On November 6, 2023, U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a General Compliance Program Guidance (GCPG) as part of its plan to renovate its library of compliance program...more
Summer 2023 saw dynamic executive, legislative, and enforcement activity in the cannabis and cannabidiol space. While the U.S. Department of Health and Human Resources (HHS) took steps to reschedule cannabis as a Schedule III...more
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
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
In November 2021, the Centers for Medicare & Medicaid Services (CMS) rescinded a short-lived program to expedite national Medicare coverage for innovative devices amid safety concerns for Medicare patients.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
Leaves Window Open for Defense Based on Subjective Belief -
On June 1, 2023, the U.S. Supreme Court issued a decision in a consolidated appeal of two healthcare qui tam cases that removes a very powerful defense from...more
6/9/2023
/ Drug Pricing ,
False Claims Act (FCA) ,
Healthcare ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Reasonable Interpretations ,
Safeco ,
Safeco Insurance Co of America v Burr ,
Scienter ,
SCOTUS ,
US ex rel Thomas Proctor v Safeway Inc ,
US ex rel Tracy Schutte et al v SuperValu Inc et al
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
The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) is continuing its long-laid plans to update its existing compliance program guidance documents (CPGs). On April 24, 2023, OIG...more
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
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
On January 30, 2023, the Biden administration announced its intent to end the national emergency and public health emergency (PHE) declarations on May 11, 2023. These emergency declarations have been in place since early...more
Businesses making health claims about their products (e.g., foods and dietary supplements) or services (e.g., apps) should take note of new guidance that the Federal Trade Commission (FTC) released at the end of December...more
Wilson Sonsini is pleased to present the latest edition of The Life Sciences Report. This issue features an article on interlocking boards in the life sciences sector and the antitrust risk they pose to firms and investors;...more
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
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
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
On June 30, 2022, California Governor Gavin Newsom signed into law SB 54, putting into place some of the nation’s strictest, far-reaching regulations on packaging materials. The legislation mandates significantly reduced use...more
On May 25, 2022, the U.S. Food and Drug Administration (FDA) issued a guidance document intended to help pharmacists and wholesale drug distributors understand and comply with its final rule regarding the import of certain...more
In May 2022, the Center for Drug Evaluation and Research (CDER) of the U.S. Food and Drug Administration (FDA) announced the launch of a new program for expediting the development of new treatment options for rare...more
On May 4, 2022, the U.S. Food and Drug Administration (FDA) issued warning letters to five companies for selling products labeled as containing delta-8 tetrahydrocannabinol (delta-8 THC) in ways that violate the Federal Food,...more
Earlier this month, the U.S. Department of Justice (DOJ) Civil Division's Consumer Protection Branch (CPB) released its first-ever annual "recent highlights" report. The report describes the CPB's accomplishments from October...more
4/26/2022
/ Consumer Product Safety Commission (CPSC) ,
Coronavirus/COVID-19 ,
Corporate Counsel ,
Department of Justice (DOJ) ,
Food and Drug Administration (FDA) ,
Healthcare ,
Healthcare Fraud ,
Opioid ,
Pfizer ,
Pharmaceutical Industry ,
Popular ,
Purdue Pharma ,
Vaccinations
On February 22, 2022, the U.S. Food and Drug Administration (FDA) hosted a webinar on two draft guidance documents for the transition plans for medical devices commercialized pursuant to either Emergency Use Authorization...more
Some Worry Reduction in Pharmaceutical Revenues May Impact New Drug R&D and Innovation -
Lowering prescription drug pricing has been a hotly debated issue well before 2022 and is expected to continue in 2022. In November...more
On December 22, 2021, the U.S. Food and Drug Administration (FDA) issued two draft guidance documents for the transition plans for medical devices commercialized pursuant to either Emergency Use Authorization (EUA) or the...more
On November 5, 2021, the Centers for Medicare and Medicaid Services (CMS) issued an Interim Final Rule (IFR) with Comment Period, 86 Fed. Reg. 61555 (Nov. 5, 2021), requiring mandatory COVID-19 vaccination of staff of many...more
11/12/2021
/ Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Employer Liability Issues ,
Employer Mandates ,
Health and Safety ,
Health Care Providers ,
Healthcare Facilities ,
Healthcare Workers ,
Home Health Care ,
Human Resources Professionals ,
Infectious Diseases ,
Long Term Care Facilities ,
Vaccinations ,
Workplace Safety