What’s Ahead: This Week

Hearings –

  • Wednesday, March 18
    • Senate HELP Committee, “An Emerging Disease Threat: How the U.S. is Responding to COVID-19, the Novel Coronavirus – Part 2.”

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

Legislative Activity –

Committee Actions and Votes –

  • On March 11, the House Energy & Commerce Committee, Health Subcommittee passed by a voice vote the Beneficiary Enrollment Notification and Eligibility Simplification Act of 2019 (H.R. 2477) and the Protecting Patients Transportation to Care Act (H.R. 3935). The Health Subcommittee also passed by a voice vote the Cosmetic Safety Enhancement Act of 2019 (H.R. 5279), the Making Objective Drug Evidence Revisions for New Labeling Act of 2020 (H.R. 5668), the Safeguarding Therapeutics Act (H.R. 5663), the Fairness in Orphan Drug Exclusivity Act (H.R. 4712), the Food Allergy Safety, Treatment, Education, and Research Act of 2019 (H.R. 2117), the School-Based Allergies and Asthma Management Program Act (H.R. 2468), the National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2019 (H.R. 4866), the Scarlett’s Sunshine on Sudden Unexpected Death Act (H.R. 2271), the Healthy Start Reauthorization Act of 2019 (H.R. 4801), the Ensuring Lasting Smiles Act (H.R. 1379) and the Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act (H.R. 5534). The bills now move to the full Committee for consideration. Action Summary: http://bit.ly/2TLGZEH
  • On March 12, the House Veterans’ Affairs Committee unanimously passed the VA Medical Cannabis Research Act (H.R. 712), the Veterans Equal Access Act (H.R. 1647), the Homeless Veterans with Children Reintegration Act (H.R. 2224), the Equal Access to Contraception for Veterans Act (H.R. 3798), H.R. 5781, which would improve liability for GI Bill debts, the VA Family Leave Act of 2020 (H.R. 6036), the VET TEC Expansion Act (H.R. 5766), the Veterans in STEM Act (H.R. 6140), H.R. 6018, which would authorize the Secretary of Veterans Affairs to collect overpayments of specially adapted housing assistance, the Transparency for Student Veterans Act (H.R. 6157), the Veterans’ Compensation COLA Act (H.R. 6168), the Vet OUTREACH Act (H.R. 5284), the Vietnam Era Veterans Hepatitis-C Testing Enhancement Act (H.R. 2816), the VET CARE Act (H.R. 2628), the Long Term Care Veterans Choice Act (H.R. 1527), the Streamlining GI Bill Processing Act of 2020 (H.R. 5750) and S. 3084, which would modify the limitation on pay for certain high-level employees and officers of the Department of Veterans Affairs. The bills now move to the full House for consideration. Press release: http://bit.ly/2U20vMa All Bill text: http://bit.ly/2wTASoV

