Alston & Bird Healthcare Week in Review, February 10, 2017

I. Regulations, Notices, & Guidance

• On February 6, 2017, The Department of Health and Human Services (HHS) issued a notice entitled, 30-Day Submission Period for Requests for ONC-Approved Accreditor (ONC-AA) Status. The notice announces the 30-day period for submission of requests for ONC-Approved Accreditor (ONC-AA) status. The 30-day submission period ends on March 9, 2017.
• On February 8, 2017, HHS issued a notice entitled, Health Resources And Services Administration National Vaccine Injury Compensation Program List of Petitions Received. The notice is publishing petitions received under the National Vaccine Injury Compensation Program, as required by the Public Health Service (PHS) Act, as amended.
• On February 9, 2017, HHS issued a notice entitled, Declaration under the Public Readiness and Emergency Preparedness Act for Zika Virus Vaccines. The notice issues a Declaration pursuant to the PHS Act to provide liability immunity protection for activities related to Zika Virus vaccines consistent with the terms of the Declaration. The Declaration is effective as of August 1, 2016.
• On February 8, 2017, the Food and Drug Administration (FDA) issued a guidance entitled, Dear Health Care Provider letters: Improving Communication of Important Safety Information. The guidance provides recommendations to industry and FDA staff on the content and format of Dear Health Care Provider (DHCP) letters.

• February 22 – 23, 2017: The National Committee on Vital and Health Statistics (NCVHS) announced an advisory committee meeting. On the first day, the Committee will focus on two items ready for action: a recommendation letter that addresses de-identification of protected health information under HIPAA, and “Measuring Health at the Community Level: Data Gaps and Opportunities,” a workshop summary and overview of the NCVHS Measurement Framework for Community Health and Well-Being effort. The Committee will review and discuss draft materials of work in progress including the NCVHS 12th Report to Congress, an analytic review of HealthData.gov, and plans for hearings in June 2017 focused on standards. On the second day, the Committee will continue to focus on planning efforts being organized by the Standards Subcommittee, planning efforts for a Fall 2017 hearing on vital statistics in the U.S., and follow-up items on actions from the previous day. Staff from the Centers for Medicare & Medicaid Services (CMS) will give a briefing on its Social Security Number Removal Initiative, and the Committee will engage in additional strategic discussions regarding its work plan and areas of focus for 2017.
• March 6 – 7, 2017: HHS announced a meeting of the Advisory Committee on Training in Primary Care Medicine and Dentistry (ACTPCMD). The ACTPCMD will discuss issues related to the Committee report on the integration of behavioral health into primary care and oral health training; and clinical trainee and faculty well-being and resiliency.

II. Congressional Legislation & Committee Action

U.S. Senate

• There were no health care related hearings scheduled for the week of February 6, 2017.

• On February 7, 2017, the House Small Business Committee held a hearing entitled, Reimagining the Health care Marketplace for America’s Small Businesses. The witnesses included Mr. Tom Secor, President of the Durable Corporation, Norwalk Ohio, representing the National Small Business Association; Mr. Keith Hall, President and CEO of the National Association for the Self-Employed; and Mr. Kevin Kuhlman, Director of Government Relations at the National Federation of Independent Business.
• On February 7, 2017, the House Energy and Commerce Health Subcommittee held a markup of H.R. 181, The Close Annuity Loopholes in Medicaid (CALM) Act; and H.R. 829, The Prioritizing the Most Vulnerable Over Lottery Winners Act of 2017.  H.R. 829, The Prioritizing the Most Vulnerable Over Lottery Winners Act of 2017 would clarify the treatment of lottery winnings and other lump sum income for purposes of income eligibility under the Medicaid program, and for other purposes. H.R. 181, The CALM Act would count portions of income from annuities of a community spouse as income available to institutionalized spouses for purposes of eligibility for medical assistance, and for other purposes. H.R. 829 was reported favorably to the full Committee by a roll call vote of 20-12 and H.R. 181, as amended, was reported favorably to the full Committee by a roll call vote of 19-13.

• On February 15, 2017, the Senate Appropriations Labor, Health and Human Services, Education and Related Agencies Subcommittee will hold a hearing entitled, Mental Health Care: Examining Treatments and Services. The witnesses include Joseph Parks, Medical Director of the National Council for Behavioral Health; David Johnson, CEO of Navos Mental Health Solutions; Dennis Freeman, CEO of Cherokee Health Systems; and Donald De Lucca, President of the International Association of Chiefs of Police. The hearing will take place at 10:30 a.m. in 138 Dirksen.
• On February 16, 2017 the Senate Finance Committee will hold a hearing on the nomination of Seema Verma to be the CMS administrator. The hearing will take place at 10:00 a.m. in 215 Dirksen.

