A&B Healthcare Week in Review, May 20, 2016

I. REGULATIONS, NOTICES, & GUIDANCE

• On May 16, 2016, the Equal Employment Opportunity Commission (EEOC) issued a final rule entitled, “Genetic Information Nondiscrimination Act.” The final rule amends the regulations implementing Title II of the Genetic Information Nondiscrimination Act of 2008 as they relate to employer-sponsored wellness programs. The rule addresses the extent to which an employer may offer an inducement to an employee for the employee’s spouse to provide information about the spouse’s manifestation of disease or disorder as part of a health risk assessment (HRA) administered in connection with an employer-sponsored wellness program.
• On May 16, 2016, EEOC issued a final rule entitled, “Regulations under the Americans with Disabilities Act." The final rule amends the regulations and interpretive guidance implementing Title I of the Americans with Disabilities Act (ADA) to provide guidance on the extent to which employers may use incentives to encourage employees to participate in wellness programs that ask them to respond to disability-related inquiries and undergo medical examinations. This rule applies to all wellness programs that include disability-related inquiries and/or medical examinations whether they are offered only to employees enrolled in an employer-sponsored group health plan, offered to all employees regardless of whether they are enrolled in such a plan, or offered as a benefit of employment by employers that do not sponsor a group health plan or group health insurance.
• On May 16, 2016, the Food and Drug Administration (FDA) issued a draft guidance entitled, “Use of Electronic Health Record Data in Clinical Investigations.” The draft guidance is intended to assist sponsors, clinical investigators, contract research organizations, institutional review boards (IRBs), and other interested parties on the use of electronic health record (EHR) data in FDA-regulated clinical investigations. Public comments are due July 16, 2016.
• On May 17, 2016, the Health Resources and Services Administration (HRSA) issued a notice entitled, “The Teaching Health Center Graduate Medical Education (THCGME) Program Eligible Resident/Fellow FTE Chart.” The THCGME Program Eligible Resident/Fellow full-time equivalent (FTE) Chart requires applicants to provide data related to the size and/or growth of the residency program over previous academic years, the number of residents enrolled in the program during the baseline academic year, and a projection of the program’s proposed expansion over the next 5 academic years. HRSA noted that it is imperative that applicants complete this chart and provide evidence of a planned expansion, as per the statute, THCGME funding may only be used to support an expanded number of residents in a residency program or to establish a new residency training program. Public comments are due by July 17, 2016.
• On May 17, 2016, HRSA issued a notice entitled, “Rural Network Allied Health Training Program Performance Improvement Measurement System (PIMS).” The Rural Network Allied Health Training Program will support the development of formal, mature rural health networks that focus on activities that achieve efficiencies, expand access to, coordinate and improve the quality of essential health care services, and strengthen the rural health care system as a whole. This purpose will be achieved through the recruitment, clinical training, and retention of allied health professionals. Public comments are due June 17, 2016.
• On May 17, 2016, the National Institutes of Health (NIH) issued a notice entitled, “Survey to Assess the Feasibility of Establishing a Gynecologic Specimen Bank.” NIH is assessing the feasibility of developing a tissue bank that would include tube and ovary tissues from women undergoing surgery for benign conditions, risk reduction, and early stage cancer. Collecting tissues from tubes and ovaries containing clinically unsuspected precursors or early stage cancer is challenging, especially among women that are not at increased genetic risk. However, given that many pathology laboratories have enhanced their processing protocols for gynecologic surgical specimens removed for benign indications, it may be possible to develop a tissue resource. Public comments are due June 17, 2016.
• On May 16, 2016, the Centers for Medicare & Medicaid Services (CMS) issued a change request (CR) entitled, “Revisions to Private Contracting/Opt-out Manual Sections Due to the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA).” The CR 9616 alerts physicians and practitioners who signed a valid opt-out affidavit on or after June 16, 2015, that the affidavit will automatically renew every two years. CR 9616 revises the "Medicare Benefit Policy Manual” to be consistent with the MACRA amendments. If physicians and practitioners who filed affidavits effective on or after June 16, 2015, do not want their opt out to automatically renew at the end of a 2 year opt-out period, they may cancel the renewal by notifying all Medicare Administrative Contractors (MACs) with which they filed an affidavit in writing at least 30 days prior to the start of the next opt-out period.
• On May 18, 2016, HHS issued a notice entitled, “Health Insurance Reform Security Standards – Final Rule.” This notice extends the existing approved information collection for applicable compliance activities associated with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security Rule. Public comments are due by June 18, 2016.
• On May 18, 2016, HHS issued a notice entitled, “HIPAA Privacy, Security, and Breach Notification Rules, and Supporting Regulations Contained in 45 CFR parts 160 and 164.” This revision does not change any requirements of the HIPAA Privacy, Security, and Breach Notification Rules. The notice requests to rename the information collection and incorporate into it the substance of two other information collections. Public comments are due June 18, 2016.
• On May 18, 2016, FDA issued a notice entitled, “Advisory Committee; Blood Products Advisory Committee; Renewal." The notice announced the renewal of the Blood Products Advisory Committee by the Commissioner of FDA. The Commissioner has determined that it is in the public interest to renew the Blood Products Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until May 13, 2018.
• On May 18, 2016, FDA issued a notice entitled, “Charter Renewals: Drug Safety and Risk Management Advisory Committee." The notice announced the renewal of the Drug Safety and Risk Management Advisory Committee by the Commissioner of FDA. The Commissioner has determined that it is in the public interest to renew the Drug Safety and Risk Management Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until May 31, 2018.
• On May 18, 2016, FDA issued a notice entitled, “Charter Renewals: Peripheral and Central Nervous System Drugs Advisory Committee.” The notice announced the renewal of the Peripheral and Central Nervous System Drugs Advisory Committee by the Commissioner of FDA. The Commissioner has determined that it is in the public interest to renew the Peripheral and Central Nervous System Drugs Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until June 4, 2018.
• On May 19, 2016, HRSA issued a notice entitled, “Agency Information Collection Activities; Proposals, Submissions, and Approvals: 340B Drug Pricing Program Reporting Requirements.” HRSA noted that information is necessary to ensure the orderly conduct of manufacturer audits. In addition, the informal dispute resolution process requires the participating manufacturer or covered entity requesting dispute resolution to provide the Office of Pharmacy Affairs (OPA) with a written request. The party alleged to have committed a section 340B violation may provide a response or rebuttal to OPA. Information is necessary to ensure that the dispute will be resolved in a fair and equitable manner. Public comment is due by June 19, 2016.
• On May 19, 2016, FDA issued a draft guidance entitled, “Draft Guidance for Industry: Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment.” The guidance is intended to assist sponsors in designing a clinical development program for new drug products for the treatment of chronic obstructive pulmonary disease (COPD). This guidance revises the draft guidance of the same name, issued November 9, 2007, by adding information regarding the St. George’s Respiratory Questionnaire (SGRQ). Public comments are due by July 19, 2016.
• On May 19, 2016, FDA issued a notice entitled, “Advisory Committees; Filing of Closed Meeting Reports.” The Agency filed with the Library of Congress the annual reports of the FDA advisory committees that held closed meetings during the fiscal year 2015.
• On May 20, 2016, HHS issued a notice entitled, “Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria." The Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria requests information from the general public and stakeholders related to efforts and strategies to combat antibiotic resistance. In the process of developing their report, Initial Assessments of the National Action Plan for Combating Antibiotic-Resistant Bacteria, the Advisory Council followed the framework of the National Action Plan for Combating Antibiotic Resistant Bacteria (Action Plan) to hear about a wide range of ongoing and planned activities by the federal government, including some stakeholders/sectors relevant to this overall effort. Public comments are due June 20, 2016.

