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Second Opinion

Learn about policy issues important to medical schools and teaching hospitals, with Executive Vice President Atul Grover, M.D., Ph.D.

House and Senate to go to Conference on Tax Reform

December 7, 2017—While committee staff works to resolve the differences between the House and Senate passed tax bills, party leadership in both the House and Senate have announced their selections for the Tax Cuts and Jobs Act Conference Committee.

The AAMC co-signed a Dec. 6 community letter of organizations impacted by the changes to private activity bonds (PABs) advocating that the conference committee maintain the tax exemption of PABs. The AAMC is also finalizing a letter that will be sent to conferees outlining our specific concerns.

The AAMC continues to advocate that conferees:

  • Reject the new excise tax based on investment income of private colleges and universities,
  • Reject the repeal of advance refunding bonds,
  • Reject the repeal of the tax exemption of PABs,
  • Reject the repeal of various student benefits, including the Lifetime Learning Credit, the Student Loan Interest Deduction, the qualified tuition reduction, and educational assistance,
  • Reject the excise tax on compensation for certain employees at tax-exempt organizations, and
  • Reject the repeal of the individual mandate as included in the Affordable Care Act (ACA).

House Speaker Paul Ryan (R-Wis.) Dec. 6 announced the House Republicans selected to negotiate the final package on tax reform. These members include:

  • From the House Committee on Ways and Means,

  • Chair Kevin Brady (R-Texas) who will chair the entire conference committee,
  • Devin Nunes (R-Calif.),
  • Peter Roskam (R-Ill.),
  • Diane Black (R-Tenn.), and 
  • Kristi Noem (R-S.D.)
  • From the House Committee on Natural Resources,
  • Chair Rob Bishop (R-Utah.), and
  • Don Young (R-Alaska)
  • From the House Energy and Commerce Committee,
  • Fred Upton (R-Mich.), and
  • John Shimkus (R-Ill.)

Democratic Leader Nancy Pelosi (D-Calif.) Dec. 5 appointed the following members to the conference committee:

  • From the House Committee on Ways and Means,
  • Ranking Member Richard Neal (D-Mass.),
  • Sander Levin (D-Mich.), and
  • Lloyd Doggett (D-Texas)
  • From the House Committee on Natural Resources,
  • Raúl Grijalva (D-Ariz.)
  • From the House Committee on Energy and Commerce
  • Kathy Castor (D-Fla.)

Senate Majority Leader Mitch McConnell Dec. 6 announced Senate Republican conferees:

  • Orrin Hatch (R-Utah), chair of the Senate Finance Committee,
  • Mike Enzi (R-Wyo.), chair of the Senate Budget Committee,
  • Lisa Murkowski (R-Alaska), chair of the Senate Energy and Natural Resources Committee,
  • John Cornyn (R-Texas),
  • John Thune (R-S.D.)
  • Rob Portman (R-Ohio)
  • Tim Scott (R-S.C.)
  • Pat Toomey (R-Pa.)

At the time of this publication, Senate Democrats had not yet named their conferees.

The two chambers will now meet to reconcile the differences between the House- and Senate-passed versions of H.R. 1, the Tax Cuts and Jobs Act (see Washington Highlights, Dec. 1).  A date for the conference committee to meet has not yet been scheduled.

Contact:

Catie Spivey, JD
Sr. Legislative Analyst, Gov't Relations
Telephone: 202-862-6042
Email: cspivey@aamc.org

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Bipartisan Senate Letter Asks Leadership to Prevent Cuts to 340B

December 7, 2017—A bipartisan group of six senators sent a Dec. 5 letter to Senate Majority Leader Mitch McConnell (R-Ky.) and Minority Leader Chuck Schumer (D-N.Y.) to show support for the 340B Drug Pricing Program and urge the Senate to include legislation in a year-end package, which would prevent the Medicare payment cuts to hospitals that participate in the program.

The Centers for Medicare and Medicaid Services (CMS) Nov. 1 issued the Outpatient Prospective Payment System (OPPS) final rule that would dramatically reduce the payment rate for certain Medicare Part B drugs purchased through the 340B program from the average sales price (ASP) plus 6 percent to ASP minus 22.5 percent. CMS projects that this will result in an annual reduction of $1.6 billion [see Washington Highlights, Nov. 3].

