House members introduce companion medical device tax repeal bill

medical device taxA quartet of U.S. representatives today introduced a companion bill to a Senate measure that would do away with the medical device tax altogether.

The 2.3% levy on U.S. medical device sales went into effect in 2013 but was only in place for two years before Congress put a moratorium in place. When that ended in January 2018, a second moratorium was enacted that’s due to expire at the end of this year. In 2018, the U.S. House of Representatives passed a bill to repeal the tax 283-132, but the Senate failed to act.

Last month Democratic presidential candidate Sen. Amy Klobuchar (D-Minn.) and Sen. Pat Toomey (R-Penn.) reintroduced a bill to permanently repeal the excise tax on medical device sales. Today, Reps. Ron Kind (D-Wis.), Jackie Walorski (R-Ind.), Scott Peters (D-Calif.), and Richard Hudson (R-N.C.) introduced a companion measure in the lower chamber, also called the Protect Medical Innovation Act.

In a February letter seeking to drum up co-sponsors, Kind called the 2.3% excise tax “extremely punitive to medical technology investors,” and said that since its inception there has been “growing bipartisan support” to end it. He must have been persuasive, as the H.R. 2207 bill introduced today enjoys 227 co-sponsors from both sides of the aisle, according to a press release.

“Medical devices and new technologies improve the lives and health of millions of Americans every year. Given that this tax applies to revenues – not profits – it is extremely punitive to medical technology innovators. It’s time we permanently repeal this outdated tax on innovation, and support jobs and well-being across the country,” Kind said in prepared remarks.

“The medical device tax would limit patient access to lifesaving technologies and put countless jobs at risk in northern Indiana, where Hoosiers are proud to be leaders in innovation and manufacturing. It’s time to end this job-killing tax once and for all. Permanently repealing the medical device tax will boost American manufacturing, support good-paying jobs, encourage research and innovation, and protect patients who depend on these products. The Protect Medical Innovation Act has broad, bipartisan support in Congress, and I hope we will vote on this bill without delay,” Walorski added.

CardioFocus chairman Paul LaViolette, who is also chairman of the Medical Device Manufacturers Assn., said the group has been working on killing the tax for a decade.

“MDMA continues the tireless work we began in 2009 with the numerous stakeholders who recognize how important it is that the United States leads the world in medical technology innovation, and repealing the medical device tax is a critical part of achieving this common goal,” LaViolette said in a statement. “MDMA thanks Congressman Kind and Congresswoman Walorski for building a broad bipartisan coalition of 227 original cosponsors who are committed to repealing the medical device tax. The harm this policy caused when it was in place is well known, and we cannot allow the device tax to divert one more dollar away from research and development into the cures and therapies of tomorrow or to destroy one more job.”

Medtech reporting would change under new opioid law

A section of the recently-passed bill to address the opioid crisis could have implications for medtech.

The 250-page Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT for Patients and Communities Act) contains a provision that would require manufacturers of certain medical devices, drugs and biologics covered by Medicare, Medicaid, or the Children’s Health Insurance Program to report payments or other transfers of value made to “covered recipients.”

“Covered recipients,” as originally written in the sunshine provision of the Affordable Care Act, were only physicians and teaching hospitals. Section 6111 of SUPPORT would expand that to include physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists and certified nurse-midwives as of January 1, 2022. Also known as H.R. 6, the bill has passed both houses of Congress and is awaiting President Trump’s signature.

The reporting changes needn’t have anything to do with opioids, and this provision’s effective date is ambiguous, according to an FDA law blog post by the Washington, D.C. law firm Hyman, Phelps & McNamara. Stay tuned for CMS to clear this up in forthcoming regulations.






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