On June 6, 2024, Reps. Diana DeGette (D-CO) and Larry Bucshon, MD (R-IN) released a letter requesting information from stakeholders on their 21st Century Cures initiative, a policy effort focused on medical research and health care transformation and reforms. With this opportunity to comment, the lawmakers have renewed their commitment to developing the initiative with … Continue Reading
Private equity’s investment in healthcare has increased rapidly over the past decade, and this is now drawing attention from regulators. Signifying this increased scrutiny is a joint Request for Information (RFI) issued in March by the Department of Justice’s (DOJ) Antitrust Division, Federal Trade Commission (FTC), and Department of Health and Human Services (HHS) seeking … Continue Reading
On February 28, 2024, President Biden issued a groundbreaking executive order (EO) establishing the framework for new restrictions on transactions involving US persons’ sensitive personal data and “countries of concern,” including China, or related parties.… Continue Reading
Federal appropriations provide annual discretionary funding for our government to carry out its mission and, in turn, spur various healthcare organizations towards efficiencies and achievements. Whether you serve an entity interested in the government’s work in disease research or a nonprofit hospital requesting community project funding for infrastructure needs, it is important for those seeking … Continue Reading
On December 18, 2023, the US Department of Justice (DOJ) and Federal Trade Commission (FTC) (collectively, the “government”) released the final 2023 Merger Guidelines (the “Guidelines”) which set forth factors and frameworks the government will use when assessing mergers and acquisitions. While the Guidelines are not legally binding, they provide important guidance on how the … Continue Reading
Over the past several weeks, Congressional Republicans have indicated they are gearing up to tackle various health policy issues – and have offered health stakeholders the opportunity to provide feedback and their expertise in policy development. On August 25, Republicans on the House of Representatives’ Committee on the Budget established a “Health Care Task Force.” … Continue Reading
Demonstrating that hospital finances and billing practices continue to be of interest to federal lawmakers, on August 7, a group of bipartisan senators sent letters to the Internal Revenue Service (IRS) and the Treasury Inspector General for Tax Administration (TIGTA) questioning the oversight of nonprofit hospitals. Sens. Elizabeth Warren (D-MA), Chuck Grassley (R-IA), Raphael Warnock … Continue Reading
Months following the Supreme Court’s ruling in Dobbs v. Jackson Women’s Health Organization, the reproductive health climate remains clouded with terms lawyers—not to mention patients—never like to hear: “wait and see,” “to be decided,” “gray area,” “it depends.” Perhaps nowhere is the information gap of more crucial import than at the moment a patient walks through … Continue Reading
The European Commission President Ursula von der Leyen has put an emphasis on health policy since the beginning of her term, by promoting the development of a number of initiatives that will be published in the months and years to come. Inevitably, the COVID-19 pandemic has generated a growing demand for better coordination across EU Member … 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
On Friday, March 27, the Coronavirus Aid, Relief, and Economic Security (CARES) Act was enacted into law. The CARES Act provides broad relief to the many sectors of the economy reeling from the effects of COVID-19, including provisions aimed at giving critical financial and operational relief to hospitals and other providers on the front lines … Continue Reading
UPDATE: Saved by the Gel…again? Since our original post, the UK’s Competition and Markets Authority (CMA) issued a statement March 5 that it will be monitoring reports of changes to sales and pricing practices for coronavirus-related products. The CMA will consider direct enforcement action in appropriate cases if it has evidence that businesses have broken … Continue Reading
Deputy Attorney General Rod J. Rosenstein announced a revision of the “Yates Memo” concerning credit a company will receive for cooperating with an investigation. Instead of an “all or nothing” approach, the new policy permits a company to “identify all individuals substantially involved in or responsible for the misconduct at issue.” More about this change … Continue Reading
The Food and Drug Administration (“FDA”) has greatly increased its activity around cybersecurity initiatives and medical devices. As we approach the end of the year, this is a great opportunity to review recent developments. FDA Medical Device Cybersecurity Guidance On October 18, 2018, the FDA published draft guidance, “Content of Premarket Submissions for Management of … 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
The June 13, 2018 publication of Practical Law features a Practice Note co-written by Squire Patton Boggs attorneys Mark A. Salzberg, Elliot M. Smith, John E. Wyand and Sarah H. Stec titled “State Legalized Marijuana Businesses and Access to the Bankruptcy Code”. The Practice Note discusses the federal statutory scheme governing marijuana, its tension with … Continue Reading
PROPOSAL TO INCREASE RURAL HEALTH CARE FUNDING RECEIVES MAJORITY SUPPORT AT FCC Majority Of Federal Communications Commission (FCC) Supports 40%+ Annual Increase In Rural Health Care Program Funding – Following on a proposal to review annual funding for the FCC’s Rural Health Care Program (RHCP), which currently provides $400 million in annual subsidies for telecommunications … Continue Reading
Right to Try Investigational Drugs Signed Into Law On May 30, 2018, S. 204, the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 (Pub. L. No. 115-176, “Right to Try Act”) was signed into law. The Right to Try Act amends the Federal Food, Drug, and Cosmetic Act … Continue Reading
On Thursday, May 17, the House Energy and Commerce Committee (E&C) cleared 32 additional opioid-related measures during its second markup on the issue. In total, E&C has now advanced 57 bills to combat the opioid overdose crisis. While most measures were easily approved on a bipartisan basis, committee members disagreed over a number of bills … Continue Reading
On Friday, May 11, 2018, President Trump vowed to fix “the injustice of high drug prices” by announcing the “Blueprint to Lower Drug Prices” (the Blueprint) to address the following challenges: Excessively high drug prices Seniors and government programs overpaying for drugs High out-of-pocket costs for consumers Lack of transparency in drug pricing Free-riding by … Continue Reading
The Trump Administration submitted its annual budget request to Congress on February 12, 2018, formally spurring the development of Fiscal Year (FY) 2019 federal spending bills. In light of its release, recently confirmed U.S. Department of Health and Human Services (HHS) Secretary Alex Azar issued the following statement: “The President’s budget makes investments and reforms … Continue Reading
