K&L Gates Triage: 340B Regulatory Update: CMS Proposal and Draft Executive Order Could Have Big Impact on 340B Program
On January 28th, President Biden issued an “Executive Order on Strengthening Medicaid and the Affordable Care Act.” The E.O. states that the Biden Administration will promote policies that “protect and strengthen Medicaid and...more
On December 29, 2020, the United States Court of Appeals for the District of Columbia issued its opinion in American Hospital Association v. Azar (the Opinion) upholding the Hospital Transparency Regulation (the Rule) issued...more
On December 29, 2020, the U.S. Court of Appeals for the District of Columbia Circuit upheld a CMS final rule promulgated in November 2019 that requires hospitals to disclose various forms of pricing information related to the...more
On June 23, the U.S. District Court for the District of Columbia dismissed a challenge to a federal rule requiring hospitals to disclose prices they privately negotiated with insurers....more
President Trump has issued an Executive Order instructing several federal agencies to begin rulemaking processes intended to increase the transparency of hospital pricing. Among other measures, the Executive Order directs the...more
On June 24, 2019, the President issued his Executive Order on Improving Price and Quality Transparency in American Healthcare to Put Patients First. The Executive Order directs regulators to take action to improve healthcare...more
CMS recently announced through an MLN Matters article that it intended to place new home health agencies (HHAs) under enhanced oversight for a provisional period. The authority for CMS's oversight flows from a provision in...more
On November 20, 2018, Virginia submitted an application to CMS for a Section 1115 demonstration program entitled Virginia COMPASS (Creating Opportunities for Medicaid Participants to Achieve Self-Sufficiency). The application...more
Resolving a split in the lower courts, the Federal Circuit issued two decisions on June 14, 2018, wherein the Court held that health insurers Moda Health Plan Inc. (Moda Health) and Land of Lincoln Mutual Health (Land of...more
Congress returned from its spring recess with a host of issues to address—trade, Trump administration nominations and opioid legislation sitting atop the priority list. Given the ongoing data scandal at Facebook, privacy...more
This week, President Trump will go before Congress for his first State of the Union address. Will it be olive branches or brickbats? The next deadline for a government-funding bill is February 8th, a week from Thursday. Will...more
The Senate Health, Education, Labor, & Pensions (HELP) Committee held the first hearing on the confirmation for Secretary of Health and Human Services (HHS) nominee Alex Azar on Wednesday, November 29. Notably, only the...more
As Part of an ongoing series, we have previously provided details on the structure, funding, and evaluation of the Maternal, Infant, Early Childhood, Home Visiting (MIECHV) program, Medicare therapy caps, and community health...more
With the FY2017 reconciliation instructions behind us, we look ahead to what is left in store for health care between now and the end of the calendar year. While Secretary Price’s departure was expected, what he leaves behind...more
Tom Price, the orthopedist and foe of the Affordable Care Act, may have been jettisoned from his job as Health and Human Services secretary, but his agency’s effort to sabotage Obamacare smolders on....more
The first 100 days of a new presidential administration serves as a traditional, if somewhat arbitrary, demarcation point. April 29, 2017, serves as the 100th day of the Trump administration, and we now have insight into how...more
Doctors should hold the prime role in the nation’s medical policy making, Tom Price, the orthopedist who is the Trump Administration’s top health expert, has insisted. But will the U.S. Health and Human Services Secretary...more
Arkansas - Governor Proposes Changes to Medicaid Expansion Waiver as House Passes Bill to Cap Expansion Enrollment - Governor Asa Hutchinson (R) released a proposal to amend the State's Medicaid expansion waiver by...more
While the titans on Capitol Hill clash over the best answer to the Affordable Care Act (ACA), the Trump administration is promoting action at the state level that could produce meaningful impact soon. Health industry...more
Early in the morning of February 10, 2017, the U.S. Senate confirmed Rep. Tom Price (R-GA) to be the Secretary of Health and Human Services. Senators voted along party lines, 52 to 47, to confirm Rep. Price, an orthopedic...more
Republicans jammed through their health policy guru in the middle of the night, and they and their new HHS Secretary are still trying to figure out what to do with the Affordable Care Act, aka Obamacare. Insurance markets are...more
The Department of Health and Human Services, Office of Inspector General (OIG) published a final rule on January 12, 2017, expanding the OIG’s authority to exclude providers from participation in federal healthcare programs....more
In contemplating the ways in which physicians may be affected by the possible repeal of the Affordable Care Act (ACA)—and certain features of any legislation that may replace it—a good place to start is with the person...more
President-elect Trump and congressional Republicans have promised to “repeal and replace” the Affordable Care Act (ACA), but there is deep division regarding which provisions will be rescinded and around the details of the...more
On Saturday, December 31, 2016, a federal judge in Texas entered a nationwide preliminary injunction barring the enforcement of antidiscrimination protections pertaining to transgender and abortion health services and...more