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
On June 16, 2016, the Supreme Court of the United States rendered a unanimous decision in the highly anticipated False Claims Act (“FCA”) case of Universal Health Services, Inc. v. United States ex rel. Escobar.[1] In its...more
On March 31, 2015, a 5-4 plurality of the Supreme Court of the United States ruled that Medicaid providers do not have a private right of action under the Medicaid statute to challenge reimbursement rates. The Supreme Court’s...more
On March 9, 2015, the Supreme Court ruled unanimously that when a federal administrative agency wants to amend or repeal an “interpretive rule,” it does not have to follow the notice-and-comment procedures set forth in the...more
On November 21, 2014, the National Institutes of Health (“NIH”) published a notice of proposed rulemaking regarding requirements for clinical trial registration and the reporting of results (“Notice” or “Proposed Rule”)....more
On November 20, 2014, the Centers for Medicare and Medicaid Services (“CMS”) published its latest round of guidance on its Coverage with Evidence Development (“CED”) policy for selected items and services under the Medicare...more
On May 5, 2014, the Centers for Medicare & Medicaid Services ("CMS") announced an opportunity to submit comments on the dispute resolution and correction procedures proposed in the final rule on the Open Payments reporting...more
The rulemaking process often accommodates a variety of interests, including the preference of regulatory agencies to maintain some flexibility and the rights of interested parties to participate in the regulatory process. On...more
On February 12, 2014, the Office of Medicare Hearings and Appeals ("OMHA") hosted a Medicare Appellant Forum ("Forum") to address its current backlog of appeals. OMHA is responsible for hearings before Administrative Law...more
A unanimous Supreme Court has issued its opinion in Sebelius v. Auburn Regional Medical Center, No. 11-1231 (Jan. 22, 2013), rejecting a challenge by hospitals to Medicare's Supplemental Security Income ("SSI") fraction...more