What’s Ahead: This Week

 Congressional Recess –

• Congress is currently in recess, and will return the week of September 4.

Notable Policy Events –

• Monday, August 6 – Thursday, August 9
  • National Association of Insurance Commissioners, “Summer 2017 National Meeting.” (Philadelphia, PA) Additional information: http://bit.ly/2vDJlK5
• Tuesday, August 7
  • National Academy of Social Insurance, “Demystifying Health Policy: Medicare, Medicaid and the Individual Marketplace.” Additional information: http://bit.ly/2vDo5nE
  • National Business Group on Health, “Large Employers’ 2018 Health Care Strategy and Plan Design Survey.” Additional information: http://bit.ly/2vDNSMs

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

 Nominations –

• On August 3, the Senate unanimously approved a number of nominations, including Lance Allen Robertson to serve as Assistant Secretary for Aging, Dr. Brett Giroir to serve as Assistant Secretary for Health, Dr. Robert Kadlec to serve as Assistant Secretary for Preparedness and Response, Dr. Elinore McCance-Katz to serve as Assistant Secretary for Mental Health and Substance Use, and Dr. Jerome Adams to serve as Surgeon General of the Public Health Services. Press release: http://bit.ly/2u9lhLn

 Legislative Activity –

• On July 31, Sen. Donnelly (D-IN) introduced two bills, the Community Facilities Direct Loans and Grants Act and the Distance Learning and Telemedicine Act (S. 1677 and S.1678) which would improve access to grants and loans for evidence-based substance use disorder treatment services in rural areas. Press release: http://bit.ly/2vxJvTs
• Also on July 31, Sen. Sanders (I-VT) introduced S. 1681, which would require persons who undertake federally funded research and development of drugs to enter into reasonable pricing agreements with the Secretary of Health and Human Services. Rep. DeFazio (D-OR) introduced companion legislation in the House (H.R. 3536). Press releases: http://bit.ly/2v3jPf9 and http://bit.ly/2vxI1IQ Bill text: http://bit.ly/2vy45Tq
• On August 1, the Senate passed the Veterans Appeals Improvement and Modernization Act of 2017 (H.R. 2288), which would reform the rights and processes relating to appeals of decisions regarding claims for benefits under the laws administered by the Secretary of Veterans Affairs. The bill now moves to the President for signature. Press release: http://bit.ly/2v3plOR
• Also on August 1, Sen. Klobuchar (D-MN) and 33 cosponsors introduced the S. 1688, which would allow the Secretary of Health and Human Services to negotiate fair prescription drug prices under Part D of the Medicare program. Press release: http://bit.ly/2v3Jx2X
• Also on August 1, Reps. Jenkins (R-KS) and Kind (D-WI) introduced the Local Coverage Determination Clarification Act (H.R. 3635), which would improve the process whereby Medicare Administrative Contractors issue local coverage determinations under the Medicare program. Press release: http://bit.ly/2v3Cx60
• On August 2, Sens. Roberts (R-KS), Warner (D-VA), Crapo (R-ID), Cardin (D-MD), Young (R-IN), and Cornyn (R-TX) introduced the Dialysis Access Improvement Act (S. 1729), which would provide for independent accreditation for dialysis facilities and assurance of high quality surveys. Press release: http://bit.ly/2vmRL8T
• Also on August 2, Sen. Sanders (I-VT) introduced the Strengthening Veterans Health Care Act of 2017 (S. 1723) which would appropriate amounts to the Department of Veterans Affairs to improve health care furnished by the Department. Press release: http://bit.ly/2vxRgZe
• Also on August 2, Reps. Jenkins (R-KS), Thompson (D-CA), Harper (R-MS) and Lujan (D-NM) introduced the Furthering Access to Coordinated Treatment for Seniors (FACTS) Act, which would provide prescription drug plans under part D of the Medicare program with parts A and B Medicare claims data to promote the appropriate use of medications and improve health outcomes. Press release: http://bit.ly/2vDpQkP Bill text: http://bit.ly/2vDGvVD
• On August 3, the Senate passed by a vote of 94-1 the FDA Reauthorization Act of 2017 (H.R. 2430), which would reauthorize the prescription drug, medical device, and generic drug user fee amendments. The bill now moves to the President for signature. Press release: http://bit.ly/2vxPqHP
• Also on August 3, the Senate unanimously passed Jessie’s Law (S. 581), which would require the Department of Health and Human Services to develop and disseminate best practices for hospitals and physicians regarding displaying the history of opioid addiction in the medical records of patients who have provided information about their addiction to a health care provider. The bill now moves to the House for consideration. Press release: http://bit.ly/2vzQUSH
• Also on August 3, the Senate unanimously passed the BENEFIT Act of 2017 (S. 1052), which would strengthen the use of patient-experience data within the benefit-risk framework for approval of new drugs. The bill now moves to the House for consideration. Press release: http://bit.ly/2weLyJS
• Also on August 3, the Senate unanimously passed the Trickett Wendler Right to Try Act (S. 204), which would authorize the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with state law. The bill now moves to the House for consideration. Press release: http://bit.ly/2vy5gCe
• Also on August 3, Sens. Warner (D-VA) and Isakson (R-GA) and 15 bipartisan cosponsors introduced the Medicare Home Infusion Therapy Access Act of 2017 (S. 1738) which would provide for a home infusion therapy services temporary transitional payment under the Medicare program. Press release: http://bit.ly/2vy64r3
• Also on August 3, Sens. Whitehouse (D-RI) and Portman (R-OH) introduced the Improving Access to Behavioral Health Information Technology Act (S. 1732), which would promote testing of incentive payments for behavioral health providers for adoption and use of certified electronic health record technology. Press release: http://bit.ly/2vxgsza
• Also on August 3, Sen. Stabenow (D-MI) and eight cosponsors introduced the Medicare at 55 Act (S. 1742), which would provide for an option for any citizen or permanent resident of the United States age 55 to 64 to buy into Medicare. Press release: http://bit.ly/2uaXSgF

