risk Adjustment Defaults Could Set Bad Precedent

Recently, CMS revealed that health insurers Bright Health Group, Inc. and Friday Health Plans Management Services Company, Inc., have failed to pay $1.1 billion that they owe to other health insurers through the Affordable Care Act’s risk adjustment program. While Friday will never be able to pay its share — since state regulators have taken over the failed insurer — the government’s repayment agreement with Bright is raising questions about whether the current rules governing ACA risk adjustment need an overhaul.

“Insurers that attract high-cost enrollees need to be able to count on being compensated by the risk adjustment system, and if they’re not going to be compensated, then insurers will be less willing to offer generous plan designs,” Matthew Fiedler, Ph.D., a fellow with the Brookings Schaeffer Initiative for Health Policy, tells AIS Health, a division of MMIT.

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Texas Messes With ACA Rating Areas — With Promising Results

Merging urban and rural Affordable Care Act marketplace rating areas in Texas significantly increased carrier and plan choices and lowered overall plan premiums in rural Texas, according to a recent Health Affairs study.

When calculating premiums for customers, the ACA permits insurers to consider those customers’ area of residence — or rating area — among other factors including age, smoking status and family size. Yet the use of rating areas can lead to higher premiums for rural areas, where residents tend to have greater health care needs and where there’s a smaller risk pool due to lower population density.

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KFF: Medicaid MCOs Will Grapple With Higher Rates, New Mandates in 2024

In 2024, managed care organizations will have to manage more complex care coordination requirements and compliance with ambitious equity goals in many states — even as Medicaid programs have been forced to step up reimbursement rates across many care categories. That’s according to the 2023 edition of KFF's annual survey of state Medicaid officials, which was released on Nov. 14.

The overwhelming majority of states are increasing Medicaid reimbursement rates across many care categories. Forty-eight states increased rates for at least one care category in 2023, and 47 will do the same in 2024. Only 21 states implemented at least one rate restriction in 2023, and 19 expect to do so in 2024.

That means total state spending for the safety net health insurance program is likely to increase, despite the ongoing reduction in total enrollment due to the return of eligibility redeterminations. Medicaid spending per enrollee is likely to increase in 2024, KFF found, while total Medicaid spending growth in the surveyed states will likely be 8.3% in 2023, down from 9.8% in 2022.

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With 2025 ACA Exchange Reg, Feds Seem to Have Georgia on Their Mind

In the 2025 version of the government’s annual mega-regulation governing the Affordable Care Act exchanges, multiple proposals appear to be aimed at ensuring state-based marketplaces are adhering to the same standards that apply to the federal marketplace, HealthCare.gov. One health policy expert says it’s probably not a coincidence that the proposed policy changes would take effect the same year that conservative-leaning Georgia is slated to launch its own state-based exchange.

“I see some proposals in here that are trying to safeguard against efforts to reduce the quality of exchange operations or run an exchange on the cheap,” says Sabrina Corlette, co-director of Georgetown University’s Center on Health Insurance Reforms.

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Senate Could Make Medicare Telehealth Rules Permanent

The U.S. Senate Finance Committee seems poised to take up legislation that would make permanent the significant, pandemic-era reforms to Medicare telehealth rules, including rules governing site of care origination and audio-only telehealth encounters, which are otherwise set to expire at the end of next year. Medicare Advantage plan and provider trade groups back the legislation and have pushed for telehealth reforms to be permanent when they were up for renewal in previous legislative cycles.

Emergency reforms to Medicare reimbursement rules were a key reason that the telehealth industry boomed in recent years. Telehealth was the only option for many types of outpatient care during the early parts of the COVID-19 pandemic, and patients, plans and providers became accustomed to using telehealth modalities for a wide variety of low-acuity encounters. Those encounters wouldn’t have been reimbursable if it weren’t for temporary, emergency reforms of Medicare telehealth billing rules passed as parts of COVID relief bills and executive orders by Presidents Donald Trump and Joe Biden.

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Operationalizing MA Supplemental Benefits, Network Adequacy Proposals Could Impact Stars

In a Nov. 15 rule proposing policy and technical changes for the 2025 Medicare Advantage and Part D plan year, CMS made numerous changes aimed at protecting beneficiaries from “predatory marketing” and ensuring they enroll in the MA plans that best meet their needs. And depending on how plans execute these new provisions, some have the potential to impact Star Ratings, industry experts observe. At the same time, the rule proposed several methodological enhancements, clarifications and operational updates to the 2025 Star Ratings.

For example, CMS provided an update on its plans to include the Universal Foundation of quality measures that would align across all CMS programs and to provide a “building block to which programs will add additional aligned or program-specific measures.” As part of this plan, CMS said it has submitted the Initiation and Engagement of Substance Use Disorder Treatment (IET) Part C measure to the Measures Application Partnership (MAP) for review as a measure under consideration. Additionally, CMS indicated that it will submit three other Universal Foundation measures — Adult Immunization Status, Depression Screening and Follow-Up, and Social Need Screening and Intervention, which are now reported as display measures — to MAP prior to proposing the use of those measures in future rulemaking.

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Proposed MA Rule Targets Broker Pay, Unused Supplemental Benefits, SSBCI Evidence

Continuing a theme of protecting consumers and ensuring appropriate use of Medicare dollars, the Biden administration on Nov. 6 released its annual rule proposing policy and technical changes for the Medicare Advantage and Part D program. The 2025 MA and Part D proposed rule contains provisions aimed at improving access to behavioral health, streamlining enrollment options for dual eligibles, encouraging biosimilar product substitution, and assessing the impact of prior authorization policies on health equity. But some of the rule’s most detailed proposals centered on two hot-button program areas: supplemental benefits in MA and misleading marketing practices.  

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