Summary On December 27, 2024, the U.S. Department of Health and Human Services, Office for Civil Rights (“HHS”) published its Notice of Proposed Rulemaking (“NPRM”) titled HIPAA Security Rule to Strengthen the Cybersecurity of Electronic Protected Health Information. HHS seeks comments on proposed modifications to the Security Standards for the Protection of Electronic Protected Health … Continue Reading
In response to the shifting legal landscape around reproductive health care, the U.S. Department of Health and Human Services, Office for Civil Rights (OCR) finalized amendments to the HIPAA Privacy Rule to strengthen privacy protections for highly sensitive protected health information (PHI) related (or potentially related) to reproductive health care. OCR announced the final rule … Continue Reading
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
The June 13, 2018 Practical Law Practice Note co-written by Squire Patton Boggs attorneys Mark A. Salzberg, Elliot M. Smith, and John E. Wyand titled “State Legalized Marijuana Businesses and Access to the Bankruptcy Code” was recently updated to reflect recent case law as well as changes to the Controlled Substances Act. The Practice Note … Continue Reading
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
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
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
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
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 $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
