Alston & Bird Healthcare Week In Review, January 12, 2018 | News & Insights

I. Regulations, Notices, & Guidance

On January 8, 2018, the Department of Veterans Affairs (VA) issued a rule entitled, Reimbursement for Emergency Treatment. The VA revised its regulations concerning payment or reimbursement for emergency treatment for non-service-connected conditions at non-VA facilities to implement the requirements of a recent court decision. Specifically, this rulemaking expands eligibility for payment or reimbursement to include veterans who receive partial payment from a health-plan contract for non-VA emergency treatment and establishes a corresponding reimbursement methodology. This rulemaking also expands the eligibility criteria for veterans to receive payment or reimbursement for emergency transportation associated with the emergency treatment, in order to ensure that veterans are covered when emergency transportation is necessary.
On January 11, 2018, the Department of Health and Human Services (HHS) issued a proposed rule entitled, Regulatory Agenda: Semiannual Regulatory Agenda. The Regulatory Flexibility Act of 1980 and Executive Order (EO) 12866 require the semiannual issuance of an inventory of rulemaking actions under development throughout the HHS. The inventory is available for public review.
On January 11, 2018, the Food and Drug Administration (FDA) issued a notice entitled, Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases; Draft Guidance for Industry; Availability; Extension of Comment Period. The FDA is extending the comment period for the notice of availability that appeared in the Federal Register of December 20, 2017. In the notice of availability, the FDA requested comments on the draft guidance for industry entitled “Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases.” The FDA is extending the comment period in response to public interest in the draft guidance and to allow interested persons additional time to submit comments.
On January 12, 2018, the HHS issued a notice entitled, Annual Update of the HHS Poverty Guidelines. The notice provides an update of the HHS poverty guidelines to account for last calendar year’s increase in prices as measured by the Consumer Price Index.
On January 12, 2018, the Government Accountability Office (GAO) issued a notice entitled, Request for Medicaid and CHIP Payment and Access Commission (MACPAC) Nominations. The Children’s Health Insurance Program Reauthorization Act of 2009 (CHIPRA) established MACPAC to review Medicaid and CHIP payment and access policies and to advise Congress on issues affecting Medicaid and CHIP. CHIPRA gave the Comptroller General of the United States responsibility for appointing MACPAC’s members. GAO is now accepting nominations for MACPAC appointments that will be effective May 1, 2018. Letters of nomination and resumes should be submitted no later than February 5, 2018 to ensure adequate opportunity for review and consideration of nominees prior to the appointment of new members. Nominations should be sent to the email or mailing address listed in the link.

