Earlier today, the US Court of Appeals for the Third Circuit issued a much-anticipated decision in one of the 340B contract pharmacy cases. The decision is a win for drug manufacturers who have sought to restrict access to...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
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 January 13, 2023, the Internal Revenue Service (IRS) released a memorandum (CCA 202302012) concluding that a qualified appraisal is required when a taxpayer claims a charitable contribution deduction exceeding $5,000 for...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
In December 2022, the Center for Medicare and Medicaid Services (CMS) unexpectedly issued a proposed rule that would materially change the obligations of entities participating in the Medicare program to report and return...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
Many pharmaceutical manufacturers currently require 340B covered entities to provide de-identified pharmacy claims data for dispensed 340B drugs to a third party, 340B ESP, as a condition of receiving discounts under the 340B...more
12/2/2022
/ Data Management ,
Discount Pricing ,
Drug Pricing ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Manufacturers ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Section 340B ,
Webinars
Rural emergency hospitals (REHs) are a new provider type that will allow Medicare to pay for emergency department and other outpatient hospital services in rural areas beginning on January 1, 2023, without requiring the...more
11/29/2022
/ Centers for Medicare & Medicaid Services (CMS) ,
Emergency Rooms ,
Final Rules ,
Health Care Providers ,
Hospitals ,
Medicare ,
Outpatient Services ,
Provider Payments ,
Rural Areas ,
Rural Health Care Providers ,
Stark Law
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
The US Centers for Medicare & Medicaid Services (CMS) released a Request for Information (RFI) seeking comments on the creation of a national directory of healthcare providers and services that would become a “centralized...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity between August 21 and September 20, 2022, including a guilty plea from a telemedicine physician who wrote prescriptions for...more
10/7/2022
/ Advisory Opinions ,
Anti-Kickback Statute ,
Antitrust Violations ,
Biotechnology ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare Fraud ,
Hospitals ,
Medicare ,
Medicare Shared Savings Program ,
Nurses ,
OIG ,
Pharmaceutical Industry ,
Physicians ,
Prescription Drugs ,
Price Transparency ,
Technology ,
Telehealth ,
TRICARE
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 enforcement activity between July 21 and August 20, 2022. Key updates include a case in which the US Court of Appeals for the Eighth Circuit...more
9/1/2022
/ Affordable Care Act ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
False Claims Act (FCA) ,
Health Care Providers ,
Hospitals ,
Inflation Reduction Act (IRA) ,
Long Term Care Facilities ,
Medicare ,
OIG ,
Payment Systems ,
Section 1557 ,
Skilled Nursing Facility
Beginning in 2023, Medicare will recognize a new provider type: the Rural Emergency Hospital (REH). The establishment of REHs is intended to preserve access to emergency departments and other outpatient services in rural...more
8/11/2022
/ Centers for Medicare & Medicaid Services (CMS) ,
Critical Access Hospitals ,
Emergency Rooms ,
Health Care Providers ,
Hospitals ,
Medicare ,
Outpatient Services ,
Physician Ownership ,
Physicians ,
Proposed Rules ,
Provider Payments ,
Rural Areas ,
Rural Health Care Providers ,
Stark Law ,
Statutory Requirements ,
Webinars
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
Rural emergency hospitals (REHs) are a new Medicare provider type that will allow Medicare to pay for emergency department and other outpatient hospital services in rural areas beginning on January 1, 2023, without requiring...more
7/21/2022
/ Affordable Care Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Conditions of Participation (CoP) ,
Dedicated Emergency Departments ,
Enrollment ,
Hospitals ,
Medicare ,
Mental Health ,
Outpatient Prospective Payment System (OPPS) ,
Outpatient Services ,
Proposed Rules ,
Rural Health Care Providers
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
Tucked into the recent proposed rule establishing Rural Emergency Hospital Conditions of Participation (CoPs) is a proposal to change the CoPs for critical access hospitals (CAHs). The Centers for Medicare & Medicaid Services...more
On June 30, 2022, the Centers for Medicare & Medicaid Services (CMS) released the long-awaited proposed rule establishing the Conditions of Participation (CoPs) that Rural Emergency Hospitals (REHs) would be required to meet...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights notable enforcement activity between April 21 and May 20, 2022, including a telemedicine case involving $64 million in false and fraudulent claims. We also...more
6/14/2022
/ Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
Competition ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare Fraud ,
Hospitals ,
Information Technology ,
Inpatient Prospective Payment System (IPPS) ,
Medical Devices ,
Nursing Homes ,
OIG ,
Payment Systems ,
Physicians ,
Regulatory Agenda ,
Skilled Nursing Facility ,
Telehealth ,
Telemedicine
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