The White House recently announced that the COVID-19 national emergency and public health emergency (PHE) declarations will end on May 11, 2023. These declarations have been in place since the beginning of the COVID-19...more
3/14/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Children's Health Insurance Program (CHIP) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Home Health Care ,
Hospice ,
Hospitals ,
Long Term Care Facilities ,
Medicaid ,
Public Health Emergency ,
Reasonable Expectation of Coverage ,
Regulatory Requirements ,
Rural Health Care Providers ,
Telehealth ,
Vaccinations ,
Virus Testing ,
Waivers
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
As of April 11, 2022, the Health Resources & Services Administration (“HRSA”) is now offering providers who missed the original Provider Relief Fund (“PRF”) reporting deadlines the opportunity to request the ability to report...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
In July 2020, we discussed a ruling by the D.C. Court of Appeals upholding the Department of Health and Human Services’ (HHS) site-neutral payment rules. On Monday, June 28, 2021, the Supreme Court declined, without comment,...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
As the pandemic rages on, and the United States has seen a spike in coronavirus cases in recent days, many healthcare providers are still struggling to care for patients and remain afloat. In response, HHS is continuing...more
On July 17, 2020, in a blow to health care providers, the U.S. Court of Appeals for the D.C. Circuit overturned a lower court’s more favorable ruling and held that the Department of Health and Human Services (“HHS”)...more
As the COVID-19 emergency continues to heavily impact the U.S. and its health care system, CMS has issued additional flexibilities for providers and payors seeking to respond to the pandemic. These new flexibilities are...more
On Friday, April 10, 2020, the Department of Health and Human Services (“HHS”) began distributing $30B of the $100B appropriated in the Coronavirus Aid, Relief, and Economic Security (“CARES”) Act to the Public Health and...more
The Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”) provides many avenues of potential funding relief for health care providers and suppliers who are suffering increased expenses and lost revenues as a result...more
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 Friday, March 27, the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”) was enacted. Organized below are concise summaries of select CARES Act sections that will impact various sectors of the health...more
3/31/2020
/ CARES Act ,
Centers for Disease Control and Prevention (CDC) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
FQHC ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Long Term Care Facilities ,
Material Adverse Change Clauses (MACs) ,
Relief Measures ,
SBA ,
Telehealth ,
Waivers
On a daily basis, if not more frequently, we are astounded by our clients’ efforts to prepare for and respond to the COVID-19 pandemic. As the federal government works to respond to the COVID-19 pandemic, guidance from HHS...more
As the coronavirus strain (COVID-19) continues to spread, the government, insurance companies and medical providers are rushing to find paths to more efficiently and effectively provide care for those in need. The Centers for...more
3/17/2020
/ Centers for Disease Control and Prevention (CDC) ,
Centers for Medicare & Medicaid Services (CMS) ,
Children's Health Insurance Program (CHIP) ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare Facilities ,
Hospitals ,
Medicaid ,
Medicare ,
Telehealth
On August 13, 2018, President Trump signed into law the National Defense Authorization Act (NDAA) of 2019. While the annual NDAAs are tracked, analyzed, and picked apart with great care by the federal contracting community,...more
1/31/2020
/ China ,
Department of Veterans Affairs ,
Federal Contractors ,
Health Care Providers ,
Huawei ,
National Institute of Health (NIH) ,
NDAA ,
Prime Contractor ,
Technology ,
TRICARE ,
ZTE
The “Granston Memo” has proven to be a boon again in 2019 for False Claims Act (“FCA”) defendants. In a January 15, 2019 Sheppard Mullin FCA Defense Blog article, we highlighted a growing movement by the Department of Justice...more
12/5/2019
/ Anti-Kickback Statute ,
Appeals ,
Department of Justice (DOJ) ,
Dismissals ,
False Claims Act (FCA) ,
Government Investigations ,
Health Care Providers ,
Healthcare Fraud ,
Mortgage Fraud ,
Pharmaceutical Industry ,
Qui Tam ,
Relators ,
Shell Corporations ,
The Granston Memo
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
On July 31, 2019, the U.S. Court of Appeals for the Eleventh Circuit affirmed a lower court’s decision to grant summary judgment to hospital operator HCA and dismiss relator Thomas Bingham’s allegations. Bingham v. HCA (S.D....more
8/19/2019
/ Anti-Kickback Statute ,
Discovery ,
False Claims Act (FCA) ,
Federal Pleading Requirements ,
Health Care Providers ,
Healthcare Fraud ,
Motion To Strike ,
Physician Compensation Arrangements ,
Relators ,
Rule 9(b) ,
Stark Law
On May 3, 2019, the Centers for Medicare and Medicaid Services (“CMS”) released long-awaited draft guidance (the “Guidance”), proposing to allow hospitals to co-locate with other hospitals or healthcare facilities in certain...more
5/10/2019
/ Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Draft Guidance ,
Emergency Rooms ,
EMTALA ,
Health Care Providers ,
Healthcare Facilities ,
Hospitals ,
Medicare ,
Patient Safety ,
Policies and Procedures ,
Shared Space Arrangements