Introduced Legislation –

  • On March 9, Rep. Schakowsky (D-IL) introduced the No More Narrow Networks Act (H.R. 6135), which would amend the Patient Protection and Affordable Care Act to require Exchanges to establish network adequacy standards for qualified health plans. Press release: http://bit.ly/2VZGJmS Bill text: http://bit.ly/38BzWmh
  • Also on March 9, Rep. Schakowsky (D-IL) introduced the Protecting Consumers from Unreasonable Rates Act (H.R. 6136), which would amend the Public Health Service Act to provide protections for consumers against excessive, unjustified, or unfairly discriminatory increases in premium rates. Press release: http://bit.ly/2VZGJmS Bill text: http://bit.ly/33eQWxC
  • Also on March 9, Rep. Underwood (D-IL) and twenty-three cosponsors introduced the Black Maternal Health Momnibus (H.R. 6142), which includes nine bills to end preventable maternal mortality and severe maternal morbidity in the United States and close disparities in maternal health outcomes. The Maternal Health Momnibus includes the Social Determinants for Moms (H.R. 6132); the Honoring Kira Johnson (H.R. 6144); the Protecting Moms Who Served (H.R. 6141); the Perinatal Workforce (H.R. 6164); the Data to Save Moms (H.R. 6165); the Moms MATTER (H.R. 6143); the Justice for Incarcerated Moms (H.R. 6129); the Tech to Save Moms (H.R. 6138); and the Innovative Maternal Payment and Coverage To Save Moms Act (H.R. 6137). Sen. Harris and twelve cosponsors introduced companion legislation in the Senate (S. 3424). Rep. Underwood (D-IL) Press release: http://bit.ly/335glK0 Sen. Harris (D-CA) Press release: http://bit.ly/2W72FfR One-pager: http://bit.ly/38E30cH Section-by-section: http://bit.ly/3aKNPzM
  • Also on March 9, Reps. Cartwright (D-PA), Katko (R-NY) and Cicilline (D-RI) introduced the Help Extend Auditory Relief (HEAR) Act (H.R. 6147), which would amend title XVIII of the Social Security Act to provide for coverage under the Medicare program of hearing aids and related hearing services. Press release: http://bit.ly/2TUWybW
  • Also on March 9, Rep. Cole (R-OK) and Luria (D-VA) introduced the TRICARE ECHO Improvement Act (H.R. 6148), which would amend title 10, United States Code, to expand benefits available under the TRICARE Extended Health Care Option program. Press release: http://bit.ly/2IK9Na5 Bill text: http://bit.ly/3cS9kAA 
  • Also on March 9, Rep. Cunningham (D-SC) introduced the Medicaid REACH Act (H.R. 6149), which would amend title XIX of the Social Security Act to enhance reporting requirements for non-expansion States. Press release: http://bit.ly/2Q8az4T  
  • Also on March 9, Rep. Finkenauer (D-IA) and Buchanan (R-FL) introduced the Comprehensive Access to Robust Insurance Now Guaranteed (CARING) for Kids Act H.R. 6151, which would amend title XXI of the Social Security Act to permanently extend the Children’s Health Insurance Program. Press release: http://bit.ly/39J0djR
  • On March 10, Rep. Kim (D-NJ) and Barr (R-KY) introduced the Cardiomyopathy Health Education, Awareness, Research, and Training in the Schools (HEARTS) Act (H.R. 6166), which would authorize and support the creation and dissemination of cardiomyopathy education, awareness, and risk assessment materials and resources to identify more at-risk families, to authorize research and surveillance activities relating to cardiomyopathy. Press release: http://bit.ly/2vjafcA
  • Also on March 10, Rep. Lipinski (D-IL) introduced the Dogs Offering Gentle Support Act (H.R. 6170), which would direct the Secretary of Health and Human Services to carry out a pilot program to study the efficacy of dog-assisted therapy on vulnerable populations. Press release: http://bit.ly/3cUhlVO
  • Also on March 10, Reps. Bonamici (D-OR), Nadler (D-NY), Grijalva (D-AZ), Blumenauer (D-OR) and Sablan (D-MP) introduced the Enhancing Questions to Understand Intentions for Pregnancy (EQUIP) Act (H.R. 6178), which would provide for a demonstration program to facilitate the clinical adoption of pregnancy intention screening initiatives by health care and social service providers. Press release: http://bit.ly/2W0vA5s Summary: http://bit.ly/39GKq5a Bill text: http://bit.ly/2ICZZ1L
  • Also on March 10, Reps. Cardenas (D-CA), Hudson (R-NC), Craig (D-MN) and Fitzpatrick (R-PA) introduced the Increasing Access to Biosimilars Act of 2020 (H.R. 6179), which would require the Secretary of Health and Human Services to establish a demonstration project to increase access to biosimilar biological products under the Medicare program. Press release: http://bit.ly/38DNHRb
  • Also on March 10, Reps. DeLauro (D-CT), McGovern (D-MA), Pingree (D-ME), Hayes (D-CT), Lee (D-CA) and Fudge (D-OH) introduced the Ensuring Emergency Food Security Act (H.R. 6181), which would prevent the changing of regulations governing the Supplemental Nutrition Assistance Program, to provide for expanded food security. Press release: http://bit.ly/2IFARHC
  • Also on March 10, Sens. Blackburn (R-TN) and Menendez (D-NJ) introduced the Securing America’s Medicine Cabinet Act (S. 3432), which would support the advanced manufacturing technologies program of the Food and Drug Administration, to establish National Centers of Excellence in Advanced Pharmaceutical Manufacturing. Press release: http://bit.ly/2W4dq2H
  • Sen. Thune (R-SD) and Cardin (D-MD) introduced companion legislation in the Senate (S. 3447). Press release: http://bit.ly/2w4LnW6
  • Also on March 11, Sen. Scott (R-FL) and Sinema (D-AZ) introduced the Lower Health Insurance Deductibles Act (S. 3439), which would permit high deductible health plans to divide the deductible between medical and drug costs for purposes of qualifying for health savings accounts. Press release: http://bit.ly/2TLZDML
  • On March 12, Sen. Moran (R-KS) introduced the Consumer Data Privacy and Security Act (S. 3456), which would protect the privacy of consumers. Press release: http://bit.ly/3aSFREK Bill text: http://bit.ly/2vlbrw2 Section-by-section: http://bit.ly/2vkpcLq
  • Also on March 12, Sen. Durbin (D-IL) and ten bipartisan cosponsors introduced the Commission on America’s Medical Security (S. 3478), which would require a report to assess, evaluate, and address the dependence of the United States on critical drugs and devices sourced or manufactured outside of the United States. Press release: http://bit.ly/2U39Lzp

