What’s Ahead: This Week

Hearings and Markups –

  • Tuesday, March 12
    • House Oversight & Reform Committee, Subcommittee on Economic and Consumer Policy, “Examining the Public Health Risks of Carcinogens in Consumer Products.”
    • House Education & Labor Committee, “Growing a Healthy Next Generation: Examining Federal Child Nutrition Programs.”
    • House Energy & Commerce Committee, Subcommittee on Health, “Fiscal Year (FY) 2020 HHS Budget Request.”
  • Wednesday, March 13
    • House Energy & Commerce Committee, Subcommittee on Health, “Lowering the Cost of Prescription Drugs: Reducing Barriers to Market Competition.”
    • House Appropriations Committee, Subcommittee on Labor, HHS, and Education, “FY 2020 HHS Budget Request.”
  • Thursday, March 14
    • Senate Finance Committee, “The President’s FY 2020 Budget.”

 Notable Policy Events –

  • Monday, March 11
    • Heritage Foundation, “Affirming Ethical Options for the Terminally Ill.” Additional information: https://herit.ag/2TvxECA
  • Tuesday, March 12
    • Department of Veterans Affairs (VA) and Sanford Health, “News Conference to Announce New Patient Care Initiative.”
  • Wednesday, March 13
    • Nextgov, “Healthcare 2030: The Future of Intelligent Healthcare.” Additional information: https://bit.ly/2STV27f
  • Wednesday, March 13 – Thursday, March 14
    • America’s Health Insurance Plans (AHIP), “2019 National Health Policy Conference.” Additional information: https://bit.ly/2BJlWKv
  • Thursday, March 14 – Friday, March 15
    • AHIP, “2019 National Conference on the Individual and Small Group Markets.” Additional information: https://bit.ly/2oRzbka
  • Friday, March 15
    • Bipartisan Policy Center (BPC), “A New Era for Federal Evaluation: Implementing the Evidence Act.” Additional information: https://bit.ly/2XMr88T
    • National Coalition on Health Care (NCHC), “IS Arbitration a Solution to High Drug Prices?” Additional information: http://bit.ly/2Uv82Cb


