Policy

Subscribe to Policy RSS Feed

Congressional Republicans Solicit Comments from Health Stakeholders

By Beth Goldstein on Posted in Legislation, Policy
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

Group of Bipartisan Senators Inquire Into the Oversight of Nonprofit Hospitals’ Tax-Exempt Requirements and Compliance

By Beth Goldstein on Posted in Community Benefit, Hospitals, Nonprofits, Policy, Tax
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

Dobbs Puts New Emphasis on Proactive Provider Transparency in Care Offerings

By Elizabeth Trende on Posted in Dobbs, Physician Practice, Policy, U.S. Supreme Court
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

EU Pharmaceutical Strategy

By Christina Economides on Posted in EU, Pharmaceutical, Policy
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

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

By David LesStrang, John Wyand and Squire Patton Boggs on Posted in 2020 Election, Policy
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

The CARES Act Throws a Lifeline to Hospitals and Providers Confronting the COVID-19 Pandemic

By Beth Goldstein on Posted in CARES Act, COVID-19, Legislation, Policy
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

Saved by the Gel?

By Dickie Chan on Posted in COVID-19, Policy, Regulations
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

Yates Memo Softened

By Gabriel Colwell on Posted in DOJ, Fraud and Abuse, Policy
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

Digital Health Update: Recent FDA Cyber Initiatives

By Jennifer Tharp on Posted in Cybersecurity, Data Protection, Department of Health and Human Services, Digital Health, FDA, Life Sciences, Medical Device, Policy, Regulatory Compliance, Technology
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

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

By John Wyand and Victoria Cram on Posted in DOJ, Policy
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

By John Wyand and Victoria Cram on Posted in Legislation, Policy
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

By John Wyand and Victoria Cram on Posted in Legislation, Policy
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

By John Wyand and Paul Besozzi on Posted in Digital Health, FDA, Policy, Telehealth
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

Squire Patton Boggs Attorneys Publish Practical Law Practice Note on State Legalized Marijuana Businesses and Access to the Bankruptcy Code

By John Wyand on Posted in Bankruptcy, Compliance, DEA, DOJ, Drug, FDA, Life Sciences, Pharmaceutical, Policy
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

By John Wyand and Paul Besozzi on Posted in Digital Health, FCC, Policy, Technology, Telehealth
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

By John Wyand on Posted in Department of Health and Human Services, FDA, Insurance, Life Sciences, Pharmaceutical, Policy
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

House Energy and Commerce Committee Clears Opioid-Related Measures

By John Wyand on Posted in Legislation, Pharmaceutical, Policy
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

The New Federal Blueprint to Lower Drug Prices

By John Wyand, John Bunch and Doug Anderson on Posted in 340B Program, CMS, Drug, EU, International Healthcare, Legislation, Medicare Part D, Pharmaceutical, Policy, Reimbursement
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

Analysis of President Trump’s Fiscal Year 2019 Budget Request – Healthcare Impact

By Squire Patton Boggs on Posted in Policy
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

National Institutes of Health Extends Effective Date of sIRB Policy

By Squire Patton Boggs and John Wyand on Posted in Life Sciences, Medical Device, NIH, Policy, Research
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

President Obama Signs 21st Century Cures Act Into Law

By Robert Nauman and Beth Goldstein on Posted in Legislation, Policy, Reimbursement
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

Two-Midnight Rule Update: CMS Proposes to Eliminate .2% Payment Reduction By Increasing FY 2017 IPPS Rates

By Robert Nauman on Posted in CMS, Department of Health and Human Services, Hospitals, Payer/Insurance Reform, Policy, Proposed Rule, Reimbursement
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

Ohio's Attempt to Uncloak Health Care Pricing – The Yellow Brick Road to Cost Transparency

By Squire Patton Boggs on Posted in Legislation, Policy, Price Transparency
  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
LexBlog