This weekly series provides brief summaries to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets on more than 40 340B cases to provide you with a quick...more
This weekly series provides brief summaries to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets on more than 40 340B cases to provide you with a quick...more
On December 2, 2022, the US Department of Health and Human Services (HHS) issued an FAQ announcing that it will not enforce the requirement for convening providers and convening facilities to include expected charges for...more
12/22/2022
/ Consolidated Appropriations Act (CAA) ,
Department of Health and Human Services (HHS) ,
Enforcement ,
Good Faith ,
Health Care Providers ,
Healthcare Facilities ,
Information Technology ,
No Surprises Act (NSA) ,
Proposed Regulation ,
Rulemaking Process ,
Surprise Medical Bills
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity between October 21 and November 18, 2022, including recent enforcement activity, new litigation associated with the Office of...more
12/9/2022
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Criminal Prosecution ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Health Care Violations ,
Healthcare ,
Healthcare Fraud ,
OIG ,
Regulatory Agenda ,
Settlement
Citing “policy and operational challenges” with the current 340B Administrative Dispute Resolution (ADR) Process, the US Department of Health and Human Services (HHS) has issued a new Proposed Rule to modify the current ADR...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant activity between September 21 and October 20, 2022. We review several criminal and civil enforcement actions related to Anti-Kickback Statute...more
11/15/2022
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Cost-Sharing ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Healthcare ,
Healthcare Reform ,
Medicare Part D ,
OIG ,
Regulatory Agenda
Consistent with the US Supreme Court’s ruling in AHA v. Becerra and its statements in the 2023 Outpatient Prospective Payment System (OPPS) Proposed Rule, the Centers for Medicare & Medicaid Services (CMS) has finalized its...more
11/8/2022
/ American Hospital Association et al v Becerra Secretary Of Health And Human Services et al ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Final Rules ,
MedPAC ,
Outpatient Prospective Payment System (OPPS) ,
Payment Systems ,
Physician Fee Schedule ,
SCOTUS ,
Section 340B
On September 28, 2022, the US District Court for the District of Columbia vacated the 2022 rule under which the US Department of Health and Human Services (HHS) reduced Medicare Part B payments on 340B drugs paid under the...more
10/4/2022
/ American Hospital Association ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Medicare Part B ,
Outpatient Prospective Payment System (OPPS) ,
Payment Rates ,
Permanent Injunctions ,
Proposed Rules ,
Reimbursements ,
Restoration Terms ,
SCOTUS ,
Section 340B ,
Vacated
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant activity between June 21 and July 20, 2022. During this period, the Supreme Court of the United States overturned Roe v. Wade, which historically...more
8/8/2022
/ Advisory Opinions ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
CLIA ,
Department of Health and Human Services (HHS) ,
Disproportionate Share Adjustments ,
Dobbs v. Jackson Women’s Health Organization ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare Fraud ,
Hospitals ,
Long Term Care Facilities ,
Medicare ,
Nursing Homes ,
OIG ,
Pharmaceutical Industry ,
Pharmacies ,
Roe v Wade ,
Skilled Nursing Facility
A federal district court likely will determine the 340B program definition of “patient” following a decision by the US Court of Appeals for the Fourth Circuit in Genesis Healthcare v. Becerra. The issue was whether the...more
This special inaugural issue of McDermott’s Healthcare Regulatory Check-Up highlights noticeable enforcement activity, OIG regulatory developments, CMS regulatory developments and other key developments for healthcare...more
5/27/2022
/ Advisory Opinions ,
Anti-Kickback Statute ,
Co-payments ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Drug Pricing ,
False Claims Act (FCA) ,
Health Care Providers ,
Manufacturers ,
Medicaid Drug Rebate Program ,
OIG ,
Pharmaceutical Industry ,
Prescription Drugs ,
Stark Law
This special inaugural issue of McDermott’s Healthcare Regulatory Check-Up highlights noticeable enforcement activity, OIG regulatory developments, CMS regulatory developments and other key developments for healthcare...more
5/26/2022
/ Advisory Opinions ,
Anti-Kickback Statute ,
Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Federal Nursing Home Reform Act (FNHRA) ,
Global Code of Ethics ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
OIG ,
Regulatory Agenda
