In late January 2023, the Centers for Medicare and Medicaid Services (CMS) issued two updates relevant to provider and supplier organizations enrolled in Medicare: (1) a redesign to the Provider Enrollment, Chain and...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
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
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
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
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
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
The US Department of Justice recently intervened in an qui tam alleging false and fraudulent claims involving the acquisition of physician practice locations by a health system and subsequent management of the health system’s...more
4/19/2022
/ Anti-Kickback Statute ,
Asset Purchase Agreements ,
Department of Justice (DOJ) ,
Drug Pricing ,
Enforcement Actions ,
False Claims Act (FCA) ,
Health Care Providers ,
Hospitals ,
Medicare ,
Physicians ,
Professional Services Contract ,
Qui Tam ,
Reimbursements ,
Reversal ,
Section 340B
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
Hospital and health systems rely on vendors and other partners to provide vital services that support patient care, efficient operations and smooth administrative functions. However, the regulations governing different types...more
Hospital and health systems rely on vendors and other partners to provide vital services that support patient care, efficient operations and smooth administrative functions. However, the regulations governing different types...more
Hospital and health systems rely on vendors and other partners to provide vital services that support patient care, efficient operations and smooth administrative functions. However, the regulations governing different types...more
In December 2021, the US Centers for Medicare and Medicaid Services (CMS) issued the second part of its FY 2022 Inpatient Prospective Payment System (IPPS) Final Rule with Comment Period. Among other policies, the Final Rule...more
1/10/2022
/ Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Consolidated Appropriations Act (CAA) ,
Deadlines ,
Final Rules ,
FTEs ,
Graduate Medical Education ,
Health Care Providers ,
Inpatient Prospective Payment System (IPPS) ,
Medical School ,
Residency Requirements ,
Rural Areas ,
Rural Health Care Providers
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
On November 12, 2021, the Centers for Medicare and Medicaid Services (CMS) released an updated version of its Quality, Safety and Oversight Group memorandum, QSO-19-13-Hospital, containing much-anticipated final guidance on...more
On November 2, 2021, the Centers for Medicare & Medicaid Services (CMS) issued the calendar year (CY) 2022 Medicare Physician Fee Schedule (MPFS) final rule which, among other policy and regulatory changes, finalized...more
On November 2, 2021, the Centers for Medicare and Medicaid Services (CMS) announced that it will implement increased penalties for hospitals that do not comply with the Hospital Price Transparency Rule, effective January 1,...more
The Centers for Medicare and Medicaid Services (CMS) has started phasing out certain program flexibilities granted during the COVID-19 public health emergency. Beginning in October 2021, CMS will resume several provider and...more
On July 19, 2021, President Joseph R. Biden’s administration released a proposed rule that would increase penalties for hospitals that do not comply with the Hospital Price Transparency Rule, effective January 1, 2022. The...more