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

 Legislative Activity –

  • On March 4, Sen. Kennedy (R-LA) introduced the Phair Pricing Act of 2019 (S. 640), which would direct all price reductions, incentive payments, and adjustments between a PBM and pharmacy be included at the point-of-sale. Rep. Collins (R-GA) introduced companion legislation in the House in February (H.R. 1034). Press release: https://bit.ly/2HnmR6a
  • Also on March 4, Rep. Abraham (R-LA) and 8 cosponsors introduced the Income Verification Act (H.R. 1495), which would require state agencies to use federal tax return information to verify income eligibility for Medicaid, TANF, and SNAP. Sen. Kennedy (R-LA) introduced companion legislation in the Senate (S. 588). Press release: https://bit.ly/2NOzdVN
  • Also on March 4, Rep. Rush (D-IL) introduced the Protecting Consumer Access to Generic Drugs Act of 2019 (H.R. 1499), which would prohibit brand name drug and biologic manufacturers from compensating generic drug and biosimilar manufacturers to delay the entry of generics into the market. Press release: https://bit.ly/2J0UWvc
  • Also on March 4, Rep. Dingell (D-MI) and 7 cosponsors introduced the Medicare Hearing Aid Coverage Act (H.R. 1518), which would expand Medicare to cover hearing aids for beneficiaries. Press release: https://bit.ly/2C9qglo
  • Also on March 4, Sens. Coons (D-DE) and Cassidy (R-LA) introduced the Medicare Choices Empowerment and Protection Act (S. 618), which would offer a small, one-time financial incentive to encourage Medicare beneficiaries to provide clear legal guidance to their medical providers and family members should they become incapable of speaking for themselves. Press release: https://bit.ly/2J25B8N
  • On March 5, Reps. Kind (D-WI), Ruiz (D-CA), Reed (R-NY), and Guthrie (R-KY) introduced the Treat and Reduce Obesity Act (H.R. 1530), which would expand access to treatment options for Medicare enrollees affected by obesity. Press release: https://bit.ly/2IZjwMX
  • Also on March 5, Rep. Higgins (R-LA) and 5 bipartisan cosponsors introduced the Long Term Care Veterans Choice Act (H.R. 1527), which would authorize VA to place veterans into medical foster homes that meet VA standards. Press release: https://bit.ly/2EZsCW1
  • Also on March 5, Sen. Braun (R-IN) introduced the Drug Price Transparency Act (S. 657), which would extend the Department of Health of Human Services’ (HHS) proposed rebate rule to the commercial insurance market and prohibit PBMs from receiving any rebates or reductions in price from manufacturers. Press release: https://bit.ly/2tTri0j
  • Also on March 5, Sen. Braun (R-IN) introduced the Accelerated Drug Approval for Prescription Therapies (ADAPT) Act (S. 658), which would create an expedited drug approval process at FDA for drugs that are currently approved for sale in developed countries. Press release: https://bit.ly/2tTri0j
  • Also on March 5, Sens. Collins (R-ME), Kaine (D-VA) and 4 bipartisan cosponsors introduced the Biologic Patent Transparency Act (S. 659), which would require companies to publicly disclose patents that protect their biologics. Press release: https://bit.ly/2SPobAx Bill text: https://bit.ly/2TJ0qyV
  • Also on March 5, Sen. Braun (R-IN) introduced the Efficiency and Transparency in Petitions Act (S. 660), which would require any petition submitted to FDA regarding a pending generic drug application be submitted within a year of when the petitioner first discovers the issue that is the basis for the petition. Press release: https://bit.ly/2tTri0j
  • On March 6, Reps. Engel (D-NY) and Stivers (R-OH) introduced the Quality Care for Moms and Babies Act (H.R. 1551), which would develop maternity care quality measures and supporting care collaboratives in Medicaid and CHIP. Press release: https://bit.ly/2XIy6LX
  • Also on March 6, Reps. Hastings (D-FL), Dingell (D-MI), and Jackson Lee (D-TX) introduced the Outpatient Mental Health Modernization Act of 2019 (H.R. 1564), which would require Medicare to reimburse Partial Hospitalization Programs (PHPs) for providing transportation, food, nutritional services, and vocational counseling to psychiatric patients. Press release: https://bit.ly/2Ca6IO2 Bill text: https://bit.ly/2XERj14
  • Also on March 6, Rep. Payne (D-NJ) and 122 bipartisan cosponsors introduced the Removing Barriers to Colorectal Cancer Screening Act of 2019 (H.R. 1570), which would waive coinsurance under Medicare for colorectal screening tests, regardless of whether therapeutic intervention is required during the screening. Sen. Brown (D-OH) and 42 bipartisan cosponsors introduced companion legislation in the Senate (S. 668). Press release: https://bit.ly/2H69bNu Bill text: https://bit.ly/2SRHxF6
  • Also on March 6, Sen. Thune (R-SD) and 8 bipartisan cosponsors introduced the Personal Health Investment Today (PHIT) Act (S. 680), which would allow individuals to use a portion of the money saved in their HSA/FSA toward qualified sports and fitness purchases. Press release: https://bit.ly/2Uw3pb6
  • Also on March 6, Sens. Heinrich (D-NM), Rounds (R-SD) and 23 bipartisan cosponsors introduced the Middle Class Health Benefits Tax Repeal Act of 2019 (S. 684), which would repeal the ACA’s “Cadillac Tax.” Press release: https://bit.ly/2EPIBom Bill text: https://bit.ly/2tWZhoM
  • On March 7, Reps. Dingell (D-MI), Morelle (D-NY), Fitzpatrick (R-PA), and McMorris Rodgers (R-WA) introduced the Senior and Disability Home Modification Assistance Initiative Act of 2019 (H.R. 1583), which creates an initiative buy the HHS Assistant Secretary for Aging to coordinate, review, and promote federal home modification programs and resources that are available to older adults and people with disabilities. Sen. King (I-ME) introduced companion legislation in the Senate (S. 702). Press release: https://bit.ly/2H5iA85
  • Also on March 7, Rep. Gabbard (D-HI) and 23 bipartisan cosponsors introduced the Marijuana Data Collection Act of 2019 (H.R. 1587), which would direct the HHS Secretary to enter into a 10-year arrangement with the National Academy of Sciences to conduct and update biennially a study on the effects of state legalized marijuana programs. Press release: https://bit.ly/2EXswyd
  • Also on March 7, Reps. Katko (R-NY) and Suozzi (D-NY) introduced H.R. 1614, which would establish registration requirements for prescribers of opioids. Sen. Gillibrand (D-NY) introduced companion legislation in the Senate (S. 724).
  • Also on March 7, Sens. Casey (D-PA), Blumenthal (D-CT), Gillibrand (D-NY), and Baldwin (D-WI) introduced the Medicare Extra Rx HELP Act (S. 691), which would expand access to assistance with out-of-pocket costs under Medicare Part D for low-income seniors and individuals with disabilities. Press release: https://bit.ly/2UrhA13
  • Also on March 7, Sens. Toomey (R-PA), Klobuchar (D-MN) and 23 bipartisan cosponsors introduced S. 692, which would repeal the medical device excise tax. Press release: https://bit.ly/2Tp5Y1W
  • Also on March 7, Senate Aging Committee Chair Collins (R-ME) and Ranking Member Casey (D-PA) introduced S. 709, which would establish an interactive dashboard to allow the public to review information on the price and utilization of prescription drugs purchased by federal programs. Press release: https://bit.ly/2H6Vo9s Bill text: https://bit.ly/2TJ0qyV
  • Also on March 7, Senate Veterans’ Affairs Ranking Member Tester (D-MT) and 8 bipartisan cosponsors introduced the Care and Readiness Enhancement (CARE) for Reservists Act (S. 711), which would expand eligibility for VA mental health services to include members of the reserve components of the Armed Forces. Press release: https://bit.ly/2Tp4yES Bill text: https://bit.ly/2SUpcHI                                                                                       