Sens. John Thune (R-S.D.), Rob Portman (R-Ohio), Shelley Moore Capito (R-W.Va.), Bill Nelson (D-Fla.), Tammy Baldwin (D-Wisc.), and Debbie Stabenow (D-Mich.), sent the letter. They also led a “Dear Colleague” letter signed by 57 senators to express concern over the proposed regulation before it was finalized.

The Dec. 5 letter notes that the “340B program has been critical to supporting safety-net providers in helping low-income and vulnerable individuals across the country access affordable, comprehensive health care services for more than 25 years.” It continues, “With a January 1, 2018 start date and over half of the Senate and House of Representatives having expressed concerns with CMS’ rule, we request your help in ensuring the long-term sustainability of the 340B program by preventing these changes in an end of year package.”

In the House, Representatives David McKinley (R-W.Va.) and Mike Thompson (D-Calif.) have introduced legislation (H.R. 4392) that would prevent the cuts from being implemented [see Washington Highlights, Nov. 17]. The bill currently has nearly 100 cosponsors.

Contact:

Jason Kleinman
Sr. Legislative Analyst, Govt. Relations
Telephone: 202-903-0806
Email: jkleinman@aamc.org

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Spending Bill Negotiations Continue As CR Expiration Looms

December 7, 2017—House lawmakers Dec. 7 were expected to consider a spending measure (H.J.Res. 123) extending from Dec. 8 to Dec. 22 a continuing resolution (CR, P.L. 115-56) to keep the government operating. If enacted, the bill would carry forward all provisions from the previous CR, including a prohibition on any changes to support provided by the National Institutes of Health (NIH) for research facilities and administrative (F&A) costs.

The House Rules Committee advanced the measure Dec. 6 under a closed rule prohibiting changes to the CR. The committee’s approval came after postponing the hearing by a day, as members of the conservative House Freedom Caucus urged GOP leaders to use Dec. 30 as the expiration date for the CR instead of Dec. 22.

Instead, House leaders opted to keep the stopgap to two weeks, setting the stage for Congress to complete negotiations on a budget framework that would raise the caps on discretionary spending, followed by another CR into January to allow appropriators time to draft and finalize the 12 annual spending bills for FY 2018 under the revised caps.

House and Senate leaders in both parties were scheduled to meet with the president Dec. 7 to discuss such a budget deal, with Democrats pressing for any increases in the defense spending caps be matched by equal increases in nondefense spending. Democrats also are seeking a commitment to include a fix for individuals with Deferred Action for Childhood Arrivals (DACA) status as part of any year-end legislation, which Republican leaders have rebuffed.

Early Dec. 7, House Minority Leader Nancy Pelosi and other House Democrats were pledging to vote against the CR. Without support from the Democrats, House leaders would need members of the House Freedom Caucus to vote for the CR for it to advance to the Senate.

House Speaker Paul Ryan (R-Wis.) expressed confidence over the vote to reporters Dec. 7. Freedom Caucus members were softening their objections to the CR by Dec. 6, citing assurances that GOP leaders would not cut deals with Democrats when drafting the subsequent CR to extend government funding past Dec. 22. Press reports also suggested a potential movement to include full year appropriations for the Department of Defense to the expected Dec. 22 CR, a proposal that Leader Pelosi criticized as a nonstarter for Democrats.

Prospects for the CR also remain unclear in the Senate, where Republicans need at least eight Democrats to support the measure to send it to the president’s desk.

In addition to keeping the federal government open, the CR also includes a provision that would allow the administration to provide additional funding through Dec. 31, for certain states experiencing shortfalls in funding their Children’s Health Insurance Program (CHIP). Federal funding for CHIP expired Sept. 30, and Congress has yet to reauthorize funding for the program. Both chambers support a five year extension for CHIP funding.

Contact:

Tannaz Rasouli
Sr. Director, Public Policy & Strategic Outreach
Telephone: 202-828-0525
Email: trasouli@aamc.org

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HPNEC, AAMC Congressional Briefing on HRSA Workforce Programs

December 7, 2017—The Health Professions and Nursing Education Coalition (HPNEC), an AAMC-led group of over 60 national organizations, hosted a November 28 briefing titled How HRSA Workforce Programs Address Today’s Public Health Concerns: Opioids, Rural Access, Health Equity, and Preventive Medicine.

