[Editor’s note: Check out Medtech Insight’s US Congress Tracker for a comprehensive look at the details and status of all medtech-related legislation that has been introduced in the current congressional session.]
The US Senate passed a bill this week to address the opioid crisis with an overwhelming 99-1 margin, but one provision in the legislation that would expand disclosure requirements under the Physician Payment Sunshine Act is causing concern among device companies.
The device sector generally supports the "Opioid Crisis Response Act" (S. 2680). It includes a range of reforms intended to attack the opioid problem and to help spur approvals of new pain-control alternatives, including new medical devices.
The House passed a similar package of 24 opioid crisis response bills on June 22, H.R. 6,, but the combined package, the “Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) Act,” did not include a provision expanding Open Payments reporting requirements.
“The goal of the reporting provision is to curb opioid prescribing, and medical devices are wholly separate from pioids, which are a pharmaceutical product," AdvaMed CEO Scott Whitaker says.
The provision Senators approved Sept. 17 would make changes to the US Centers for Medicare and Medicaid Services (CMS) Open Payments program that was created by the Sunshine Act. Specifically, it would expand the payments or other transfers of value that drug and device manufacturers must track and publicly disclose on the Open Payments database to include a broader group of health-care professionals.
Currently, device, and drug, firms need only report qualifying "transfers of value" made to physicians and teaching hospitals, but the Senate provision would add physician assistants, nurse practitioners, clinical nurse specialists, and certified nurse midwives to that list. "Transfers of value" means anything that a drug or device manufacturer provides, from meals and accommodations at medical conferences to stock options, research payments, speaker fees, consulting payments, entertainment or even coffee and donuts, above certain minimums. (Also see "Open Payments: Zimmer, Medtronic Top List Of Spenders" - Medtech Insight, 16 Jul, 2018.)
The provision is presumably focused primarily on tracking financial tie-ins between opioid prescribers and manufacturers. AdvaMed CEO Scott Whitaker says devices should not be included in this section.
“The goal of the provision is to curb opioid prescribing, and medical devices are wholly separate from opioids, which are a pharmaceutical product,” Whitaker pointed out.
“While we support the existing Sunshine law, we do not believe this provision will provide the public with meaningful information, and device companies will bear a significant compliance burden,” Whitaker added.
Reducing Barriers To Opioid Alternatives, Expediting Device Substitutes
Among the many industry-supported provisions that the Senate approved Sept 17 is a section clarifying and expediting FDA’s approvals for non-addictive and non-opioid pain control products, including devices. Section 1301 requires the agency to hold one or more public meetings on challenges and barriers to developing alternative devices and treatments for pain, and it authorizes use of expedited pathways like the Breakthrough Device pathway, to hasten approvals for the products.
The section is mirrored in a House Energy and Commerce Committee “21stCentury Tools for Pain and Addiction” bill, H.R. 5806, sponsored by Rep. Michael Burgess, R-Texas, that was passed by the committee May 17, and is likely to be incorporated into an overall conference committee on both chambers’ opioids legislation packages. (Also see "Bills Supporting Device Opioid Alternatives Advance In House" - Medtech Insight, 18 May, 2018.)
The provisions align with efforts already ongoing at US FDA. The agency issued an "innovation challenge" in May to medical device companies to accelerate the development of new pain control products to serve as alternatives to opioids, or to hasten approval for addiction treatment technologies, by submitting ideas to the agency for such products by Sept. 30. (Also see "FDA Issues Challenge To Medtech To Fight Opioid Crisis" - Medtech Insight, 31 May, 2018.)
“This innovation challenge is an example of FDA’s commitment to an all-of-the-above approach to confront the opioid epidemic,” said FDA Commissioner Scott Gottlieb in early May. “We hope to accelerate development of new technologies, whether a device, diagnostic test, mobile medical app, or even new clinical decision support software, to reduce the scope of this crisis.”
Also in the House package of opioid bills, H.R. 6, are several other pieces of legislation matching the Senate bill, including H.R. 5197, introduced by Rep. Bill Pascrell, D-N.J., H.R. 5775, introduced by Rep. Erik Paulsen, D-Minn., and H.R. 5590, sponsored by Rep. Adam Kinzinger (see descriptions below).
For example, a provision cleared by the Senate in its comprehensive opioids bill calls on the Department of Health and Human Services to provide technical assistance to hospitals and a grant program to support management of patients’ pain with device and drug alternatives to opioids. That section is matched by H.R. 5197, the bill sponsored by Reps. Pascrell, and David McKinley, R-W.Va., and was approved by the House on June 12. (Also see "Bills Calling For Non-Pharma Alternatives To Opioids Clear US House" - Medtech Insight, 22 Jun, 2018.)
Senate Package Matches House Opioids Action Plan, Enhanced Telehealth Use
The Senate also approved a section in its opioid bill that calls on federal government agencies including CMS and the National Institutes of Health to expedite research on device and drug alternatives for patient pain management. That is mirrored by the Kinzinger bill, H.R. 5590, and called,“Opioid Addiction Action Plan Act,” which passed the House on June 19.
The Paulsen bill, H.R. 5775, requires Medicare and Medicare Advantage prescription drug plan sponsors to notify beneficiaries about alternatives to use of opioids, including pain control devices and non-opioid pharmaceuticals. It appears in the Senate bill as “Medicare opioid safety education” for Medicare beneficiaries.
And another measure in the House, sponsored by Reps. Doris Matsui, D-Calif., and Bill Johnson, R-Ohio, H.R. 5603, instructs CMS to support and further evaluate use of telehealth services in treating patients with substance-use disorders. That bill is mirrored in the Senate opioid response package by Section 2102, which calls for “expanding the use of telehealth services for treatment of opioid use disorders. It is also expected to be considered by House and Senate conferees."
Sen. Lamar Alexander, R-Tenn., who sponsored the Senate opioid response package, said that he and House leaders are already working out compromises between the House and Senate versions. “We are already working to combine the Senate and House-passed bills into an even stronger law to fight the nation’s worst public health crisis, and there is a bipartisan sense of urgency to send the bill to the president quickly,” he said Sept. 17.
From the editors of The Gray Sheet