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
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
5/26/2022
/ 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 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 November 20, 2020, the US Department of Health and Human Services (HHS) released final rules amending the regulations to the physician self-referral law (Stark Law) (Stark Rule) and the Anti-Kickback Statute (AKS) and...more
11/25/2020
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Department of Health and Human Services (HHS) ,
Electronic Medical Records ,
Final Rules ,
Medical Devices ,
OIG ,
Pharmaceutical Industry ,
Safe Harbors ,
Stark Law ,
Telehealth
The Centers for Medicare and Medicaid Services (CMS) issued blanket waivers under Section 1135 of the Social Security Act (Section 1135 waivers) on April 30, 2020. Fast on the heels of a more modest waiver announcement on...more
5/7/2020
/ 1135 Waivers ,
CARES Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Hospice ,
Long Term Care Facilities ,
OCR ,
Public Health Emergency ,
Relief Measures ,
Telehealth ,
Telemedicine
As previously reported, President Trump’s Opening Up America plans introduce measures to slowly ease business and social restrictions and require enhanced testing and reporting of Coronavirus (COVID-19) incidences in long...more
On April 21, 2020, the Centers for Medicare and Medicaid Services (CMS) issued explanatory guidance on the scope and application of a series of nationwide Section 1135 waivers of the physician self-referral law (Stark Law)...more
On April 19, 2020, the Centers for Medicare and Medicaid Services (CMS) issued a Quality, Safety and Oversight Group (QSO) memorandum (QSO-20-26-NH) informing long term care facilities, including nursing homes, about certain...more
The Centers for Medicare and Medicaid Services (CMS) recently provided Section 1135 waivers and guidance granting flexibilities to home health agencies (HHAs) and hospices during the Coronavirus (COVID-19) pandemic national...more
This On the Subject was updated on April 7, 2020, to address the Department of Health and Human Services Office of Inspector General’s (OIG’s) April 3, 2020, Policy Statement and its potential impact as well.
The Centers...more
On April 3, 2020, the Centers for Medicare & Medicaid Services (CMS) issued Quality, Safety & Oversight memorandum QSO-20-24-ASC (the QSO Memo), addressed to state survey agencies to provide guidance on processing attestation...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 Centers for Medicare and Medicaid Services is expediting Medicare enrollment applications and allowing certain categories of practitioners to temporarily enroll in Medicare Part B to increase the number of healthcare...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
A few days before Thanksgiving, the news media published an internal memo by the Office of General Counsel (OGC) at the US Department of Health and Human Services (Department) to officials at the Centers for Medicare and...more
12/6/2019
/ Administrative Procedure Act ,
Azar v Allina Health Services ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
Local Coverage Determination (LCD) ,
Medicare ,
Medicare Part C ,
New Guidance ,
Notice and Comment ,
OGC ,
Overpayment ,
Provider Payments ,
Rulemaking Process ,
SCOTUS ,
Social Security Act
To help accelerate the transformation of the US healthcare system from a fee-for-service to a value-based system, the US Department of Health & Human Services (HHS) launched its “Regulatory Sprint to Coordinated Care”...more
11/13/2019
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Electronic Medical Records ,
Health Care Providers ,
Healthcare Reform ,
Incentives ,
Patients ,
Physicians ,
Proposed Rules ,
Regulatory Burden ,
Reimbursements ,
Safe Harbors ,
Self-Referral ,
Stark Law ,
Value-Based Care ,
Webinars
On October 9, 2019, the US Department of Health and Human Services Centers for Medicare and Medicaid Services (CMS) published proposed changes to the physician self-referral law (Stark Law). Physician practices are subject to...more
The Department of Health & Human Services’ (HHS) proposed changes to the Stark Law, the Anti-Kickback Statute, and the Civil Monetary Penalty Law, released today as part of the Regulatory Sprint to Coordinated Care, would...more
10/11/2019
/ Anti-Kickback Statute ,
Beneficiary Inducement ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Comment Period ,
Department of Health and Human Services (HHS) ,
Exceptions ,
Health Care Providers ,
Healthcare Reform ,
Hospitals ,
OIG ,
Physicians ,
Proposed Rules ,
Public Comment ,
Regulatory Requirements ,
Safe Harbors ,
Stark Law ,
Value-Based Care
On September 10, 2019, the US Department of Health and Human Services Centers for Medicare & Medicaid Services (CMS) published a final rule (Final Rule) expanding Medicare, Medicaid and Children’s Health Insurance Program...more
10/1/2019
/ Affiliates ,
Centers for Medicare & Medicaid Services (CMS) ,
Children's Health Insurance Program (CHIP) ,
Comment Period ,
Disclosure Requirements ,
Document Retention Policies ,
Enrollment ,
Final Rules ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Medicaid ,
Medicare ,
Opt-Outs ,
Physicians ,
Public Comment ,
Reporting Requirements
On July 29, 2019, the Centers for Medicare & Medicaid Services (CMS) published the CY 2020 Medicare Physician Fee Schedule Proposed Rule, which included substantial changes to the physician self-referral law (Stark Law)...more
8/16/2019
/ Advisory Opinions ,
Centers for Medicare & Medicaid Services (CMS) ,
Certification Requirements ,
Comment Period ,
Department of Health and Human Services (HHS) ,
Fees ,
Health Care Providers ,
Medicare ,
Physician Fee Schedule ,
Physicians ,
Proposed Amendments ,
Proposed Rules ,
Public Comment ,
Self-Referral ,
Stark Law
The Centers for Medicare and Medicaid Services has issued long-awaited draft guidance addressing the use of shared space and contracted services. Though aiming to increase transparency into the scope and interpretation of its...more
The Centers for Medicare and Medicaid Services (CMS) announced a new round of competitive bidding for certain durable medical equipment, prosthetics, orthotics and supplies (DMEPOS), with contracts scheduled to become...more
The Centers for Medicare and Medicaid Services (CMS) recently posted revisions to the Voluntary Self-Referral Disclosure Protocol (SRDP). In an attempt to streamline the self-disclosure process, CMS requires the use of new...more
On December 8, 2016, the Centers for Medicare and Medicaid Services (CMS) published the Medicare Outpatient Observation Notice (MOON), which educates Medicare beneficiaries on the effect of outpatient status, particularly as...more