Event Notices

• June 3, 2016, HRSA announced a public meeting of the Advisory Commission on Childhood Vaccines (ACCV).
• June 20, 2016, FDA announced a public advisory committee meeting of the Blood Products Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA’s regulatory issues. At least one portion of the meeting will be closed to the public.
• June 28, 2016, FDA announced a public advisory committee meeting of the Endocrinologic and Metabolic 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.
• August 22 &23, 2016, HHS announced the summer meeting of the Advisory Panel on Hospital Outpatient Payment for 2016. It also announced that the Panel will begin meeting once a year in the summer, beginning in Calendar Year 2017. Currently, the Panel convenes twice yearly. The purpose of the Panel is to advise the Secretary of HHS and the Administrator of CMS on the clinical integrity of the Ambulatory Payment Classification (APC) groups and their associated weights and hospital outpatient therapeutic services supervision issues.
• August 29, 2016, FDA’s Center for Drug Evaluation and Research (CDER), is sponsoring a public workshop entitled “Diabetes Outcome Measures Beyond Hemoglobin A1c (HbA1c).” The purpose of this public workshop is to have a forum for dialogue with the public, patients, patient advocacy groups, and the industry to gain greater appreciation of the extent to which the current regulatory paradigm for antidiabetic drug therapies addresses the needs of patients with diabetes and to identify additional outcomes, beyond HbA1c, that are of direct relevance and importance to patients living with the disease.

