Medicare Part D

Advocates’ Frustration Mounts Amid CMS Inaction on Copay Accumulators

Although a newly finalized health insurance regulation clocks in at 748 pages, it is missing something patient advocates have been eagerly hoping to see: language stating CMS will enforce a court ruling regarding the use of copay accumulator programs. Due to that omission, a patient advocacy group says it is once again exploring its legal options to curtail the practice in which payers prevent drug manufacturer coupons from applying toward patients’ out-of-pocket cost obligations.

Patients and advocacy groups for years have filed official comments on the annual Notice of Benefit and Payment Parameters (NBPP), urging federal officials to curtail the use of copay accumulator programs, according to Carl Schmid, executive director of the HIV+Hepatitis Policy Institute. “And every year, they’ve completely ignored those comments,” he tells AIS Health, a division of MMIT.

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© 2024 MMIT

Part D Formularies Get More Restrictive, but MA-PDs Beat PDPs on Access

Medicare Part D formularies are becoming more restrictive over time, asserts new research published in the March issue of Health Affairs. Studying Medicare administrative data that included Part D claims and plan formulary characteristics, researchers from the University of Southern California and Blaylock Health Economics found that utilization management tactics such as prior authorization, step therapy and formulary exclusions became far more commonplace between 2011 and 2020. In 2011, an average of 31.9% of drugs were restricted in some form, vs. 44.4% in 2020.

Restrictions varied based on drug costs and the availability of generic alternatives to brand-name drugs. Nearly 70% of brand-name compounds with no generic alternatives were restricted in 2020, compared to 30% of drugs with generic availability. Additionally, the lower the cost of the drug, the less likely it was to be restricted. In 2020, only 16.7% of drugs with generic availability that cost less than $100 per prescription faced restrictions, vs. 83.7% of brand-name only drugs that cost more than $1,000.

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News Briefs: Habitat Health Launches PACE Program in California With Kaiser Permanente

With support from Kaiser Permanente and investment firm Town Hall Ventures, Habitat Health has established a new Program of All-Inclusive Care for the Elderly (PACE) provider. Offering comprehensive care to adults who wish to live independently in their homes and communities, Habitat Health will serve aging and low-income adults in California in partnership with Kaiser and eventually expand to other states with local care partners. Habitat Health plans to begin serving PACE-eligible individuals in Los Angeles and Sacramento in 2025 and will serve as payer for all participants’ Medicare and Medicaid services. The new PACE provider will “benefit from Kaiser Permanente’s expertise in creating efficient systems and developing innovative technology to integrate complex care, and from Town Hall Ventures’ experience building successful care delivery companies that support underserved communities,” stated a March 27 press release from all three entities. Town Hall Ventures, whose leadership includes former CMS Acting Administrator and White House adviser Andy Slavitt, was founded in 2018 and has invested in or participated in the launch of 35 health care companies, including Cityblock Health, Landmark Health, Signify Health and VillageMD.

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Part D GLP-1 Spend Soars as CMS Makes Key Coverage Decision

Medicare is spending billions on GLP-1s, the groundbreaking diabetes drugs that are now seeing skyrocketing demand for their ability to help patients lose weight. While Medicare Part D plans are prohibited from covering weight loss therapies, a new FDA decision for Novo Nordisk’s Wegovy (semaglutide) could reshape the coverage landscape for some GLP-1s — and drive Part D spending even higher.

A March 22 analysis from KFF found that Part D spending on Novo’s Ozempic (semaglutide) alone reached $4.6 billion in 2022, a 77% increase from the prior year and a 207% increase from 2020. (Novo brands its injectable semaglutide as Ozempic for the treatment of Type 2 diabetes and as Wegovy for weight loss.) KFF found that Part D spending on GLP-1s has grown exponentially every year since 2018. Eli Lilly’s Trulicity (dulaglutide), an older GLP-1 that hit the market in 2014, saw the second-highest gross Part D spending among all therapies in 2022 at $6.2 billion. Ozempic, meanwhile, sat at No. 6. KFF speculated that both Ozempic and Novo’s oral semaglutide Rybelsus could be selected for Medicare drug price negotiation as early as 2025.

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No News Is Bad News for MAOs Hoping to See Pay Hike in 2025

The April 1 release of final rate projections for Medicare Advantage and Part D plans was largely uneventful as CMS maintained the same all-in estimate of what plans can expect to see, on average, in terms of a reimbursement update next year. But the market did not respond well: MA-exposed insurers’ shares took a tumble and equity analysts warned that a revenue decline — before coding trend — could lead to benefit cuts and footprint reductions.

