POLICY BRIEFINGS


Opioid Bill Signed into Law


President Trump has signed H.R. 6, the SUPPORT for Patients and Communities Act, into law. H.R. 6 is a bipartisan, comprehensive legislative package aimed at curbing the opioid crisis. HHS Secretary Alex Azar stated last week that the number of drug overdose deaths has plateaued after reaching a record high last year, citing preliminary statistics from the Centers for Disease Control and Prevention (CDC). “We are so far from the end of the epidemic, but we are, perhaps, at the end of the beginning,” Azar stated, cautioning that drug overdoses are not declining, but rather are increasing at a slower rate than previously observed. He credited federal, state, and local government efforts for the progress.

Sens. Elizabeth Warren (D-Mass.) and Patty Murray (D-Wash.) highlighted a report last week which they argue demonstrates that the administration has taken almost no meaningful action in response to the opioid epidemic. The Government Accountability Office (GAO) report details the three emergency authorities used by the Trump Administration related to the opioid crisis: one to assess prescribing trends for a medication used to treat opioid use disorder and the barriers to prescribing it, one to speed the development and approval of state pilot programs related to substance-use disorder (SUD) treatment, and one to expedite research on opioid use disorder treatments and the dissemination of information on opioid misuse and addiction. The GAO identifies 14 other authorities that became available as a result of the declaration of a public health emergency that have not been used by the administration.

The Department of Justice (DOJ) has also announced the creation of the Appalachian Regional Prescription Opioid (ARPO) Strike Force. The strike force will combine federal and state enforcement resources with a focus on stopping illegal opioid prescriptions. It will include representatives from the FBI, DOJ, HHS Office of Inspector General (OIG), and the Drug Enforcement Administration (DEA). Strike Force prosecutors can pursue both narcotics violations as well as medical necessity cases.


Grassley Questions NIH Vetting Process


Senate Judiciary Committee Chairman Chuck Grassley (R-Iowa) has written to the Director of the National Institutes of Health (NIH) Francis Collins regarding the vetting process for foreign researchers. According to Grassley, the NIH is investigating cases in which researchers who received federal grants may not have disclosed financial contributions from foreign governments. “Congress requires a better understanding of these processes and the steps NIH has taken to ensure their integrity,” Grassley writes. He asks for a description of the process by which NIH conducts background checks of researchers and institutions prior to awarding NIH grants.


Lawmakers Comment on ACO Rule Changes


A bipartisan group of lawmakers have written to CMS requesting changes to the agency’s latest rule on the Medicare Shared Savings Program (MSSP). The letter outlines concerns that the new rule will negatively impact the ability of accountable care organizations (ACOs) to participate in the program. The rule would reduce the amount of time organizations can spend in upside-only risk models from six years to two years and decrease the shared savings rate from 50 percent to as low as 25 percent. The letter was signed by Reps. Diane Black (R-Tenn.), Suzan DelBene (D-Wash.), Gene Green (D-Texas), Tom Reed (R-N.Y.), Roger Marshall (R-Kansas), Peter Welch (D-Vt.), David Roe (R-Tenn.), Greg Gianforte (R-Mont.), and Brad Wenstrup (R-Ohio).


Hatch Considers Policing of Online Drug Sales


Senate Finance Committee Chairman Orrin Hatch (R-Utah) has written to two drug safety nonprofits asking for help in curbing the sale of counterfeit online prescriptions. In letters to the Alliance for Safe Online Pharmacies and the Pharmaceutical Security Institute, Sen. Hatch requests details about how the organizations respond when fraudulent medicines are identified.


Paulsen, DelBene Seek to Increase Access to CAR T Therapy


Reps. Erik Paulsen (R-Minn.) and Suzan DelBene (D-Wash.) are circulating a sign-on letter among their colleagues asking CMS to create a technical expert panel (TEP) to determine a sustainable way to reimburse for chimeric antigen receptor (CAR) Tcell therapies in the inpatient and cancer hospital setting. CAR T therapies are currently used in the treatment of relapsed and refractory cancers, but the inadequacy of current Medicare reimbursement threatens to limit seniors’ access to such treatment. The lawmakers recommend that CMS establish a TEP to develop unique payment options to ensure greater Medicare beneficiary access to CAR T therapies.


Pelosi Pitches Idea of Transitional Speakership


House Minority Leader Nancy Pelosi (D-Calif.) is floating the idea of a transitional speakership should Democrats win the House in next month’s midterm election. Pelosi would serve as Speaker of the House until the end of next Congress, giving the party more time to choose a successor to be the next Democratic leader. Pelosi has led House Democrats since 2003. Although there is no clear rival to challenge Pelosi, her transition pitch has been met with a mixed reaction among younger members of the party seeking fresh leadership. Democratic leadership elections will take place at the end of November, with a formal vote for Speaker of the House slated for early January.


Upcoming Congressional Hearings and Meetings


Senate Health, Education, Labor, and Pensions Committee hearing “Reducing Health Care Costs: Improving Affordability through Innovation”; 10:00 a.m., 430 Dirksen Bldg.; November 28



October 29, 2018: | Page 1 Page 2

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