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Stark Law & Mailing Physician-Dispensed Prescriptions: From COVID-19 Waivers to Federal Legislative Action

By Michele Munk on Posted in Legislation, Stark Law
In August 2024, a federal district court dismissed a lawsuit filed by the Community Oncology Alliance (“COA”), holding that the “in-office ancillary services” exception to the Stark Law does not permit physicians to dispense medications through the physician’s office and then mail prescriptions to the patient’s home.  COA v. Becerra, Case No. 23-cv-2168, Doc. 40, United … Continue Reading

FEPA: the New Tool in the DOJ’s Fight Against Corruption

By Squire Patton Boggs on Posted in DOJ, International, International Healthcare, Legislation
Members of our Government Investigations & White Collar team recently presented a timely webinar on the new Foreign Extortion Prevention Act (FEPA).  The Act, which has been referred to as  “the most consequential anti-foreign-bribery law passed in almost 50 years,” allows the DOJ to prosecute foreign officials who demand or accept a bribe from a … Continue Reading

Beware the Ides of March: Four Questions and Answers to Guide Your Organization’s Preparation for the Upcoming Appropriations Process

By Beth Goldstein and David LesStrang on Posted in Legislation, Policy
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

Webinar:  The New Foreign Extortion Prevention Act – What It Means for US Companies

By Squire Patton Boggs on Posted in DOJ, Events, International, Legislation
On Tuesday January 30, we hope you will join a seasoned team of former Department of Justice (DOJ) prosecutors for what will certainly be a robust a discussion on “the most consequential anti-foreign-bribery law passed in almost 50 years”: the Foreign Extortion Prevention Act (FEPA). Passed as part of the National Defense Authorization Act (NDAA), … Continue Reading

California Takes Steps Towards a Unified Health Care Financing System

By Ima Nsien on Posted in California, Legislation
On October 7, 2023, California’s Governor approved Senate Bill (“SB”) 770, which directs the Secretary of the California Health and Human Services Agency (“Secretary”) to take steps towards designing a health care delivery system that provides benefits through a unified health care financing system, such as a single-payer health care system. Prior law established the … Continue Reading

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

Updated: Ohio Hospitals May Soon be Subject to License Requirements

By Robert Nauman on Posted in Hospitals, Legislation, Licensing, Ohio
Unlike most other states, Ohio does not currently have a hospital licensure system. While Ohio hospitals are subject to registration and information reporting requirements, as well as licensure requirements for certain discrete hospital services, Ohio does not require hospitals to obtain a state license in order to operate. That may change if certain provisions in … Continue Reading

Election 2020 Puts Cannabis Center Stage

By Mara Sheldon, David Schnittger and Gabriel Colwell on Posted in Cannabis/Hemp, Legislation
The cannabis industry was center stage during the November election, collecting a trove of wins making recreational marijuana legal now in 15 states and approved it for medical use virtually nationwide. The overwhelming nods in the recent election made marijuana more mainstream across the country and proved the cannabis industry has built a profound and … Continue Reading

Senators Announce Bipartisan Bill Requiring Pharmaceutical Supply Chain Report

By John Wyand on Posted in Legislation, Life Sciences, Pharmaceutical
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

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

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

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

Ohio Expands Prescriptive Authority for Certain Advanced Practice Registered Nurses

By Robert Nauman on Posted in Hospitals, Legislation, Nurses, Ohio, Pharmaceutical, Proposed Rule
On May 17, the Ohio Board of Nursing (the Board) adopted a new formulary which expands the prescriptive authority for certain of Ohio’s advanced practice registered nurses (APRNs). Specifically, this new “exclusionary” formulary applies to Ohio’s certified nurse practitioners, clinical nurse specialists and certified nurse midwives.  The new formulary was adopted pursuant to Ohio’s House … Continue Reading

House Ways and Means Committee Approves Revenue Provisions Relating to Proposed Repeal and Replacement of the Affordable Care Act

By Robert Nauman on Posted in ACA, Legislation, Tax
The House Ways and Means Committee approved legislation that would repeal the taxes enacted to fund the Affordable Care Act, and defer for five years the “Cadillac tax” on expensive health insurance policies. It also approved eliminating the penalty tax for not having health insurance, adopting a new refundable credit to help Americans pay for … 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

CMS Releases Final Rule Implementing Site Neutral Payment Rule for Hospital Outpatient Departments

By Robert Nauman and John Wyand on Posted in CMS, Hospitals, Legislation, Reimbursement
On November 1, CMS released final rules implementing Section 603 of the Bipartisan Balanced Budget Act of 2015 (the Final Rule).  Section 603 effectively reduces Medicare compensation paid to certain off-campus hospital outpatient departments (HOPDs) beginning January 1, 2017 by eliminating their eligibility for compensation under Medicare’s Hospital Outpatient Prospective Payment System (OPPS).  The Final … 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

FDA Considers Regulating Refurbishers and Other Third Parties

By Squire Patton Boggs on Posted in FDA, International Healthcare, Legislation, Medical Device, Medical Device, Pharmaceutical, Quality and Performance Measures, Regulatory Compliance
The Food and Drug Administration (FDA) requested comments on March 4 regarding definitions and possible regulations governing medical device refurbishers, reprocessors, and other third parties. Medical device manufacturers have the duty, under 21 C.F.R. Part 820, to provide instructions to third parties that may service or install their products.  However, manufacturers may not be able … Continue Reading

2014 Mid-Term Election Analysis

By Robert Nauman on Posted in ACA, Legislation, Policy
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
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