 ACA Repeal and Replacement Activity –

• On July 31, the House Problem Solvers Caucus, a group of 43 bipartisan representatives, announced a set of agreed upon solutions to stabilize the health insurance markets and to provide relief to individuals, families, and small businesses. Press release: http://bit.ly/2vmVjbr
• On August 1, Senate HELP Committee Chair Alexander (R-TN) and Ranking Member Murray (D-WA) announced their intention to hold hearings beginning the week of September 4 “on the actions Congress should take to stabilize the individual health insurance market…” Press releases: http://bit.ly/2vk3zcd and http://bit.ly/2vjKczN
• Also on July 31, Sen. Donnelly (D-IN) sent a letter to CMS Administrator Verma urging her to make a public commitment to continue cost-sharing reduction payments. Press release with text of letter: http://bit.ly/2v09eS3

ACA Implementation –

• On August 2, CMS posted an update to the Health Insurance Exchanges Issuer County Map, which shows that 19 counties are currently projected to have no issuers in 2018. Press release: http://go.cms.gov/2v5R9C0
• On August 3, the Treasury Inspector General for Tax Administration released a report finding that although required to do so by the ACA, the Internal Revenue Service did not issue notification letters to taxpayers without minimal essential coverage by the statutory June 30, 2015 deadline. Press release: http://bit.ly/2vxaOxr Report: http://bit.ly/2vwPnwq

 Medicare –

• On July 31, CMS released three final rules updating fiscal year 2018 payment and policy for Medicare Inpatient Rehabilitation Facilities (IRFs) and Skilled Nursing Facilities (SNFs), and updating the wage index and payment rates for the Medicare Hospice Benefit. The final rules increase payment rates under the IRF prospective payment system (PPS), aggregate payment rates to SNFs, and the hospice payment rates by 1.0 percent in fiscal year (FY) 2018. Press release: http://go.cms.gov/2vxT8kH IRF Fact sheet and Final rule: http://go.cms.gov/2vxQ7Rr and http://bit.ly/2vxIlY5 SNF Fact sheet and Final rule: http://go.cms.gov/2vxOJP2 and http://bit.ly/2vy0o07 Hospice Benefit Fact sheet and Final rule: http://go.cms.gov/2vxZ79i and http://bit.ly/2vya4HM
• On August 2, CMS announced that the average basic monthly premium for a Medicare Part D prescription drug plan in 2018 is projected to decline by $1.20 to an estimated $33.50 per month. Press release: http://go.cms.gov/2ub6eF6 Premium Data: http://go.cms.gov/2vxN2RC
• On August 3, CMS released the final 2018 payment and policy updates for the inpatient psychiatric facility PPS, which will increase payments by 0.99 percent in FY 2018. Fact sheet: http://go.cms.gov/2vxOC67 Final rule: http://bit.ly/2vxUKLh
• Also on August 3, CMS released final 2018 payment and policy updates for the Medicare Hospital Inpatient prospective payment system (IPPS) and the Long-term Acute Care Hospital (LTCH) PPS. Press release: http://go.cms.gov/2vxOxzl Fact sheet: http://go.cms.gov/2vxKHGh Final rule: http://bit.ly/2vxUY5k

