Pharma’s favorite summer pastime is back again: reviewing the Centers for Medicare & Medicaid Services (CMS) release of the 2025 proposed Hospital Outpatient Prospective Payment System (HOPPS) and Physician Fee Schedule (PFS)...more
7/18/2024
/ Centers for Medicare & Medicaid Services (CMS) ,
Food and Drug Administration (FDA) ,
Hospitals ,
Medicaid ,
Medicaid Drug Rebate Program ,
Medicare Part B ,
Medicare Part D ,
Outpatient Prospective Payment System (OPPS) ,
Pharmaceutical Industry ,
Physician Fee Schedule ,
Proposed Rules ,
Reimbursements ,
Section 340B ,
Shareholders
In 2021, we provided an overview of multiple federal lawsuits challenging the US Department of Health and Human Services (HHS) Health Resources and Services Administration’s (HRSA) enforcement of the 340B Drug Pricing...more
6/27/2024
/ Covered Entities ,
Department of Health and Human Services (HHS) ,
Enforcement ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
HRSA ,
Interstate Commerce ,
Manufacturers ,
Medicaid ,
Pharmaceutical Industry ,
PHRMA ,
Section 340B
On April 25, the US Court of Appeals for the Third Circuit issued its precedential opinion in Mallinckrodt v. Sanofi-Aventis, Case No. 23-1111, reminding everyone that “creditors take on risks” when it ruled that the debtor...more
The Centers for Medicare and Medicaid Services (CMS) continues to take steps implementing the Inflation Reduction Act of 2022 (IRA). Newly revised guidance issued on December 14, 2023, makes notable changes and clarifications...more
12/27/2023
/ Abbreviated New Drug Application (ANDA) ,
Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Inflation Adjustments ,
Inflation Reduction Act (IRA) ,
Infrastructure Investment and Jobs Act (IIJA) ,
Medicare ,
Medicare Part B ,
Medicare Part D ,
OIG ,
Pharmaceutical Industry ,
Rebates ,
Section 340B ,
Supply Chain ,
Supply Shortages
Here we are in fourth quarter of 2023 already! As companies start wrapping up 2023 and preparing and modeling for 2024, we thought it was a good time to highlight five regulatory developments, changes, or challenges on the...more
10/30/2023
/ Affordable Care Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Customs and Border Protection ,
DSCSA ,
Food and Drug Administration (FDA) ,
Inflation Reduction Act (IRA) ,
MDRP ,
Medicaid ,
Medicare Part B ,
Medicare Part D ,
Pharmaceutical Industry
The Internal Revenue Service (IRS) has issued guidance on the pharmaceutical excise tax that may apply to certain drug manufacturers, producers, and importers that fail to negotiate a drug-pricing agreement with the US...more
It is the annual summer pastime for the pharmaceutical community. Time to review the Centers for Medicare & Medicaid Services (CMS) release of the 2024 proposed Hospital Outpatient Prospective Payment System (HOPPS) and...more
The Centers for Medicare & Medicaid Services (CMS) issued its annual proposed rule related to the Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems for 2023 (the HOPPS Proposed Rule) on...more
8/3/2022
/ American Hospital Association et al v Becerra Secretary Of Health And Human Services et al ,
Biosimilars ,
Centers for Medicare & Medicaid Services (CMS) ,
HOPPS ,
Manufacturers ,
Payment Systems ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Rules ,
SCOTUS ,
Supply Chain
The Centers for Medicare & Medicaid Services (CMS) calendar year 2023 rule proposing changes to payment policies under the Physician Fee Schedule (PFS) and Medicare Part B (the Proposed Rule) will officially be published in...more
7/20/2022
/ Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Federal Register ,
HCPCS ,
Infrastructure Investment and Jobs Act (IIJA) ,
Interim Final Rules (IFR) ,
Manufacturers ,
Medicare Part B ,
Pharmaceutical Industry ,
Physician Fee Schedule ,
Proposed Rules ,
Social Security Act
Back in 2017, the state of Nevada passed a sweeping bill into law that addressed not only drug pricing transparency, but also reporting obligations applicable to pharmacy benefit managers and non-profit organizations and also...more
The Centers for Medicare & Medicaid Services (CMS) calendar year 2022 rule finalizing changes to payment policies under the Physician Fee Schedule (PFS) and Medicare Part B (the Final Rule) was published on November 19, 2021....more
The Centers for Medicare & Medicaid Services (CMS) has issued its annual proposed rule related to the Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems (HOPPS) (the Proposed Rule)....more
In July 2020, the Trump Administration issued an Executive Order (the EO) directing the Secretary of the Department of Health and Human Services (HHS) to take certain actions and finalize rulemakings designed to “support the...more
6/14/2021
/ Biden Administration ,
Canada ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Motion to Dismiss ,
Pharmaceutical Industry ,
Prescription Drugs ,
Rulemaking Process ,
Secretary of HHS ,
Standing ,
Subject Matter Jurisdiction
The American Rescue Plan Act of 2021, signed into law by President Biden on March 11, 2021, is a $1.9 trillion aid package that provides assistance to businesses and individuals experiencing financial hardship due to...more
With the change of administrations typically comes a flurry of activity across all government agencies, and the same can be expected with the official start of the Biden Administration now well underway. What should...more
2/1/2021
/ Biden Administration ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Final Rules ,
Government Agencies ,
Healthcare Fraud ,
Healthcare Reform ,
Medicare ,
Medicare Part D ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Proposed Rules ,
Reimbursements
Final Rule largely tracks prior proposal to make significant changes to the Discount Safe Harbor and other regulatory safe harbors to the Federal Anti-Kickback Statute.
