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HRSA to Test 340B Rebate Model in Pilot Program

By Robert Nauman on Posted in 340B Program, Hospitals, Pharmaceutical
On July 31, 2025, the U.S. Department of Health and Human Services Health Resources and Service Administration (HRSA) announced the availability of a new 340B Rebate Model Pilot Program (the Rebate Pilot Program).  Under this Rebate Pilot Program, instead of receiving discounts on the purchase price for certain drugs, covered entities will receive a post-purchase … Continue Reading

Trump Signs Executive Order to Reduce U.S. Drug Prices with “Most-favored Nation” Policy and CMS Establishes Pricing Targets

By Squire Patton Boggs on Posted in Executive Actions, Pharmaceutical
On May 12, President Trump signed an executive order entitled “Delivering Most-Favored Nation Prescription Drug Pricing to American Patients” (the “Order”). At the core of the executive order is a commitment to most-favored nation (“MFN”) pricing for drugs sold in the U.S. Under MFN pricing, Americans would pay no more for prescription drugs than the … Continue Reading

Summer Roundup: Antitrust Agencies Continue Scrutiny of Healthcare Markets and Attain Much Needed Victories

By Christopher Gordon on Posted in Accountable Care Organizations, Antitrust, DOJ, FTC, Mergers and Acquisitions, Pharmaceutical
This summer, the Federal Trade Commission (“FTC”) and U.S. Department of Justice (“DOJ”) (together “antitrust agencies” or “agencies”) continued to push boundaries on what constitutes anticompetitive conduct with the withdrawal of key healthcare policy statements and heightened scrutiny of the pharmaceutical industry. This summer also saw the DOJ and FTC score crucial enforcement wins in … Continue Reading

Antitrust Agencies Target Pharmaceutical Mergers in Enforcers Workshop and Lawsuit

By Christopher Gordon on Posted in Antitrust, Pharmaceutical
Last month the Federal Trade Commission (“FTC”) sued to block the $27.8 billion acquisition of Horizon Therapeutics plc (“Horizon”) by the biopharmaceutical corporation, Amgen Inc. (“Amgen”).  The lawsuit was the latest move by the Biden Administration to tackle the high price of prescription drugs, which President Joe Biden described as “excessive” in his July 2021 … Continue Reading

Supreme Court Rules that Arkansas Act 900, Affecting the Prices that PBMs Pay to Pharmacies, Is Not Preempted Under ERISA

By Kimberly Donovan on Posted in ERISA, Pharmaceutical, U.S. Supreme Court
On December 10, 2020, the Supreme Court released its decision in Rutledge v. Pharmaceutical Care Management Association. Justice Sotomayor wrote the Court’s opinion, which was joined by all Members of the Court except Justice Barrett, who did not participate. Justice Thomas filed a concurring opinion, which expressed his prior opinions that the Court’s ERISA preemption … 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

Brexit: Phased Approach for Northern Ireland Protocol (NIP) for the Pharmaceuticals Sector

By Adrian Spooner on Posted in Brexit, Pharmaceutical, United Kingdom
The UK Cabinet Office released a statement last Thursday 5th November 2020 that could provide some breathing space for the UK/EU pharmaceuticals sector during the Brexit transition, by indicating that a one year implementation period would apply to application of the protocol for certain matters. For the pharmaceuticals sector, these include batch testing, importation 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

Progress for the CMA in its Investigations into Suspected Anti-Competitive Agreements and Conduct in the Pharmaceutical Sector

By Sam Hare on Posted in Antitrust, Pharmaceutical
The Competition and Markets Authority (CMA), the competition regulator in the UK, has undertaken a number of investigations into suspected anticompetitive practices in the pharma sector in recent years. Most recently, the CMA announced on 3 October 2019 that it has issued a Statement of Objections to pharmaceutical companies Aspen, Amilco and Tiofarma. The CMA’s … Continue Reading

HHS Abandons Proposal to Reform Drug Manufacturer Rebate System

By Squire Patton Boggs on Posted in Anti-kickback Statute, Department of Health and Human Services, Drug, Pharmaceutical, Proposed Rule
On Thursday, July 11, 2019, the White House administration reversed course on the Department of Health and Human Services’ (HHS) recent proposal to reform drug manufacturer rebate system. As we previously reported, HHS’s February 6, 2019 proposed rule sought to modify the Anti-Kickback Statute safe harbor protection with the aim of lowering prescription pharmaceutical product … Continue Reading