Individual Market and ACA Implementation – On March 13, CMS posted guidance on third-party auditor operational readiness reviews for the Enhanced Direct Enrollment (EDE) pathway and related oversight requirements. Guidance: https://go.cms.gov/2W9Q7o3  

Medicare – On March 13, Medicare Payment Advisory Commission (MedPAC) released its March Report to Congress, which includes chapters analyzing f payment adequacy in Medicare fee-for-service, and the status of the Medicare Advantage program and the prescription drug program. Press release: http://bit.ly/3aS5YMa Fact sheet: http://bit.ly/2xBiHo5 Report: http://bit.ly/2QgweYK

Medicaid –

  • On March 9, CMS published three Maternal and Infant Health Initiative briefs designed to help states implement quality measurement and improvement projects. Summary of state projects: http://bit.ly/33epSP0 The Maternal and Infant Health Initiative Grant Program: http://bit.ly/2vj4iw4 Lessons Learned about Payment Strategies to Improve Postpartum Care: http://bit.ly/33epSP0
  • On March 10, Reps. Burgess (R-TX), Veasey (D-TX), Olson (R-TX) and Fletcher (D-TX) led the entire Texas House Congressional Delegation in sending a letter to CMS Administrator Verma expressing concern over the proposed Medicaid Fiscal Accountability Regulation (MFAR) and urging her to protect Medicaid funds for Texas hospitals. Press release: http://bit.ly/39Jck0b Letter: http://bit.ly/2vj9X5u
  • On March 13, U.S. Government Accountability Office (GAO) recommended that CMS take steps to obtain quality information on the experiences of dual-eligible beneficiaries who have been default enrolled in D-SNPs. HHS concurred with the recommendation. Summary with link to report: http://bit.ly/33izyYx
  • Also on March 13, the Medicaid and CHIP Payment and Access Commission (MACPAC) released its March Report to Congress, which includes chapters on Medicaid Disproportionate Share Hospital payments, quality of care, and timeliness of Medicaid and CHIP demonstration evaluations. Report: http://bit.ly/3d1AmG0

