James Ravitz on Medicare

HHS Names the First 10 Drugs for Medicare Price Negotiation

Listening Sessions on Drug Price Negotiations Will Be Live Streamed and Opened to the Public This Fall - In this Alert, we provide an update regarding the first 10 drugs for Medicare price negotiation selected under the...more

9/6/2023 / Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Drug Pricing , Food and Drug Administration (FDA) , Medicare , Medicare Part D , Pharmaceutical Industry , Prescription Drugs

CMS Proceeds Full Steam Ahead with Medicare Drug Price Negotiation Program

Almost 11 months after President Biden signed the Medicare Drug Price Negotiation Program (“Negotiation Program”) into law, the Centers for Medicare and Medicaid Services (CMS) has issued revised guidance that clearly details...more

7/13/2023 / Biden Administration , Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Drug Pricing , Medicaid , Medicare , Pharmaceutical Industry , Prescription Drugs

CMS Proposes a Novel Replacement for Rescinded Pathway to Expedited Reimbursement of Breakthrough Devices

In November 2021, the Centers for Medicare & Medicaid Services (CMS) rescinded a short-lived program to expedite national Medicare coverage for innovative devices amid safety concerns for Medicare patients. CMS has strived...more

6/29/2023 / Centers for Medicare & Medicaid Services (CMS) , Emerging Technologies , Health Care Providers , Healthcare , Hospitals , Medicaid , Medicare , Physicians

Medicare Contractors Buy Additional Time for the Digital Health Industry

The explosive growth in telehealth over the past five years has resulted from, among other things, the Centers for Medicare & Medicaid Services’ (CMS) extension of Medicare reimbursement to remote monitoring of patients by...more

6/1/2023 / Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Health Care Providers , Medical Reimbursement , Medicare , Medicare Administrative Contractors (MAC) , Telehealth , Telemedicine

CMS Begins Implementation of the Inflation Reduction Act: Medicare Issues List of Drugs and Biologics Subject to Inflation Rebates

The Inflation Reduction Act of 2022 (Public Law 117-169) (the Act) contained an array of novel prescription drug provisions, which we described in our August 29, 2022, alert. On Wednesday, March 15, 2023, the Centers for...more

3/20/2023 / Centers for Medicare & Medicaid Services (CMS) , Drug Pricing , Inflation Reduction Act (IRA) , Medicaid , Medicare , Medicare Part B , Medicare Part D , Prescription Drugs , Tax Credits

2022-2023 Medical Product and Service Regulatory Initiatives

The medical product and healthcare service industry is one of the most closely regulated sectors in the U.S. Several agencies actively exercise authority with constantly changing legislation and policies to keep pace with...more

2/13/2023 / False Claims Act (FCA) , Food and Drug Administration (FDA) , Health Care Providers , Healthcare , Life Sciences , Manufacturers , Medical Devices , Medicare , Pharmaceutical Industry , Private Equity , Telemedicine

DOJ Antitrust, OIG Announce Collaboration to Protect Healthcare Markets

On December 9, 2022, the Department of Justice Antitrust Division (DOJ) and the Office of the Inspector General (OIG) of the Department of Health and Human Services (HHS) announced they are joining forces to protect...more

12/15/2022 / Department of Health and Human Services (HHS) , Department of Justice (DOJ) , False Claims Act (FCA) , Health Care Providers , Healthcare , Healthcare Fraud , Healthcare Reform , Medicare , OIG , Physicians

New Reimbursement Rules Will Likely Impact Digital Health and Telemedicine

On November 1, 2022, the Centers for Medicare & Medicaid Services (CMS) issued the 2023 Physician Fee Schedule (PFS) Final Rule. CMS publishes a PFS annually so as to make changes in federal healthcare reimbursement and...more

12/5/2022 / Centers for Medicare & Medicaid Services (CMS) , Digital Health , Health Care Providers , Medicare , Physician Fee Schedule , Physicians , Reimbursements , Telehealth , Telemedicine

Prescription Drug Provisions in the Inflation Reduction Act of 2022

The Inflation Reduction Act of 2022 (the Act) includes prescription drug provisions that have significant implications for the pharmaceutical industry and Medicare beneficiaries, such as allowing the U.S. Department of Health...more

8/30/2022 / Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Drug Pricing , Food and Drug Administration (FDA) , Medicare , Medicare Part B , Medicare Part D , Pharmaceutical Industry , Prescription Drugs

Administration Issues Executive Order on Medicare Drug Pricing Which Attempts to Impose Price Controls on Drugs Purchased by the...

Yesterday, the President issued an executive order (EO) on drug pricing for pharmaceuticals covered under Medicare parts B and D. The EO, in essence, proposes a form of price controls for drugs covered under Medicare parts B...more

9/15/2020 / Drug Pricing , Executive Orders , Healthcare Costs , Medicare , Pharmaceutical Industry , Prescription Drugs , Trump Administration

In a Move Designed to Benefit Patients, the President Signs an Executive Order to Pass Drug Manufacturer Rebates Directly to...

Recently, the President issued an executive order (EO) for the purpose of ensuring that discounts offered on prescription drugs be passed down to patients. The subject matter of EO represents a key plank of a platform to 1)...more

8/12/2020 / Coronavirus/COVID-19 , Executive Orders , Medicare , Pharmaceutical Industry , Trump Administration

CMS Further Loosen Restrictions and Lighten Burdens on Providers During the COVID-19 Emergency

On April 30, 2020, the Centers for Medicare & Medicaid Services (CMS) issued new regulatory waivers and rule changes aimed at expanding access to care and allaying regulatory burdens on healthcare providers during the...more

5/6/2020 / CARES Act , Centers for Medicare & Medicaid Services (CMS) , Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Health Care Providers , Medicare , Relief Measures

James Ravitz

Wilson Sonsini Goodrich & Rosati

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