Event Notices

January 9, 2018: The FDA announced a public workshop entitled, New Insights for Product Development and Bioequivalence Assessments of Generic Orally Inhaled and Nasal Drug Products. The purpose of the workshop is to present outcomes from FDA’s recent research activities and obtain input from the public on how analytical methods and procedures should be applied in the development and review of abbreviated new drug applications (ANDAs).
January 9-10, 2018: The Department of Health and Human Services (HHS) announced a meeting of the National Committee on Vital and Health Statistics (Committee). Committee members will discuss several health data policy topics and begin work outlined in their 2018 work plan. In addition, an environmental scan report will be reviewed and discussed by the Committee as art of the Health Information Privacy and Security Beyond HIPAA project.
January 10, 2018: The FDA announced a forthcoming public advisory committee meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to the agency on FDA’s regulatory issues. The meeting will be open to the public.
January 11-12, 2018: The CDC announced a public meeting for the Board of Scientific Counselors (BSC) and the National Center for Health Statistics (BSC, NCHS). The meeting will provide an update on the National Health and Nutrition Examination Survey Reports and activities; provide an update on the Division of Health Care Statistics Reports and Activities; provide an update on vital statistics activities; and an update on the international activities of the NCHS.
January 18, 2018: The HHS announced a public meeting of the Health Information Technology Advisory Committee (HITAC). The HTAC was established in accordance with the 21^st Century Cures Act and the Federal Advisory Committee Act. The HITAC will identify priorities and make recommendations to the National Coordinator of Health Information Technology on policy to advance an interoperable health information technology infrastructure.
January 23, 2018: The NIH announced a public webinar entitled, “Machine Learning in Toxicology: Fundamentals of Application and Interpretation.” The webinar is organized on behalf of the Interagency Coordinating Committee on the Validation of the Alternative Methods (ICCVAM) by the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods. Interested parties can register for the webinar by December 18, 2018.
January 24, 2018: The FDA announced a forthcoming public advisory committee meeting of the Tobacco Products Scientific Advisory Committee (TPSAC). The general function of the TPSAC is to provide advice and recommendations to the FDA’s regulatory issues. The TPSAC will discuss modified risk tobacco product applications submitted by tobacco companies. The FDA intends to make background material available to the public no later than two business days before the meeting.
January 24, 2018: The NIH announced a meeting to review the Draft Report on Carcinogens (RoC) Monograph on Antimony Trioxide. The RoC is a congressionally mandated report that identifies agents, substances, mixtures, or exposures in the environment that pose a cancer hazard for people in the United States.
January 24, 2018: The HHS announced a meeting of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (Advisory Council). The Advisory Council provides advice, information, and recommendations to the Secretary of HHS. The Advisory Council will meet to discuss strategies to combat antibiotic-resistant bacteria.
January 25, 2018: The FDA announced a public hearing on FDA’s approach to evaluating the safety and efficacy of nicotine replacement therapy (NRT) products, including appropriate use and labeling.
January 30, 2018: The FDA announced a public hearing entitled, Opioid Policy Steering Committee: Prescribing Intervention –Exploring a Strategy for Implementation. The purpose of the hearing is to receive stakeholder input on how the FDA might, under its Risk Evaluation and Mitigation Strategy (REMS) authority, improve the safe use of opioid analgesics by curbing overprescribing and limit abuse of opioid analgesics.
January 31, 2018: The Substance Abuse and Mental Health Services Administration (SAMHSA) announced a public listening session to solicit information concerning the Confidentiality of Substance Use Disorder Patient Records regulations. The listening session will provide an opportunity for the public to provide input to SAMHSA concerning the effects of regulatory and sub regulatory guidance.
February 5-9, 2018: The CDC announced the Adapting Clinical Guidelines for the Digital Age meeting. Adapting Clinical Guidelines for the Digital Age is an initiative to improve patient care and health outcomes by working to ensure that clinical guidelines are not only evidence-based but also are used in practice. The scope of the meeting will encompass the following: gathering individual perspectives and experiences about guideline creation and summarizing the evidence; informational framework for guideline translation; dissemination modalities and communication methods; translation and implementation support; and evidence.
February 9, 2018: The FDA announced a public workshop entitled, Medical gas Regulation Workshop II. The topic to be discussed is potential areas of federal drug regulation that should be revised with respect to medical gases.
February 13, 2018: The CMS announced a Town Hall meeting to discuss fiscal year (FY) 2019 applications for add-on payments for new medical services and technologies under the hospital inpatient prospective payment system (IPPS). Interested parties are invited to the meeting to present their comments, recommendations, and data regarding whether the FY 2019 new medical services and technologies applications meet the substantial clinical improvement criterion.
February 14, 2018: The SAMHSA’s Center for Mental Health Services (Center) announced a public meeting, which will include discussions of the Center’s policy issues, presentations on SAMHSA’s policy lab, Disaster Responses and a conversation with the Assistant Secretary for Mental Health and Substance Abuse, Dr. Elinore McCance-Katz.
February 14, 2018: SAMHSA’s Center for Substance Abuse Prevention National Advisory Council (CSAP NAC) announced a public meeting. The CSAP NAC will discuss workforce issues related to substance abuse and opioid use prevention.
February 14-15, 2018: The CDC announced a meeting of the Community Preventative Services Task Force (CPSTF). The CPSTF will discuss the economics of multicomponent interventions to improve cancer screening for breast, colorectal, and cervical cancer; a proposal for housing interventions as a new topic area; school-based interventions to increase healthy lifestyle choices; prevention of intimate partner violence and sexual violence among youth; and a discussion on Community Guide economic methods. The agenda is subject to change without notice.
March 19, 2018: The FDA announced a public workshop entitled, Patient-Focused Drug Development: Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data. The workshop will discuss how to individuals can submit patient experience data to the FDA. The workshop will inform the development of patient-focused drug development guidance.

II. Congressional Legislation & Committee Action

U.S. Senate

On January 9, 2018, the Senate Health, Education, Labor and Pensions (HELP) Committee held a hearing entitled, The Opioid Crisis: An Examination of How We Got Here and How We Move Forward. Sam Quinones, author of the book Dreamland testified.
On January 9, 2018, the Senate Finance Committee held a hearing entitled, to Consider the Anticipated Nomination of Alex Michael Azar II, of Indiana, to be Secretary of the Department of Health and Human Services. Alex Azar testified.

House of Representatives

There were no health care-related hearings.

III. Reports, Studies, & Analyses

On January 11, 2018, the Congressional Budget Office (CBO) issued a presentation regarding the methodology used to estimate costs of proposals affecting health insurance coverage. The presentation can be found here.
On January 12, 2018, the CBO issued a working paper entitled, An Analysis of Private-Sector Prices for Physicians’ Services. Using 2014 claims data from three major insurers, CBO analyzed the prices paid for 20 services compared with the estimated prices paid under fee-for-service (FFS) Medicare. CBO found that average commercial prices were substantially higher than Medicare FFS prices. The study can be found here.

IV. Other Health Policy News

On January 11-12, the Medicare Payment and Advisory Council (MedPAC) held their January public meetings. MedPAC’s agenda can be found here.
On January 11, 2018 the CMS issued a letter to state Medicaid directors regarding Medicaid work requirements. The letter can be found here.