Health Care Policy Update – Weekly Wrap-up and What’s Ahead


 What’s Ahead: This Week

Hearings and Markups –

  • Tuesday, June 25
    • House Energy & Commerce Committee, Subcommittee on Health, “Reauthorizing Vital Health Programs for American Families.”
  • Wednesday, June 26
    • Senate HELP Committee, “Markup of S. 1895, the Lower Health Care Costs Act of 2019; S. 1199, the Poison Center Network Enhancement Act of 2019; and S. 1173, the Emergency Medical Services for Children Reauthorization Act of 2019.
    • House Veterans’ Affairs Committee, Subcommittee on Health, “Beyond the Million Veterans Program: Barriers to Precision Medicine.”
  • Thursday, June 27
    • Senate Judiciary Committee, “Markup of S. 1227, the Prescription Drug Pricing for the People Act; S. 440, the Preserving Access to Cost Effective Drugs (PACED) Act; S. 1224, the STALLING Act; and S. 1416, the Affordable Prescriptions for Patients Act of 2019.”

 Notable Policy Events –

  • Monday, June 24
    • National Academy of Social Insurance, “Designing Universal Family Care: State-Based Social Insurance Programs for Early Child Care and Education, Paid Family and Medical Leave, and Long-Term Services and Supports.” Additional information: https://bit.ly/2x7kVrV
  • Monday, June 24 – Tuesday, June 25
    • Rise Institute, “The National Summit on Social Determinants of Health.” Additional information: https://bit.ly/2WVujOS
  • Tuesday, June 25
    • The Hill, “Cost, Quality, and Care: The Medicare Equation.” Additional information: https://bit.ly/2L57IIg
    • USC-Brookings Schaeffer Initiative for Health Policy, “Hospital Productivity Trends: Implications for Medicare Payment Policy.” Additional information: https://brook.gs/2ZF4MX5
  • Wednesday, June 26
    • Research!America, “Improvements to Rural Health Care Through Patient-Centered Research.” Additional information: https://bit.ly/2Fkpdkk
    • Pew Charitable Trusts, “Combating the Opioid Epidemic.” Additional information: https://bit.ly/31KdZyV
  • Thursday, June 27
    • CMS, “Primary Care First Model Payment Webinar.” Additional information: https://bit.ly/31N59AM
    • American Enterprise Institute (AEI), “The Value of Our Veterans: How the VA Can Better Assist Veterans Reentering the Workforce.” Additional information: https://bit.ly/2KukqRu
    • Alliance for Health Policy, “Addressing the Drivers of Maternal Mortality.” Additional information: http://bit.ly/2XpZWiU
  • Friday, June 28
    • Bipartisan Policy Center (BPC), “Good Health is Good Business.” Additional information: https://bit.ly/2XeYFv5

 

Weekly Wrap-Up: Notable Health Care Developments from Last Week                                                                                 

Legislative Activity –

Committee Activity, Executive Actions, and Floor Votes

  • On June 18, the House approved by a vote of 371-46 the Empowering Beneficiaries, Ensuring Access, and Strengthening Accountability Act of 2019 (H.R. 3253), which would provide for certain Medicaid program extensions including Money Follows the Person and the Community Mental Health Services Demonstration. The measure now moves to the Senate for consideration. Press release: https://bit.ly/2IUZzn7 Bill text: https://bit.ly/2ZBH65A
  • On June 19, the House approved by a vote of 226-203 H.R. 2740, which includes Labor-HHS-Education appropriations for FY 2020. The bill includes a total of $99.4 billion for HHS, an increase of $8.9 billion above the 2019 enacted level and $21.3 billion above the President’s budget request. The measure now moves to the Senate for consideration. Press release: https://bit.ly/2WRM9SN Section-by-section: https://bit.ly/31HxQ21 Amendments: https://bit.ly/2J1ZWfA Bill text: https://bit.ly/2Zx3FbR
  • On June 20, the House continued work on the Commerce, Justice, Science, and Related Agencies Appropriations Act, 2020 (H.R. 3055), which includes FDA appropriations for FY 2020. The House approved by a vote of 238-194 an amendment by Reps. Underwood (D-IL) and Jeffries (D-NY) which would prohibit any funding to be used by the Administration to support its position on Texas vs. Azar. Press release: https://bit.ly/2Ir0NHB Section-by-section: https://bit.ly/2WYmpPI Bill text: https://bit.ly/31Nv4Ih

