Final Regulations/Guidance

FDA Issues Ban on Flavored Vaping Products
On Jan. 2, the Food and Drug Administration (FDA) released guidance that bans flavored vaping products containing sweet and fruity flavors, yet allows menthol pods and a range of vape liquids to remain on the market. FDA’s guidance does not permanently ban flavored or cartridge-based e-cigarettes. It also adds that manufacturers will have 30 days to take the flavored vaping products off the shelves, and open-tank systems can be sold so long as companies go to lengths to prevent children from using the products. Each manufacturer will have to submit products for review by May 2020. Find the guidance here.

CMS: Hospital Price Transparency Requirements: CY 2020 Hospital Outpatient Prospective Payment System (OPPS) Policy Changes
On Nov. 15, the Centers for Medicare and Medicaid Services (CMS) finalized policies that follow directives in President Trump’s executive order entitled “Improving Price and Quality Transparency in American Healthcare to Put Patients First.” The rule requires facilities to disclose currently confidential rates they have negotiated with insurers, what the hospital is willing to accept from a patient and the minimum and maximum negotiated charges. The requirement would apply for all items and services and be available online in a single data file. Hospitals will have to post that information online for 300 common services in an easily understandable format. CMS will specify 70 of these services, and the rest can be chosen by the hospitals. Hospitals that do not comply could face fines of up to $300 per day. Find the final rule here. In response to comments, CMS is extending the effective date to Jan. 1, 2021, to ensure hospital compliance with these regulations.


Democratic AGs Ask the U.S. Supreme Court to Take Up Individual Mandate ACA Case This Term
Democratic attorneys general filed a petition Jan. 3 asking the U.S. Supreme Court to review a recent decision by the U.S. Court of Appeals for the 5th Circuit in Texas v. U.S. The decision affirmed a lower court’s ruling that the individual mandate of the Affordable Care Act (ACA) is unconstitutional, yet did not rule on the validity of the rest of the ACA. The appeals court sent the case back to the lower court to review what portions of the ACA could or could not be severed from the individual mandate issue. The lower court had ruled that the entire law failed. Because the 5th District’s decision causes uncertainty that may harm the health of millions of Americans—in addition to doctors, clinics, patients and the health care market—the attorneys general are petitioning the Supreme Court to take up the case and resolve it before the end of the Court’s current term in June. Filing today’s petition were the attorneys general of California, Colorado, Connecticut, Delaware, Hawaii, Illinois, Iowa, Massachusetts, Michigan, Minnesota (by and through its Department of Commerce), Nevada, New Jersey, New York, North Carolina, Oregon, Rhode Island, Vermont, Virginia, Washington and the District of Columbia, as well as the governor of Kentucky.

Read more on healthcare policy on the McGuireWoods Consulting website.