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
Recently, the National Institutes of Health (“NIH”) extended the effective date of its policy on the use of the single Institutional Review Board (“IRB” or “sIRB” if a single IRB) to January 25, 2018. NIH created the sIRB policy to establish the expectation that a sIRB be used in the ethical review of multi-site, domestic, … Continue Reading
Health policy in the US is a problem in search of a solution and, despite a current pause in actions, reform efforts will continue this year. The Squire Patton Boggs policy team has put together an excellent article recapping recent events regarding the actions torepeal and replace the Affordable Care Act (ACA) and the decision … Continue Reading
On December 13, 2016, President Barack Obama signed H.R. 34, the 21st Century Cures Act (the Act), into law. This sweeping healthcare law addresses the discovery, development and delivery of new drugs and medical treatments; it also includes substantial mental health reforms and assorted Medicare- and Medicaid-related provisions. The law is a product of the … Continue Reading
Today, CMS submitted to the Federal Register (for publication on April 27th) its annual notice of proposed IPPS rates and policy changes for federal fiscal year (“FY”) 2017. Today’s notice contains a proposal to eliminate permanently the .2% payment reduction that CMS had implemented in FY 2014 to offset a projected net increase in IPPS … Continue Reading
Last legislative session, the Ohio General Assembly passed a measure in House Bill 52 requiring health care cost transparency for non-emergency services. The new measure requires that most medical service providers provide in writing, prior to a service being rendered, “a good-faith estimate” of (1) the amount the provider will charge the patient’s health … Continue Reading
On August 31, 2015, the Environmental Protection Agency (“EPA”) Administrator signed the proposed Management Standards for Hazardous Waste Pharmaceuticals rule outlining management and disposal standards for hazardous waste pharmaceuticals that are generated specifically by healthcare facilities. Additionally, this rule “clarif[ies] the regulation of the reverse distribution mechanism used by healthcare facilities for the management of … Continue Reading
The results of this year’s mid-term election, while historic, also raise considerable uncertainty regarding future legislative action. What legislative initiatives can we expect to see from the Republican controlled Congress? Will President Obama and Congress work together or will Republican control of both houses result in continued gridlock? What will happen to the ACA? To help answer … Continue Reading
