What’s Ahead: This Week

Hearings –

  • Tuesday, October 31
    • Senate HELP Committee, “Implementation of the 21st Century Cures Act: Achieving the Promise of Health Information Technology.”
  • Wednesday, November 1
    • House Rules Committee, “H.R. 849, the Protecting Seniors’ Access to Medicare Act of 2017.”

 Notable Policy Events –

  • Tuesday, October 31
    • National Coalition on Health Care, “Prevention Across the Lifespan: Examining the Vital Role of HHS Prevention Initiatives in Driving Down Costs and Improving Outcomes – Prevention at Each Life Stage for Health and Wellbeing.” Additional information: http://bit.ly/2yTeM4M
  • Tuesday, October 31 – Thursday, November 2
    • Patient-Centered Outcomes Research Institute, “Annual Meeting: Delivering Results, Informing Choices.” Additional information: http://bit.ly/2yVm9bZ
  • Wednesday, November 1 – Thursday, November 2
    • Council for Affordable Health & American Action Forum, “The Price of Good Health: How to Bend the Cost Curve.” Additional information: http://bit.ly/2iMJAhL
    • Health Level Seven & NCQA, “Digital Quality Summit.” Additional information: http://bit.ly/2yUXNyP
  • Wednesday, November 1 – Friday, November 3
  • Thursday, November 2
    • Politico, “The Opioid Crisis: Crucial Next Steps.” Additional information: http://politi.co/2ySL1RG
    • Edward M. Kennedy Institute for the United States Senate, “Across the Aisle: A Conversation on our Nation’s Opioid Epidemic.” Additional information: http://bit.ly/2iLGPgh
  • Thursday, November 2 – Friday, November 3
    • Medicare Payment Advisory Committee, “November Public Meeting.” Additional information: http://bit.ly/2ewvVXE
  • Friday, November 3
    • National Press Club, ”Headliners Luncheon with FDA Commissioner Dr. Scott Gottlieb.” Additional information: http://bit.ly/2yStXJm
    • Brookings Institution, “Policy Approaches to the Opioid Crisis, Featuring Remarks from Sir Angus Deaton, Rep. Ann McLane Kuster, and Professor Bertha K. Madras.” Additional information: http://brook.gs/2iLD4Yl


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

 FY 18 Budget Resolution

  • On October 26, the House approved by a vote of 216-212 the fiscal year 2018 Budget Resolution (H. Res. Con. 71), which paves the way for Congress to move forward on tax reform under reconciliation rules. The Resolution previously passed the Senate and does not need to be signed by the President to go into effect. Press release: http://bit.ly/2ySNh9C