II. CONGRESSIONAL LEGISLATION & COMMITTEE ACTION

U.S. Senate

• On May 18, 2016, the Senate Small Business and Entrepreneurship Committee convened a hearing entitled, “The Small Business Struggle Under Obamacare.” The witnesses included Richard G. Frank, Assistant Secretary for Planning and Evaluation, HHS; Mr. Tom Kunkel, President, Full House Marketing, Inc., Mr. Kevin Kuhlman, Director of Legislative Affairs, National Federation of Independent Business; and Mr. Mike Brey, President, Hobby Works.
• On May 17, 2016, Senate Appropriations Subcommittee on Military Construction, Veterans Affairs and Related Agencies convened a hearing entitled, “VA-DOD Electronic Health Record Interoperability.” The witnesses included Valerie Melvin, Director of Information Management and Technology Resources Issues at GAO; Lauren Thompson, Director of the Defense Department's Interagency Program Office; LaVerne Council, Assistant VA Secretary for Information and Technology and CIO; David Waltman, Program Executive at VistA Evolution and Senior Advisor to the VA undersecretary for Health; and Jonathan Nebeker, Deputy Chief Medical Information Officer for Strategy and Design in the Veterans Health Administration.
• On May 18, 2016, Senate Finance Committee Ranking Member Ron Wyden (D-OR) and Senate Health, Education, Labor and Pensions (HELP) Committee Ranking Member Patty Murray(D-WA) sent a letter to DOL Secretary Tom Perez and Health and HHS Secretary Sylvia Mathews Burwell relaying concerns about the effect of the recent Gobeille v. Liberty Mutual decision by the Supreme Court, which limited the ability of state all-payer claims databases (APCDs) to collect critical health care data.

House of Representatives

• On May 17, 2016, the House Energy and Commerce Subcommittee on Health convened a hearing entitled, “The Obama Administration's Medicare Drug Experiment: The Patient and Doctor Perspective,” and H.R.5122, to prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models. The witnesses included Mr. Joe Baker, President, Medicare Rights Center; Ms. Heather Block, Patient Advocate; Ms. Marcia Boyle, President and Founder, Immune Deficiency Foundation; Dr. Debra Patt, Vice President, Texas Oncology, Medical Director, The US Oncology Network, Chair, Clinical Practice Committee American Society of Clinical Oncology, Editor and Chief, Journal of Clinical Oncology- Clinical Cancer Informatics, Board Member, Community Oncology Alliance; and Dr. Michael Schweitz, National Advocacy Chair, Coalition of State Rheumatology Organizations.
• On May 17, 2016, the House Ways and Means Subcommittee on Health convened a hearing entitled, “Tax-Related Proposals to Improve Health Care.” The Subcommittee leadership heard from five panels of House Members on their tax proposals to improve the health care system.
• On May 18, 2016, House Ways and Means Subcommittee on Health Chairman Pat Tiberi (R-OH) and Subcommittee on Health Ranking Member Jim McDermott (D-WA), introduced the Helping Hospitals Improve Patient Care Act, bipartisan legislation to advance needed reforms for hospitals and other Medicare providers. This legislation will support current efforts to develop outpatient facilities and allow hospitals to treat more low-income and cancer patients. A key component of the bill is Section 201, which would create a "mid-build" exception to the Hospital Outpatient Department (HOPD) off-campus site neutrality provision in the Bipartisan Budget Act of 2016. The bill also includes an extension of the rural community hospital demonstration program and direction that CMS improve the notice provided to individuals upon Medicare eligibility. In addition, the legislation requires a cross walk of ten inpatient surgical codes that will be linked to outpatient surgical codes. A summary of the bill may be found here.
• On May 18, 2016, the House Ways and Means Subcommittee on Human Resources convened a hearing entitled, “The Heroin Epidemic and Parental Substance Abuse: Using Evidence and Data to Protect Kids from Harm.” The first panel included Rep. Honorable Tom Marino (D-PA) and Rep. Honorable Karen Bass (D-CA). The second panel included Ms. Tina Willauer, Director, Sobriety Treatment and Recovery Teams (START), Kentucky Cabinet for Health and Family Services; Mr. Hector Glynn, Vice President for Programs, The Village for Families and Children; Ms. Katherine Barillas, Director, Child Welfare Policy, One Voice Texas; and Mr. Bryan Lindert, Senior Director of Quality Management, Eckerd Youth Alternatives.
• On May 18, 2016, the House passed H.R. 5234, which includes House Appropriations Committee Chairman Harold Rogers’ (R-KY) $622 million funding proposal to combat Zika, with a vote count of 241-184. The passage of the House funding sets up a complicated conference process with the Senate, where the chamber approved $1.1 billion in funding to fight the Zika virus.
• On May 19, 2016, the House Energy and Commerce Committee Chairman Fred Upton (R-MI) and Oversight and Investigations Subcommittee Chairman Tim Murphy (R-PA) sent letters to FDA and NIH regarding bioresearch lab staffing and funding of Agency safety offices, External Laboratory Safety Workgroup recommendations, and for copies of the Agencies’ internal investigations following the smallpox vial discovery in July 2014.
• On May 18, 2016, the House Energy and Commerce Committee leaders sent letters to the eleven remaining ACA Consumer Operated and Oriented Plans (CO-OPs), asking for an update on the solvency of the CO-OPs. The letters were sent by full committee Chairman Fred Upton (R-MI), Health Subcommittee Chairman Joseph Pitts (R-PA), and Oversight and Investigations Subcommittee Chairman Tim Murphy (R-PA). The leaders requested a response to their questions by June 1, 2016.

