On October 29, 2020, the Department of Health and Human Services (“HHS”), the Department of Labor, and the Department of the Treasury (collectively, the “Departments”) released the Transparency in Coverage Final Rules (the...more
11/14/2020
/ Department of Health and Human Services (HHS) ,
Department of Labor (DOL) ,
Employer Group Health Plans ,
Final Rules ,
Health Insurance ,
Negotiated Rate Agreements ,
Non-Grandfathered Health Plans ,
Out-of-Pocket Expenses ,
Prescription Drug Coverage ,
Pricing Requirements ,
Transparency ,
Trump Administration ,
U.S. Treasury
In a setback to hospitals challenging deep cuts to reimbursement for prescription drugs acquired through the 340B drug pricing program (“340B Program”), the U.S. Court of Appeals for the District of Columbia, on October 19,...more
On August 3, 2020, President Trump signed Executive Order 13941 (the “Executive Order”) which expands access to certain telehealth services post-pandemic. The Executive Order focuses on telehealth access for individuals...more
8/11/2020
/ Beneficiaries ,
Coronavirus/COVID-19 ,
Executive Orders ,
FCC ,
Medicare ,
Public Health Emergency ,
Rural Areas ,
Secretary of Agriculture ,
Secretary of HHS ,
Telehealth ,
Trump Administration
On Friday, President Trump announced four executive orders directed at decreasing prescription drug prices by ordering certain actions by the Department of Health and Human Services (“HHS”). One order – which has received the...more
Many areas of the country are experiencing resurgences of COVID-19, and it is foreseeable that second and perhaps third waves of the virus will hit pockets of the country throughout the remainder of 2020. As healthcare...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 April 21, 2020, the Centers for Medicare and Medicaid Services (“CMS”) released “Explanatory Guidance” related to the March 30, 2020 Blanket Waivers of Section 1877(g) of the Social Security Act (information about those...more
When Alex Azar, the Secretary of the Department of Health and Human Services (“DHHS”), declared a national emergency on January 31, 2020 in response to the COVID-19 pandemic, he triggered an exception to the “in-person...more
On March 30, 2020, the Centers for Medicare and Medicaid Services (“CMS”) announced an Interim Final Rule with Comment Period (the “IFC”) to address numerous regulatory and administrative changes in response to the COVID-19...more
4/10/2020
/ Business Closures ,
Business Interruption ,
CARES Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Families First Coronavirus Response Act (FFCRA) ,
Federal Loans ,
Financial Stimulus ,
Health Care Providers ,
Healthcare ,
Lenders ,
Lending ,
Medicaid ,
Medicare ,
Nonprofits ,
Paycheck Protection Program (PPP) ,
Relief Measures ,
SBA ,
Small Business ,
Unemployment Insurance
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
CMS issued guidance this afternoon on expanded Medicare coverage of telehealth services during the COVID-19 outbreak. Under the guidance, Medicare will pay for office, hospital, and other visits furnished via telehealth...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
As part of HHS’ Regulatory Sprint to Coordinated Care, CMS recently published a proposed rule that, if finalized, would fundamentally change and alleviate the manner in which the Stark Law regulatory framework has...more
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 July 29, 2019, CMS released its proposed outpatient prospective payment system (“OPPS”) rule outlining a variety of changes it may implement for calendar year 2020. One proposal that has inspired immediate reactions from...more
8/6/2019
/ American Hospital Association ,
Anti-Competitive ,
Comment Period ,
Disclosure Requirements ,
Health Care Providers ,
Hospitals ,
Medicare ,
Outpatient Prospective Payment System (OPPS) ,
Price Transparency ,
Proposed Rules ,
Public Comment
In a rare act of bipartisanship, Senate Finance Committee Chairman Chuck Grassley, R-Iowa, and Ranking Member Ron Wyden, D-Ore., introduced on July 23rd a chairman’s mark, the Prescription Drug Pricing Reduction Act (PDPRA)...more
7/26/2019
/ Ambulatory Surgery Centers ,
Conflicts of Interest ,
Congressional Budget Office ,
Drug Pricing ,
Health Insurance ,
Hospitals ,
Managed Care Contracts ,
Manufacturers ,
Medicaid ,
Medicare ,
Medicare Part D ,
Outpatient Services ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Physician Fee Schedule ,
Prescription Drug Coverage ,
Prescription Drugs ,
Price Transparency ,
Public Disclosure ,
Rebates ,
Risk-Sharing
Earlier this week, the Supreme Court upheld a D.C. Circuit Court decision vacating a policy of the Centers for Medicare and Medicaid Services (“CMS”) that would have “dramatically – and retroactively – reduced payments to...more
6/7/2019
/ Administrative Procedure Act ,
Azar v Allina Health Services ,
Department of Health and Human Services (HHS) ,
Hospitals ,
Low-Income Issues ,
Medicare ,
Medicare Advantage ,
Medicare Part A ,
Medicare Part C ,
Notice and Comment ,
Pay Reductions ,
Provider Payments ,
Reaffirmation ,
Retroactive Application ,
SCOTUS ,
Substantive Rule ,
Vacated
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