Legislative Activity –

  • On October 23, House Ways & Means Committee Ranking Member Neal (D-MA) introduced the Medicare Beneficiary Opioid Addiction Treatment Act (H.R. 4097), which would provide for the coverage of methadone under Medicare part B. Press release: http://bit.ly/2yUHeU0
  • Also on October 23, Reps. Higgins (D-NY), Larson (D-CT), Courtney (D-CT), Scott (D-VA), O’Rourke (D-TX), and Polis (D-CO) introduced the Medicare-X Choice Act of 2017 (H.R. 4094), the House companion to Senate bill that would establish a public health plan to be known as the Medicare Exchange health plan. Press release: http://bit.ly/2yQRA4V
  • On October 24, Rep. Lawrence (D-MI) and 10 cosponsors introduced H.R. 4105, which would extend the health professions workforce demonstration project. Press release: http://bit.ly/2yRqFWW
  • On October 25, Rep. Doggett (D-TX) and 12 cosponsors introduced the Transparent Drug Pricing Act of 2017 (H.R. 4116), which would require reporting by drug manufacturers to increase transparency in drug pricing. Press release: http://bit.ly/2yR0OhF
  • Also on October 25, Rep. Doggett (D-TX) and 20 cosponsors introduced the Competitive Deals Resulting in Unleashed Generics and Savings, or Competitive DRUGS, Act (H.R. 4117), which would prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market. Press release: http://bit.ly/2yR0OhF
  • Also on October 25, Rep. DeLauro (D-CT) and Fitzpatrick (R-PA) and 4 bipartisan cosponsors introduced the Breast Density and Mammography Reporting Act (H.R. 4122), which would require breast density reporting to physicians and patients by facilities that perform mammograms. Sens. Feinstein (D-CA) and Heller (R-NV) introduced a companion bill (S. 2006) in the Senate. Press release: http://bit.ly/2yQ6Ajz
  • Also on October 25, Rep. Pittenger (R-NC) and 56 cosponsors introduced the No Abortion bonds Act (H.R. 4131), which would impose federal taxes on bonds used to provide facilities owned by abortion providers. Press release: http://bit.ly/2yWuHzb
  • Also on October 25, Sen. Casey (D-PA) and 17 cosponsors introduced the Combating the Opioid Epidemic Act (S. 2004), which would increase funding for the state response to the opioid misuse crisis and to provide funding for research on addiction and pain related to the substance misuse crisis. Press release: http://bit.ly/2yYom6r
  • Also on October 25, Sens. Shaheen (D-NH) and Hassan (D-NH) introduced the revised Combating the Heroin Epidemic Through Forensic Drug Testing Act of 2017 (S. 2008), which would combat the opioid epidemic and drug sample backlogs. Press release: http://bit.ly/2yVtLLC
  • Also on October 25, Sens. Sanders (I-VT), Leahy (D-VT) and 5 cosponsors introduced the Medicare Drug Price Negotiation Act of 2017 (S. 2011), which would provide for the negotiation of lower covered Part D drug prices on behalf of Medicare beneficiaries and the establishment and application of a formulary by the Secretary of Human Services under Medicare Part D. Reps. Cummings (D-MD), Doggett (D-TX), and Welch (D-VT) introduced a companion bill in the House (H.R. 4138). Press release: http://bit.ly/2yX5y7A
  • On October 26, Rep. Correa (D-CA) introduced H.Res.590, which calls on the Secretary of Veterans Affairs to conduct a clinical study assessing the effectiveness of treating chronic pain in veterans with cannabis in comparison to opioids. Press release: http://bit.ly/2yX53dU
  • Also on October 26, Sens. Cruz (R-TX) and Johnson (R-WI) introduced the RESULT Act (S. 2022), which would provide for reciprocal marketing approval of certain drugs, biological products, and devices that are authorized to be lawfully marketed abroad. Press release: http://bit.ly/2yWPQcs
  • Also on October 26, Sen. Nelson (D-FL) introduced the S. 2026, which would make improvements to the treatment of the United States territories under the Medicare and Medicaid programs. Press release: http://bit.ly/2iK20zE

 Market Stabilization & Reform –

  • On October 24, Senate Finance Committee Chair Hatch (R-UT) and House Ways & Means Committee Chair Brady (R-TX) announced their plan to introduce a market stabilization bill that would provide two years of funding for cost-sharing reductions in exchange for relief from the individual and employer mandates. Press release: http://bit.ly/2y4kqNy
  • Also on October 24, 180 bipartisan House members joined a letter to House Speaker Ryan (R-WI), urging him to prioritize repealing the ACA’s 2.3 percent tax on medical devices, which is set to take effect on January 1. Press release: http://bit.ly/2yOvlNi Letter: http://bit.ly/2yOvxMw
  • On October 25, Congressional Budget Office released an analysis of the Bipartisan Health Care Stabilization Act, finding that the bill would decrease the deficit by $3.8 billion over the next decade, and that it would not substantially change the number of people with health coverage. Analysis: http://bit.ly/2yMJb2G HELP Committee Press release: http://bit.ly/2yOxiZZ
  • On October 25, Sen. Schatz (D-HI) and 18 cosponsors introduced the State Public Option Act (S. 2001), which would establish a state public option through Medicaid to be offered on the insurance marketplace. Rep. Lujan (D-NM) and 24 cosponsors representatives introduced a companion bill in the House (H.R. 4129). Press release: http://bit.ly/2yMjIq0
  • Also on October 25, Rep. Lujan Grisham (D-NM) introduced the Health Care Choice and Affordability Act (H.R. 4128), which would allow states with exchanges with low-insurer participation to offer a Medicaid buy-in plan. Press release: http://bit.ly/2yW6nxu
  • Also on October 26, Sens. Cruz (R-TX) and Rubio (R-FL) introduced the Health Care Choice Act (S. 2021), which would provide for cooperative governing of individual health insurance coverage offered in interstate commerce. Press release: http://bit.ly/2yWPQcs

