On January 19, 2017, the United States Food and Drug Administration (“FDA”) unveiled a new drug designation process for regenerative advanced therapies, an important first step toward implementation of the regenerative medicine provisions of the 21st Century Cures Act. Products for which a designation as a regenerative advanced therapy (“RAT”) is obtained are eligible
Long-Awaited Accessibility Standards for Medical Diagnostic Equipment Are Released
Our colleagues Joshua A. Stein and Frank C. Morris, Jr., at Epstein Becker Green have a post on the Health Employment And Labor blog that will be of interest to many of our readers: “The U.S. Access-Board Releases Long-Awaited Final Accessible Medical Diagnostic Equipment Standards.”
Following is an excerpt:
As part of
New Federal and State Initiatives Seek to Combat Antimicrobial Resistance
Recent federal and state legislative efforts signal an increased focus on a significant and largely underappreciated public health threat – antimicrobial resistance (i.e., when a microorganism (such as a bacteria or virus) is able to resist the effects of medications such as antibiotics and antivirals, causing such medications to be ineffective). The results of a
District Court Invalidates Payment of Cost-Sharing Subsidies, Setting Up Additional Legal Tests for the Affordable Care Act
In its recent decision in U.S. House of Representatives v. Burwell,[1] the U.S. District Court for the District of Columbia ruled that the Obama administration’s payment of cost-sharing subsidies for enrollees in plans offered through the Affordable Care Act’s Exchanges is unauthorized for lack of Congressional appropriation. The decision would affect future cost-sharing subsidies,
Defend Trade Secrets Act Signed Into Law
On May 11, 2016, President Obama signed into law the Defend Trade Secrets Act (“DTSA”), which became effective immediately. The DTSA provides the first private federal cause of action for trade secret misappropriation, and it allows parties to sue in federal court for trade secret misappropriation—regardless of the dollar value of the trade secrets at
Surprise Health Care Bill Protections Addressed in President Obama’s 2017 Budget for Health and Human Services
In its Fiscal Year 2017 Private Insurance Legislative Proposals, President Obama’s Budget contains a provision seeking to “eliminate surprise out-of-network healthcare charges for privately insured patients.” Described as an attempt to “promote transparency on price, cost, and billing for consumers,” this measure requires hospitals and physicians to collaborate so that patients receiving treatment at
Bipartisan Budget Act of 2015 – Potential Impact on Hospitals
House Republican leaders introduced legislation on Monday, finalizing a two-year budget agreement between Congressional leaders and the White House. This legislation is currently being considered and may be up for a vote as early as Wednesday on the bipartisan budget deal.
Hospitals should note the language in Section 603 (which is on pages 35-39 of
SCOTUS Upholds Exchange Subsidies – King v. Burwell
In a split decision announced today, June 25, the U.S. Supreme Court, in King v. Burwell, ruled in upholding the tax credits to individuals in all states, including those with only a federal exchange. In a 6-3 decision, Chief Justice Roberts delivered the opinion of the Court.
“Congress passed the Affordable Care Act to
President Obama to Announce New Privacy Initiatives in SOTU
The State of the Union Address, scheduled for January 20, 2015, will contain new initiatives related to privacy, White House officials say. The known initiatives are the introduction of a data breach reporting bill, a bill restricting the sale of student information, and a Consumer Privacy Bill of Rights.
SETTING
Comment Period on Proposed QHP Certification Guidance and Proposed Rule That May Impact Health Insurance Issuers’ Offering of Private Health Insurance Products
Stakeholders received insight on the Obama administration’s expected approach to the certification and oversight of qualified health plans (“QHPs”) late Friday, December 19, 2014, with the release by the Centers for Medicare & Medicaid Services (“CMS”) of its Draft 2016 Letter to Issuers in the Federally-facilitated Marketplaces (“Draft Letter”). This annual release comes more than