Industry trade groups did not respond favorably, either. In a statement released immediately after the rate announcement, AHIP President and CEO Mike Tuffin said the finalized policies would “put even more pressure on the benefits and premiums of 33 million Medicare Advantage beneficiaries who will be renewing their coverage this fall,” particularly as the MA and Part D programs face regulatory and legislative changes.

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Wegovy Coverage Question Puts Part D Plans in Tricky Position

In newly released guidance, CMS told Medicare Part D plans that they’re allowed to cover weight-loss drugs if they’ve been approved for another medical use — a description fitting Novo Nordisk’s Wegovy (semaglutide) after it recently received an FDA nod for preventing major heart problems.

So far, CVS Health Corp., Elevance Health, Inc. and Kaiser Permanente have said their Part D plans will cover Wegovy for its newest approved use: reducing the risk of heart attacks and strokes in people who have cardiovascular disease and who meet body-weight criteria, the Wall Street Journal reported on March 28.

For other insurers that sell Part D plans, the decision about whether to cover Wegovy represents an additional challenge to grapple with, as they’re also facing significant regulatory changes.

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© 2024 MMIT

Wegovy Coverage Question Puts Part D Plans in Tricky Position

In newly released guidance, CMS told Medicare Part D plans that they’re allowed to cover weight-loss drugs if they’ve been approved for another medical use — a description fitting Novo Nordisk’s Wegovy (semaglutide) after it recently received an FDA nod for preventing major heart problems.

So far, CVS Health Corp., Elevance Health, Inc. and Kaiser Permanente have said their Part D plans will cover Wegovy for its newest approved use: reducing the risk of heart attacks and strokes in people who have cardiovascular disease and who meet body-weight criteria, the Wall Street Journal reported on March 28.

For other insurers that sell Part D plans, the decision about whether to cover Wegovy represents an additional challenge to grapple with, as they’re also facing significant regulatory changes.

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Stelara Formulations, White Bagging Bring Complexity to IRA Negotiated Drug List

As CMS engages in the initial round of Inflation Reduction Act (IRA)-mandated drug price negotiations with manufacturers, one of the agents on the list of Medicare Part D drugs to be negotiated has certain aspects that make it a not-so-straightforward candidate. Stelara (ustekinumab) from the Janssen Pharmaceutical Companies of Johnson & Johnson has particular qualities that could result in unintended consequences, asserts one industry expert.

Stelara is unique among the first drugs to be negotiated in that it is available in both subcutaneous and intravenous formulations. The human interleukin-12 and -23 antagonist is approved for subcutaneous use for the treatment of people at least 6 years old with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy and people at least 6 with active psoriatic arthritis. It also is approved for the treatment of adults with moderately to severely active Crohn’s disease and adults with moderately to severely active ulcerative colitis, for whom treatment is initiated with a single intravenous dose, followed by subcutaneous maintenance dosing.

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Part D Formularies Get More Restrictive, but MA-PDs Beat PDPs on Access

Medicare Part D formularies are becoming more restrictive over time, asserts new research published in the March issue of Health Affairs. Studying Medicare administrative data that included Part D claims and plan formulary characteristics, researchers from the University of Southern California and Blaylock Health Economics found that utilization management tactics such as prior authorization, step therapy and formulary exclusions became far more commonplace between 2011 and 2020. In 2011, an average of 31.9% of drugs were restricted in some form, vs. 44.4% in 2020.

Restrictions varied based on drug costs and the availability of generic alternatives to brand-name drugs. Nearly 70% of brand-name compounds with no generic alternatives were restricted in 2020, compared to 30% of drugs with generic availability. Additionally, the lower the cost of the drug, the less likely it was to be restricted. In 2020, only 16.7% of drugs with generic availability that cost less than $100 per prescription faced restrictions, vs. 83.7% of brand-name only drugs that cost more than $1,000.

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COA: New Part D Reimbursement Is Not ‘Reasonable and Relevant’

Specialty pharmacies and oncology practices dispensing costly specialty medications have long complained that Medicare Part D direct and indirect remuneration (DIR) fees are not appropriate for these drugs. Efforts to do away with these retroactive fees were finally successful, but revamped reimbursement has brought a new problem — underwater reimbursement — claims the Community Oncology Alliance (COA).

DIR includes rebates and price concessions that occur after the point of sale. According to CMS, total DIR “has been growing significantly in recent years.…In 2020, pharmacy price concessions accounted for about 4.8 percent of total Part D gross drug costs ($9.5 billion), up from 0.01 percent ($8.9 million) in 2010.”

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© 2024 MMIT