III. REPORTS, STUDIES, & ANALYSES

• On May 17, 2016, the Congressional Budget Office (CBO) released a report entitled, “Cost Estimate of H.R. 4111, Rural Health Care Connectivity Act of 2015.” H.R. 4111 would make certain skilled nursing facilities (SNFs) eligible for grants under the Universal Service Fund’s Rural Health Care (RHC) program. CBO estimates that enacting H.R. 4111 would increase direct spending by $193 million and revenues by $212 million over the 2017-2026 period, resulting in an estimated net reduction in the deficit of $19 million. CBO estimates that implementing the bill would have no significant discretionary costs.
• On May 18, 2016, the Blue Cross Blue Shield Association (BCBSA) released a report entitled, “The Growth in Specialty Drug Spending from 2013 to 2014.” The report represents a comprehensive, in-depth study of costs for both medical and pharmacy claims. BCBSA found that there was an $87 annual per member increase in specialty pharmacy spending from 2013 to 2014. BCBSA noted that the increasing costs of specialty drug treatments were the primary driver of the growth in spending. BCBSA also found that annual specialty drug spending was 17 percent higher per member in the individual market compared to the employer market in 2014.

IV. OTHER HEALTH POLICY NEWS

• On May 19, 2016, the Medicaid and CHIP Payment and Access Commission (MACPAC) convened a series of meetings. At the meeting, the Commission held sessions on the following topics: review of the Commission’s conflict of interest policy; briefing on the Medicaid Managed Care Final Rule; issues in the forthcoming proposed rule on the Payment Error Rate Measurement program and the Medicaid Eligibility Quality Control program; key components for the future of children’s health insurance coverage; premium assistance for employer coverage under CHIP; review of the Medicare-Medicaid Coordination Office’s Report to Congress; review of the HHS Report to Congress on the Community First Choice Option; and next steps for MACPAC work on Disproportionate Share Hospital Payments. More details on the meeting are available here.
• On May 17, 2016, CMS posted monitoring data that shows the Agency’s efforts succeeded in reducing Medicare program expenditures for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) items, while continuing to provide equipment to patients that need the items and supplies. The data reveal that DMEPOS suppliers in these non-competitive bidding areas have continued to accept the new, adjusted DMEPOS payment rates as payment in full. If the new, lower fee schedule amounts do not cover the suppliers’ costs, these suppliers could require beneficiaries to pay the difference between the new and old rates. But according to the data, barely any suppliers chose to do so. CMS suggested that these findings indicate that the adjusted fee schedule rates continue to be more than adequate to cover the costs of furnishing the DMEPOS items in all areas.