ACA and Individual Market –

  • On March 5, House New Democrat Coalition members sent a letter to House Ways & Means Committee Chair Neal (D-MA), House Energy & Commerce Committee Chair Pallone (D-NJ), and House Education and Labor Committee Chair Scott (D-VA), urging them to prioritize strengthening the ACA. Press release: https://bit.ly/2NUzg2E Letter: https://bit.ly/2VCdBPl
  • On March 6, CMS issued a request for information (RFI) soliciting recommendations on how to eliminate regulatory, operational, and financial barriers to enhance issuers’ ability to sell health insurance coverage across state lines. Comments are due by May 10. Press release: https://go.cms.gov/2SK6cLT RFI: https://bit.ly/2EQfLUT

 Medicare and Medicaid –

  • On March 5, CMS announced several updates to the Nursing Home Compare and Five-Star Quality Rating System, which are intended to strengthen consumers’ ability to compare quality between nursing homes. Press release: https://go.cms.gov/2IZMcVS
  • Also on March 5, CMS issued guidance addressing violations of health and safety regulations that cause serious harm or death to a patient and require immediate action to prevent further serious harm – otherwise known as immediate jeopardy. Guidance: https://go.cms.gov/1ifReTN Blog: https://go.cms.gov/2tVGYAo
  • On March 6, CMS released data underlying the proposed policies regarding the use of extrapolation in the MA Risk Adjustment Data Validation (RADV) audits and fee-for-service adjustor. Data: http://bit.ly/2J3SLa8
  • On March 8, CMS released a fact sheet on the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Round 2021, including new updates to the program. Fact sheet: https://go.cms.gov/2ENwW9i
  • Also on March 8, Senate Finance Committee Chair Grassley (R-IA) and Subcommittee on Healthcare Chair Toomey (R-PA) sent a letter to CMS Administrator Verma requesting data on recoveries and eligibility error rates to better understand the depth and breadth of improper eligibility-related payments. Press release: http://bit.ly/2TGKjSa Letter: http://bit.ly/2TFTCSh

Payment and Delivery System Reform –

  • On March 5, CMS posted slides from the February 28 Deep Dive webinar on the Medicare Advantage Value-Based Insurance Design (VBID) and Part D Modernization models. Applications to participate in the VBID model for 2020 are due March 15. Slides: https://bit.ly/2HsY0hl

 Drug and Medical Device Prices and Regulation –

  • On March 4, Sens. Smith (D-MN), Durbin (D-IL), Kramer (R-ND), and Cassidy (R-LA) sent a letter to FDA Commissioner Gottlieb urging the FDA to reverse course on changes the agency has proposed that would make it harder for lower-cost generic insulin products to come to market. Press release: http://bit.ly/2J4R1NZ Letter: http://bit.ly/2J6zJ2M
  • On March 5, U.S. Food and Drug Administration (FDA) Commissioner Gottlieb announced his intention to resign from the agency in April 2019. HHS press release: https://bit.ly/2NRMugr CMS press release: https://go.cms.gov/2EHRFeK
  • Also on March 5, the GOP Doctors Caucus penned a letter to HHS Secretary Azar in support of the Department’s proposed rule to limit the use of rebates in the Medicare Part D supply chain. Press release: https://bit.ly/2EPW1ke Letter: https://bit.ly/2SPCBRb
  • On March 7, FDA released draft guidance to help secure pharmacovigilance so that FDA can effectively monitor all biological products in the post market and promote patient safety. Press release: https://bit.ly/2tY53Xc Draft guidance: https://bit.ly/2CadJOS

