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CMS: 75K Individuals Affected By Direct Enrollment Pathway Breach

CMS Friday (Oct. 19) revealed that its Direct Enrollment pathway that allows agents and brokers to enroll subsidy-eligible individuals into plans sold through healthcare.gov has been breached, and is now temporarily disabled.

Latest News

HHS: Proposal At OMB Would Implement 340B Ceiling Price Rule In January

HHS told a federal court that it intends to release by Nov. 1 a proposal that would move the effective date for the 340B ceiling prices and penalties rule to Jan. 1, up from July 1, and for that reason the court should put a lawsuit over the date on hold.

Judge Belatedly Denies States’ Request To Block Health Insurance Tax

Two weeks after the IRS collected an Obamacare tax from Medicaid managed care plans, a federal judge denied a request from six GOP-led states that sought to bar the collection of that tax.

Azar Touts Upcoming Work On Privacy For Substance Abuse Histories

HHS Secretary Alex Azar touted the agency's Regulatory Sprint to Coordinated Care on Wednesday (Oct. 17), including upcoming work on 42 CFR Part 2 privacy requirements, and the administration’s fall unified agenda indicates the Substance Abuse and Mental Health Services Administration intends to publish a proposed rule on the privacy requirements next year.

Gottlieb: FDA To Focus On Communicating Opioid Dosing, Potency

FDA wants to help health care providers better understand the different levels of potency across opioid medications, FDA Commissioner Scott Gottlieb said Thursday (Oct. 18).

Gottlieb: FDA To Implement Opioid Packaging Requirements 'Very Quickly'

FDA plans to “very quickly” begin implementing requirements that opioid makers package their drugs in unit-dose packaging to provide for shorter duration prescriptions, such as one or two days, agency commissioner Scott Gottlieb said Thursday (Oct. 18).

CMS Approves Medicaid Expansion In Virginia; Enrollment To Start Nov. 1

CMS has approved Virginia’s plan to expand Medicaid and the state will begin enrolling beneficiaries in the expansion population Nov. 1, with coverage taking effect in 2019, Gov. Ralph Northam (D) announced Thursday (Oct. 18).

FDA To Advise DHS On Risks Of Medical Device Cyber Vulnerabilities

FDA and the Department of Homeland Security (DHS) have agreed to formally work together to stave off cybersecurity threats facing medical devices.

Expert: FDA Needs 'Muscle Behind Its Words' To Curb Citizen Petition Abuse

Legal experts point to what they view as flaws in FDA's recently announced plan to alert the Federal Trade Commission (FTC) when brand-drug makers use the citizen petition process to delay generics from entering the market.

Device Lawyer Is Cautiously Optimistic About Revised Third-Party Reviews

A device industry lawyer expressed guarded confidence in a draft guidance FDA released last month that aims to revamp the agency’s 510(k) third-party review program, where qualified organizations review 510(k) submissions for certain low-risk devices.