ACA Implementation –

  • On October 23, Iowa announced its decision to withdraw its section 1332 waiver, citing the length of time the Administration has said it would need to review the total federal pass-through funding that can be allocated to the state. IA Press release: http://bit.ly/2yLsDJP Senate HELP Committee Chair Alexander Press release: http://bit.ly/2y4CFCm Senate Judiciary Committee Chair Grassley (R-IA) Press release: http://bit.ly/2y4tzFB
  • Also on October 23, CMS sent a preliminary notice of incompleteness to Massachusetts regarding its section 1332 waiver. Notice: http://go.cms.gov/2yLOy3u Senate HELP Committee Ranking Member Alexander Press release: http://bit.ly/2y40URg
  • On October 25, HHS Office of the Inspector General (OIG) released a report finding that the Administration’s January decision to cancel open enrollment advertisements and outreach cost the Administration at least $1.1 million. Report: http://bit.ly/2yNLzX1
  • Also on October 25, CMS released a fact sheet outlining several improvements to the Healthcare.gov website, including a new direct enrollment option, updated help content, updated provider and prescription drug search functionality, and updated eligibility notices. Fact sheet: http://go.cms.gov/2yQ0tvJ
  • On October 26, House Pro-Choice Caucus Co-Chairs DeGette (D-CO) and Slaughter (D-NY) led 189 members of Congress in a letter to Treasury Secretary Mnuchin, Labor Secretary Acosta and HHS Acting Secretary Hargan urging them to reverse the “recent moves to limit women’s access to birth control. Press release: http://bit.ly/2ySdqFr Letter: http://bit.ly/2ySK1em
  • On October 27, CMS released its proposed notice of benefit and payment parameters for 2019, which seeks to “increase flexibility in the individual market, improve program integrity, and reduce regulatory burdens associated with the ACA.” Comments are due by November 27. Fact sheet: http://go.cms.gov/2yUnZYv EHB Guidance: http://go.cms.gov/2yUrWwj SHOP Fact sheet: http://go.cms.gov/2yQR1bn Payment notice: http://bit.ly/2yTq1s3
  • Also on October 27, CMS released frequently asked questions (FAQ) related to the federally-facilitated marketplace’s user fee adjustment submission requirements for benefit year 2016. FAQ:  http://go.cms.gov/2yRPZvN

Medicare –

  • On October 26, leaders of the House Energy & Commerce and Ways & Means Committee announced a bipartisan agreement on a permanent repeal of the annual limit on per-patient therapy expenditures in Medicare, known as “therapy caps.” Press release: http://bit.ly/2yThzZu Policy: http://bit.ly/2yT3lYN
  • On October 27, CMS released final policies and payment rates for the end-stage renal disease Prospective Payment System, Quality Incentive Program, and payment for renal dialysis services furnished to individuals with acute kidney disease. Fact sheet: http://go.cms.gov/2yRLuRV Final rule: http://bit.ly/2yTEXq6

Medicaid and CHIP

  • On October 26, Sens. Warner (D-VA) and Kaine (D-VA) sent a letter to Senate Majority Leader McConnell (R-KY) urging him to bring legislation that would reauthorize the Children’s Health Insurance Program to the floor for a vote as soon as possible. Press release: http://bit.ly/2yRXIdc  Letter: http://bit.ly/2yQKLQT

 New Payment and Delivery System Models –

  • On October 23, HHS Office of Inspector General (OIG) published a report finding that CMS complied with federal requirements when assigning beneficiaries to ACOs in the Medicare Shared Savings Program (MSSP) during performance years 2013 through 2015 by ensuring that MSSP beneficiaries were assigned to only one ACAO and were not assigned to other savings programs. Report: http://bit.ly/2yWtuYO
  • On October 26, CMS published third evaluation reports for the Bundled Payments for Care Improvement Initiative Models 2, 3, and 4. Model 2 Report: http://bit.ly/2yWsbZT Model 3 Report: http://bit.ly/2yWsfsB Model 4 Report: http://bit.ly/2yX7Kw2

 Mental Health and Substance Abuse –

  • On October 25, Sen. Stabenow (D-MI) led a group of 18 senators in sending a letter to President Trump urging him to follow the recommendations of his Commission on Combating Drug Addiction and the Opioid Crisis and allow the government to negotiate lower prices for naloxone. Press release with text of letter: http://bit.ly/2yTtHfc
  • On October 26, President Trump directed Acting HHS Secretary Hargan to declare a national public health emergency (PHE) for the opioid epidemic. While it is not immediately clear how the PHE will be implemented, it can be used to “accelerate temporary appointments of specialized personnel to address the emergency; work with DEA to expand access for certain groups of patients to telemedicine for treating addiction; and provide new flexibilities within HIV/AIDS programs.” WH Memorandum and fact sheet: http://bit.ly/2yWPzpV and http://bit.ly/2yVtwQx Press releases from HHS and CMS: http://bit.ly/2yUPYJL and http://go.cms.gov/2yWOIpi Press releases from SAMHSA and FDA: http://bit.ly/2yRXIKo and http://bit.ly/2yUsUZt Declaration: http://bit.ly/2yXwljY
  • On October 27, HHS Office of Civil Rights issued guidance clarifying HIPAA rules on “when and how healthcare providers can share a patient’s health information with his or her family members, friends, and legal personal representatives when that patient may be in crisis and incapacitated, such as during an opioid overdose.” Press release: http://bit.ly/2yUfhtq Guidance: http://bit.ly/2yTaFU4
  • Also on October 27, House Energy & Commerce Chair Walden (R-OR) sent a letter to Attorney General Sessions requesting information about the Drug Enforcement Administration’s enforcement abilities related to opioid trafficking. Press release: http://bit.ly/2yRZStu Letter: http://bit.ly/2yToQsq
  • Also on October 27, CDC released data finding that over half of people in 10states who died of opioid overdoses during the second half of 2016 tested positive for fentanyl. Press release: http://bit.ly/2ziULpd Data: http://bit.ly/2zhNdTB

