Effective March 1st, certain providers choosing to self-disclose Stark Law violations must use forms updated by the Centers for Medicare & Medicaid Services (“CMS”)....more
Since its passage in late 2018, the Eliminating Kickbacks in Recovery Act (EKRA) (18 U.S.C. § 220) has posed interpretive challenges. Our detailed critical analysis of EKRA is available here...more
CMS’ most recent Stark Law rulemaking includes important changes to the rules that allow physician practices to satisfy the definition of “Group Practice” while distributing designated health services (“DHS”) – based profit...more
On July 13, 2021, the Centers for Medicare and Medicaid Services (“CMS”) released a Proposed Rule that proposes to amend certain regulations implementing the Physician Self-Referral Law, otherwise known as the “Stark Law”....more
As mentioned in our November 25, 2000 Healthcare Law Blog article, “Big Changes for Health Care Fraud and Abuse: HHS Gifts Providers Updates to the Stark Law and the AKS, Just in Time for the Holidays,” the Centers for...more
On November 20, 2020, the Centers for Medicare and Medicaid Services (“CMS”) and the Office of Inspector General (“OIG”) promulgated much-anticipated and significant final rules intended to “modernize” and “clarify”...more
11/30/2020
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Cybersecurity ,
Electronic Medical Records ,
Exceptions ,
Health Care Providers ,
New Guidance ,
OIG ,
Physicians ,
Proposed Rules ,
Safe Harbors ,
Stark Law ,
Value-Based Care
On Monday, March, 30, 2020, CMS released a blanket waiver (the “Waiver”) of the physician self-referral law under section 1135 of the Social Security Act to enable health care provider responses to the COVID-19 outbreak. ...more
4/1/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Department of Homeland Security (DHS) ,
Emergency Response ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Medicare ,
OCR ,
Physician Medicare Reimbursements ,
Physicians ,
Public Health ,
Relief Measures ,
Telehealth ,
Telemedicine ,
Waivers
On October 9, 2019, the Department of Health and Human Services (“HHS”) Centers for Medicare and Medicaid Services (“CMS”) and Office of Inspector General (“OIG”) released proposed rules in conjunction with HHS’ “Regulatory...more
10/11/2019
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
OIG ,
Physicians ,
Proposed Rules ,
Regulatory Requirements ,
Safe Harbors ,
Stark Law ,
Value-Based Care
On September 17, 2019, the U.S. District Court for the District of Columbia ruled against the Centers for Medicare and Medicaid Services (“CMS”), vacating CMS’ 2018 Final OPPS Rule, which cut Medicare reimbursement rates for...more
9/20/2019
/ Centers for Medicare & Medicaid Services (CMS) ,
Final Rules ,
Grandfathered Status ,
Health Care Providers ,
Health Clinics ,
Hospitals ,
Medicare ,
Off-Campus Departments ,
Outpatient Prospective Payment System (OPPS) ,
Physician Fee Schedule ,
Physician Medicare Reimbursements ,
Physicians ,
Reimbursements ,
Vacated
In a highly anticipated opinion in the AseraCare case, issued on September 9, 2019, the Eleventh Circuit Court of Appeals affirmed the district court’s holding that “a clinical judgment of terminal illness warranting hospice...more
9/12/2019
/ Defense Strategies ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare Fraud ,
Hospice ,
Medical Necessity ,
Motion for Summary Judgment ,
Physicians ,
Qui Tam ,
Relators ,
Remand ,
Sua Sponte
On September 5, 2019, the Centers for Medicare and Medicaid Services (“CMS”) released a final rule with comment period entitled, “Program Integrity Enhancements to the Provider Enrollment Process” (the “Final Rule”). The...more
9/11/2019
/ Ambulance Providers ,
Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Enrollment ,
Final Rules ,
Health Care Providers ,
Healthcare Fraud ,
Home Health Agencies ,
Hospice ,
Hospitals ,
Medicaid ,
Medicare ,
Physicians ,
Public Comment ,
Revocation ,
Skilled Nursing Facility ,
Suppliers
U.S. Attorney’s Offices (“USAOs”) across the country are issuing warning letters to physicians and other prescribers (collectively, “Prescribers”) cautioning them about their opioid prescribing practices (the “Warning...more
2/7/2019
/ Criminal Investigations ,
DEA ,
Department of Justice (DOJ) ,
Enforcement Actions ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Opioid ,
Pharmaceutical Industry ,
Pharmacies ,
Physicians ,
Prescription Drugs ,
Regulatory Oversight ,
Risk Mitigation ,
U.S. Attorney ,
Warning Letters
I. Introduction -
The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act (the “SUPPORT Act”), passed at the end of October 2018, seeks to prohibit...more
1/9/2019
/ Anti-Kickback Statute ,
Clinical Laboratories ,
Drug & Alcohol Abuse ,
Health Care Providers ,
Healthcare Facilities ,
Hospitals ,
Investors ,
Kickbacks ,
Opioid ,
Patients ,
Pharmaceutical Industry ,
Physicians ,
Prescription Drugs ,
Safe Harbors ,
Substance Abuse
Medicare Advantage and Part D Preclusion List -
The proposed rule issued November 1, 2018 (the “Proposed Rule”) by the Centers for Medicare and Medicaid Services (“CMS”) includes a number of regulatory changes to the...more
11/2/2018
/ Appeals ,
Centers for Medicare & Medicaid Services (CMS) ,
Fee-for-Service ,
Final Rules ,
Health Care Providers ,
Managed Care Contracts ,
MCOs ,
Medicaid ,
Medicare ,
Medicare Advantage ,
Medicare Advantage Organizations (MAOs) ,
Medicare Beneficiaries ,
Medicare Part D ,
OIG ,
Pharmaceutical Industry ,
Pharmacies ,
Physicians ,
Prescription Drug Coverage ,
Prescription Drugs ,
Proposed Rules