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 October, 1, 2020, the U.S. Department of Health and Human Services (HHS) announced the availability of an additional $20 billion in relief funding for providers – including specifically for behavioral health providers and...more
10/19/2020
/ CARES Act ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Federal Grants ,
Health Care Providers ,
Healthcare Facilities ,
Hospitals ,
Medicare ,
Provider Relief Fund ,
Relief Measures ,
Terms and Conditions
On October 1, 2020, U.S. Department of Health and Human Services Secretary Azar renewed his declaration of a public health emergency (PHE) due to the coronavirus pandemic...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
So you’ve retained funds provided under the Public Health and Social Services Emergency Fund in the CARES Act. What next?
We’ve compiled a checklist to maintain your compliance with the program’s conditions and reduce the...more
On April 24, 2020, President Trump signed into law the Paycheck Protection Program and Health Care Enhancement Act (HCEA), which appropriated an additional $75 billion to the Public Health and Social Services Emergency Fund...more
On March 27, 2020, Congress passed the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”), the third and by far the largest stimulus package passed by Congress to respond to the COVID-19 outbreak. As discussed...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
On July 25, 2019 the Senate Finance Committee voted to advance their long-awaited drug pricing package to the Senate floor (we anticipate a Floor vote sometime this Fall). The Prescription Drug Pricing Reduction Act (PDPRA)...more
8/15/2019
/ Drug Pricing ,
Generic Drugs ,
Health Care Providers ,
Hospitals ,
Medicaid ,
Pharmaceutical Industry ,
Pharmacies ,
Pharmacy Benefit Manager (PBM) ,
Proposed Legislation ,
Rebates ,
Risk-Sharing ,
Senate Finance Committee
On June 13, 2019, the Internal Revenue Service (IRS), Department of Labor and Department of Health and Human Services (HHS) issued a new regulation that is intended to increase the use of tax-favored health reimbursement...more
Excerpt:
I. Introduction -
In February of 2019, the Department of Health and Human Services’ Office of Inspector General (HHS-OIG) issued a Proposed Rule that, if adopted, would upend the current prescription drug...more
In February of 2019, the Department of Health and Human Services’ Office of Inspector General (HHS-OIG) issued a Proposed Rule that, if adopted, would upend the current prescription drug rebate system. According to HHS-OIG,...more
I. Introduction -
In May 2018, the Department of Health and Human Services (HHS) introduced a “Blueprint” and Request for Information setting forth proposed actions and policies as a means to purportedly help lower...more
On November 13, 2017, a group of hospital trade associations (the American Hospital Association, the Association of American Medical Colleges, and America’s Essential Hospitals), along with two health system providers, filed...more
On Tuesday, November 7, 2017, the Massachusetts Executive Office of Labor and Workforce Development issued proposed regulations to implement the Employer Medical Assistance Contribution (EMAC) supplemental assessment that was...more
On October 12, 2017, President Trump signed an Executive Order (EO) entitled “Promoting Healthcare Choice and Competition Across the United States.” The much-anticipated EO directs the Departments of Treasury, Labor, and...more