The U.S. Court of Appeals for the Third Circuit is currently hearing arguments from pharmaceutical manufacturers Novo Nordisk, Sanofi and AstraZeneca and the Department of Health and Human Services (HHS) on whether the 340B program prohibits pharmaceutical manufacturers from imposing restrictions on how their drugs are distributed. Read the full Alert.… Continue Reading
On Aug. 4, the Department of Health and Human Services (HHS) published its proposed rule, Nondiscrimination in Health Care and Activities (Proposed Rule), to revise its regulations pertaining to Section 1557 of the Affordable Care Act (ACA). The aim of Section 1557 is to ensure access to health care and coverage in certain health programs … Continue Reading
On Aug. 2, the U.S. Department of Justice (DOJ) filed suit against the state of Idaho to block a state abortion law set to take effect on Aug. 25, claiming that it violates the federal Emergency Medical Treatment and Labor Act of 1986 (EMTALA). Under EMTALA, a hospital that receives Medicare funds must provide treatment … Continue Reading
To coincide with the 32nd anniversary of the Americans with Disabilities Act (ADA), the Department of Health and Human Services Office for Civil Rights (OCR) and the Department of Justice’s Civil Rights Division (CRT) jointly issued Guidance on Nondiscrimination in Telehealth: Federal Protections to Ensure Accessibility to People with Disabilities and Limited English Proficient Persons … Continue Reading
Authored by: Amy E. Fouts (Partner) and Claire M. Bass (Associate) On July 28, U.S. Department of Health and Human Services (HHS), alongside the Department of Labor (DOL) and the Department of Treasury, warned that limiting coverage of contraceptives following the U.S. Supreme Court ruling in Dobbs violates the Affordable Care Act (ACA).… Continue Reading
On Monday, July 11, 2022, the secretary of Health and Human Services (HHS) issued a letter to healthcare providers regarding the Emergency Medical Treatment and Active Labor Act (EMTALA), indicating that when a state law prohibits abortion and does not provide an exception that aligns with EMTALA’s emergency medical condition definition, that state law is … Continue Reading
With a bold finish, the Department of Health and Human Services (HHS) crossed the finish line of its race to modernize and clarify the regulations interpreting the federal physician self-referral law (Stark) and anti-kickback statute (AKS) through final rules released Nov. 20, 2020. With one exception, the Stark and AKS rules, based on October 2019 … Continue Reading
CORONAVIRUS WORRIES CONTINUE AFTER EMERGENCY FUNDING BILL Congressional approval last week of emergency spending to address the coronavirus hasn’t allayed Capitol Hill’s concerns about preparedness and response as the impact of the virus in the United States rapidly escalates. Two lawmakers – Sen. Ted Cruz, R-Texas, and Rep. Paul Gosar, R-Ariz. – announced this weekend … Continue Reading
AZAR TO TESTIFY THIS WEEK BEFORE HOUSE, SENATE COMMITTEES Health and Human Services Secretary Alex Azar faces a marathon week of testimony, appearing before four congressional committees to discuss his department’s fiscal 2021 budget. In addition to funding issues, Azar is likely to face questions on the federal government’s response to the coronavirus outbreak. Last … Continue Reading
SURPRISE BILLING PROGRESS DRIVES THE WEEK Legislation to address surprise medical bills is moving forward this week, as two House committees mark up their own plans to protect patients. After progress stalled at the end of last year, the House Ways and Means Committee jump-started it by announcing it would move forward with its proposal. … Continue Reading
SURPRISE BILLING FIX REGAINING TRACTION? Legislation to address unexpected bills for out-of-network medical care appears to be making a comeback, after a committee turf battle stalled its progress at the end of last year. House leaders want to pass a bill by May, when they intentionally created a deadline for several popular health programs that will need … Continue Reading
CONCERNS ABOUT CORONAVIRUS GROW ON CAPITOL HILL As coronavirus cases continue to emerge in the United States and worldwide, lawmakers are seeking briefings from federal health officials about the outbreak that originated in China and what steps U.S. health agencies are taking to protect Americans. Five cases were confirmed in the United States, but there … Continue Reading