• On February 16, 2017, the House Judiciary, Regulatory Reform and Commercial and Antitrust Law Subcommittee will holding a hearing on R. 372, The Competitive Health Insurance Reform Act of 2017. The hearing will take place at 10:00 a.m. in 2141 Rayburn. The witnesses are TBD.

• On February 6, 2017, the Office of Inspector General (OIG) released a report entitled, Medicare Market Shares of Mail Order Diabetes Test Strips From July Through September 2016. The report found that From July through September 2016, sampled suppliers provided 18 types of diabetes test strips via mail order. The top strip type accounted for 43 percent of the mail-order market, and the top 10 strip types accounted for 98 percent. A supplier could comply with the MIPPA 50-percent rule by committing to provide two strip types.
• On February 6, 2017, the Government Accountability Office (GAO) released a report entitled, Medicaid: Program Overnight Hampered by Data Challenges, Underscoring Need for Continued Improvements. The report found that available Medicaid expenditure and utilization data do not provide CMS with sufficient information to consistently ensure that payments are proper or that beneficiaries have access to covered services. CMS, the agency within HHS that administers the Medicaid program, relies on two key data sources for program oversight: the CMS-64, which serves as the basis for calculating the amount of federal matching funds for states, and the Medicaid Statistical Information System (MSIS), which is designed to report individual beneficiary claims data. The CMS-64 and MSIS have the potential to offer a robust view of payments, overall spending, and services in the Medicaid program; however, the GAO found that the usefulness of these data is limited because of issues with completeness, accuracy, and timeliness.
• On February 6, 2017, the GAO released a report entitled, Foster Care: HHS Has Taken Steps to Support States’ Oversight of Psychotropic Medications, but Additional Assistance Could Further Collaboration. The report found that state child welfare and Medicaid officials in seven selected states reported a variety of practices to support the appropriate use of psychotropic medications, which affect mood, thought, or behavior, for children in foster care. Practices include screening for mental health conditions, developing prescription guidelines, and monitoring a child’s health while on medication. Additional state efforts aim to increase mental health knowledge among stakeholders and improve access to mental health services. However, officials in four selected states and from five national mental health organizations said limited access to mental health services was a challenge. Five of the selected states have begun offering remote consultation services that connect patients with mental health specialists. State officials said strong interagency collaboration and outreach to stakeholders helped them implement practices more effectively.
• On February 8, 2017, the GAO released a report entitled, Medicaid Managed Care: Improved Oversight Needed of Payment Rates for Long-Term Services and Supports. The report found that out of six states with Medicaid managed long-term services and supports (MLTSS) programs that the GAO selected for review, five set clear financial incentives in their payment rates for managed care organizations (MCO) to provide care in the community versus in an institution. However, most of the selected states did not opt to link payments or penalties to MCO performance on MLTSS goals. The GAO found that CMS’s oversight of state payment structures was limited. CMS expects states’ MLTSS programs to enhance the provision of community-based care. However, the GAO found that CMS does not consistently require states to report on whether the payment structures—including payment rates, incentive payments, and penalties—are achieving MLTSS goals. According to federal internal control standards, federal agencies should use quality information to achieve agency objectives. Without requiring information on states’ progress toward MLTSS goals, CMS will continue to pay billions of dollars to states without knowing if states have sufficient incentives for community-based care.
• On February 8, 2017, the GAO released a report entitled, Medical Devices: Cancer Risk Led FDA to Warn Against Certain Uses of Power Morcellators and Recommend New Labeling. The report found that FDA documentation shows the agency cleared 25 510(k) submissions for power morcellators to be marketed in the United States between 1991 and 2014. In clearing the first of the 25 power morcellators in 1991, the FDA determined the new device was substantially equivalent to an electromechanical system for cutting tissue during minimally invasive surgeries performed on joints, known as an arthroscopic surgical system. The report also found that the FDA was aware of the potential for spreading tissue when using a power morcellator prior to receiving the first adverse event reports; however, the general understanding was that the risk of an unsuspected cancer that could be spread when using the device was low.

IV. Other Health Policy News

• On February 6, 2017, CMS extended the attestation deadline for providers participating in the Medicare HER Incentive Program to March 13, 2017.

• This past weekend, President Trump said he did not expect a Republican replacement for the Affordable Care Act (ACA) to be done until late 2017 or early 2018. However, during an interview on February 7^th, House Speaker Paul Ryan (R-WI) said “we are going to be done legislating with respect to healthcare and Obamacare this year.”

• The House Ways & Means Committee is still discussing what policies to include in the reconciliation package that would provide relief to individuals hurt by the ACA and allow more flexibility for states and individuals. Meanwhile, House Energy & Commerce health subcommittee member Michael Burgess (R-TX) said a repeal of big chunks of the ACA will come through the House in late February or early March.