CMS Publishes COVID-19 FAQs for 340B Stakeholders
In March 2020, the Health Resources and Services Administration published a set of frequently asked questions (FAQs) for 340B stakeholders related to the COVID-19 pandemic. The FAQs address certain flexibilities and exemptions available to covered entities during the...
Drug Manufacturers File Independent Lawsuits in Response to 340B Advisory Opinion
After the Health and Resource Service Administration (HRSA) issued a December Advisory Opinion requiring 340B discounts for drugs dispensed through contract pharmacies, four drug manufacturers—Eli Lilly, AstraZeneca, Sanofi, and Novo Nordisk—have now filed four...
CMS Releases Guidance Allowing States to Pursue Block Grants for Certain Medicaid Populations
On January 30, 2020, CMS released a letter to state Medicaid directors outlining the agency’s block grant initiative titled “Healthy Adult Opportunity.” CMS will allow states to pursue either an aggregate cap or per-capita-cap approach to managing their Medicaid...
GAO Releases Report on 340B Program, Urging More HHS Oversight on Duplicate Discounts
On January 27, 2020, the Governmental Accountability Office (GAO) released a report on the Medicaid 340B Drug Discount Program, particularly how the 340B program intersects with the Medicaid Drug Rebate Program. The GAO argued that a lack of transparency and...
CMS Issues Guidance on Avoiding Duplicate Discounts in 340B Program
On January 8, 2020, the Centers for Medicare and Medicaid (CMS) issued an informational bulletin outlining a series of best practices for states to consider for avoiding duplicate discounts in the 340B program. According to CMS, the guidance is in response to...
Texas Files Suit Against HHS Seeking Reversal of $25 Million Disallowance
On December 2, 2019, the Texas Health and Human Services Commission filed suit against HHS seeking reversal of an August 2018 DAB decision that upheld a $25 million disallowance against the state. The complaint, filed in D.C District Court, argues that the standard...
Trump Administration Releases Transparency Rules for Hospitals and Insurers
On Friday November 15, the Trump administration released a set of rules aimed at increasing transparency in the hospital and health insurance industries. A proposed rule targeting both exchange and employer-sponsored health plans would require insurers to disclose...
CMS Proposes Sweeping Medicaid Financing Changes through Fiscal Accountability Rule
On November 12, 2019, CMS issued a proposed rule that, if finalized, would have a sweeping impact on Medicaid programs across the country. The 222-page “Medicaid Fiscal Accountability Regulation” seeks to implement significant policy changes to some of the key...
CMS Releases 2019 OPPS Final Rule
On November 1, 2019, CMS issued its FY 2019 Outpatient Prospective Payment Systems (OPPS) Final Rule.
Three Federal District Courts Block DHS Public Charge Rule
Federal district courts in Washington, New York, and California have blocked the Trump Administration's public charge rule from going into effect. The Southern District of New York's ruling applies on a nationwide basis, with the other two rulings limited to the...
President Trump Issues Executive Order Curbing Agency use of Informal Guidance
On October 9, 2019, President Trump issued an executive order on agency reliance on informal guidance documents. The order seeks to curb what the Administration believes to be a “back-door” practice of regulation that allows agencies to improperly bypass the formal...
Trump Administration Issues Proposed Rules to Revamp Fraud and Abuse Laws
On October 9, 2019, the Trump administration released two proposed rules seeking to revamp current fraud and abuse regulations to support the transition to value-based payment. The first would amend regulations implementing the anti-kickback statute and civil monetary...
President Trump Issues Proclamation Requiring Health Insurance for Immigrants
On October 4, 2019, President Trump issued a proclamation requiring immigrants seeking entry into the U.S. to prove that they will obtain health insurance within 30 days of entering the United States or have the resources to pay for “reasonably foreseeable medical...
President Trump Issues Executive Order Promoting Medicare Advantage
On October 3, 2019, President Trump issued an executive order requiring the Medicare program to implement more market-based policies—some which were included in his October 2017 executive order—and support the Medicare Advantage program. Specifically, the order calls...
Senate Approves Temporary Delay in DSH Cuts
On September 26, 2019, the Senate approved a bipartisan continuing resolution to temporarily delay $4 billion in cuts to Medicaid disproportionate share hospital (DSH) payments. The cuts, originally set to take place on October 1, will now take effect on November 22nd.
CMS Issues Final Rule on DSH Cut Methodology
On September 23, 2019, CMS issued a final rule implementing its Disproportionate Share Hospital (DSH) reduction methodology. The DSH payment cuts were part of the Affordable Care Act (ACA) and are currently scheduled to begin in 2020 after a series of two-year delays....
Federal Judge Overturns CMS Site Neutral Policy
On September 18, 2019, the D.C. District Court ruled that CMS exceeded its authority when it extended site-neutral payment to certain services in grandfathered clinics. The policy, issued as part of the November 2018 Outpatient Prospective Payment System (OPPS) Final...
Tennessee Releases Draft Medicaid Block Grant Proposal
On September 17, 2019, Tennessee released a draft amendment proposal to its 1115 “TennCare” waiver that would restructure its Medicaid program into a block grant. Though this option has been discussed in various states, and encouraged by CMS under Administrator Seema...