John Wyand

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42 C.F.R. Part 2 Final Rule to Align with the HIPAA Privacy Rules

The US Department of Health and Human Services, Office for Civil Rights (OCR)and the Substance Abuse and Mental Health Services Administration issued a Final Rule modifying the Confidentiality of Substance Use Disorder (SUD) Patient Records regulations under 42 C.F.R. Part 2 (Part 2), applicable to certain federally assisted SUD treatment programs (Part 2 Programs), and … Continue Reading

FDA Delays Enforcement of MOCRA Deadlines for Facility Registration and Product Listing to July 1, 2024

Background President Biden signed into law the “Consolidated Appropriations Act, 2023” on December 29, 2022. The Act includes the Modernization of Cosmetics Regulation Act of 2022 (“MOCRA”), which increased the authority of the United States Food and Drug Administration (FDA) to regulate cosmetics products and provide enhanced cosmetics protections for consumers. For insight, please see … Continue Reading

Revamping Cosmetics Safety and Regulation: Updates from FDA on Regulatory Changes under MOCRA.

On December 29, 2022, President Biden signed into law the “Consolidated Appropriations Act, 2023.” The Act includes the Modernization of Cosmetics Regulation Act of 2022 (“MOCRA”), which increased the authority of the United States Food and Drug Administration (FDA) to regulate cosmetics products and provide enhanced cosmetics protections for consumers. For insight, please see our … Continue Reading

Florida Electronic Health Records Exchange Act Amended – Health Records Maintained by Qualifying Health Care Providers Must Be Stored in the U.S., U.S. Territories, and Canada Only

On May 8, 2023, Governor Ron DeSantis of Florida signed CS/CS/SB 264, amending a suite of Florida statutes to impose heightened requirements on business activities involving foreign interests.  As related to the health care industry, CS/CS/SB 264 amended the Florida Electronic Health Records Exchange Act (“Act”) to, among other things, require “health care providers” that … Continue Reading

Roadmap to the Phased Transition Process for Medical Devices after Covid-19 Public Health Emergency

On March 27, 2023, the U.S. Food &Drug Administration (FDA) released two final guidance documents to assist with the transition of medical devices that were legally distributed: (1) subject to certain enforcement policies issued during the COVID-19 public health emergency (PHE) or (2) Emergency Use Authorizations (EUAs). Manufacturers, distributors, and industry stakeholders that have products … Continue Reading

CMS Blanket Stark Waivers will Terminate Upon End of COVID-19 Emergency

Earlier this year, the U.S. Department of Health and Human Services (“HHS”) announced the expiration of the COVID-19 public health emergency declarations effective May 11, 2023.  As a result, many of the regulatory waivers and flexibilities available to health care providers, including the blanket waivers applicable to many Stark Law requirements (the “Stark Waivers”), will … Continue Reading

Healthcare Entities Must Still Comply with 2023 Privacy Laws

As we head into the fourth quarter, US businesses need to assess their progress in preparing for sweeping changes to the California Consumer Privacy Act (“CCPA”) that become effective January 1, 2023, and with compliance with four new state consumer privacy laws (in Colorado, Connecticut, Utah and Virginia) that become effective throughout 2023 (collectively, “2023 … Continue Reading

Biden Administration 60-day Regulatory Freeze

On Wednesday, January 20, 2021, President Biden’s chief of staff, Ronald A. Klain, circulated a memorandum (memo) to the heads of federal executive departments and agencies outlining an Executive Action implementing a 60-day freeze on any new or pending regulations. This is a customary practice for new administrations. The freeze allows the administration to conduct … Continue Reading

Kamala Harris – Where the Vice Presidential Nominee Stands on Key Healthcare Issues

On Tuesday, August 11, 2020, presumptive Democratic presidential nominee Joe Biden announced Sen. Kamala Harris (D-CA) as his vice presidential running mate. Since joining Congress in 2017, Sen. Harris has largely served as a bridge between progressive and moderate Democratic positions and policies. She has made immigration, equal pay and reproductive health rights core planks of her … Continue Reading

Senators Announce Bipartisan Bill Requiring Pharmaceutical Supply Chain Report

U.S. Senators Marco Rubio (R-FL) and Elizabeth Warren (D-MA) recently announced plans to cosponsor S. 4191, the United States Pharmaceutical Supply Chain Review Act. According to bill text released by Senator Warren’s office, the bill directs the Federal Trade Commission (FTC) and the Secretary of the Treasury, in consultation with the Secretary of the Treasury, … Continue Reading

USDA’s Hemp Production Program Advances

On January 29, 2020, the comment period closed for the United States Department of Agriculture (USDA) interim final rule, published on October 31, 2019, to establish the Domestic Hemp Production Program. The comment period, which the USDA extended by 30 days, received over 4,000 comments from interested parties, including states, tribal governments, and hemp industry … Continue Reading