The event featured three panelists: Marianna Footo-Linz, PhD; Juanita Garcia, Med, RN, PhD(c); and Yalda Jabbarpour, MD, who spoke about their work with the Health Resources and Services Administration (HRSA) Title VII health professions and Title VIII nursing workforce diversity programs.
During the panel discussion, the participants detailed how Title VII and VIII grants funded programs at their institutions which enhanced the cultural competency of their trainees, increased access to health care for patients, addressed health inequities, and improved workforce diversity, increasing quality of care for the patients in their communities.

The panelists attributed partial success of their programs to funding from the Graduate Psychology Education, Behavioral Health Workforce Education and Training, Nursing Workforce Diversity, and Primary Care Training and Enhancement programs of Title VII and Title VIII.

As budget negotiations continue for FY 2018, HPNEC recommends $580 million for these workforce programs in order for them to continue their important work.

Contact:

Matthew Shick, JD
Director, Gov't Relations & Regulatory Affairs
Telephone: 202-862-6116
Email: mshick@aamc.org

Tyler Hanson, JD
Legislative Analyst II
Telephone: 202-862-6082
Email: thanson@aamc.org

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Senate VA Committee Approves VA Choice Reform Bill, Preserves Academic Affiliations

December 7, 2017—The Senate Committee on Veterans Affairs Sept. 29 approved the Caring for Our Veterans Act of 2017 (S. 2193), sending the measure to the full Senate for consideration. The sole “no” vote during the mark up came from Sen. Jerry Moran (R-Kansas), who later introduced the Veterans Community Care and Access Act of 2017 (S. 2184) with Sen. John McCain (R-Ariz.). It would incorporate different veteran eligibility criteria for accessing community care among other changes. 

In line with draft House legislation and the Department of Veterans Affairs (VA) legislative proposal [see Washington Highlights, Oct. 27], S. 2193 retains VA’s authority for direct health care resource contracts with VA’s academic affiliates under 38 U.S. Code § 8153, often referred to as sole-source affiliate contracts.

Also of importance to academic medicine, the bill would increase VA graduate medical education (GME) by an additional 1,500 positions over 10 years. Unlike current VA GME, residents rotating through these positions would incur a service obligation at the VA after they complete their training. The bill would also establish a GME pilot program for the VA to partner with Indian Health Service (IHS) in rural locations. Residents rotating through these programs would also incur a service obligation, but would be eligible for IHS loan repayment. Another pilot would provide tuition reimbursement and loan repayment for students and health care providers practicing in underserved VA facilities.

The committee-approved bill has support from multiple Veterans Service Organizations. It is unlikely that the full Senate or the House VA Committee will take up their respective VA Choice reform legislation before the end of the year.

Contact:

Matthew Shick, JD
Director, Gov't Relations & Regulatory Affairs
Telephone: 202-862-6116
Email: mshick@aamc.org

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Senate Appropriations Committee Holds Hearing on Opioid Crisis

December 7, 2017—The Senate Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies Dec. 5 held a hearing to discuss federal efforts to address the opioid epidemic.

Witnesses for the hearing included Francis Collins, MD, PhD, director of the National Institutes of Health (NIH); Patrick Kennedy, former Congressman (D-RI) and member of the President’s Commission on Combatting Drug Addiction and the Opioid Crisis; Elinore McCance-Katz, MD, PhD, assistant secretary for mental health and substance use for the Substance Abuse and Mental Health Services Administration; and Debra Houry, MD, MPH, director for the National Center for Injury Prevention and Control at the Centers for Disease Control and Prevention.

Subcommittee Chair Roy Blunt (R-Mo.) began the hearing by calling the opioid crisis “the worst drug epidemic our nation has ever faced.” The Subcommittee’s Ranking Member Patty Murray (D-Wash.) also shared her concerns, saying “Every day, from every corner of our country, we hear more about the devastation being caused by the opioid crisis - from doctors who are treating babies born addicted to opioids, to parents who have lost children to an overdose, to veterans in chronic pain who are struggling with addiction – unfortunately the list could go on and on.” Highlighting the committee’s work, Chairman Blunt pointed out, “Over the last three years that Senator Murray and I have been the Chair and Ranking Member of the Labor/HHS Subcommittee, we have written bills that have increase opioid funding by $760 million, or over 1,300 percent.”

