The Centers for Medicare & Medicaid Services (CMS) recently published the CMS Advancing Interoperability and Improving Prior Authorization Processes Final Rule (“PA Final Rule”) in the Federal Register....more
Only a few days remain for stakeholders—which includes drug manufacturers, patients, health care providers, pharmacies and others— to take advantage of a rare opportunity to influence the statutory contours of the 340B Drug...more
3/26/2024
/ Children's Health Insurance Program (CHIP) ,
Comment Period ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Health Care Providers ,
Health Insurance ,
Healthcare Reform ,
HRSA ,
Legislative Agendas ,
Life Sciences ,
MACPAC ,
Manufacturers ,
Medicaid ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Regulatory Agenda ,
Section 340B
On August 24, 2023, the U.S. District Court for the Eastern District of Texas issued an opinion and order in Texas Medical Association, et al. v. United States Department of Health and Human Services(“HHS”)(“TMA III”). TMA...more
8/30/2023
/ Billing ,
Department of Health and Human Services (HHS) ,
Dispute Resolution ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Healthcare Reform ,
No Surprises Act (NSA) ,
Out of Network Provider ,
Out-of-Pocket Expenses ,
Surprise Medical Bills
On August 3, 2023, the U.S. Department of Health & Human Services (“HHS”), the Department of Labor, and the Department of Treasury (collectively, the “Departments”) temporarily suspended the federal Independent Dispute...more
8/14/2023
/ Billing ,
Department of Health and Human Services (HHS) ,
Department of Labor (DOL) ,
Dispute Resolution ,
Fees ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Healthcare Reform ,
No Surprises Act (NSA) ,
Out of Network Provider ,
Surprise Medical Bills ,
U.S. Treasury
On June 9, 2023, the Centers for Medicare & Medicaid Services (CMS) issued its next list of Part B drugs subject to the Medicare Prescription Drug Inflation Rebate Program’s adjusted coinsurance rates (“Rebatable Drugs”) from...more
The Centers for Medicare & Medicaid Services (CMS) has issued an information collection request (ICR) addressing the collection of data elements CMS must use to determine its offer amount when negotiating a selected drug’s...more
IRA Provision: The Medicare Prescription Drug Inflation Rebate Program -
The Centers for Medicare & Medicaid Services (CMS) issued a fact sheet and a list of 27 Part B “rebatable drugs”...more
With the recent midterm elections changing the composition of Congress, and the Biden administration’s first opportunities to advance its policy priorities from the very beginning of the rulemaking process, what are the key...more
To the relief of many providers and facilities and with just three weeks to go until the implementation date, the U.S. Department of Health & Humans Services (HHS) announced that it is extending its policy of not enforcing...more
On February 23, 2022, in the case captioned Texas Med. Ass’n v. U.S. Dep’t of Health & Human Servs., No. 6:21-cv-00425-JDK (E.D. Tex.), the U.S. District Court for the Eastern District of Texas issued the first major judicial...more
During a National Stakeholder Call on January 18, 2022, Ellen Montz—Deputy Administrator and Director of the Center for Consumer Information and Insurance Oversight (CCIIO) at the Centers for Medicare and Medicaid Services...more
The Biden administration has released a series of rules and guidance to implement the No Surprises Act, which went into effect on January 1. All providers and facilities must now provide a good faith estimate to uninsured and...more
On December 27, 2020, President Trump signed into law the No Surprises Act as part of the $2.3 billion Consolidated Appropriations Act. Recently, the Biden administration issued its first interim final rule in order to...more
On July 13, 2021, the U.S. Departments of Health and Human Services, Labor, and the Treasury, and the Office of Personnel Management (collectively, “Departments”) published their highly anticipated interim final rule (“First...more
On July 13, 2021, the Biden administration (“Administration”) officially published the “Requirements Related to Surprise Billing; Part I”—its first regulatory response to the enactment of the No Surprises Act (“NSA”)—as an...more
When introducing the No Surprises Act (“NSA”)—signed into law on December 27, 2020, as part of the Consolidated Appropriations Act, 2021—leaders of the responsible committees of the U.S. House of Representatives announced...more
Following months of congressional negotiations, on December 27, 2020, President Trump signed into law the Consolidated Appropriations Act, 2021, a $2.3 trillion piece of legislation that includes $900 billion in federal...more
On November 30, 2020, the U.S. Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) published a final rule (“Final Rule”) that removes safe harbor protection under the discount safe harbor to...more
In response to the 2019 novel coronavirus (“COVID-19”) pandemic, one of Congress’s first actions was the passage of emergency supplemental appropriations on March 5, 2020. Then, on March 18, 2020, a subsequent relief bill,...more
Through a January 9, 2020, press release, the Department of Justice (“DOJ”) reported more than $3 billion in total recoveries from settlements and judgments from fraud-related civil matters brought under the False Claims Act...more
1/13/2020
/ Department of Justice (DOJ) ,
Enforcement Actions ,
Failure to Comply ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare Fraud ,
Life Sciences ,
Medicare ,
Pharmaceutical Industry ,
Physician Medicare Reimbursements ,
Physicians ,
Qui Tam ,
Relators ,
Stark Law ,
Statistical Analysis
Yesterday, a final rule issued by the Centers for Medicare & Medicaid Services (CMS) establishing new enforcement initiatives aimed at removing and excluding previously sanctioned entities from Medicare, Medicaid, and the...more
11/5/2019
/ Affiliates ,
Bad Actors ,
Centers for Medicare & Medicaid Services (CMS) ,
Children's Health Insurance Program (CHIP) ,
Durable Medical Equipment ,
Enrollment ,
Health Care Providers ,
Healthcare Fraud ,
Healthcare Reform ,
Medicaid ,
Medicare ,
Revocation ,
Suppliers