Major Milestone for Hemp Production: USDA Issues Interim Final Rule

On October 31, the US Department of Agriculture (USDA) published an interim final rule to establish the Domestic Hemp Production Program. This program, as required by the 2018 Farm Bill, attempts to clarify the regulatory framework for individuals hoping to capitalize on the production and sale of domestic hemp. The interim final rule requires states … Continue Reading

Court Sides with Hospitals on CMS Site Neutral Payment Rule for Hospital Outpatient Departments

In a ruling on September 17, 2019 by Judge Rosemary M. Collyer, the U.S. District Court for the District of Columbia vacated portions of a 2018 Centers for Medicare & Medicaid Services (CMS) rule that reduced Medicare payments for clinic-visit services at off-campus hospital outpatient departments (HOPDs). By rulemaking, on January 1, 2019, CMS instituted … Continue Reading

Medical Imaging Company Pays $3 Million Data Security Fine

A medical imaging company is paying for its flawed data security system. In addition to its system failures, the company failed to investigate and respond properly when alerted to problems by the FBI. As a result, the Office of Civil Rights imposed a $3 million penalty and required a corrective action plan. This yet another … Continue Reading

HHS Proposes Changes to the Discount Safe Harbor Framework to Realign Incentives and Put Downward Pressure on Drug Prices

On February 6, 2019, the Department of Health and Human Services (HHS) published a Proposed Rule modifying the Anti-Kickback Statute safe harbor protection with the aim of lowering prescription pharmaceutical product prices and out-of-pocket costs for (primarily Medicare Part D and Medicaid Managed Care Plan) consumers. With the Proposed Rule, HHS hopes to encourage medication … Continue Reading

CMS Proposes to Lower Drug Prices and Reduce Out-of-Pocket Drug Spending with Respect to Medicare Coverage

On Friday, November 30, 2018, the US Centers for Medicare & Medicaid Services (CMS) issued a proposed rule (Proposed Rule) to revise Medicare Part D (Part D) and Medicare Advantage (MA) regulations to promote health plan negotiation of lower drug prices and to reduce out-of-pocket spending for enrollees. The Proposed Rule contains four areas of … Continue Reading

Federal Court Held HHS Lacks the Authority to Impose Dramatic 340B Reimbursement Rate Reduction

On December 27, 2018, the provider community scored a major victory when the U.S. District Court for the District of Columbia held that the Medicare statute did not authorize the Department of Health and Human Services (“HHS”) to impose a nearly 30% reduction in 340B Reimbursement rates. The legal implications of this decision may be … Continue Reading

Justice Department Allots Additional US$70 Million to Battle Opioid Crisis

In tandem with President Trump’s signing of H.R. 6, (now former) US Attorney General Jeff Sessions announced new Department of Justice (DOJ) funding awards aimed at curbing drug trafficking and supporting youth impacted by America’s opioid epidemic. At DOJ’s first-ever National Opioid Summit, Sessions and Deputy Attorney General Rod Rosenstein highlighted sustained federal law enforcement efforts … Continue Reading

Congress' Extensive Opioid Legislation Becomes Law

On Wednesday, October 24, President Trump signed the Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act (H.R. 6) into law. The bill signing occurred three weeks following Congress’ overwhelming approval of the measure, and nearly one year since the Trump Administration deemed America’s opioid crisis a federal … Continue Reading

Senate Overwhelmingly Clears Bipartisan Opioid Package

Nearly three months following House passage of a legislative proposal related to America’s opioid epidemic, the Senate overwhelmingly cleared its own comprehensive, bipartisan package to address the crisis. On Monday, September 17, senators replaced the House-passed text with a substitute amendment and approved The Opioid Crisis Response Act of 2018 (H.R. 6) by a vote … Continue Reading

FCC COMMENCES INQUIRY ON ESTABLISHING $100-MILLION TELEHEALTH PILOT PROGRAM

FCC COMMENCES INQUIRY ON ESTABLISHING $100M TELEHEALTH PILOT PROGRAM On August 2, 2018, The Federal Communications Commission has unanimously approved a Notice of Inquiry (“NOI”) to establish a $100-million  telehealth pilot program. FCC seeks to identify how the agency can “help advance and support the movement in telehealth towards connected care everywhere and improve access … Continue Reading

House Panel Examines 340B Legislative Reforms

On Wednesday, July 11, 2018, House lawmakers again signaled their intent to reform the US Department of Health and Human Services (HHS), Health Resources and Services Administration’s (HRSA) 340B Drug Pricing Program (340B) during an Energy and Commerce (E&C) Subcommittee on Health hearing. Since 2015, both E&C and the Senate Health, Education, Labor, and Pensions … Continue Reading

DOL Issues Final Rule Expanding Access to Association Health Plans

On June 21, 2018, the US Department of Labor (DOL or the Department) published its final rule, amending the definition of “employer” under section 3(5) of the Employee Retirement Income Security Act (ERISA) to allow for the establishment of group or association health plans (AHPs) (Final Rule). Similar to a corresponding proposed rule issued earlier … Continue Reading
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