News & Analysis as of

Medical Research Centers for Medicare & Medicaid Services

Developments in Regenerative Medicine: FDA Announces Plans to Clarify Its Oversight of Cellular Therapy Products and Approves...

by Holland & Knight LLP on

FDA Commissioner Scott Gottlieb, on Aug. 28, 2017, announced steps the agency is taking to begin rolling out policies and guidance documents to clarify its oversight over regenerative medicine products. Dr. Gottlieb...more

OIG Approves Cost-Sharing Arrangement Involving Clinical Research Study

by Baker Ober Health Law on

The U.S. Department of Health and Human Services, Office of the Inspector General (OIG), issued a favorable advisory opinion, No. 17-02, regarding a proposed arrangement under which the cost-sharing amounts owed by...more

2017 Omnibus Agreement: Key Health Provisions

by Polsinelli on

Congress has completed action on H.R. 244, the “Consolidated Appropriations Act for FY 2017” [P. L. 115-31]. This bipartisan legislation, which funds the Federal government for the balance of the fiscal year, passed the House...more

21st Century Cures Act Provides Some Welcome Relief

by Foley & Lardner LLP on

The 21st Century Cures Act (the “Cures Act”) (Pub. L. No. 114-255), which was signed into law by President Obama on December 13, 2016, includes a number of important health care provisions, and several address the...more

Reducing the Delay Between FDA Approval and CMS Reimbursement Coverage

by Knobbe Martens on

The Centers for Medicare & Medicaid Services (CMS) recently confirmed that the Parallel Review program (first announced in 2010 and most recently extended until December 18, 2015) will be made permanent. ...more

Washington Healthcare Update

by McGuireWoods LLP on

This Week: Obamacare repeal passes Senate and goes to the House... Tax extenders still under development... Focus on drug pricing continues... Congress looks to create an omnibus appropriations bill to fund the government by...more

CMS Open Payment Program Data Indicates $6.49 Billion Paid by Manufacturers, GPOs to Physicians and Hospitals in 2014

by King & Spalding on

CMS recently released data collected through the Open Payments Program in accordance with the Affordable Care Act from applicable manufacturers and group purchasing organizations (GPOs) about payments and other transfers that...more

Health Care E-Note - April 2015

by Burr & Forman on

In This Issue: - New Smartphone Software Provides Groundbreaking Opportunity for Medical Research - The Many Levels of Supervision - Health Care Business Today: A Historical Perspective on Health Care...more

Washington Healthcare Update

by McGuireWoods LLP on

This Week: House Approves FY 2016 Budget Proposal... House Passes Permanent SGR Reform and Two-Year CHIP Reauthorization... Senate Passes FY 2016 Budget Plan... HHS Report: ACA Led to $7.4 Billion Decline in Uncompensated...more

Is CMS Feeling the Sunshine Heat? – Part 2

by Cooley LLP on

As follow-up to our recent post on the issues that the Centers for Medicare & Medicaid Services (CMS) is experiencing with its Open Payments database, there is new information that additional data also may be excluded when...more

Academic Medical Centers: Clinical Care, Research and Teaching (or Maybe Not?)—Graduate Medical Education and the Future

by BakerHostetler on

In the world of healthcare policy and law, we usually discuss issues impacting providers, but don’t often report about the training and infrastructure behind what allows our healthcare system to treat patients in our...more

OIG Releases Report on Questionable Billing for Sleep Studies; CMS to Take Action

by Foley & Lardner LLP on

The Office of the Inspector General (OIG) released a report earlier this month on Medicare spending on polysomnography (sleep studies to diagnose and guide treatment for conditions such as sleep apnea), which indicated that...more

Proposed Medicare Cuts Would Significantly Impact Independent Laboratories

Last week, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule setting forth revisions to payment policies under the Medicare Physician Fee Schedule (MPFS) and other revisions to Medicare Part B for...more

Physician Payment Sunshine Rule is Finalized

by Baker Donelson on

The Final Rule implementing the Physician Payment Sunshine Act was announced on February 1st and published in the Federal Register on February 8th. The Final Rule establishes procedures for drug and device manufacturers to...more

CMS Issues Final Rule for Implementing Sunshine Act

On February 8, 2013, 16 months after the statutory deadline, the Centers for Medicare & Medicaid Services (CMS) published in the Federal Register the final regulation implementing the physician payment transparency...more

CMS Issues Final Rule to Implement Physician Payments Sunshine Act

by King & Spalding on

On Friday, February 1, 2013, the Centers for Medicare and Medicaid Services (CMS) released the highly anticipated final rule to implement the federal Physician Payments Sunshine Act (the “Sunshine Act”). The final rule will...more

CMS Issues Final Physician Payment Sunshine Rule

by Holland & Knight LLP on

In an action that will have broad implications for drug and device manufacturers, researchers, distributors, teaching hospitals and physicians, on February 1, the Centers for Medicare and Medicaid Services (CMS) publicly...more

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