On May 21, the U.S. Court of Appeals for the D.C. Circuit issued a unanimous decision in favor of drug manufacturers, finding that certain manufacturer restrictions on the use of contract pharmacies under the 340B drug...more
5/24/2024
/ Appeals ,
Covered Entities ,
Drug Pricing ,
Healthcare ,
Healthcare Reform ,
HRSA ,
Life Sciences ,
Manufacturers ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Section 340B
Asembia’s 20th Annual Specialty Pharmacy Summit once again brought investors and operators in the specialty pharmacy ecosystem to Las Vegas for learning sessions and networking. Bass, Berry & Sims brought a team of four...more
5/15/2024
/ Acquisitions ,
Ambulatory Surgery Centers ,
Health Care Providers ,
Healthcare ,
Inflation Reduction Act (IRA) ,
Investment ,
Investors ,
Life Sciences ,
Medicare ,
Mergers ,
Pharmaceutical Industry ,
Pharmacies ,
Section 340B ,
Technology Sector
On January 16, the Centers for Medicare & Medicaid Services (CMS) & the U.S. Department of Health and Human Services (HHS) withdrew an appeal to a recent copay accumulator court decision, HIV and Hepatitis Policy Institute et...more
W ith various headwinds resulting in down volume in 2023, buyers and sellers alike find themselves asking whether 2024 will see a rebound in deal activity. As we begin 2024, we have highlighted the issues and trends that...more
1/9/2024
/ Acquisitions ,
Artificial Intelligence ,
Corporate Transparency Act ,
Department of Justice (DOJ) ,
Diversity ,
Equity Markets ,
FinCEN ,
Funding ,
Healthcare ,
Investment ,
Investors ,
Mergers ,
Non-Compete Agreements ,
Pharmaceutical Industry ,
Popular ,
Privacy Laws ,
Private Equity ,
Reporting Requirements ,
Restrictive Covenants ,
Risk Management ,
Safe Harbors ,
Section 340B ,
Self-Disclosure Requirements ,
Value-Based Care
On November 3, a federal district court issued a monumental decision endorsing an expansive view of who is a “patient” of a 340B program covered entity eligible to receive a 340B drug. In Genesis Healthcare, Inc. v. Becerra,...more
11/6/2023
/ Audits ,
Comment Period ,
Covered Entities ,
Drug Pricing ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
HRSA ,
Patients ,
Pharmaceutical Industry ,
Prescription Drugs ,
Section 340B
On October 26, the Health Resources and Services Administration (HRSA) issued a notice clarifying the registration requirements for offsite hospital outpatient facilities under the 340B drug pricing program. The Notice, which...more
On August 24, the U.S. District Court for the Eastern District of Texas once again struck down parts of the regulations governing the arbitration process created by the No Surprises Act (NSA) to settle payment disputes...more
9/13/2023
/ Billing ,
Department of Health and Human Services (HHS) ,
Department of Labor (DOL) ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
No Surprises Act (NSA) ,
OMB ,
Out of Network Provider ,
Out-of-Pocket Expenses ,
Surprise Medical Bills ,
Texas ,
U.S. Treasury
On August 3, the U.S. District Court for the Eastern District of Texas again struck down portions of the regulations governing the arbitration process created by the No Surprises Act (NSA) to settle payment disputes between...more
On July 7, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule to implement a remedy in response to last year’s Supreme Court decision finding the Medicare Part B payment policy for hospitals in the 340B...more
7/12/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
Hospitals ,
Medicare ,
Medicare Administrative Contractors (MAC) ,
Medicare Advantage ,
Medicare Part B ,
Medicare Payment Reform ,
Outpatient Prospective Payment System (OPPS) ,
Pharmaceutical Industry ,
Prescription Drugs ,
Section 340B
On February 6, the U.S. District Court for the Eastern District of Texas struck down key regulations implementing the federal arbitration process created under the No Surprises Act (NSA) to settle out-of-network payment...more
