Medical Device Legal News with Sam Bernstein: Episode 19
Midyear Premium Increases and Cafeteria Plan Rules
K&L Gates Triage: An Insider’s Perspective on the Health Care Debate in Washington, DC
K&L Gates Triage: 340B Regulatory Update: CMS Proposal and Draft Executive Order Could Have Big Impact on 340B Program
Collaborating Before The PTAB
Every year, the New Jersey legislature passes statutes that impact healthcare beyond rate increases under the Medicaid program. Last year was no different, and the discussion below highlights some of those statutes, such as...more
What New Obligations Does the No Surprises Act Impose on Health Systems and Health Plans—and How Can You Prepare for the Impact? Learn the Answer at a New Manatt Webinar. The No Surprises Act (NSA)—set to take effect...more
On July 1, 2021, the Office of Personnel Management (“OPM”), the Internal Revenue Service (“IRS”), the Department of Treasury (“Treasury”), the Employee Benefits Security Administration (“EBSA”), the Department of Labor...more
On March 10, 2021, the U.S. House of Representatives narrowly passed H.R. 1319, the American Rescue Plan Act of 2021, on a largely partisan basis by a 220-211 vote. Final passage came four days after the U.S. Senate amended...more
On October 29, 2020, HHS, the Department of Labor, and the Department of Treasury (the Departments) jointly issued a final rule requiring health plans to disclose price and cost-sharing information to participants,...more
As the coronavirus spreads throughout the country, hospitals and other health care providers are finding themselves inundated with patients. Those providers who are in-network with payors have and will likely continue to...more
As the number of coronavirus cases across the country continue to rise, CMS has issued several coronavirus-specific memorandums to healthcare providers and laboratories. In the past two weeks, CMS has issued disease-specific...more
2019 saw court hearings of a number of cases related to the Affordable Care Act (ACA). Several other Trump administration policies were also challenged, including Medicare payment policies, price transparency, how the...more
Federal executive agencies recently published two rules, one final and one proposed, aimed at publicizing the various costs associated with health care. A final rule, promulgated by the Department of Health and Human Services...more
Employer-sponsored health plans and health insurers may be required to post online - and to provide participants upon request - a range of pricing and cost-sharing information beginning in 2021. Proposed Affordable Care...more
On November 15, 2019, the Department of Health and Human Services, the Department of Labor, and the Department of the Treasury (collectively, the Departments), unveiled a proposed rule (scheduled to be published on November...more
On November 15, the Trump Administration released a final rule requiring hospitals to publicly disclose hospital charges, including negotiated prices with third-party payers by January 1, 2021. We outline key considerations...more
August 24, 2018 marked a busy day for the U.S. Department of Health & Human Services' (HHS) self-designated "Regulatory Sprint to Coordinated Care," an initiative aimed at dismantling the regulatory barriers to providers...more
In Advisory Opinion No. 18-07, issued July 30, 2018, the OIG permitted a group purchasing organization (GPO) to serve health care facilities owned by the same parent organization as the GPO. While acknowledging that the...more
With Advisory Opinion 18-06, issued July 11, 2018, the OIG added to the ever-growing number of favorable advisory opinions addressing an agreement between a Medicare Supplemental Health Insurance (Medigap) insurer and a...more
Hospitals and Health Systems Prepare for a Value-Based Future - Editor’s Note: Hospitals and health systems are actively working to service their communities in numerous ways, including through the adoption of initiatives...more
Lawmakers return to Capitol Hill this week ahead of more self-imposed deadlines to resolve a series of thorny healthcare policies, including funding for the Department of Health and Human Services (HHS) and the rest of the...more
With Advisory Opinion 17-04, issued August 24, 2017, the U.S. Department of Health and Human Services, Office of Inspector General (OIG) adds to the ever-growing number of favorable advisory opinions regarding an agreement...more
Recently, the U.S. Department of Health and Human Services, Office of Inspector General (“OIG”) issued an Advisory Opinion (17-02) that allows for waivers or reductions of cost-sharing amounts owed by financially needy...more
This episode outlines the basics of the 340B Drug Pricing Program and discusses potential changes affecting the program, including CMS’s recent proposal to cut reimbursement for Part B drugs purchased under the 340B program....more
On December 7, 2016, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) published a final rule to amend the Anti-Kickback Statute (AKS or Statute) by adding new safe harbors. The Final Rule...more
A federal report finds that Marketplace premiums are lower in expansion states; Massachusetts and Pennsylvania launch prescription drug monitoring systems; and Kentucky submits a slightly modified Medicaid expansion waiver to...more
Hospitals now have additional time before they must meet federal requirements to provide written notice to Medicare patients who are receiving observation services. Congress passed the Notice of Observation Treatment and...more
On November 2, 2015, President Obama signed the Bipartisan Budget Act of 2015 (“Act”) into law significantly impacting how Medicare pays certain off-campus hospital departments. Specifically, Section 603 of the Act provides...more
HHS Office of Inspector General (OIG) recently clarified its guidance related to the provision of free or discounted prescription drugs in two contexts: (1) hospital discounts or waivers of self-administered drugs in...more