Benefit Design

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.

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Oncologists Are Showing More Enthusiasm for Carvykti Than Are Payers

With its Feb. 28 approval, the Janssen Pharmaceutical Companies of Johnson & Johnson and Legend Biotech USA, Inc.’s Carvykti (ciltacabtagene autoleucel; cilta-cel) becomes the second chimeric antigen receptor T-cell (CAR-T) therapy to treat multiple myeloma. Payers report being less likely to prefer it over some or all other multiple myeloma treatments with a similar indication, but oncologists are showing more enthusiasm for prescribing the new agent, according to Zitter Insights.

The FDA approved Carvykti for the treatment of adults with relapsed or refractory multiple myeloma after at least four lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody. The product is a B-cell maturation antigen (BCMA)-directed CAR-T agent. The one-time treatment will have a phased launch and will be available through a limited network of certified treatment centers. The FDA gave the drug breakthrough therapy and orphan drug designations. The therapy’s wholesale acquisition cost is $465,000.

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Adbry, Others Add to Growing Class Of Atopic Dermatitis Biologics

The FDA has approved a handful of drugs to treat atopic dermatitis recently. Among them is LEO Pharma Inc.’s Adbry (tralokinumab-ldrm), an interleukin-13 (IL-13) antagonist. According to a Zitter Insights survey, payers may take a bit of a restrictive approach in managing the drug. And with multiple new biologics approved for the condition and more potential agents coming onto the market, payers may impose more utilization management strategies on the therapeutic class as a whole, say industry experts.

On Dec. 28, the FDA approved Adbry for the treatment of people at least 18 years old with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those treatments are not advisable. The decision made it the first biologic that LEO Pharma has launched in the U.S. Recommended dosing is an initial dose of 600 mg via four 150 mg subcutaneous injections and then 300 mg every other week.

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Geographic Expansions Assisted 2022 AEP Winners’ Major Gains

Medicare Advantage membership has grown by 8.5% since February 2021 to top 28.6 million lives, according to AIS Health’s analysis of data that included enrollment during the 2022 Annual Election Period (AEP). While nearly two-thirds of all new enrollees selected a plan from market leaders UnitedHealthcare, Humana Inc. or CVS Health Corp.’s Aetna, several regional insurers performed well above average, driven largely by service area expansions, provider pacts and benefit enhancements. (Per AIS’s research methodology, the following figures do not include lives enrolled in CMS’s Financial Alignment Initiative demonstration plans serving about 451,000 Medicare-Medicaid dual eligibles or participants in Programs of All-Inclusive Care for the Elderly.)

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News Briefs: CMS Is Seeking Applicants for the 2023 MA VBID and Part D Senior Savings Models

CMS on March 1 issued a request for applications (RFA) for the 2023 Medicare Advantage Value-Based Insurance Design Model, which will include new elements such as a Health Equity Incubation Program that will encourage testing of interventions in “the most promising focus areas” (e.g., food insecurity) and designing best practices for such interventions. Thirty-four MA organizations are currently offering benefit packages that feature tailored VBID model benefits and rewards and incentives to more than 3.7 million enrollees, according to the model’s website. CMS on Feb. 28 also released an RFA from Medicare Part D sponsors and pharmaceutical manufacturers interested in participating in the 2023 Part D Senior Savings Model. Now in its third year, the insulin-focused model is intended to lower out-of-pocket costs for seniors by featuring “predictable” copayments of no more than $35 for a broad set of insulins. The voluntary model has 106 participants, including five manufacturers. CMS is accepting applications for the VBID model through April 15 and for the SSM through April 8.

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FDA Approves Adbry for Use in the Growing Class of Atopic Dermatitis Biologics

The FDA has approved a handful of drugs to treat atopic dermatitis recently. Among them is LEO Pharma Inc.’s Adbry (tralokinumab-ldrm), an interleukin-13 (IL-13) antagonist. According to a Zitter Insights survey, payers may take a bit of a restrictive approach in managing the drug.

On Dec. 28, the FDA approved Adbry for the treatment of people at least 18 years old with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those treatments are not advisable. The decision made it the first biologic that LEO Pharma has launched in the U.S. Recommended dosing is an initial dose of 600 mg via four 150 mg subcutaneous injections and then 300 mg every other week.

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Infographic: Out-of-Pocket Prescription Drug Costs Remain a Burden for Medicare Beneficiaries

Most older adults in the U.S. have been diagnosed with one or more chronic illnesses, and managing these conditions presents a significant cost burden, according to a January study in JAMA Internal Medicine. The authors studied eight of the most common chronic conditions, both as single disease states and in clusters, and determined hypothetical annual out-of-pocket (OOP) costs for individual seniors enrolled in Medicare Advantage-Prescription Drug plans and Standalone Part D plans in 2009 and 2019. While annual costs for many of the conditions dropped, likely due to the availability of new generic drugs, OOP costs for atrial fibrillation, type 2 diabetes and heart failure skyrocketed. This was attributed to the introduction of brand-name therapies without generic alternatives that received clinical guideline recommendations. To remedy this, study authors urged Congress to act on drug pricing reforms, including allowing Medicare to negotiate list prices and cap annual OOP costs for seniors.

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New York Medicaid Insurer Hopes Virtual Care Will Boost Access

MVP Health Care has launched a new virtual care offering for its New York Medicaid members that allows them to connect with primary care and specialty care physicians through an app made by the digital health company Galileo. Kimberly Kilby, M.D., the insurer’s vice president and medical director of health and well-being, and Christopher Del Vecchio, president and CEO of MVP Health Care, tell AIS Health that they want the new partnership to improve health equity for the insurer’s Medicaid beneficiaries.

The new partnership with Galileo is part of a multiyear effort at MVP to address an unmet need for virtual care. “Over the last 18 months, nearly 40% of MVP’s Medicaid members have not seen a primary care physician (PCP), often due to competing demands on time and resources such as transportation and language barriers,” Del Vecchio tells AIS Health, a division of MMIT, via email.

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FDA Approves Novartis Drug That Will Go Up Against PCSK9s

More than a year after pandemic travel restrictions pushed back the FDA’s approval decision on Novartis Pharmaceuticals Corp.’s inclisiran, the agency finally approved it. The new first-in-class therapy targets so-called bad cholesterol and is set to compete with two other biologics that target the same protein.

On Dec. 22, the FDA approved Leqvio as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with clinical atherosclerotic cardiovascular disease (ASCVD) or heterozygous familial hypercholesterolemia (HeFH) who require additional lowering of low-density lipoprotein cholesterol (LDL-c).

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Insurers Are Wary, but States Say Standard Exchange Plans Work

In their public comments about a proposed rule that would bring back standardized plans to the Affordable Care Act exchanges, two health insurer trade groups make it clear that they believe such a move will “stifle innovation” in plan design. However, state-based marketplaces that already require plan standardization appear to have found a way to make that policy work for consumers and insurers alike, sources tell AIS Health.

“I’m not aware of anything to suggest that innovation — however one might define that — has been hampered to the detriment of consumers in the states where we see this policy in place,” says Justin Giovannelli, an associate research professor at Georgetown University’s Center on Health Insurance Reforms. Giovannelli co-authored a July 2021 piece for The Commonwealth Fund examining various states’ ACA plan standardization requirements.

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