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Monthly Round-Up of What to Read on Pharma Law and Policy

Bill of Health

The selections feature topics ranging from a review of the regulatory consequences of the FDA’s accelerated approval of eteplirsen, to a comparison of the safety and effectiveness of generic and brand-name fluticasone-salmeterol for COPD, to an analysis of free speech challenges to Medicare drug price negotiation under the Inflation Reduction Act.

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DIR Reform: what you need to know

Natalia Mazina

Many pharmacy and patient advocacy groups have spoken out against the obscure methods employed by PBMs to increase their profits. These groups have advocated for the fees to be applied at the time a patient picks up the medication at the pharmacy rather than subjecting pharmacies to these fees months later.

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TAKE TWO: CMS’s Second Attempt to Streamline Breakthrough Device Coverage Limited to 5 Devices Per Year

Health Law Advisor

On June 22, 2023, the Centers for Medicare & Medicaid Services (CMS) announced its proposed “Transitional Coverage for Technologies” (TCET) pathway—the Biden administration’s highly anticipated take on a mechanism to expedite coverage for certain devices designated by the U.S. Food and Drug Administration (FDA) as breakthrough devices. [1]

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White House looks to CMMI to test new ways to lower drug prices

C&M Health Law

The EO comes two months after the president signed the Inflation Reduction Act (IRA) which promises to lower the cost of prescription drugs for many Medicare beneficiaries. This is not the first time that the White House will try to leverage CMMI’s testing authority to create models that would lower drug costs in Medicare.

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California pharmacies will no longer be required to pay back the state under its new reimbursement methodology

Natalia Mazina

Several pharmacists and patient advocacy groups filed legal actions against the DHCS and worked with legislature to eliminate these chargebacks to pharmacies. This lead to overpayments to pharmacies.

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Patient advocacy groups slam UnitedHealthcare over 'misleading' Medicare Advantage marketing

Fierce Healthcare

Several patient advocacy organizations are urging the Biden administration to look into allegedly misleading marketing from UnitedHealthcare about its Medicare Advantage plans.

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Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) Funding Opportunity: Measure Development for the Quality Payment Program

CMS.gov

Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) Funding Opportunity: Measure Development for the Quality Payment Program. They are concrete quality topics which reflect core issues that are most vital to high quality care and better patient outcomes. Jeremy.Booth@c…. Fri, 03/02/2018 - 16:30. Kate Goodrich, M.D.,