 ubstance Use and Mental Health –

  • On March 4, FDA sent letters to various companies inquiring further about the companies’ sale of e-cigarette products to youths. Press release: https://bit.ly/2HfCDjq
  • On March 6, HHS released a report on best practices and barriers to engaging people with substance use disorders (SUD) in treatment. Summary with link to report: https://bit.ly/2tZGHMw
  • Also on March 6, Sens. Manchin (D-WV) and Capito (R-WV) led a group of 11 bipartisan Senators in urging HHS Secretary Azar to initiate a rulemaking process to alter 42 CFR Part 2 in order to give health care providers access to a patient’s complete medical history, including substance use treatments. Press release: https://bit.ly/2CbghMF Letter: https://bit.ly/2CdDqhc
  • Also on March 6, the New Hampshire Congressional delegation penned a letter to President Trump, urging him to prioritize funding for State Opioid Response (SOR) grants in his annual budget proposal to Congress. Press release: https://bit.ly/2SStZJN Letter: https://bit.ly/2tXvUm4
  • On March 7, HHS released a Notice of Funding Opportunity (NOFO) for a new Rural Communities Opioid Response Program (RCORP) initiative called RCORP-Implementation. HHS plans to award approximately 75 grants to rural communities as a part of this opportunity. Press release: https://bit.ly/2JaakoO
  • Also on March 7, U.S. Government Accountability Office (GAO) released a report containing preliminary observations on the 2019 National Drug Control Policy. GAO notes that the strategy does not include certain legally required information, such as specific targets against which agency success can be measured. Summary with link to report: https://bit.ly/2Hr2xAR

 Health Data and IT –

  • On March 4, Senate Finance Committee Chair Grassley (R-IA) released a set of frequently asked questions related to CMS’ Electronic Health Records program. FAQ: http://bit.ly/2J2MkE5
  • Also on March 4, Senior Advisor to the President Kushner, White House Deputy Chief of Staff for Policy Coordination Liddell, and CMS Administrator Verma penned an op-ed highlighting the opportunities and benefits that may result from the recent proposed rules from CMS and ONC on interoperability and information blocking. Op-ed: http://bit.ly/2J32QnS
  • On March 5, HHS announced that an app called PRISM won a multi-phase competition to address the need for greater use of standardized patient-reported outcomes data in clinical care and research. Press release: https://bit.ly/2NJob4h
  • On March 6, HHS released a report to help better understand the context of how evaluation and research results are used to make decisions within the government. Summary with link to report: https://bit.ly/2TzChuy
  • Also on March 6, HHS released a report on the experiences of Medicaid programs and health centers in implementing telehealth, finding that if health centers could serve as both originating and distant sites, it could spur further utilization of telehealth, among other findings. Summary with link to report: https://bit.ly/2IZ6ejC
  • On March 7, HHS announced a challenge competition to develop new online tools to present and encourage use of free, publicly available social determinants of health data to better understand and predict communities’ unmet health care needs. Press release: https://bit.ly/2H5mlud

 Veterans and Military Health –

  • On March 5, President Trump signed an executive order titled “National Initiative to Empower Veterans and End Veterans Suicide,” which focuses on improving the quality of life for veterans and ending veteran suicide. Press release: https://bit.ly/2HluwSd Executive Order: https://bit.ly/2TvB9cc
  • On March 7, Department of Veterans Affairs (VA) announced the selection of 18 medical facilities to lead the way in the department’s efforts to transform VA into a high reliability organization (HRO). Press release: https://bit.ly/2TxAgyZ

 Misc. –

  • On March 4, CMS Administrator Verma delivered remarks at the Federation of American Hospitals 2019 Public Policy Conference, in which she highlighted the interactions between federal payers and hospitals. Transcript: https://go.cms.gov/2H9xvhd
  • On March 7, Senate HELP Committee Ranking Member Murray (D-WA) issued a memo to Senate Democrats with public comments in opposition to the Trump Administration’s Title X final rule. Press release: https://bit.ly/2NS4DLg Memo: https://bit.ly/2TnIBpq
  • Also on March 7, House Energy & Commerce Committee Chair Pallone (D-NJ) and Ranking Member Walden (R-OR), along with 6 bipartisan members of the Committee, penned a letter to Indian Health Service (IHS) Acting Director Weahkee requesting information about reported medical errors and systemic failures at IHS hospitals. Press release: https://bit.ly/2C89z9Y Letter: https://bit.ly/2HnF6IE
  • Also on March 7, Sens. Cortez Masto (D-NV), Tester (D-MT), and Udall (D-NM) penned a letter to HHS Secretary Azar calling on him to explain why HHS removed health care resources for tribal communities from its Office of Minority Health and Administration for Native Americans websites. Press release: https://bit.ly/2TmNpvr Letter: https://bit.ly/2VM9pN6