A recent case before the US Court of Appeals for the Fourth Circuit addressed the issue of which persons qualify as “patients” of a 340B program participating entity (covered entity). Court-ordered filings in ongoing...more
By July 2022, the US Supreme Court is expected to release its opinion in American Hospital Association v. Becerra, a case that not only has significant ramifications for healthcare providers but may also impacts the deference...more
2/15/2022
/ American Hospital Association ,
Appeals ,
Centers for Medicare & Medicaid Services (CMS) ,
Chevron Deference ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Medicaid Reimbursements ,
Medicare ,
Outpatient Prospective Payment System (OPPS) ,
SCOTUS ,
Section 340B
On December 27, 2020, the No Surprises Act was signed into law as part of the Consolidated Appropriations Act, 2021. In July and October 2021, respectively, the Department of Health and Human Services, the Department of...more
12/31/2021
/ Billing ,
Consent ,
Consolidated Appropriations Act (CAA) ,
Department of Health and Human Services (HHS) ,
Department of Labor (DOL) ,
Disclosure Requirements ,
Good Faith ,
Health Care Providers ,
Interim Final Rules (IFR) ,
Out of Network Provider ,
Surprise Medical Bills ,
Telehealth ,
Telemedicine ,
U.S. Treasury
The US Supreme Court has announced that it will take up review of the decision by the US Court of Appeals for the District of Columbia Circuit upholding Medicare’s 2018 payment cuts to 340B drugs. The case will be closely...more
7/7/2021
/ Appeals ,
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
On November 20, 2020, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) released a final rule as part of ongoing administration drug pricing reform efforts and in conjunction with the...more
On September 13, 2020, the White House issued an Executive Order titled “Lowering Drug Prices by Putting America First” (the Executive Order), which directed the Secretary of the US Department of Health and Human Services...more
9/17/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Executive Orders ,
Medicare Part B ,
Medicare Part D ,
Pharmaceutical Industry ,
Prescription Drugs ,
Rulemaking Process ,
Secretary of HHS ,
Trump Administration
On May 11, 2020, the Centers for Medicare and Medicaid Services (CMS) issued a new suite of blanket waivers to ensure that healthcare facilities have the flexibility they need to treat patients during the Coronavirus...more
The updated waivers build upon the more limited set of Section 1135 waivers issued on March 13, 2020, and address common concerns among Medicare providers and suppliers as they deal with the Coronavirus (COVID-19) pandemic....more
4/1/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Emergency Response ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Medicare ,
OCR ,
Physicians ,
Public Health ,
Relief Measures ,
Telehealth ,
Telemedicine ,
Waivers
The US Department of Health and Human Services, Office of Inspector General has created an information portal and established a process to provide guidance on the application of the Anti-Kickback Statute and Beneficiary...more
On March 13, 2020, President Donald Trump declared a national emergency under the National Emergencies Act and made an emergency determination under the Stafford Act. This announcement follows the January 31, 2020,...more
The Centers for Medicare and Medicaid Services (CMS) released several fact sheets on COVID-19 coverage and benefits, and announced a second Healthcare Common Procedure Coding System (HCPCS) code, U0002, for billing COVID-19...more
3/11/2020
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Diagnostic Tests ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Hospitals ,
Medicare ,
Medicare Administrative Contractors (MAC) ,
Medicare Part A ,
Medicare Part B ,
Medicare Part D ,
Physicians ,
Provider Payments
Hospitals and health systems are facing consumer demand for innovation, the need to expand and enhance streams of revenue and the push for improved quality, all while navigating changing regulations, federal enforcement,...more
2/6/2020
/ Antitrust Litigation ,
Centers for Medicare & Medicaid Services (CMS) ,
CMIA ,
Cyber Attacks ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Federal Trade Commission (FTC) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Hospitals ,
Medicare ,
No-Poaching ,
OCR ,
Popular ,
Ransomware
On January 27, the Government Accountability Office (GAO) published a report concluding that the US Department of Health and Human Services (HHS) has provided limited oversight of the 340B and Medicaid Drug Rebate Programs,...more
2/5/2020
/ Audits ,
Centers for Medicare & Medicaid Services (CMS) ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Fee-for-Service ,
GAO ,
HRSA ,
Managed Care Contracts ,
Medicaid ,
Pharmaceutical Industry ,
Popular ,
Prescription Drugs ,
Section 340B