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HHS finalizes changes to Section 1557 regulations strengthening anti-discrimination protections

On April 26, 2024, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) and the Centers for Medicare & Medicaid Services (CMS) finalized updates to regulations implementing Section 1557 of the...more

The Genesis case: The beginning of the end of HRSA’s “patient” definition?

On November 3, 2023, the U.S. District Court for the District of South Carolina issued a decision granting in large part Genesis Health Care’s (Genesis’s) motion for summary judgment in its litigation against the Health...more

CMS Proposes Significant Changes to Medicaid Drug Rebate Program

On May 23, 2023, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule entitled Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program...more

HHS OIG issues ASP reports exploring need for guidance and increased oversight in ASP reporting

On January 3, 2023, the Department of Health and Human Services Office of Inspector General (OIG) publicly released two reports with respect to Medicare Part B average sales price (ASP)....more

Inflation Reduction Act’s Medicare Part D benefit redesign explained

In the third of a three-part webinar series on the recently enacted Inflation Reduction Act of 2022 (IRA), Hogan Lovells partners Ken Choe and Melissa Bianchi discussed the Medicare Part D redesign and answered questions from...more

Inflation Reduction Act’s Medicare Part B and D inflation rebates explained

In the second of a three-part webinar series on the recently enacted Inflation Reduction Act of 2022 (IRA), Hogan Lovells partners Alice Valder Curran and Ken Choe, as well as David Chan, President and General Manager of...more

Inflation Reduction Act’s Drug Price Negotiation Program explained

In the first of a three-part webinar series on the recently enacted Inflation Reduction Act of 2022 (IRA), Hogan Lovells partners Alice Valder Curran and Ken Choe discussed the Drug Price Negotiation Program established by...more

[Ongoing Program] Unpacking the prescription drug provisions of the Inflation Reduction Act of 2022 - Part 3: Medicare Part D...

On August 7, 2022, the Senate passed the proposed Inflation Reduction Act of 2022, which includes a number of significant prescription drug-related provisions. The bill generally revives many of the prescription drug...more

[Ongoing Program] Unpacking the prescription drug provisions of the Inflation Reduction Act of 2022 - Part 2: Medicare Part B and...

On August 7, 2022, the Senate passed the proposed Inflation Reduction Act of 2022, which includes a number of significant prescription drug-related provisions. The bill generally revives many of the prescription drug...more

[Ongoing Program] Unpacking the prescription drug provisions of the Inflation Reduction Act of 2022 - Part 1: Drug price...

On August 7, 2022, the Senate passed the proposed Inflation Reduction Act of 2022, which includes a number of significant prescription drug-related provisions. The bill generally revives many of the prescription drug...more

Senate Passes Drug Pricing Legislation

On August 7, 2022, the Senate passed the proposed Inflation Reduction Act of 2022, which includes a number of significant drug pricing-related provisions.  The bill generally revives many of the drug pricing provisions...more

D.C. District Court rules for PhRMA in PBM accumulator programs Final Rule litigation

On Tuesday, May 17, 2022, the U.S. District Court for the District of Columbia issued a decision granting the Pharmaceutical Research and Manufacturers of America’s (PhRMA)’s motion for summary judgment and vacating (i.e.,...more

U.S. House passes drug pricing legislation

This morning, the U.S. House passed drug pricing legislation as part of the Build Back Better Act (BBBA) (specifically the Rules Committee version available here and the manager’s amendments available here). In prelude to...more

No Surprises Act prohibits balance billing, creates arbitration process for out-of-network providers

Effective January 1, 2022, the “No Surprises Act” signed into U.S. law as part of H.R. 133, “Consolidated Appropriations Act, 2021,” implicates (1) emergency services provided by non-participating providers at participating...more

Expanded access to telehealth services during the COVID-19 pandemic

In response to the COVID-19 pandemic, the U.S. Congress, the Centers for Medicare and Medicaid Services (CMS), many state legislatures and state Medicaid programs, and private payers have implemented significant changes to...more

CMS proposes changes to new-technology add-on payment amounts and criteria in the inpatient prospective payment system proposed...

On 23 April 2019 the Centers for Medicare & Medicaid Services (CMS) issued the inpatient prospective payment system (IPPS) and long-term care hospital (LTCH) prospective payment system proposed rule for fiscal year (FY) 2020...more

Medicare further expands payment for and coverage of telehealth and similar services

Through several recently published rules, the Centers for Medicare & Medicaid Services (CMS) is making it possible for Medicare beneficiaries to have greater access to health care services provided remotely through telehealth...more

CMS considers linking Medicare drug payment rates to international prices

On October 25, 2018, the Centers for Medicare & Medicaid Services (CMS) issued an advance notice of proposed rulemaking (ANPRM) describing a potential mandatory model to test Medicare reimbursement based on an "International...more

Expanded coverage of telehealth

The recently enacted Bipartisan Budget Act of 2018 expands Medicare’s coverage for telehealth services in several ways. Inclusion of these provisions, which had been part of a Senate bill called the CHRONIC Care Act, is...more

Bundle Up: CMS Releases Request for Applications for New Version of Bundled Payments for Care Improvement Model

This week, the Centers for Medicare & Medicaid Services (CMS) released details on the much-anticipated new version of the Bundled Payments for Care Improvement (BPCI) payment model, which will be known as BPCI Advanced. Like...more

CMS request for information presents rare opportunity for medicare stakeholder engagement

On 14 April 2017, the Centers for Medicare & Medicaid Services (CMS) published the fiscal year (FY) 2018 Medicare Hospital Inpatient Prospective Payment System (IPPS) and Long Term Acute Care Hospital (LTCH) Prospective...more

Calling for Ideas—CMS Releases Final 2018 Medicare Advantage and Part D Rate Announcement and Call Letter

On 3 April 2017, the Centers for Medicare & Medicaid Services (CMS) released its final Medicare Advantage (MA) and Part D Rate Announcement and Call Letter (Call Letter) for calendar year 2018. The Call Letter is part of...more

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