Alston & Bird Healthcare Week in Review, January 5, 2018

I. Regulations, Notices, & Guidance

• On January 2, 2018, the Substance Abuse and Mental Health Services Administration (SAMHSA) issued a final rule entitled, Confidentiality of Substance Use Disorder Patient Records. The final rule makes changes to the SAMHSA regulations governing the Confidentiality of Substance Use Disorder Patient Records. According to SAMHSA, these changes are intended to better align the regulations with advances in the U.S. health care delivery system while retaining important privacy protections for individuals seeking treatment for substance use disorders. The final rule addresses the prohibition on re-disclosure notice by including an option for an abbreviated notice. The rule also addresses the circumstances under which lawful holders and their legal representatives, contractors, and subcontractors may use and disclose patient identifying information for purposes of payment, health care operations, audits, and evaluations. Finally, this rule makes technical corrections to ensure accuracy and clarity in SAMHSA’s regulations.
• On January 2, 2018, the Food and Drug Administration (FDA) issued a final order entitled, Hematology and Pathology Devices; Classification of Cervical Intraepithelial Neoplasia Test System. The FDA is classifying the cervical intraepithelial neoplasia (CIN) test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the CIN test system’s classification. The FDA is taking this action because they have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. The FDA believes this action will also enhance patients’ access to beneficial innovative devices, in part by reducing regulatory burdens.
• On January 2, 2018, the FDA issued a notice entitled, Establishing Effectiveness for Drugs Intended to Treat Male Hypogonadotropic Hypogonadism Attributed to Non-Structural Disorders; Draft Guidance for Industry; Availability. This draft guidance provides key design considerations, including recommendations for patient enrollment criteria and efficacy endpoints, for clinical trials to establish effectiveness for drugs intended to treat male hypogonadotropic hypogonadism associated with obesity and other conditions that do not cause intrinsic damage to the hypothalamus or pituitary gland. This draft guidance is consistent with recommendations FDA received at the December 2014 advisory committee meeting on the appropriately indicated population for testosterone replacement therapy, and the December 2016 advisory committee meeting on hypogonadotropic hypogonadism.
• On January 4, 2018, the Department of Labor (DOL) issued a proposed rule entitled, Definition of “Employer” under Section 3(5) of ERISA -- Association Health Plans. The proposed regulation would broaden the criteria under Title I of the Employee Retirement Income Security Act (ERISA) section 3(5) for determining when employers may join together in an employer group or association that is treated as the “employer” sponsor of a single multiple-employer “employee welfare benefit plan” and “group health plan.” According to the DOL, by treating the association as the employer sponsor of a single plan, the regulation would facilitate the adoption and administration of such arrangements. The regulation would modify the definition of “employer,” in part, by creating a more flexible “commonality of interest” test for the employer members. The regulation would also distinguish employment-based plans from commercial insurance programs and administrative service arrangements marketed to employers. The proposal would also permit working owners of an incorporated or unincorporated trade or business, including partners in a partnership, to elect to act as employers for purposes of participating in an employer group or association sponsoring a health plan and also to be treated as employees with respect to a trade, business or partnership for purposes of being covered by the employer group’s or association’s health plan. According to the DOL, the goal of the rulemaking is to expand access to affordable health coverage, especially among small employers and self-employed individuals, by removing restrictions on the establishment and maintenance of association health plans under ERISA.
• On January 5, 2018, the Centers for Medicare and Medicaid Services (CMS) issued a notice entitled, Agency Information Collection Activities: Proposed Collection; Comment Request. The CMS announced an opportunity for the public to comment on CMS’ intention to collect information from the public. The information to be collected is related to standards for reinsurance, risk corridors, and risk adjustment. The data collection and reporting requirements will be used by HHS to run the permanent risk adjustment program, including validation of data submitted by issuers, on behalf of certain states. HHS will also use the data to adjust the payment transfer formula for risk associated with high-cost enrollees.
• On January 5, 2018, the CMS issued a notice entitled, Request for Information: Revisions to Personnel Regulations, Proficiency Testing Referral, Histocompatibility Regulations and Fee Regulations under Clinical Laboratory Improvement Amendments of 1988. The request for information seeks public comment regarding several items related to Clinical Laboratory Improvement Amendments of 1988 (CLIA) personnel requirements, histocompatibility requirements, and proficiency testing referrals. The request also seeks public comment regarding the collection of other fees CMS is authorized to collect for revised certificates, post survey follow-up visits, compliant investigations, and activities related to imposition of sanctions. The CMS will consider public input to update the existing CLIA regulations through future rulemaking.

• 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.
• 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 14-15, 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

• There were no health care-related hearings.

• There were no health care-related hearings.

• On January 3, 2018 the New England Journal of Medicine published a survey entitled, The Public and the Opioid-Abuse Epidemic. The survey examined data from seven national polls conducted in 2016 and 2017. According to the survey, 53 percent of the public considers addiction to prescription pain medication a major problem but does not deem it a national emergency. Only 16 percent of the public viewed the opioid crisis as an emergency. The survey concluded that there is a clear need for the medical and scientific communities to educate the public about the issues surrounding the potential effectiveness of treatment.

IV. Other Health Policy News

• On January 5, 2018, the Congressional Budget Office (CBO) updated their score for the Senate bill funding the Children’ Health Insurance Program (CHIP). The bill is now projected to increase the deficit by $800 million over the next decade compared to the CBO’s earlier estimate of $8.2 billion.