NEW SENATOR JOINS HEALTH COMMITTEE Newly sworn-in Sen. Kelly Loeffler, R-Ga., is the newest member of the Senate Health, Education, Labor and Pensions Committee. Loeffler took the oath of office last week, replacing retired Sen. Johnny Isakson, R-Ga. Committee Chairman Lamar Alexander, R-Tenn., praised Loeffler as having the background and skills to “immediately become an … Continue Reading
SPRING DEADLINE DRIVES 2020 HEALTH POLICY AGENDA Few policy issues consumed more political oxygen on Capitol Hill last year than prescription drug prices and surprise medical bills – but without significant legislative achievement on either. But Congress is going to try again, setting up a spring deadline to force action on key healthcare provisions. Despite … Continue Reading
ACA TAXES ON CHOPPING BLOCK IN YEAR-END BUDGET DEAL Congressional leaders are poised to announce an agreement today that would permanently repeal the Affordable Care Act (ACA) taxes on medical device manufacturers, insurers and high-cost health plans as part of a spending package that would avoid a government shutdown later this week. If the tax … Continue Reading
YEAR-END LEGISLATIVE OVERDRIVE This week is crunch time on a host of legislative priorities, and various health-related provisions hang in the balance. Lawmakers and staff worked all weekend negotiating on legislation to fund the government beyond next Friday’s deadline, when current funding expires. As the only true must-pass legislative vehicle before the end of the … Continue Reading
HEALTH PROVISIONS FACE UNCERTAINTY AS CONGRESS RETURNS FOR BUSY DECEMBER Congress returns to Washington this week after the Thanksgiving holiday with only 18 days before the government runs out of money – and that’s not even the most important issue lawmakers will face in what is shaping up as a cramped year-end calendar. In addition … Continue Reading
UPDATE ON DRUG PRICING LEGISLATION AS CONGRESS RECONVENES Congress reconvenes this week after a monthlong summer recess and begins what likely will be a final push toward overhauling prescription drug prices, but lack of consensus on the underlying policy and the intensifying 2020 presidential campaign will complicate efforts to advance a bill to President Donald … Continue Reading
Below is this week’s “Capitol Hill Healthcare Update,” which is posted on Mondays when Congress is in session. SENATORS RACE TO FINISH DRUG PRICING BILL AS TRUMP PLANS STALL With only 15 legislative days before a scheduled monthlong recess, Senate leaders are scrambling this week to seek consensus on ambitious legislation to lower prescription drug … Continue Reading
Below is this week’s “Capitol Hill Healthcare Update,” which is posted on Mondays when Congress is in session. Note that because Congress will be in recess for the Memorial Day holiday, the next “Capitol Hill Healthcare Update” will be posted on June 3. LAWMAKERS QUESTION DEMOCRATS’ STRATEGY ON DRUG PRICING House Democrats last week combined … Continue Reading
Here is this week’s “Capitol Hill Healthcare Update,” which is posted on Mondays when Congress is in session HOUSE TO VOTE ON BILL COMBINING ACA, DRUG PRICING PROVISIONS The House is scheduled to vote on legislation Thursday that would package new funding for state-based marketplaces and enrollment outreach efforts under the Affordable Care Act (ACA), with provisions designed to … Continue Reading
On March 6, 2019, the U.S. Department of Justice (DOJ) announced that Linda Sue Kalina pled guilty to wrongfully disclosing the protected health information (PHI) of another individual in violation of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Kalina was a patient information coordinator with the University of Pittsburgh Medical Center (UPMC) … Continue Reading
Senate Democrats recently introduced the Stop Price Gouging Act (S. 378), which seeks to place an excise tax on pharmaceutical companies in proportion to price spikes on prescription drugs. The bill generally requires a company to justify to the Department of Health and Human Services (DHHS) any spike in prescription drug prices, but it is … Continue Reading