Since 1984, the “Chevron doctrine” had served as the bedrock of many regulatory actions by the U.S. Department of Health and Human Services (HHS) and other federal agencies. Under the doctrine, courts followed a two-step...more
On April 10, 2024, the Centers for Medicare & Medicaid Services (CMS) published the fiscal year (FY) 2025 Medicare Hospital Inpatient Prospective Payment Systems (IPPS) Proposed Rule, an annual rulemaking that broadly...more
On January 30, 2024, CMS published in the Federal Register an RFI to seek input from the public regarding increased public releases of MA data to improve transparency in the program. CMS stated responses to this RFI may be...more
This morning the Centers for Medicare & Medicaid Services (CMS) published, for the first time, a list of drugs subject to price negotiation under the Inflation Reduction Act’s (IRA) Medicare Drug Price Negotiation program....more
On August 16, 2022, President Biden signed into law the Inflation Reduction Act of 2022 (IRA). The drug pricing provisions in Subtitle B of Title I of the IRA, entitled “Prescription Drug Pricing Reform,” enact government...more
On November 6, 2021, the Fifth Circuit Court of Appeals temporarily blocked enforcement of the OSHA vaccination-or-testing rule. Citing “grave statutory and constitutional issues” with the rule, a three-judge panel issued the...more
11/8/2021
/ Anti-Discrimination Policies ,
Appeals ,
Centers for Disease Control and Prevention (CDC) ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Civil Rights Act ,
Coronavirus/COVID-19 ,
Enforcement ,
Equal Employment Opportunity Commission (EEOC) ,
Health Care Providers ,
Healthcare Workers ,
Interim Final Rules (IFR) ,
Order to Stay ,
OSHA ,
Religious Exemption ,
Title VII ,
Vaccinations ,
Virus Testing
On October 13th our friends over at STAT broke the news [sorry, Paywall] about a “warranty” pilot program from Pfizer that offers both patients and health plans (including Medicare Part D plans) the opportunity to receive a...more
10/15/2021
/ Alternative Payment Models (APM) ,
Centers for Medicare & Medicaid Services (CMS) ,
Medicaid ,
Medicare Part D ,
Patients ,
Pfizer ,
Pharmaceutical Industry ,
Pilot Programs ,
Prescription Drug Coverage ,
State Health Plans ,
Value-Based Purchasing
On September 9, 2021, President Biden unveiled his administration’s plan to combat the recent COVID-19 surge across the United States, referred to by the administration as the “Path out of the Pandemic.” The plan, in...more
9/13/2021
/ Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Department of Labor (DOL) ,
Employer Mandates ,
Executive Orders ,
Federal Contractors ,
Healthcare Workers ,
OSHA ,
Vaccinations ,
Workplace Safety
While CMS has been relatively quiet as of late from a public-facing perspective as it waits for new political leadership to arrive (including newly announced CMS Administrator, Chiquita Brooks-LaSure), a recent review by your...more
This just in – as previously discussed, on January 4, 2021 CMS Administrator Seema Verma sent a letter (available here) to State Medicaid Directors requesting they sign a Letter of Agreement “as soon as possible” establishing...more
A quick, timely update for our reader. As reported in our previous posts on the recently approved Tennessee waiver, in likely anticipation of the Biden Administration withdrawing the newly approved, but controversial waiver,...more
Now that we have had the chance to read and meditate on the historic Medicaid waiver approved on Friday January 8th, giving Tennessee permission from the Federal government to fundamentally alter Medicaid’s traditional...more
1/12/2021
/ Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Essential Health Benefits ,
Health Insurance ,
Manufacturers ,
Medicaid ,
Medicare Part D ,
Medication-Assisted Treatment (MAT) ,
Prescription Drugs ,
Rebates ,
Section 340B ,
Waivers
...On Friday January 8th, in the final days of the Trump Administration, CMS announced approval of a first-in-the-nation waiver that would permit Tennessee to transition from Medicaid’s longstanding, open-ended financing...more
On Friday, November 20, 2020, 60 calendar days prior to the inauguration of President-Elect Biden, the Trump administration released three rulemakings with significant implications for life sciences companies and healthcare...more
11/30/2020
/ Anti-Kickback Statute ,
Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Health Care Providers ,
Life Sciences ,
OIG ,
Pharmaceutical Industry ,
Rulemaking Process ,
Stark Law ,
Trump Administration
Back in March, Tom gave you, our readers, an overview of the Administration’s and Congress’ initial response to the COVID-19 pandemic, including the inclusion in the second Congressional package (the Families First...more
On September 24, 2020 the U.S. Food and Drug Administration took two major steps to implement its Safe Importation Action Plan, including publishing a new Final Rule allowing the importation of certain prescription drugs from...more
9/29/2020
/ Canada ,
Centers for Medicare & Medicaid Services (CMS) ,
Drug Approvals ,
FDA Approval ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Guidance ,
Final Rules ,
Food and Drug Administration (FDA) ,
Importation Limits ,
MDRP ,
Medicaid ,
Medicaid Drug Rebate Program ,
Prescription Drugs
As many of our astute readers are aware, on June 17, 2020 CMS released a long-awaited Medicaid proposed rule addressing a number of far-ranging issued involving Medicaid coverage and payment for prescription drugs, including...more
As my colleague Tom Barker wrote last week, the second emergency COVID-19 supplemental bill (officially referred to as the Families First Coronavirus Response Act), signed by the President on March 18, 2020, included a new...more
We are still reviewing the just-released draft waiver from Oklahoma, but wanted to share with our readers in the meantime. As we’ve discussed... we expected Oklahoma to be the first-mover after release of the Trump...more
On January 30, 2020, the Centers for Medicare & Medicaid Services (CMS) issued its long awaited and highly anticipated State Medicaid Director Letter (SMD Letter) announcing the “Healthy Adult Opportunity” (HAO) initiative...more
UPDATED: It’s out! The much anticipated guidance, entitled the “Healthy Adult Opportunity” (HAO), from CMS introducing ways to revamp Medicaid financing has been out for nearly a week and we have had some time to review the...more
We’ve written previously about the the 2014 final regulation issued by the Obama administration making significant updates to the requirements for the qualities of settings eligible for reimbursement for Medicaid...more
12/17/2019
/ Centers for Medicare & Medicaid Services (CMS) ,
Disabilities ,
Final Rules ,
HCBS Waivers ,
Healthcare ,
Home and Community Based Services (HCBS) ,
Home Health Care ,
Long Term Care Facilities ,
MACPAC ,
Medicaid ,
New Regulations
On November 19, 2019, CMS announced key results from the 2019 HHS Agency Financial Report, which generally provides fiscal and high-level performance data for HHS for the reporting period of October 1, 2018 through September...more
11/25/2019
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Eligibility ,
Federal Contractors ,
Fee-for-Service ,
Financial Reporting ,
Health Care Providers ,
Managed Care Contracts ,
Medicaid ,
Medicare ,
PERM ,
Proposed Rules ,
Regulatory Agenda
We’ve posted previously the long-standing rumor (substantiated by several folks within the Administration) that CMS is working on a guidance document to states to receive their Medicaid funding through a block grant. In June,...more
On September 17, 2019, Tennessee released its proposal to block grant most of the funding the state’s Medicaid program (TennCare) receives from the Federal government. If approved by CMS, the amendment to the state’s...more