K&L Gates Triage: 340B Regulatory Update: CMS Proposal and Draft Executive Order Could Have Big Impact on 340B Program
K&L Gates Triage: 340B Eligibility - Hospital Covered Entities
The wait is over, and now the work begins for health plan sponsors. Much-anticipated final rules implementing the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA) were...more
Sharpen your pencils and locate your reading glasses: the final Medicare payment regulations for calendar year (CY) 2024 will be released within the next week. In the last Regs & Eggs blog post, I discussed a major issue...more
Report on Medicare Compliance 31, no. 35 (September 26, 2022) - The HHS Office of Inspector General (OIG) on Sept. 23 unveiled a new template for requesting advisory opinions. - In a new report, OIG said CMS edits...more
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more
CMS’ 340B Rate Cut Continues to Dampen Hospital Outpatient Expansion Efforts - Hospitals hoping to benefit from favorable 340B drug pricing when acquiring independent physician practices for conversion to hospital...more
KEY POINTS - - A new CMS Medicare Rule for Calendar Year 2020 reduces the default level of supervision required for hospital outpatient therapeutic services in all hospitals, from "direct" to "general" supervision. -...more
On Feb. 9, 2018, the Trump Administration released a 30-page report analyzing domestic and global factors influencing drug pricing. The report by the Council of Economic Advisers (CEA) is expected to inform the HHS' Fiscal...more
On July 31, 2017, the United States District Court for the District of Connecticut certified a nationwide class of Medicare beneficiaries in an action against HHS regarding whether patients can appeal their status as an...more
The US Department of Health and Human Services and the Health Resources and Services Administration recently issued final rules related to the 340B Drug Pricing Program that impose fines on drug manufacturers that overcharge...more
On October 3, 2016, the U.S. Department of Health & Human Services, Office of the Inspector General (OIG), issued an advisory opinion approving a local health care district’s proposal to cooperate with another district to...more
CMS Releases Medicare Outpatient Observation Notice For Public Comment – CMS announced that the public has the opportunity to comment on the Medicare Outpatient Observation Notice (MOON). The MOON is a standardized form...more
I. REGULATIONS, NOTICES, & GUIDANCE - On March 15, 2016, the Centers for Disease Control and Prevention (CDC) issued voluntary guidelines entitled, “CDC Guidelines for Prescribing Opioids for Chronic Pain — United...more