Reporting Requirements Medical Devices

News & Analysis as of

Connecticut Legislature Reduces Mandatory Reporting of Payments to APRNs

On May 11, 2015, Connecticut Governor Dannel P. Malloy signed into law Public Act 15-4, “An Act Concerning Reporting of Payments by Manufacturers to Independently-Practicing Advanced Practice Registered Nurses” (P.A. 15-4)....more

Blog: Connecticut Delays Payment Reporting Until 2017

Under a Connecticut law enacted in 2014, pharmaceutical and medical device manufacturers were required to begin reporting payments made to advanced practice registered nurses (APRNs) on July 1, 2015. ...more

Blog: Vermont AG Announces Another Disclosure Law Enforcement Action

the Vermont Office of the Attorney General (“VT AG”) previously published several enforcement actions taken against manufacturers of pharmaceutical, biological and medical devices for failing to comply with the state’s...more

Potentially Burdensome Reporting Obligations Ahead for Industry Interactions with APRNs in Connecticut

The Connecticut Department of Consumer Protection (Department) recently released its Expenditure Disclosure Form for manufacturers subject to section 75 of Public Act 14-217, which requires manufacturers of a covered drug,...more

CMS Publishes Guidance Regarding Reporting CME Payments Under Open Payments

On Monday, December 15, 2014, CMS published guidance regarding pharmaceutical and medical device manufacturers’ obligations under the Open Payments requirements to report payments they provide indirectly to U.S. physicians in...more

CMS Changes Sunshine Rules for CME, Revises List of Data Elements to be Reported

The Centers for Medicare & Medicaid Services (CMS) published a final rule with comment period addressing, among other issues, changes to the reporting and data collection requirements imposed upon “applicable manufacturers”...more

CME Payments Largely Remain Excluded From Sunshine Act Reporting

The Centers for Medicare & Medicaid Services (“CMS”) has finalized changes to a number of reporting requirements under the regulations implementing the Physician Payments Sunshine Act (“Final Rule”). When CMS proposed...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 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

FDA Issues Final Rule Requiring Electronic MDR Reporting

On February 14, 2014, the U.S. Food and Drug Administration (FDA or “the Agency”) issued a final rule titled Medical Device Reporting: Electronic Submission Requirements that will require medical device manufacturers and...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

Data Collection Under The Sunshine Act

Data collection requirements under the Physician Payment Sunshine Act commenced August 1, 2013. This provision of the Patient Protection and Affordable Care Act and the corresponding regulations require an entity that is...more

FDA Issues Draft Guidance on Medical Device Reporting for Manufacturers

On July 9, 2013, the FDA issued a draft guidance document titled “Medical Device Reporting for Manufacturers.” Written in a question and answer format, the draft guidance provides the FDA’s current views on the FDA’s medical...more

FDA Releases Draft Guidance on Medical Device Reporting - Will Supersede 1997 Guidance

On July 9, 2013, the U.S. Food and Drug Administration (FDA or “the Agency”) released a draft guidance document titled Medical Device Reporting for Manufacturers (hereinafter “Draft Guidance”). FDA has not updated its formal...more

FDA Issues New Medical Device Reporting Guidance

Device manufacturers should be aware of new issues and policy changes, which include the removal of the "two-year rule" for malfunctions. On July 9, the U.S. Food and Drug Administration (FDA) issued a new draft...more

FDA’s Medical Device “Enhancement” Reporting Has Potential Product Liability Implications

The U.S. Food and Drug Administration (FDA) recently issued a draft guidance document that could potentially require medical device manufacturers to report a wide variety of device improvements, ranging from routine updates...more

Getting Ready For The Physician Payment ‘Sunshine’ Rule

Originally Published in BNA Bloomberg, Medical Devices Law & Industry Report on March 20, 2013. On February 1, 2013, the Centers for Medicare and Medicaid Services (CMS) published the long-awaited final regulations for...more

Final Sunshine Act Arrives: Now the Hard Part

The Centers for Medicare and Medicaid Services (CMS) issued the final regulations on the U.S. Sunshine Act on February 8, 2013. Transparency Reports and Reporting of Physician Ownership or Investment Interests, 78 Fed. Reg....more

FDA Issues Draft Guidance on Medical Device Recalls - How to Distinguish Recalls from Product Enhancements

On February 22, 2013, the U.S. Food and Drug Administration (FDA) released a long-anticipated draft guidance document entitled Distinguishing Medical Device Recalls from Product Enhancements; Reporting Requirements. With the...more

CMS Issues Final Physician Payment Sunshine Act Regulations

On February 1, 2013, the Centers for Medicare and Medicaid Services (CMS) published the long-awaited final regulations implementing the Physician Payment Sunshine Act (Act or Sunshine Act). The Sunshine Act requires drug,...more

Physician Payment Sunshine Rule Finalized; Let The Sun Shine In; Payment Reports Flow

The Centers for Medicare and Medicaid Services (CMS) recently published the final rule implementing the Physician Payment Sunshine Act (Sunshine Act) that requires most manufacturers of drugs, devices, biologics or medical...more

CMS Publishes Final Sunshine Act Rule; Data Collection to Begin on August 1, 2013

The long-awaited final rule (the Final Rule) implementing the Physician Payments Sunshine Act (Sunshine Act) has arrived at the Federal Register. It amends key definitions and adds new terms; retains broad reporting...more

CMS Issues Final Physician Payment Sunshine Rule

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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