 Introduced Legislation

  • On June 18, Reps. Finkenauer (D-IA), Kind (D-WI), Smith (R-NE), LaHood (R-IL), and Sewell (D-AL) introduced the Keep Physicians Serving Patients Act of 2019 (H.R. 3302), which would adjust the Medicare geographic practice cost index (GPCI) to more accurately reflect the cost of labor and practice expenses. Press release: https://bit.ly/2WP51wS Bill text: https://bit.ly/2Ks27wg
  • On June 19, Rep. Horsford (D-NV) introduced the Health Providers Training Act of 2019 (H.R. 3342), which would make hospitals eligible for health professions opportunity grants under Section 2008 of the Social Security Act. Press release: http://bit.ly/2XBFZ92
  • Also on June 19, Rep. Kildee (D-MI) introduced the Technical Assistance for Health Grants Act (H.R. 3343), which would provide for technical assistance under the health profession opportunity grant program. Press release: http://bit.ly/2XtXlnT
  • Also on June 19, Rep. Moore (D-WI) introduced the Opportunities to Support Mothers and Deliver Children Act (H.R. 3344), which would provide grants for the conduct of demonstration projects designed to provide education and training for eligible individuals to enter and follow a career pathway in the field of pregnancy or childbirth under the health profession opportunity grant program. Press release: http://bit.ly/2XseoGZ
  • Also on June 19, Rep. Hartzler (R-MO) and 19 bipartisan cosponsors introduced the VA Emergency Transportation Act (H.R. 3350), which would reimburse veterans for the cost of emergency medical transportation to a federal facility. Press release: https://bit.ly/2Y01GfF
  • Also on June 19, Senate HELP Committee Chair Alexander (R-TN) and Ranking Member Murray (D-WA) introduced the Lower Health Care Costs Act of 2019 (S. 1895), which addresses surprise billing issues, health care price transparency, drug pricing issues, and other topics related to health care costs. Press release: https://bit.ly/2XpGEKv Section-by-section: https://bit.ly/2XXAONo Bill text: https://bit.ly/31Nnz4q
  • Also on June 19, Sens. Smith (D-MN) and Young (R-IN) introduced the Advancing Emergency Preparedness Through One Health Act (S. 1903), which would improve public health preparedness by ensuring federal agencies advance a “One Health” approach to prevent and respond to disease outbreaks. Press release: https://bit.ly/2x93ZBa Bill text: https://bit.ly/2FmFuFb
  • Also on June 19, Sen. Baldwin (D-WI) and 21 cosponsors introduced the Expand Navigators’ Resources for Outreach, Learning, and Longevity (ENROLL) Act (S.1905), which would restore funding for the ACA’s Navigator program. The House companion legislation passed as part of H.R. 987 last month. Press release: https://bit.ly/2ZyQZ43 Bill text: https://bit.ly/2MZW7gt
  • On June 20, Rep. Schakowsky (D-IL) and 16 bipartisan cosponsors introduced the Price Relief, Innovation, and Competition for Essential Drugs (PRICED) Act (H.R. 3379), which would amend the Public Health Service Act to shorten the exclusivity period for brand name biological products from 12 to 5 years. Press release: http://bit.ly/2WYEwoE
  • Also on June 20, Rep. Collins (R-NY) introduced the Protect the Uninsured Act of 2019 (H.R. 3386), which would amend Title XI of the Social Security Act to require hospitals and critical access hospitals to provide uninsured individuals with access to the lowest negotiated rate for items and services furnished to such individuals. Press release: https://bit.ly/2FpaZyJ Bill text: https://bit.ly/2ZJ927X
  • Also on June 20, Reps. Sensenbrenner (R-WI) and Moore (D-WI) introduced the Function Gastrointestinal and Motility Disorders Research Enhancement Act (H.R. 3396), which would expand the research activities of National Institutes of Health (NIH) with respect to functional gastrointestinal and motility disorders. Press release: https://bit.ly/2IXzcgk Bill text: https://bit.ly/2XtkZRy
  • Also on June 20, Sens. Rosen (D-NV) and Murkowski (R-AK) introduced the Provider Training in Palliative Care Act (S. 1921), which would update the National Health Service Corps program to include palliative care medicine as an eligible primary care service. Press release: https://bit.ly/2WYyyZH
  • Also on June 20, Sen. Portman (R-OH) introduced the Combating Meth & Cocaine Act (S. 1925), which would expand the use of State Opioid Response Grant funding to address rising use and overdose deaths attributed to the abuse of methamphetamine and cocaine. Press release: https://bit.ly/2xadi48 Bill text: https://bit.ly/2ZH1Vgd
  • Also on June 20, Sen. Harris (D-CA) introduced the PrEP Access and Coverage Act (S. 1926), which would require all public and private health insurance plans to cover HIV pre-exposure prophylaxis. Press release: https://bit.ly/31KsC5s Bill text: https://bit.ly/2ZI0NsP
  • Also on June 20, Sens. Portman (R-OH) and Casey (D-PA) introduced the Enrollment REFORM Act (S. 1928), which would require clear coordination between small group health plans and Medicare as an employed individuals ages into the Medicare program. Press release: https://bit.ly/2KymrvY
  • Also on June 20, Sen. Brown (D-OH) and 20 cosponsors introduced the Family Coverage Act (S. 1935), which would fix the “family glitch” by allowing an employee’s dependents to access tax credits if the cost of family coverage offered by an employer is greater than 9.86% of household income. Press release: https://bit.ly/2Kuney1
  • Also on June 20, Sen. Blackburn (R-TN) and 10 bipartisan cosponsors introduced the Protecting Access to Lifesavings Screenings (PALS) Act of 2019 (S. 1936), which would postpone recommendations from the U.S. Preventive Services Taskforce (USPSTF) that would limit access to breast cancer screening for women in their 40s. Press release: https://bit.ly/31OXmCg

