On March 3, 2025, the Secretary of Health and Human Services published a policy statement in the Federal Register that reverses a policy adopted over 50 years ago that was intended to expand public participation in the...more
Closing out 2024, the Centers for Medicare & Medicaid Services (CMS) has issued a proposed rule entitled “Contract Year 2026 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit...more
On August 1, 2024, the Centers for Medicare & Medicaid Services (CMS) released a final rule updating the Medicare inpatient prospective payment system (IPPS) for acute care hospitals and the Medicare prospective payment...more
The Centers for Medicare & Medicaid Services (CMS) recently issued the Medicare Advantage (MA) and Part D proposed rule for contract year 2024 (the “Proposed Rule”), which represents the Biden administration’s broadest effort...more
The No Surprises Act (NSA) will go into effect on January 1, 2022. Since our last episode on the topic, the federal government has issued additional interim final rules and guidance to implement the NSA, including the second...more
In the clearest indication yet of the increased enforcement of the Mental Health Parity and Addiction Equity Act (“MHPAEA”) under the Biden-Harris administration, two settlement agreements filed on August 11 provide that...more
On July 13, 2021, the U.S. Departments of Health and Human Services, Labor, and the Treasury, and the Office of Personnel Management (collectively, “Departments”) published their highly anticipated interim final rule (“First...more
On July 13, 2021, the Biden administration (“Administration”) officially published the “Requirements Related to Surprise Billing; Part I”—its first regulatory response to the enactment of the No Surprises Act (“NSA”)—as an...more
The Centers for Medicare & Medicaid Services ("CMS") and the Office of Inspector General ("OIG") of the Department of Health and Human Services have at last published their long-awaited companion final rules advancing...more
4/8/2021
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Exceptions ,
Final Rules ,
Health Care Providers ,
OIG ,
Physicians ,
Safe Harbors ,
Stark Law ,
Value-Based Care
On December 2, 2020, the Centers for Medicare & Medicaid Services (“CMS”) and the Office of Inspector General (“OIG”) of the Department of Health and Human Services (“HHS”) published in the Federal Register companion final...more
12/21/2020
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
OIG ,
Physicians ,
Proposed Rules ,
Safe Harbors ,
Stark Law ,
Value-Based Care
On December 2, 2020, the Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) and the Centers for Medicare & Medicaid Services (“CMS”) published in the Federal Register long-awaited, companion...more
12/4/2020
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
OIG ,
Physicians ,
Proposed Rules ,
Safe Harbors ,
Stark Law ,
Value-Based Care
In a completely unexpected move, on November 20, 2020, the Centers for Medicare & Medicaid Services (“CMS”) and the Department of Health and Human Services (“HHS”) Office of the Inspector General (“OIG”) published advance...more
On November 12, 2020, the Trump administration published its final rule on price transparency (the “Final Rule”) requiring affected entities to publicly release personalized information on out-of-pocket costs as well as...more
As infections of COVID-19 continue to increase throughout the nation, health care policymakers have focused primarily on increasing acute-care hospital bed capacity, promoting (and decreasing the regulatory requirements...more
On March 13, 2020, when President Trump declared a national emergency under the Stafford Act, the Secretary of Health and Human Services utilized his authority to take particular actions, such as temporarily waiving or...more
4/2/2020
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Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Emergency Management Plans ,
EMTALA ,
Executive Orders ,
Health Care Providers ,
Healthcare ,
Medicaid ,
Medicare ,
Waivers
In response to the 2019 novel coronavirus (“COVID-19”) pandemic, one of Congress’s first actions was the passage of emergency supplemental appropriations on March 5, 2020. Then, on March 18, 2020, a subsequent relief bill,...more
On January 27, 2020, the Centers for Medicare & Medicaid Services (“CMS”) issued a national coverage determination (“NCD”) that authorizes Medicare coverage of next-generation sequencing (“NGS”) as a diagnostic laboratory...more
2/7/2020
/ Cancer ,
Centers for Medicare & Medicaid Services (CMS) ,
Clinical Laboratories ,
Diagnostic Tests ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Genetic Testing ,
Laboratory Developed Tests ,
Local Coverage Determination (LCD) ,
MACs ,
Medicare
On October 29, 2019, the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed decision memo with a national coverage determination (“NCD”) that would allow for Medicare coverage of next-generation sequencing...more
11/8/2019
/ Cancer ,
Centers for Medicare & Medicaid Services (CMS) ,
Clinical Laboratories ,
Diagnostic Tests ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Genetic Testing ,
Laboratory Developed Tests ,
Local Coverage Determination (LCD) ,
MACs ,
Medicare
On January 3, 2018, the Substance Abuse and Mental Health Services Administration (“SAMHSA”) published a final rule (“Final Rule”) to further update the Confidentiality of Substance Use Disorder Patient Records regulations...more
1/15/2018
/ Confidential Information ,
Consent ,
Electronic Protected Health Information (ePHI) ,
Final Rules ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Medical Records ,
Mental Health ,
Patient Privacy Rights ,
SAMHSA ,
SNPRM ,
Substance Abuse
On November 28, 2017, the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule titled “Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan,...more
In April 2015, Congress established a new framework for Medicare Part B physician payments through the passage of the Medicare Access and CHIP Reauthorization Act of 2015 (“MACRA”), which the Centers for Medicare & Medicaid...more
Employers in the health care industry are likely to face significant changes under President-elect Donald J. Trump’s administration and should expect a healthy dose of uncertainty for the next few months. During his campaign,...more
12/7/2016
/ Affordable Care Act ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Final Rules ,
Health Care Providers ,
Hiring & Firing ,
Non-Discrimination Rules ,
OCR ,
Patient Privacy Rights ,
Trump Administration ,
Unions ,
Vaccinations
Health insurers and group health plan sponsors must closely review the final rule titled “Nondiscrimination in Health Programs and Activities” (“Final Rule”) implementing Section 1557 of the Affordable Care Act (“ACA”) that...more
On May 9, 2016, the Centers for Medicare & Medicaid Services (“CMS”) published a proposed rule addressing the implementation of physician payment reforms included in the Medicare Access and CHIP Reauthorization Act of 2015...more
On May 9, 2016, the Centers for Medicare & Medicaid Services (“CMS”) published a proposed rule addressing the implementation of physician payment reforms included in the Medicare Access and CHIP Reauthorization Act of 2015...more