 Health IT –

  • On October 24, Food and Drug Administration (FDA) Commissioner Gottlieb published a statement highlighting new steps the FDA will take to advance medical device innovation and help patients gain faster access to beneficial technologies, including the first qualification of a medical device development tools to provide a more objective platform for developing devices. Statement: http://bit.ly/2yWUA22
  • On October 25, FDA published draft guidance for the Breakthrough Devices Program, established by the 21st Century Cures Act. The guidance clarifies certain principles and features of the new program, the designation criteria for Breakthrough Devices, the designation request review process, the process for withdrawing from the program, as well as the recommended information device manufacturers should provide in their designation request for entrance into the program. Draft Guidance: http://bit.ly/2yYTu5A

Prescription Drugs –

  • On October 23, FDA announced new steps to better inform physicians about biosimilars through the development of educational materials to seek to help providers gain a better understanding of these products. Blog post: http://bit.ly/2yXccuo
  • On October 24, FDA published draft guidance to help sponsors of investigational new drug applications and applicants of new drug applications evaluate drug-drug interactions (DDIs) during drug development and communicate the results and recommendations from DDI studies. Draft guidance: http://bit.ly/2yWZ6O2
  • Also on October 24, FDA published draft guidance intended to help drug developers plan and evaluate studies to determine the DDI potential of an investigational drug product, focusing on in vitro experimental approaches to evaluate the interaction potential between investigational drugs that involves metabolizing enzymes and/or transporters. Draft guidance: http://bit.ly/2yXX2p5
  • On October 26, FDA announced the issuance of two Emergency Use Authorizations (EUAs) for in vitro diagnostic devices for detection of the Zika virus in response to the Zika virus outbreak in the Americas. Notice: http://bit.ly/2yXZAmT

 Misc. –

  • On October 24, Centers for Disease Control and Prevention (CDC) announced that a new free Milestone Tracker app is available for use for parents to track, support, and celebrate their young child’s development. Press release: http://bit.ly/2yXJR7y
  • Also on October 24, CDC published data from the National Health Interview Survey on long-term trends in health insurance coverage from 1968 to 2016. Survey Data: http://bit.ly/2yWH6mK
  • Also on October 24, CDC published a health advisory for providers treating patients in or recently returned from hurricane-affected areas, including Puerto Rico and the US Virgin Islands, noting that conditions for outbreaks of infectious diseases exist due to compromised drinking water and decreased access to safe water, food, and shelter. Health Advisory: http://bit.ly/2yXoy5L
  • On October 26, U.S. Government Accountability Office (GAO) published a report finding that given the reduction in funding for low-dose radiation research, agencies will need to work together to determine how to best use resources to address research priorities in the area. Report: http://bit.ly/2yYkvpS
  • On October 27, CMS published a quarterly notice listing CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from July through September 2017, relating to the Medicare and Medicaid programs and other programs administered by CMS. Notice: http://bit.ly/2yYCpcf
  • Also on October 27, CDC published a report finding that before 2014, many women and men of reproductive age did not receive many recommended preventive services. Report: http://bit.ly/2yZ8ArR
  • Also on October 27, Senate HELP Committee Ranking Member Murray (D-WA) led a group of 13 democrats in a letter to HHS Acting Secretary Hargan urging him to revise the draft HHS strategic plan, arguing that it “prioritizes ideology over science and fails to address the diverse health needs of the people the Department serves.” Press release: http://bit.ly/2yTnu0O Letter: http://bit.ly/2yTnBJM
  • Also on October 27, Senate HELP Committee Ranking Member Murray (D-WA) and Senate Finance Committee Ranking Member Wyden (D-OR) sent a letter to HHS Acting Secretary Hargan requesting that he provide information on the Department’s ongoing hurricane response effort in Puerto Rico and the U.S. Virgin Islands. Press release: http://bit.ly/2yScdhr Letter: http://bit.ly/2yTomm6