In his testimony, former Rep. Kennedy called for “real, substantial, emergent dollars” saying we aren’t doing “nearly enough” to address this crisis. Before concluding, Rep. Kennedy demanded that Congress allocate “no less than $25 billion in supplemental appropriations” to address the opioid epidemic and said, “if Congress can spend over $50 billion to address natural disasters, it can absolutely spend just half that to address an escalating national disaster killing more than 100,000 American’s just this year.”

The federal witnesses – Drs. McCance-Katz, Houry, and Collins – submitted joint written testimony to the committee, which discusses the Department of Health and Human Services’ five-point opioid strategy and highlights President Trump’s Oct. 26 declaration of a Nationwide Public Health Emergency. Also of note are the NIH’s efforts to support research through public-private partnerships and advance the practice of pain management.

Contact:

Tannaz Rasouli
Sr. Director, Public Policy & Strategic Outreach
Telephone: 202-828-0525
Email: trasouli@aamc.org

Joseph Bañez
Legislative Analyst
Telephone: 202-739-2995
Email: jbanez@aamc.org

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House Republicans Introduce Higher Education Act Reauthorization Legislation

December 7, 2017—House Education and Workforce Committee Chair Virginia Foxx (R-N.C.) Dec. 1 released a higher education reform bill called the Promoting Real Opportunity, Success and Prosperity Through Education Reform (PROSPER) Act (H.R. 4508). The PROSPER Act is intended to reauthorize the Higher Education Act (HEA), which authorizes programs at the Department of Education, including federal student loans.

The 542-page legislation makes significant changes to federal financial aid and would reshape how students benefit from a federal system of support. Among the bill’s provisions is a proposal to phase out the federal direct loan program and to create a new “Federal ONE Loan Program.” The bill also would set new higher unsubsidized loan limits and eliminate loan origination fees, but would also eliminate the GradPLUS program that allows medical students to borrow up to the full cost of attendance at a higher interest rate.

In an attempt to simplify federal financial aid, the bill also would pare the number of repayment plans to two options: a 10-year standard repayment plan and an income-driven repayment plan capped at the 10-year standard repayment amounts. The bill’s phase-out of direct loans by 2024 ultimately would prevent new borrowers from becoming eligible for Public Service Loan Forgiveness (PSLF) after that time; only direct loans are eligible for PSLF.

In a press release Chairman Foxx wrote, “With six million unfilled jobs and over a trillion dollars in student debt, simply reauthorizing the Higher Education Act will help no one. A hard truth that students, families, and institutions must face is that the promise of a postsecondary education is broken. We need a higher education system that is designed to meet the needs of today’s students and has the flexibility to innovate for tomorrow’s workforce opportunities. The PROSPER Act is higher education’s long overdue reform.”

In response, Senate Health, Educations, Labor, and Pensions (HELP) Committee Ranking Member Patty Murray (D-Wash.) released a statement saying, “it’s extremely disappointing that House Republicans are taking another partisan step in the wrong direction and introducing a plan that would harm students by cutting billions in financial aid.”

While the introduction of this legislation signifies a step forward for reauthorization, both the House and Senate must agree on an HEA proposal before the reauthorization becomes law. The House committee has not yet publicly announced a date to mark up the PROSPER Act. In a recent hearing, Senate HELP Committee Chair Lamar Alexander (R-Tenn.) indicated that the Senate plans to take action on HEA reauthorization early in 2018.

Contact:

Joseph Bañez
Legislative Analyst
Telephone: 202-739-2995
Email: jbanez@aamc.org

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FDA Commissioner Gottlieb and NIH Director Collins Discuss the Promise of Regenerative Medicine

December 7, 2017—The Food and Drug Administration (FDA) and the National Institutes of Health (NIH) hosted the Regenerative Medicine Innovation Workshop on Dec. 6-7, 2017, in Rockville, MD.  The workshop explored the field of regenerative medicine using adult stem cells and approaches to advance clinical research while ensuring interventions are safe and effective.

Both Francis S. Collins, MD, PhD, Director of the NIH, and Scott Gottlieb, MD, Commissioner of the FDA, provided introductory remarks during the workshop. Each noted the progress in implementing the Regenerative Medicine Innovation Project (RMIP), established through the 21st Century Cures Act as a collaboration between the NIH and FDA. Congress has authorized $30 million in funding for RMIP over four years and in year one of the project (fiscal year 2017), NIH issued eight awards totaling $4.7 million. Additionally, on Nov. 16, the FDA issued four guidance documents outlining the regenerative medicine policy framework.