New Payment and Delivery System Models –

  • On March 10, CMS announced a series of Medicare Advantage Value-Based Insurance Design -hospice benefit component office hours. Information: http://bit.ly/2W3anrB
  • Also on March 10, the Physician-Focused Payment Model Technical Advisory Commission (PTAC) published a report providing an overview of proposed models PTAC deliberated and voted on as of December 2019, and a report summarizing PTAC voting patterns and comments on the proposed models. Press release: http://bit.ly/2xDnWDZ Overview report: http://bit.ly/2wRpKJ4 PTAC Voting Patterns and Comments: http://bit.ly/2TPcz4v
  • On March 11, CMS announced a new Part D Senior Savings Model, which will test the impacts of offering beneficiaries an increased choice of enhanced alternative Part D plan options that offer lower out-of-pocket costs for insulin. CMS released requests for applications (RFAs) for Part D sponsors and for pharmaceutical manufacturers. Applications are due by March 18 for pharmaceutical manufactures. A letter of intent (LOI) is due by April 10 and applications are due by May 1 for Part D sponsors. Press release: https://go.cms.gov/2IQqGAl Fact sheet: https://go.cms.gov/3aLru5b RFA for pharmaceutical manufacturers: http://bit.ly/2ICKRBF RFA for Part D sponsors: http://bit.ly/38Hwsyz
  • Also on March 11, CMS posted a timeline of upcoming events for the Direct Contract Model Options and Medicare Shared Savings Program. Timeline: http://bit.ly/2vhEAbs

Prescription Drug and Medical Device Policy –

  • On March 9, HHS Office of Inspector General (OIG) found that in the third quarter of 2019, 11 drug codes met CMS’ price substitution criteria, whereby CMS makes price substitutions when the average sales price (ASP) exceeds the average manufacturer prices (AMP) by 5 percent in the two previous quarters or three of the previous four quarters. HHS OIG is requiring CMS to determine whether to pursue price substitutions that would limit excessive payments for Part B drugs. Summary with link to report: http://bit.ly/3aQVuNf
  • Also on March 9, Senate Finance Committee Chair Grassley (R-IA) joined the Rare Disease Congressional Caucus. Press release: http://bit.ly/2TXxMbd
  • On March 10, HHS OIG issued a brief focusing on three key tools to safeguard Part D against pharmacy fraud including pharmacy enrollment, revocation and preclusion. HHS OIG finds that if these three key tools were available to Part D, CMS could take direct action against pharmacies that pose risks to the Medicare program or beneficiaries. Summary with link to brief: http://bit.ly/2w1x2dd
  • Also on March 10, the White House sent Congress a set of principles for drug pricing reform which include capping Medicare Part D beneficiary annual out-of-pocket pharmacy expenses, providing an option to cap Medicare Part D beneficiary monthly out-of-pocket pharmacy expenses, offering protection for seniors against the out-of-pocket cost cliff created by the ACA, giving insurance companies an incentive to negotiate better prices for costs drugs, and limiting drugmakers’ price increases. Press release: http://bit.ly/38IDbs2 White House Press Secretary Statement: http://bit.ly/2TFhOnc
  • On March 13, FDA finalized guidance for industry on applications for drugs with inadequate generic competition and how drugs can be designated competitive generic therapies. Brief: http://bit.ly/2TNx3dF Guidance: http://bit.ly/3cXeJX9
  • Also on March 13, Senate Finance Committee Chair Grassley (R-IA) and Ranking Member Wyden (D-OR) announced that the Congressional Budget Office estimated that the Prescription Drug Pricing Reduction Act (S. 2543) would save $95 billion over ten years. Press release: http://bit.ly/2TPGl94 CBO score: http://bit.ly/2TPIyBw

