On July 31, 2024, the Centers for Medicare & Medicaid Services (“CMS”) issued its proposed rule (“Proposed Rule”) for the 2025 Medicare Physician Fee Schedule, which includes implications for telehealth services reimbursable...more
Late last week, the Department of Health and Human Services Office of the Inspector General (“OIG”) posted Advisory Opinion No. 23-07 affirming the broad protection available for compensation to employed physicians under the...more
10/17/2023
/ Advisory Opinions ,
Ambulatory Surgery Centers ,
Anti-Kickback Statute ,
Compensation ,
Department of Health and Human Services (HHS) ,
Employees ,
Employer Liability Issues ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
OIG
On February 13, 2023, the Centers for Medicare and Medicaid Services (CMS) published the revised List of Telehealth Services for Calendar Year (CY) 2023 (List). The List includes the services that are payable under the...more
On June 24, 2022, the United States Supreme Court issued its opinion on Dobbs v. Jackson Women’s Health Organization, No. 19-1392 (2022), holding that the United States Constitution provides no basis for a right to...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
The use of digital health to deliver healthcare has seen unprecedented growth over the past few years, with significant acceleration due to the COVID-19 Public Health Emergency (PHE). As patients seek ways to empower...more
Scope of practice expansion has been a hot-button issue within medical communities and state legislatures for more than thirty years. The debate is centered on what services advanced practice providers (“APPs”) who hold...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
Now approaching a year-long battle, drug manufacturers and 340B covered entities, which include hospitals and community health centers, participating in the 340B Drug Pricing Discount Program (“340B Participants”) continue to...more
On April 27, 2021, the Centers for Medicare and Medicaid Services (“CMS”) released the Hospital Inpatient Prospective Payment System (“IPPS”) and Long-Term Care Hospital (“LTCH”) unpublished Proposed Rule for 2022 (“Proposed...more
On January 13, 2021, Brad Smith, the current (and fourth) director of the Center for Medicare and Medicaid Innovation (the “Center”), published an article in the New England Journal of Medicine in which he evaluates the...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
As part of the “CY 2021 Medicare Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System Final Rule” (the “Final Rule”) published on December 2, 2020, the Centers for Medicare and Medicaid...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
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 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
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 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