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
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
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 December 17, 2021, the Centers for Medicare & Medicaid Services (CMS) released the fiscal year (FY) 2022 inpatient prospective payment system (IPPS) final rule. In light of the significant volume of comments, CMS declined...more
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
Under current Medicare program rules, Medicare does not recognize “freestanding emergency departments” or other non-hospital providers of emergency department services. Medicare will only pay for these services at facilities...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
On July 13, 2021, the Centers for Medicare & Medicaid Services (CMS) released the calendar year (CY) 2022 Medicare Physician Fee Schedule (MPFS) proposed rule (Proposed Rule). The Proposed Rule sets forth CMS’ plans to revise...more
7/16/2021
/ Billing ,
Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Medicare ,
Medicare Payment Reform ,
MPFS ,
New Regulations ,
Nurse Practitioners ,
Physician Assistants ,
Physicians ,
Proposed Rules
The 340B Program has gained national attention over the last decade, in part due to the opportunities it provides to generate revenue for participating entities without risk of significant enforcement penalties for...more
7/12/2021
/ Best Practices ,
Compliance ,
Continuing Legal Education ,
Covered Entities ,
DSH ,
Eligibility ,
Enforcement Actions ,
Health Care Providers ,
Hospitals ,
Medicaid ,
Medical Billing Codes ,
Medicare ,
Overpayment ,
Payor Contracts ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Physicians ,
Prescription Drugs ,
Refunds ,
Regulatory Oversight ,
Section 340B ,
Webinars
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
This must-attend webinar will give 340B covered entities and their partners up-to-the-minute insights into the most pressing issues affecting their business today and the trends that will shape the market tomorrow.
Our...more
3/16/2021
/ Biden Administration ,
Billing ,
Covered Entities ,
Dispute Resolution ,
Drug Pricing ,
Health Care Providers ,
Legislative Agendas ,
Manufacturers ,
Medicaid ,
Pharmaceutical Industry ,
Pharmacies ,
Physicians ,
Prescription Drugs ,
Section 340B ,
Webinars
The Consolidated Appropriations Act, 2021, creates 1,000 new Medicare-funded graduate medical education (GME) residency positions, expands opportunities for rural residency training, and allows hospitals that have very low...more
1/18/2021
/ Consolidated Appropriations Act (CAA) ,
Coronavirus/COVID-19 ,
FTEs ,
Graduate Medical Education ,
Health Care Providers ,
Hospitals ,
Medicare ,
Physicians ,
Public Health Emergency ,
Teaching Hospitals ,
Training
Year-end COVID-19 relief legislation approved by Congress established Rural Emergency Hospitals (REHs) as a new Medicare provider type effective January 1, 2023. REHs, defined as providers that furnish certain outpatient...more
1/6/2021
/ Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Health Care Providers ,
Hospitals ,
Medicare ,
New Legislation ,
Outpatient Prospective Payment System (OPPS) ,
Provider Payments ,
Reimbursements ,
Relief Measures ,
Rural Health Care Providers
On December 10, 2020, the Health Resources and Services Administration (HRSA) released a Final Rule to establish an administrative dispute resolution (ADR) process and ADR panels to resolve certain 340B Program disputes...more
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 24, 2020, the Health Resources and Services Administration (HRSA) released a proposed rule that, if finalized, would require 340B-participating recipients of federal grants under Section 330(e) of the Public...more