News & Analysis as of

FDA Approves Cancer Screening Test as First Device Under Parallel Review Pilot

On August 11, 2014, the Food and Drug Administration (FDA) issued a premarket approval (PMA) for Exact Sciences’ Cologuard, a colorectal cancer screening test, and the Centers for Medicare & Medicaid Services (CMS) issued a...more

FDA to Strengthen Oversight of Certain In Vitro Diagnostic Devices

In the wake of a new Medicare reimbursement framework, FDA plans stricter regulation of some in vitro diagnostic devices. On July 31, 2014, the U.S. Food and Drug Administration (FDA; Agency) announced its intent to...more

CMS Shuts Down Sunshine Act Online Verification Process

On August 7, 2014, the Centers for Medicare & Medicaid Services (CMS) announced that the Open Payments system is “temporarily” off-line. The CMS announcement did not state when the Open Payments system would be back on-line....more

Health Care: As Sunshine Act Deadlines Approach Physicians and Hospitals Should Prepare for Transparency in Their Financial...

On September 30, 2014, in accordance with the Federal Sunshine Act (the Sunshine Act), the Centers for Medicare and Medicaid Services (CMS) will publically disclose payments and "other transfers of value" by pharmaceutical,...more

Teaching Hospitals and Physicians Must Take Action Now to Correct Erroneous Reports about them Submitted Under the Sunshine Act

On September 1, 2014, the Centers for Medicare and Medicaid Services (CMS) will make public the reports submitted by pharmaceutical and medical device manufacturers under the Sunshine Act. These reports will disclose...more

You Are Now on the Clock — Sunshine Act Dispute Window Now Open

Beginning Monday, July 14, 2014, the review, dispute and correction process outlined the National Physician Payment Transparency Program (also known as the "Sunshine Act") opens on CMS's Open Payments website. Physicians and...more

CMS Releases New Resources, Schedules Teleconference for Sunshine Review and Dispute Process

As we informed you last week, the Open Payments review, dispute and correction process started today and will continue through September 11, 2014. This is the process that allows physicians and teaching hospitals to review...more

CMS Wants To Shine Light On CME Payments To Physicians

It’s a question CMS has been wrestling with since the enactment of the Sunshine Act (sometimes called the Open Payments Program) as part of the Affordable Care Act. The Sunshine Act generally requires a manufacturer to...more

CMS Proposes Changes to Sunshine Act Reporting

Drug and device manufacturers breathing a sigh of relief after completing their 2013 data submissions under the Physician Payment Sunshine Act (the “Sunshine Act’) must now contend with four proposed changes to the Sunshine...more

Applicable Manufacturers Face June 30th Deadline for Sunshine Act Reporting

CMS will begin to enforce what could be significant penalties on manufacturers who fail to report required data. The Centers for Medicare & Medicaid Services (CMS) has announced a short timeframe before detailed...more

Cloudy Skies Ahead for Providers? CMS’ Release of Medicare Billing Data Combined with Physician Payment Sunshine Act Data May...

In February 2013, we reported (on our Healthcare Law Blog) that the Centers for Medicare and Medicaid Services (CMS) announced the final rule for the Physician Payments Sunshine Act. In the interest of providing more...more

CMS's Focus on DMEPOS Fraud and Abuse Risks Continues

The focus by the Centers for Medicare & Medicaid Services (CMS) on Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) as an area rife with unnecessary utilization and a high improper payment rates...more

Regulating Point of Care Diagnostics

Personalized medicine relies on diagnostic medicine to identify the best therapy for the patient at the right time. Tests that match a therapy to the patient fall into one of two categories. In vitro diagnostic devices or...more

Health Headlines: Also in the News - May 2014

CMS Releases Proposed Rule on Prior Authorizations for DMEPOS Items – On May 22, 2014, CMS released a Proposed Rule setting out a prior authorization process for certain types durable medical equipment, prosthetics,...more

Health Care Reform Implementation Update - May 2014

Congress held several hearings last week ranging from Sylvia Burwell’s nomination for Secretary of the Department of Health and Human Services (HHS), to Medicare payment oversight, to post-acute care in Medicare. The Centers...more

Sunshine Act/Open Payments Alert

On Monday, May 5, 2014, CMS published in the Federal Register an unexpected notice seeking additional public comment specifically around the Dispute Resolution process, which is the process CMS is establishing to give...more

CMS To Publish Financial Relationships Between Physicians and Drug Manufacturers Beginning September 2014

Beginning in September 2014, the Centers for Medicare and Medicaid Services (“CMS”) will publish a list of all payments and transfers of value paid by drug manufacturers to physicians and teaching hospitals on a publicly...more

CMS Releases Physician Medicare Billing Data

The U.S. Department of Health and Human Services (HHS) announced on April 9th a “historic” release of Medicare payment data to provide consumers with “unprecedented transparency on the medical services physicians provide and...more

Chance to Comment on Future of DMEPOS Payments

CMS recently took the unusual step of issuing an Advance Notice of Proposed Rulemaking (ANPR) regarding changes to Medicare payment methodologies for durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS)...more

DMEPOS Competitive Bidding Program: CMS Begins to Move Toward Nationwide Implementation and Seeks Public Comments Regarding...

The Centers for Medicare & Medicaid Services ("CMS") recently announced that the agency is seeking public comments as it moves toward nationwide implementation of the Medicare Durable Equipment, Prosthetics, Orthotics, and...more

More Open Questions About Open Payments Under the Sunshine Act

Last week, the Centers for Medicare & Medicaid Services (“CMS”) clouded the process for pharmaceutical and medical device manufacturers, and group purchasing organizations (“GPOs”), to register and submit reports under the...more

Capital Thinking: Health Care

LEGISLATIVE ACTIVITY - This Week’s Hearings: - Wednesday, January 15: The House Committee on Veterans’ Affairs will hold a hearing titled “Vendors in the OR- VA’s Failed Oversight of Surgical Implants.” The House...more

Joint Commission Standards Updates for 2014

For 2014, the Joint Commission approved standards changes for hospitals, critical access hospitals, and others concerning medication management and provision of diagnostic imaging services. The Joint Commission also revised...more

Physician Groups Seek Sunshine Act Changes

Seventy-four state and federal physician organizations, including the American Medical Association, recently asked the Centers for Medicare & Medicaid Services (“CMS”) to exclude textbooks and peer-reviewed medical journal...more

10 Tips for Medical Technology Companies

The Centers for Medicare & Medicaid Services (CMS) has initiated a new review process of existing national coverage determinations (NCDs). This new process is designed to retire old policies and may present increased risks to...more

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