While the pandemic is not over, the COVID-19 public health emergency (PHE) is expected to expire soon, which means that a number of operational, safety, and billing standards that were waived at the beginning of the pandemic...more
11/10/2022
/ Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Fraud and Abuse ,
Health Care Providers ,
Hospitals ,
Long Term Care Facilities ,
Medicare ,
Mental Health ,
Public Health Emergency ,
Telehealth ,
Waivers
In a recent unanimous decision, the Supreme Court found that the Centers for Medicare and Medicaid Services (“CMS”), part of the federal Department of Health and Human Services (“HHS”), erred when it significantly reduced...more
6/24/2022
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Health Care Providers ,
Hospitals ,
Medicare ,
Outpatient Prospective Payment System (OPPS) ,
Pharmaceutical Industry ,
Prescription Drugs ,
SCOTUS ,
Section 340B
As a holiday gift to providers, the U.S. Department of Health and Human Services (HHS) General Counsel recently issued a strongly worded Advisory Opinion indicating that federal law requires drug manufacturers to deliver...more
1. 340B ADR Process Established -
At long last, more than ten years after Congress directed it to do so, HHS has finalized an alternative dispute resolution (“ADR”) process for both providers and pharmaceutical...more
12/15/2020
/ American Depository Receipts (ADRs) ,
Department of Health and Human Services (HHS) ,
Dispute Resolution ,
Drug Pricing ,
Health Care Providers ,
Manufacturers ,
Outpatient Prospective Payment System (OPPS) ,
Pharmaceutical Industry ,
Prescription Drugs ,
Relief Measures ,
Section 340B
Neither COVID-19 nor continued legal challenges appear likely to derail the Centers for Medicare & Medicaid Services (CMS) Hospital Price Transparency Rule from going into effect on January 1, 2021. Hospitals therefore should...more
On June 3, 2019, the U.S. Supreme Court (“Court”) issued a 7-1 decision in Azar v. Allina Health Services, favoring hospitals that had sued the U.S. Department of Health and Human Services (“HHS”) over a Medicare payment...more
6/7/2019
/ Administrative Procedure Act ,
Azar v Allina Health Services ,
Department of Health and Human Services (HHS) ,
Hospitals ,
Low-Income Issues ,
Medicare ,
Medicare Advantage ,
Medicare Part A ,
Medicare Part C ,
Notice and Comment ,
Pay Reductions ,
Provider Payments ,
Reaffirmation ,
Retroactive Application ,
SCOTUS ,
Substantive Rule ,
Vacated
The U.S. Department of Health and Human Services (“HHS”) recently published a final rule on the 340B Drug Pricing Program (“340B Program”), moving the effective date for changes to the program up to January 1, 2019. Making...more
12/18/2018
/ Civil Monetary Penalty ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Final Rules ,
Health Care Providers ,
Health Clinics ,
Hospitals ,
Manufacturers ,
Pharmaceutical Industry ,
Prescription Drugs ,
Section 340B