Health Data and IT –

  • On March 9, CMS published the Interoperability and Patient Access final rule, which among other things, requires CMS-regulated payers to implement and maintain a secure, standards-based API, make provider directory information publicly available via a standards-based application programming interface (API), and exchange certain patient clinical data at the patient’s request. Press release: https://go.cms.gov/3cSEPdI Fact sheet: https://go.cms.gov/2IG4aK5 Final rule: https://go.cms.gov/3aI2RWY
  • Also on March 9, HHS published the Interoperability, Information Blocking, and the ONC Health IT Certification Program final rule, which among other things, establishes secure, standards-based API requirements and identifies and finalizes the reasonable and necessary activities that do not constitute information blocking while establishing new rules to prevent “information blocking” practices by healthcare providers, developers of certified health IT, health information exchanges, and health information networks. Press release: https://go.cms.gov/3cSEPdI Blog post: http://bit.ly/3391CxH Final rule: http://bit.ly/2W2fZCe
  • On March 12, HHS posted a blog highlighting details of the ONC 21st Century Cures Act final rule including what is allowed under information blocking and calls for additional work on secondary uses of patient data. Blog post: http://bit.ly/3cWLnIi

Mental Health and Substance Use Policy – On March 10, HHS OIG found that the Substance Abuse and Mental Health Services Administration’s (SAMHSA) oversight of accreditation bodies for opioid treatment programs did not comply with federal requirements. HHS OIG recommended that SAMHSA identify steps it can take to ensure it meets its goal for the number of OTPs it inspects each year and review the results of inspections and take action to address accreditation bodies’ noncompliance with survey requirements. Summary with link to report: http://bit.ly/337MhgS  

Veterans and Military Health – On March 11, VA announced that as part of the MISSION Act, VA is transitioning its urgent care network manager effective March 18, which will result in new urgent care providers being added to VA’s contracted network, while others will be removed. Press release: http://bit.ly/338rr0E

Public Health –

  • On March 9, FDA issued draft guidance proposing that drug companies will no longer be required to conduct large cardiovascular safety studies for all new type 2 diabetes therapies. Comments are due by June 8. Press release: http://bit.ly/2ICemU1 Proposed guidance: http://bit.ly/3cPMlpR 
  • On March 10, FDA issued warning letters to 22 online and brick-and-mortar e-cigarette product retailers and manufacturers across the country to remove unauthorized e-cigarette products from market. Press release with letters: http://bit.ly/2W5ijsc
  • On March 12, CDC published an annual report finding that cancer death rates have continued to decline from 2001 to 2017 in the United States for all cancer sites. Cancer death rates decreased in all major racial and ethnic groups and among men, women, adolescents, young adults, and children. Press release: http://bit.ly/2xyEBZj Report: http://bit.ly/2Q8XfNV
  • Also on March 12, HHS posted a report on rethinking the role of primary care in reducing hospital readmissions and re-examining the dynamic to involve primary and specialty physicians, hospitals and other partners in providing complete and coordinated care. Blog: http://bit.ly/2Qb00Or Report: http://bit.ly/2TOf07h 

Misc. –

  • On March 11, HHS released a report on 47 patient safety practices, including technological and staffing-related practices, a series of specific hygiene and disinfection interventions for reducing healthcare-associated infections, and several practices designed to prevent medication errors and reduce opioid misuse and overdoses. Press release: http://bit.ly/39K5hEx Report: http://bit.ly/38McC53
  • On March 12, HHS posted a series of documents to assist states in planning a comprehensive array of services that help prevent the need for foster care placement by braiding Title IV-E prevention services reimbursement with Medicaid and other funding mechanisms. Introduction to the toolkit: http://bit.ly/2Q8TVlC Identifying and engaging partners: http://bit.ly/2U47Daz Assessing population, service needs, and service coverage: http://bit.ly/3aOjws6 Determining priorities, goal and actions: http://bit.ly/38Lphp5 Understanding roles of funding and decision points: http://bit.ly/2vhvA69 Developing a plan for Title IV-E prevention services: http://bit.ly/3aKvUJA
  • Also on March 12, GAO found that spending for major health and retirement programs will grow more rapidly than the gross domestic product (GDP) in coming decades as a consequence of both an aging population and projected continued increases in health care costs per beneficiary. Summary with link to report: http://bit.ly/2W9ElKz