 Individual Market and ACA Implementation –

  • On June 17, CMS released a blueprint for approval of state-based health insurance Exchanges for states seeking approval to operate either a state-based Exchange (SBE) or state-based Exchange on the federal platform (SBE-FP) for coverage years beginning on or after January 1, 2019. Blueprint: https://go.cms.gov/2RsubA7
  • Also on June 17, CMS published potential payment updates to the HHS Hierarchical Condition Categories (HHS-HCCs) for the HHS-operated individual market risk adjustment program. Report: https://go.cms.gov/2WV8Wgu

 Medicare and Medicaid –

  • On June 17, CMS issued a proposed rule which would allow clinicians to be able to choose to complete prior authorizations online and satisfy the terms of a prior authorization in real-time and before a prescription is transmitted to a pharmacy in Medicare Part D. Comments are due by August 16. Press release: https://go.cms.gov/2XkKZyz Proposed rule: https://bit.ly/2J0VH3Q
  • Also on June 17, Congressional Budget Office (CBO) issued a report on federal mandatory spending for means-tested programs between 2009 and 2029. CBO found that, under current law, outlays for federal mandatory means-tested programs would grow over the next decade at an average annual rate of 4 percent, whereas spending for mandatory non-means-tested programs would grow at an average rate of almost 6 percent. Summary with link to report: https://bit.ly/2N30Iyq
  • On June 19, HHS Office of Inspector General (OIG) published a report finding that Medicare could have saved millions of dollars in payments for three-dimensional conformal radiation therapy planning services. OIG recommends that CMS implement billing requirements and system edits to prevent additional payments for 3D-CRT planning services that are billed before the procedure code is billed. Summary with link to report: https://bit.ly/2IxfHfA
  • On June 20, CMS issued guidance to state Medicaid agencies that outlines the necessary assurances that states should make to ensure that program resources are reserved for those who meet eligibility requirements. Press release: https://go.cms.gov/2FqeBjN Guidance: https://bit.ly/2IWHftQ
  • Also on June 20, HHS issued a request for supplemental evidence and data submissions on end-stage renal disease (ESRD) in the Medicare population. Submissions are due by July 22. Request for submissions: https://bit.ly/2WYUm7z

 Payment and Delivery System Reform –

 Drug and Medical Device Prices and Regulation –

  • On June 17, Senate Finance Committee Chair Grassley (R-IA) received a letter from Food and Drug Administration (FDA) Legislative Affairs Associate Commissioner Gross in response to his April 2018 letter seeking additional information about an investigation into a South Florida clinic that performed unproven stem cell treatments on patients that left them permanently blind. FDA notified Chair Grassley that the issue had been referred to the Department of Justice (DOJ) and a federal court granted DOJ’s motion for summary judgment. Press release: https://bit.ly/2Rwwmmj Letter: https://bit.ly/2N5CJhS
  • On June 18, FDA updated one of its databases which provides information about exclusivity related to generic challenges of patents on brand drug products; the changes are intended to help subsequent generic applicants determine when their products can be approved and marketed. Press release: https://bit.ly/2ZB2k3L Paragraph IV Patent Certifications List: https://bit.ly/2WUq3ix
  • Also on June 18, House Oversight & Reform Committee Chair Cummings (D-MD) and Senate Finance Committee Health Subcommittee Ranking Member Stabenow (D-MI) penned a letter to U.S. Comptroller General Dodaro, urging GAO to conduct a review of how HHS prevents pharmaceutical companies from infringing on government-owned patents. Press release: https://bit.ly/2XvqfE8 Letter: https://bit.ly/31MTTnU
  • On June 20, FDA issued a draft guidance which describes the application of the benefit-risk assessment framework that the agency uses in evaluating applications for opioid analgesic drugs and summarizes the information that can be supplied by opioid analgesic drug applicants to assist the agency with its benefit-risk assessment. Press release: https://bit.ly/2XkehNR Draft guidance: https://bit.ly/2XkGsMA

