News & Analysis as of

Healthcare PHSA

Cooley LLP

Blog: White House Declares Opioid “Public Health Emergency” However, Many Questions Remain

Cooley LLP on

Last week, the White House declared the opioid crisis a “public health emergency.” The declaration outlined a number of steps the Administration will take to address the epidemic. The public health emergency declaration,...more

BakerHostetler

D.C. District Court Deals Blow to HHS 340B Program Interpretive Rule

BakerHostetler on

Court says Congress has the power to make the change that HHS attempted with its Interpretive Rule, and thus it should be left to the legislative branch. A lawsuit challenging the Interpretive Rule, filed by the...more

K&L Gates LLP

HRSA Issues 340B Program Omnibus Guidance

K&L Gates LLP on

On August 28, 2015, the Health Resources and Services Administration (“HRSA”) published proposed Omnibus Guidance (the “Proposed Guidance”) governing policies related to section 340B of the Public Health Service Act (“PHSA”),...more

Franczek P.C.

Departments Issue FAQs on Cost-Sharing and Restated Enforcement Approach on Provider Nondiscrimination Rules under ACA

Franczek P.C. on

The Departments issued FAQs clarifying prior guidance on the ACA’s cost-sharing limitations applicable to non-grandfathered plans, and restating their enforcement approach with respect to the ACA’s provider nondiscrimination...more

King & Spalding

CMS Issues Guidance on Reimbursement for Biosimilars under Medicare and Medicaid

King & Spalding on

Biosimilars Are Generally Treated as Single Source Drugs - On March 30, 2015, in the wake of the first biosimilar product licensed by the Food and Drug Administration (FDA), the Centers for Medicare & Medicaid Services...more

Mintz - ML Strategies

Telehealth, Health IT, and mHealth Policy: Considerations for Stakeholders

Mintz - ML Strategies on

In recent months, as the conversation about reforming the health care system has shifted from websites and coverage expansion to achieving greater delivery system efficiencies, cost containment, and quality improvement, the...more

Mintz - ML Strategies

Telehealth and Health IT Policy: Considerations for Stakeholders

Mintz - ML Strategies on

In recent months, as the conversation about reforming the health care system has shifted to achieving greater delivery system efficiencies, cost containment, and patient satisfaction, the role of health care...more

Mintz - Employment, Labor & Benefits...

The Affordable Care Act—Countdown to Compliance for Employers, Week 26: Fitting a Round Peg (the Public Health Service Act 90-day...

The Departments of the Treasury/IRS, Labor and Health and Human Services (the “Departments”) recently issued a final regulation under the 90-day waiting period limitation, which is included among the Affordable Care Act’s...more

McDermott Will & Emery

HHS Guidance Clarifies that Insurance Companies Must Make Available Health Insurance Coverage for Same-Sex Spouses

On March 14, 2014, the Department of Health and Human Services (HHS) Centers for Medicare & Medicaid Services (CMS) released guidance clarifying the final regulations implementing Section 2702 of the Public Health Service Act...more

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