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Advancing Interoperability and Improving Prior Authorization: No One Said It Would Be Easy!

The Centers for Medicare & Medicaid Services (CMS) recently published the CMS Advancing Interoperability and Improving Prior Authorization Processes Final Rule (“PA Final Rule”) in the Federal Register....more

CMS Names Its First Ten Negotiated Part D Drugs: Inflation Reduction Act Updates

On August 29, 2023, the Centers for Medicare & Medicaid Services (CMS) announced the ten (10) Medicare Part D drugs selected for the first round of negotiations of the Medicare Drug Price Negotiation Program (Program)—a few...more

Texas Federal Court Issues Fourth Ruling Invalidating Parts of the Administration’s No Surprises Act Regulations

On August 24, 2023, the U.S. District Court for the Eastern District of Texas issued an opinion and order in Texas Medical Association, et al. v. United States Department of Health and Human Services(“HHS”)(“TMA III”). TMA...more

Independent Dispute Resolution Process Halted Following the Government’s Third Major No Surprises Act-Related Loss in Federal...

On August 3, 2023, the U.S. Department of Health & Human Services (“HHS”), the Department of Labor, and the Department of Treasury (collectively, the “Departments”) temporarily suspended the federal Independent Dispute...more

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

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...more

Podcast: Inflation Reduction Act’s Drug Price Negotiation Provisions – What’s Next? - Diagnosing Health Care [Video]

The Inflation Reduction Act (IRA), signed into law in August 2022, included significant and controversial drug-pricing provisions. What key compliance issues must industry stakeholders consider as these provisions are put...more

CMS Issues New Guidance on Medicare Drug Price Negotiation Program: Inflation Reduction Act Updates

IRA Provision: The Medicare Drug Price Negotiation Program - The Centers for Medicare & Medicaid Services (CMS) issued a fact sheet and initial guidance for the implementation of the Medicare Drug Price Negotiation...more

No Surprises Act: HHS Extends Enforcement Moratorium on Co-Provider & Co-Facility Good Faith Estimates

To the relief of many providers and facilities and with just three weeks to go until the implementation date, the U.S. Department of Health & Humans Services (HHS) announced that it is extending its policy of not enforcing...more

The No Surprises Act: New and Surprising Challenges for Clinical Laboratories

On July 13, 2021, the U.S. Departments of Health and Human Services, Labor, and the Treasury, and the Office of Personnel Management (collectively, “Departments”) published their highly anticipated interim final rule (“First...more

The No Surprises Act: Implications for Health Plans, Health Care Facilities, and Health Care Providers

Following months of congressional negotiations, on December 27, 2020, President Trump signed into law the Consolidated Appropriations Act, 2021, a $2.3 trillion piece of legislation that includes $900 billion in federal...more

Finalized HHS Drug Formulary Rebate Rule Faces Uncertain Future Under Biden Administration and Current Legal Challenge

On November 30, 2020, the U.S. Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) published a final rule (“Final Rule”) that removes safe harbor protection under the discount safe harbor to...more

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