 Substance Use and Mental Health –

  • On June 19, Sen. Durbin (D-IL) penned a letter to HHS Secretary Azar, calling on him to use his authority and full force of his agency to tackle the youth vaping epidemic. Press release: https://bit.ly/31Nax6Y Letter: https://bit.ly/2ZHcIHf
  • On June 20, Centers for Disease Control and Prevention (CDC) published a report on suicide rates for females and males by race and ethnicity in the U.S. between 1999 and 2017, finding that the age-adjusted suicide rate in the U.S. in 2017 was 33 percent higher than the rate in 1999. Report: https://bit.ly/2WTgviZ
  • On June 21, Senate HELP Committee Ranking Member Murray (D-WA) led 16 Democrats in a letter to FDA Acting Commissioner Sharpless urging the agency to act quickly and do more to protect kids from tobacco and nicotine products. Press release: https://bit.ly/2Fm1T5O Letter: https://bit.ly/2FrkEEN

Health Data and IT –

  • On June 19, Federal Communications Commission (FCC) Commissioner Carr announced that FCC will be voting at its July 10 meeting to advance a $100 million Connected Care Pilot Program to support telehealth for low-income families across the country. Press release: https://bit.ly/2ZJSz3r

 Veterans and Military Health –

  • On June 17, Department of Veterans Affairs (VA) announced a partnership with the White House to launch a veteran suicide-prevention taskforce headed by VA Secretary Wilkie and Domestic Policy Council Director Grogan. Press release: https://bit.ly/2WJrzip
  • Also on June 17, Health Affairs published research showing that VA and the Elizabeth Dole Foundation are working collectively to better integrate caregivers into a veteran’s health care treatment. Press release: https://bit.ly/2ZBMxl7
  • On June 18, House Veterans’ Affairs Committee Chair Takano (D-CA) released a statement after reports that the depressant Spravato has been fast-tracked through FDA’s approval processes and hurried through VA’s contracting process. Statement: https://bit.ly/2L79V6g
  • On June 19, U.S. Government Accountability Office (GAO) issued a report which found that Veterans Health Administration (VHA) does not ensure its networks have the appropriate staff in place to effectively operate the network and to ensure medical centers are providing timely access to care. GAO recommended that VHA develop a process to assess the performance of its network and ensure that they are appropriately staffed. Summary with link to report: https://bit.ly/2WYoqLG

 Misc. –

  • On June 17, HHS Secretary Azar issued a statement on the Department’s expansion and realignment of leadership. Judy Stecker has been named Deputy Chief of Staff for Operations and Strategy, and Secretary Azar plans on appointing a new Deputy Chief of Staff for Policy in the coming weeks. Press release: https://bit.ly/2Xmyd2D
  • Also on June 17, HHS OIG announced that it will be conducting a review of CMS’ strategic communications contracts and whether the contracts complied with applicable federal statutes, regulations, and HHS policies and procedures. Announcement: https://bit.ly/2IwrkU8
  • On June 18, House Majority Leader Hoyer (D-MD), Rep. Lee (D-CA), and 5 Democratic members of Congress penned a letter to Office of Management and Budget (OMB) Acting Director Vought, urging him not to implement the recently announced changes to the federal poverty calculations. Press release: https://bit.ly/2X0Kni7 Letter: https://bit.ly/31NfbBW
  • On June 20, GAO published a report finding that financing and oversight challenges are adversely the Black Lung Benefits Program Trust Fund. Summary with link to report: https://bit.ly/2XYZ2H7
  • On June 21, House Education & Labor Committee Chair Scott (D-VA) led eleven House Committee Chairs in a letter to OMB Director Mulvaney expressing their opposition to administratively changing the inflation measure used to adjust the poverty threshold, particularly in a way that would result in a lower threshold over time. Letter https://bit.ly/2x9XZIE