The Department of Health and Human Services Office of...more
The Department of Health and Human Services Office of the Inspector General (OIG) published a Special Fraud Alert on November 16, 2020 (the Alert) regarding a common practice within the pharmaceutical and medical device...more
11/18/2020
/ Anti-Kickback Statute ,
Department of Health and Human Services (HHS) ,
Fraud ,
Health Care Providers ,
Medicaid ,
Medical Devices ,
Medicare ,
OIG ,
Pharmaceutical Industry ,
Remuneration ,
Speaker Programs ,
TRICARE
Three organizations serving primarily HIV and AIDS patients and who each are also considered “Covered Entities” under the 340B Drug Pricing Program (the Plaintiffs) filed a lawsuit against Department of Health and Human...more
10/16/2020
/ Administrative Procedure Act ,
AIDS ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Dispute Resolution ,
Drug Pricing ,
HIV ,
HRSA ,
New Regulations ,
Pharmaceutical Industry ,
Pharmacies ,
Section 340B
CMS is soliciting comments on whether future payments for devices that may have been impacted by the COVID-19 PHE should be adjusted.
The Centers for Medicare & Medicaid Services (CMS) issued its annual proposed rule related...more
8/24/2020
/ 21st Century Cures Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
HCPCS ,
HOPPS ,
Interim Final Rules (IFR) ,
Manufacturers ,
Medical Devices ,
Medicare Part B ,
Medicare Part D ,
Outpatient Prospective Payment System (OPPS) ,
Pharmaceutical Industry ,
Pharmacist ,
Physician Fee Schedule ,
Proposed Rules ,
Public Health Emergency ,
Social Security Act
The Centers for Medicare & Medicaid Services (CMS) published a Proposed Rule on June 19, 2020 (the Proposed Rule) which, among other things, suggests updates to Medicaid policies and practices related to drug pricing and...more
A HHS Final Rule for Exchange plans states that coupons and copay cards offered directly by drug manufacturers can be counted towards a patient’s annual cost-sharing limit.
The Department of Health and Human Services (HHS)...more
On March 11, 2020, the Centers for Medicare & Medicaid Services (CMS) announced a voluntary model within the Medicare Part D program that would allow certain Part D plans to cap Medicare beneficiaries’ out-of-pocket costs for...more
In the DOJ’s first-ever criminal action against an electronic health records vendor, San Francisco-based Practice Fusion Inc. agreed to pay $145 million to resolve allegations that it received kickbacks from pharmaceutical...more
2/3/2020
/ Anti-Kickback Statute ,
Criminal Penalties ,
Deferred Prosecution Agreements ,
Department of Justice (DOJ) ,
Electronic Medical Records ,
False Billing ,
False Claims Act (FCA) ,
Health Care Providers ,
Health Information Technologies ,
Healthcare Fraud ,
Investigations ,
Kickbacks ,
Opioid ,
Pharmaceutical Industry ,
Physicians ,
Prescription Drugs ,
Qui Tam ,
Software ,
Whistleblowers
Late Friday, September 27, 2019, President Trump signed the Fair and Accurate Medicaid Pricing Act into law as part of the Continuing Appropriations Act....more
On July 8, 2019, in Merck & Co., Inc. v. United States Department of Health and Human Services, the US District Court for the District of Columbia invalidated a final rule pursuant to which pharmaceutical manufacturers would...more