DOJ Challenges Charitable Copay Subsidies

By Squire Patton Boggs on Posted in Anti-kickback Statute, DOJ, False Claims Act, Fraud and Abuse, Pharmaceutical
The Department of Justice intervened in a False Claims Act lawsuit involving “so-called charitable patient assistance funds” used for prescription drug copays. The DOJ wants to make “clear that the Department will hold accountable drug companies that pay illegal kickbacks to facilitate increased drug prices.”  See a report at the Anticorruption blog here.… Continue Reading

HHS Proposes Changes to the Discount Safe Harbor Framework to Realign Incentives and Put Downward Pressure on Drug Prices

By Robert Nauman and John Wyand on Posted in Anti-kickback Statute, Fraud and Abuse, Pharmaceutical, Proposed Rule
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

Pharmacy Benefit Managers Are Not Subject to the Any Willing Provider Laws in GA, MS, or NC, says Eighth Circuit

By Jan Kubicz on Posted in 8th Circuit, Insurance, Pharmaceutical
The Eighth Circuit has recently reviewed whether a pharmacy benefit manager (”PBM”) is a “health benefit plan” within the meaning of the state statutes in Mississippi, North Carolina, and Georgia such that a pharmacy may bring a claim to enforce the any willing provider laws against PBMs.  Many states have enacted some version of any … 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

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

UK Competition Appeal Tribunal Quashes Fines in First Pure Excessive Pricing Case

By Tatiana Siakka on Posted in International Healthcare, Pharmaceutical
On 7 June, the UK’s Competition Appeal Tribunal (CAT) annulled in part a decision by the UK’s Competition and Markets Authority (CMA) imposing fines of nearly £90 million on two pharma companies, Pfizer and Flynn, for charging excessive prices for the anti-epileptic drug, phenytoin sodium capsules. The case is notable as it marks the first … 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

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

Lawyer Misconduct Dooms FCA Suit

By Squire Patton Boggs on Posted in Anti-kickback Statute, False Claims Act, Fraud and Abuse, Pharmaceutical
A fraudulent survey of doctors sponsored by attorneys for a qui tam relator doomed a False Claims Act (FCA) complaint against a pharmaceutical company. In a forceful opinion, United States District Judge Dennis Saylor IV, District of Massachusetts, found violation of ethical rules, excised more than 100 paragraphs of the complaint as a sanction, and … 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

Healthcare Facilities Face New Rules for Disposing Pharmaceuticals

By Squire Patton Boggs on Posted in EPA, Pharmaceutical, Policy, Proposed Rule
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

CMS Finalizes Medicare Part C and Part D Program Changes for Contract Year 2015: Moderate Deviations from Proposed Rule

By Squire Patton Boggs on Posted in ACA, Compliance, Department of Health and Human Services, False Claims Act, Fraud and Abuse, Insurance, Managed Care, Medicare Part D, Payer/Insurance Reform, Pharmaceutical, Publications, Reimbursement
On January 8, 2014, we noted several proposed changes to the Medicare Part C and D programs as delineated in CMS’ January 8th proposed rule (hereinafter “Proposed Rule”). On Monday, May 19, 2014, CMS issued the final rule, titled Medicare Program; Contract Year 2015 Policy and Technical Changes to the Medicare Advantage and the Medicare … Continue Reading

Florida Proposes Pharmacy Audit Rights Legislation

By Kimberly Donovan on Posted in Compliance, Fraud and Abuse, Insurance, Managed Care, Medicare Advantage, Medicare Part D, Pharmaceutical
The Florida legislature is currently considering proposed legislation that may affect the way in which managed care organizations, insurers, third-party payors, pharmacy benefit managers and other entities audit pharmacies in Florida.  The Florida House of Representatives, Health Innovation Subcommittee, is reviewing HB 745, which proposes to create a “Pharmacy audit bill of rights.”  The Health … Continue Reading
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