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
Most Medicare Advantage (“MA”) beneficiaries rely on agents and brokers to help them navigate the complex process of selecting a health plan that will meet their needs. In exchange, brokers and agents received certain fixed...more
4/16/2024
/ Agents ,
Beneficiaries ,
Brokers ,
Centers for Medicare & Medicaid Services (CMS) ,
Compensation ,
Competition ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement ,
Fair Market Value ,
Final Rules ,
Medicare ,
Medicare Advantage ,
Medicare Advantage Organizations (MAOs) ,
Mental Health ,
OIG
As we reflect on 2023 and make predictions for 2024, it is remarkable the number of significant events occurring this past year that will be impactful for the activities of the life sciences industry going forward. Although...more
1/26/2024
/ Acquisitions ,
Amgen v Sanofi ,
Antitrust Division ,
Artificial Intelligence ,
Biden Administration ,
Biosimilars ,
Chevron Deference ,
Clawbacks ,
Clinical Trials ,
Compensation ,
Compliance ,
Corporate Integrity Agreement ,
Criminal Prosecution ,
Data Preservation ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Drug Pricing ,
Enforcement ,
EU ,
Executive Orders ,
False Claims Act (FCA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Investigations ,
Life Sciences ,
Mergers ,
Mobile Devices ,
OPDP ,
Pharmaceutical Industry ,
Pilot Programs ,
Privacy Laws ,
Proposed Rules ,
Risk Management ,
Section 340B ,
Self-Disclosure Requirements ,
Voluntary Disclosure
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
On June 15, 2022, in a win for hospitals, the Supreme Court issued its opinion in American Hospital Association et. al. v. Becerra (“Becerra”), overturning massive reimbursement reductions in the 340B drug pricing program...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
On August 13, 2021, the D.C. Circuit Court of Appeals reversed a district court opinion vacating CMS’ Overpayment Rule, 42 C.F.R. 422.326, for Medicare Advantage organizations (“MAOs”). UnitedHealthcare Insurance Co. et al....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
On December 11, 2020, five hospital groups, including the American Hospital Association (“AHA”), and an organization of hospital pharmacists representing participants in the 340B drug pricing program (“340B Program”), filed a...more
1/11/2021
/ Administrative Procedure Act ,
Advisory Opinions ,
American Hospital Association ,
Data Reporting ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
HRSA ,
Manufacturers ,
Medicaid ,
Medicare Part B ,
Pharmacies ,
Pharmacist ,
Prescription Drugs ,
Section 340B
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,” we discussed the advanced...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
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