The advancement of regenerative medicine was again a topic the following day, Dec. 7, when Dr. Collins and Dr. Gottlieb testified before the Senate Committee on Health, Education, Labor, and Pensions at the Dec. 7 hearing on the Implementation of the 21st Century Cures Act: Progress and the Path Forward for Medical Innovation. The House Energy and Commerce Health Subcommittee held a similar hearing on Nov. 30 [see Washington Highlights, Dec. 1].

Contact:

Anne Berry, MPP
Lead Specialist, Implementation Research & Policy
Telephone: 202-739-2987
Email: aberry@aamc.org

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The FDA Releases New Guidance on Advancing Digital Health Tools

December 7, 2017—The Food and Drug Administration (FDA) Dec. 7 released three guidance documents to improve the development and oversight of digital health tools, a continuation of steps the FDA has taken over the last five years to better align its regulatory approach with the evolving nature of digital health technologies. The guidance documents also make several important changes to meet requirements in the 21st Century Cures Act (“Cures Act”).

The first draft guidance, Clinical and Patient Decision Support Software, implements a risk-based approach to determining the types of clinical decision support software that would not be defined as a medical device and therefore would not require FDA regulation (e.g., programs comparing patient symptoms). Among other things, the guidance recommends that regulatory requirements should not be enforced for lower risk decision software such as patient decision support software, when that software is used independently by patients and non-health professions in the review of treatment recommendations.

The second draft guidance, Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act, provides clarification of the FDA’s interpretation of certain software that are no longer medical devices and fall outside the scope of FDA’s regulation. Comments on both draft guidance documents are due by Feb. 6, 2018, 60 days from publication in the Federal Register.

Third, the FDA issued a final guidance document Software as a Medical Device: Clinical Evaluation, establishing common principles for evaluating the safety, effectiveness, and performance of software regulated as a medical device.

In a press release, Commissioner Scott Gottlieb, MD, emphasized the importance of the FDA’s  role in the development of such technologies, stating that these guidance documents will “continue to expand our efforts to encourage innovation in the ever-changing field of digital health [and] provide more clarity on and innovative changes to our risk-based approach to digital health products so that innovators know where they stand relative to the FDA’s regulatory framework.” 

Contact:

Heather Pierce, JD, MPH
Sr. Director, Science Policy & Regulatory Counsel
Telephone: 202-478-9926
Email: hpierce@aamc.org

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On the Agenda

Dec. 12: House E&C Subcommittee on Oversight and Investigations Hearing on Patient Brokering and Addiction Treatment Fraud
10:15 a.m.; 2322 Rayburn House Office Building, Washington, D.C.
The House Energy and Commerce Committee Subcommittee on Oversight and Investigations will hold a hearing entitled “Examining concerns of Patient Brokering and Addiction Treatment Fraud.”

Dec. 12: Senate HELP Hearing on Prescription Drug Costs
10 a.m.; 430 Dirksen Senate Office Building, Washington, D.C.
The Senate HELP Committee will hold a full committee hearing entitled “The Cost of Prescription Drugs: An Examination of the National Academies of Sciences, Engineering, and Medicine Report: ‘Making Medicines Affordable: A National Imperative.’”

Dec. 13: Senate HELP Hearing on 21st Century Cures Act Implementation and Mental Health
10 a.m.; 430 Dirksen Senate Office Building
The Senate HELP Committee will hold a hearing titled, “Implementation of the 21st Century Cures Act: Responding to Mental Health Needs.”

Dec. 14-15: NIH Meeting of the Advisory Committee to the Director
9 a.m.; NIH, 31 Center Drive, Building 31, Sixth Floor Conference Room 6C, Bethesda, Md.
The National Institutes of Health (NIH) will hold a meeting of the Advisory Committee to the Director. The Agenda includes the NIH Director’s Report and ACD Working Group Reports. Contact: Gretchen Wood at 301-496-4272 Woodgs@od.nih.gov

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Washington Highlights, a weekly electronic newsletter, features brief updates on the latest legislative and regulatory activities affecting medical schools and teaching hospitals.


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For More Information

Jason Kleinman
Sr. Legislative Analyst, Govt. Relations
Telephone: 202-903-0806
Email: jkleinman@aamc.org