 Medicaid –

• On July 31, CMS released guidance on medical loss ratio credibility adjustments for Medicaid and CHIP managed care contracts for rating periods beginning July 1, 2017 or later. Guidance: http://bit.ly/2vy2Ofd
• Also on July 31, CMS released guidance highlighting strategies for ensuring provider network adequacy and service availability in Medicaid and CHIP managed care. Guidance: http://bit.ly/2vy1etK Toolkit: http://bit.ly/2vy2Zan
• On August 2, CMS released a letter to State Medicaid Directors (SMD) providing guidance on the implications of section 5007 of the 21^st Century Cures Act, which provides Supplemental Needs Trusts for individuals with disabilities. SMD Letter: http://bit.ly/2vxI5s2
• On August 3, CMS announced the approval of Florida’s section 1115 waiver request, which would extend for five-years its current Medicaid managed care demonstration waiver, and includes $1.5 billion for the state’s low-income pool to cover uncompensated care costs for safety net hospitals. Press release: http://go.cms.gov/2vnsE60 Waiver: http://bit.ly/2vnocnQ
• On August 4, House Energy & Commerce Committee Ranking Member Pallone (D-NJ) and Health Subcommittee Ranking Member Greene (D-TX) sent a letter to CMS Administrator Verma expressing concern regarding a recently submitted proposal from the state of Texas which seeks a waiver that would allow Texas to exclude certain family planning providers from the Medicaid program. Press release: http://bit.ly/2u8Ysb2 Letter: http://bit.ly/2u95jRB
• Also on August 4, Senate Finance Committee Ranking Member Wyden (D-OR), Senate Help Committee Ranking Member Murray (D-WA) and 24 Senators sent a letter to CMS Administrator Verma urging her to reject a proposed Medicaid waiver from Texas that would restrict women’s access to family planning and other preventive care. Press release: http://bit.ly/2vwPesS Letter: http://bit.ly/2vwLpUp

 Health IT –

• On August 1, HHS Office of the National Coordinator for Health IT (ONC) released a report describing how its regional extension centers are working with Medicare Accountable Care Organizations. Report: http://bit.ly/2vnd7TL
• On August 3, ONC released a blog post summarizing its 5-year goal to transition the ONC Health IT Certification Programs testing portfolio through the use of “as many industry-developed and maintained testing tools as possible in lieu of taxpayer financed testing tools.” Blog post: http://bit.ly/2vDJZrc

 Mental Health and Substance Abuse –

• On July 31, the President’s Commission on Drug Addiction and Opioid Abuse released an interim report calling on President Trump to declare a state of emergency under the Public Health Service Act or the Stafford Act to provide momentum in addressing the opioid crisis. The interim report also makes several recommendations, including expanded interoperability of state prescription drug monitoring programs, expanded use of medication-assisted therapy, and to provide model legislation for naloxone standing order laws. A final report is due by October 1. Interim report: http://bit.ly/2vc7Dee
• On August 4, the U.S. Drug Enforcement Administration released a notice proposing for a reduction in controlled substances that may be manufactured in the U.S. next year by 20 percent compared to 2017. Comments are due by September 6. Press release: http://bit.ly/2vwPhVy Notice: http://bit.ly/2vwcszy

Veterans Health –

• On August 1, the Department of Veterans Affairs (VA) announced the release of VA’s top eight best practices on pain management and opioid prescribing, called S.T.O.P.P.A.I.N. Press release: http://bit.ly/2vzlxrL
• On August 3, VA announced three initiatives that will expand access to health care for veterans across the county using telehealth technology and mobile applications: VA Telehealth, Veteran Appointment Request App, and VA Video Connect. Press release: http://bit.ly/2u8am4B

 Misc. –

• On August 1, the Department of Health and Human Services (HHS) announced that Michigan State University will receive a grant of $3.2 million to establish a registry of Flint residents who were exposed to lead-contaminated water from the Flint Water System during 2014-2015. Press release: http://bit.ly/2hknkdN
• On August 2, the Substance Abuse and Mental Health Services Administration (SAMHSA) announced $6 million in grants to support the International President’s Emergency Plan for AIDS Relief Addiction Technology Transfer Centers. Press release: http://bit.ly/2u9kvhF
• On August 4, FDA released a document outlining its plans and performance goals for an Over-the-Counter Monograph User Fee Program, which would govern the FDA’s regulation of over-the-counter drugs. Plan: http://bit.ly/2vxqwJ3
• Also on August 4, the Centers for Disease Control and Prevention (CDC) announced more than $200 million in grants to states to respond to infectious disease threats. Press release: http://bit.ly/2vxbLWt