It goes without saying that the actions of federal regulatory agencies greatly affect many essential aspects of our daily lives, among them the delivery of medical services, medicines, and therapeutic devices and the...more
Laboratories in the United States are facing a major regulatory landscape shift.
The U.S. Food and Drug Administration (FDA) has finalized a new rule ending its historical blanket enforcement discretion over laboratory...more
In a recent landmark decision, the U.S. Supreme Court overruled the Chevron doctrine in the case of Loper Bright Enterprises v. Raimondo.
This ruling has significant implications for employers and other entities in the...more
In its frequent attempts to enforce the separation of powers that the Constitution’s framers devised as a system of checks and balances among the executive, legislative, and judicial branches of the federal government, it is...more
Throughout the course of the pandemic, the Health Resources and Services Administration (HRSA) distributed $178 billion in Provider Relief Funds (PRF) to hospitals and health care providers. The Public Health Emergency has...more
A recent decision by the U.S. District Court for the District of Columbia has clarified that a Medicare beneficiary may challenge a Medicare Local Coverage Determination (LCD) without first having to exhaust the lengthy...more
What has contributed to the biotechnology industry’s explosive growth over the last several years? In this episode, special guests Don and Lisa Drakeman, two former CEOs of biotech companies, reflect on what it takes to...more
This term, the Supreme Court of the United States is set to rule in a Medicare reimbursement case that has sparked a fresh look at the historical deference often granted to agencies and whether it should remain, be modified,...more
On January 11, 2022, the Centers for Medicare and Medicaid Services (“CMS”) published an anticipated proposed National Coverage Determination (“NCD”) decision memorandum that begins the process of determining whether the...more
On October 20, 2021, the U.S. Department of Health and Human Services (HHS) published a proposed rule that would repeal regulations issued in the twilight of the Trump administration that limited HHS’s use of guidance...more
On September 30, 2021, the Provider Reimbursement Review Board (the “Board”) issued a revised set of rules that become effective November 1, 2021. These new and revised rules affect all new and some pending Medicare Part A...more
On September 15, 2021, CMS published a proposed rule that would repeal a final rule that created an expedited pathway for Medicare coverage of breakthrough devices and established formal criteria for applying the “reasonable...more
Teaching hospitals should find that their Medicare reimbursement for training physicians will be a little sweeter thanks to a decision by the United States District Court for the District of Columbia. Milton S. Hershey...more
On January 14, 2021, the Department of Health and Human Services (“HHS”) published the Transparency and Fairness in Civil Administrative Enforcement Actions final rule (“Rule”). The Rule amends and supplements the HHS Good...more
On December 7, 2020, the Department of Health and Human Services (“HHS”) published the Good Guidance Practices final rule (“Rule”), which limits HHS’s ability to issue and rely upon sub-regulatory guidance documents in...more
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
On September 1, 2020, the Centers for Medicare & Medicaid Services (“CMS”) published a proposed rule that would, for the first time, establish formal criteria to define the “reasonable and necessary” standard for Medicare...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 June 3, 2019, the U.S. Supreme Court ruled in Azar v. Allina Health Services that the Medicare statute requires the Centers for Medicare & Medicaid Services (“CMS”) to engage in public notice-and-comment rulemaking...more
6/5/2019
/ Administrative Procedure Act ,
Azar v Allina Health Services ,
Centers for Medicare & Medicaid Services (CMS) ,
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
President Trump recently signed sweeping bipartisan legislation to combat the opioid epidemic. TheSubstance Use–Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act, or the SUPPORT...more
In October 2018, the Centers for Medicare & Medicaid Services (“CMS”) announced that it made significant changes to the process by which local coverage determinations (“LCDs”) are developed and issued. These changes were...more
Evaluation and management (“E & M”) services furnished in offices or in outpatient settings account for approximately 20 percent of all Medicare Part B physician charges. Due to the volume of E & M services that are billed to...more
A controversial new Medicare national coverage determination (“Medicare NCD”) for certain next-generation sequencing (“NGS”) tests published by the Centers for Medicare & Medicaid Services (“CMS”) on March 16, 2018, could...more
On January 19, 2017, sixteen federal agencies, including the Departments of Health and Human Services and Labor, published the first revision to the federal regulations governing the protection of human subjects participating...more
2/17/2017
/ Biometric Information ,
Clinical Trials ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Human Rights ,
Informed Consent ,
IRB ,
Medical Research ,
Patient Privacy Rights ,
Personally Identifiable Information ,
Pharmaceutical Industry ,
Scientific Research ,
The Common Rule