On February 6, the U.S. District Court for the Eastern District of Texas vacated key provisions in the regulations implementing a federal arbitration process to settle out-of-network (OON) payment disputes between payers and...more
On January 30, the U.S. Court of Appeals for the Third Circuit issued a unanimous decision in favor of drug manufacturers, finding that manufacturer restrictions on the use of contract pharmacies under the 340B drug pricing...more
2/3/2023
/ Appeals ,
Distribution Rules ,
Drug Pricing ,
Enforcement Actions ,
HRSA ,
Manufacturers ,
Pharmaceutical Industry ,
Pharmacies ,
Policies and Procedures ,
Prescription Drugs ,
Section 340B
The Health Resources and Services Administration (HRSA) is seeking repayment of Provider Relief Fund (PRF) payments from providers who failed to submit the required report(s) on their use of the funds. Recipients were...more
As we kick off 2023, we are optimistic that the healthcare private equity (PE) market will be resilient despite various headwinds. As you think ahead, please consider the issues and trends summarized below that may be helpful...more
1/9/2023
/ Capital Markets ,
Cyber Attacks ,
Cybersecurity ,
Debt Market ,
Earn-Outs ,
Employee Retention ,
Environmental Social & Governance (ESG) ,
Health Care Providers ,
Healthcare ,
Healthcare Fraud ,
Investment ,
Investors ,
Minority Equity Investments ,
New Legislation ,
New Rules ,
Non-Compete Agreements ,
Physicians ,
Private Equity ,
Proposed Regulation ,
Ransomware ,
Rollover Equity ,
Section 220 Request
On December 2, the Department of Health and Human Services (HHS) announced it would not begin enforcement of a key requirement under the No Surprises Act (NSA) starting January 1, 2023, as previously scheduled...more
On November 3, the Centers for Medicare & Medicaid Services (CMS) issued an update to its Medicare Part B drug payment policy for hospitals participating in the 340B drug pricing program and reversed payment cuts in place...more
11/14/2022
/ American Hospital Association et al v Becerra Secretary Of Health And Human Services et al ,
Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Final Rules ,
Medicare ,
Medicare Part B ,
Outpatient Prospective Payment System (OPPS) ,
Reimbursements ,
Reversal ,
SCOTUS ,
Section 340B
On August 19, the federal government issued a final rule addressing certain aspects of the No Surprises Act (NSA). The NSA was enacted in December 2020 to protect commercially insured patients from receiving surprise medical...more
The U.S. House of Representatives is expected today to pass legislation passed by the U.S. Senate that will significantly alter the landscape for pharmaceutical pricing and reimbursement under the Medicare program for certain...more
8/15/2022
/ Department of Health and Human Services (HHS) ,
Drug Pricing ,
Health Care Providers ,
Medicare ,
Medicare Part B ,
Medicare Part D ,
Pharmaceutical Industry ,
Pharmacies ,
Physician Medicare Reimbursements ,
Physicians ,
Prescription Drugs ,
Proposed Legislation ,
Section 340B
On June 15, the U.S. Supreme Court issued a unanimous decision finding Medicare payment cuts to hospitals participating in the 340B drug pricing program illegal. The decision in favor of 340B hospitals is the culmination of a...more
On May 17, the U.S. District Court for the District of Columbia issued a decision vacating the Accumulator Adjustment Rule, regulations issued by the Centers for Medicare and Medicaid Services (CMS) in December 2020 as part...more
5/26/2022
/ Centers for Medicare & Medicaid Services (CMS) ,
Co-payments ,
Deadlines ,
Drug Pricing ,
Final Rules ,
Manufacturers ,
Patients ,
Pharmaceutical Industry ,
Pharmacies ,
PHRMA ,
Prescription Drugs ,
Vacated
On December 28, 2021, the federal government submitted notices to appeal three federal district court decisions related to the use of contract pharmacies under the federal 340B drug pricing program. The appeals are the latest...more
1/13/2022
/ Administrative Procedure Act ,
Appeals ,
Civil Monetary Penalty ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Enforcement ,
HRSA ,
Manufacturers ,
OIG ,
Pharmacies ,
Section 340B