A&B Healthcare Week in Review, June 3, 2016

I. REGULATIONS, NOTICES, & GUIDANCE

• On June 2, 2016, the Centers for Medicare & Medicaid Services (CMS) issued a final rule entitled, “State Health Insurance Assistance Program (SHIP).” The final rule implements a provision enacted by the Consolidated Appropriations Act of 2014 and reflects the transfer of SHIP from CMS to the Administration for Community Living (ACL) in the Department of Health and Human Services (HHS). Prior to the interim final rule, prior regulations were issued by CMS under the authority granted by the Omnibus Budget Reconciliation Act of 1990 (OBRA), Section 4360.
• On June 1, 2016, CMS Consumer Information and Insurance Oversight (CCIIO) issued an informational bulletin entitled, “Effectuation of 2016 Federally-Facilitated Marketplace Dental Enrollment.” The bulletin announces that CMS will effectuate all remaining aged 2016 initial dental enrollment for policies without advance payments of the premium tax credit (APTCs) before the September 2016 payment cycle. This policy will help ensure that all Federally-facilitated Marketplace (FFM) enrollment is accurately captured.
• On June 1, 2016, CMS Center for Medicaid and CHIP Services (CMCS) issued an informational bulletin entitled, “Medicaid Benefits Available for the Prevention, Detection, and Response to the Zika Virus.” The purpose of the bulletin is to inform Medicaid agencies and interested stakeholders about how Medicaid services and authorities can help states and territories prevent, detect, and respond to the Zika virus, including efforts to prevent the transmission and address health risks to beneficiaries from the Zika virus.
• On May 31, 2016, the Food and Drug Administration (FDA) issued a draft guidance entitled, “Draft Guidance for Industry and Staff: Assessing Adhesion with Transdermal Delivery Systems and Topical Patches for Abbreviated New Drug Applications.” The draft guidance is intended to provide recommendations for the design and conduct of studies evaluating the adhesive performance of a Transdermal Delivery System or a topical patch (collectively, TDS). The guidance, once finalized, is intended to provide updated recommendations for the design and conduct of adhesion studies submitted in support of an Abbreviated New Drug Application (ANDA) for a TDS. Public comments are due August 1, 2016.
• On June 3, 2016, CMS issued a notice entitled, “HIPAA Administrative Simplification Complaint Form.” The Health Insurance Portability and Accountability Act (HIPAA) became law in 1996 (Public Law 104–191). Subtitle F of Title II of HIPAA, titled ‘‘Administrative Simplification,’’ (A.S.) requires the Secretary of HHS to adopt national standards for certain information-related activities of the health care industry. The HIPAA provisions, by statute, apply only to “covered entities” referred to in section 1320d – 2(a) (1) of this title. Responsibility for administering and enforcing the HIPAA A.S. Transactions, Code Sets, and Identifiers has been delegated to CMS. Public comments are due by August 3, 2016.
• On May 31, 2016, FDA issued a draft guidance entitled, “Food and Drug Administration Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services with Coverage Decisions.” The guidance modifies FDA's current policy on the categorization of IDE devices, which assists CMS in determining whether or not an IDE device should be covered (reimbursed) by CMS. The draft guidance is not final nor is it in effect at this time. Public comments are due by August 1, 2016.
• On May 31, 2016, the Health Resources and Services Administration (HRSA) issued a notice entitled, “Rural Opioid Overdose Reversal Grant Program.” The purpose of this grant program is to reduce the incidences of morbidity and mortality related to opioid overdoses in rural communities through the purchase and placement of emergency devices used to rapidly reverse the effects of opioid overdose and training of licensed healthcare professionals and emergency responders on their use. Public comments are due July 1, 2016.
• On May 31, 2016, CMS issued an informational bulletin entitled, “Updated 2016 Spousal Impoverishment Standards.” In the bulletin, CMS indicates that Medicaid income and resource standards are adjusted annually in accordance with changes in the Supplemental Security Income (SSI) federal benefit rate and the Consumer Price Index (CPI). These include some of the standards described in section 1924 of the Social Security Act, which describes the financial eligibility rules that apply when married individuals seek coverage of certain long-term services and supports.
• On May 31, 2016, CMS issued a correcting amendment to a final rule entitled, “Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2016; Corrections.” This document corrects technical and typographical errors that appeared in the final rule with comment period published in the November 16, 2015, Federal Register (80 FR 70886 through 71386) entitled "Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2016.” The effective date for the rule was January 1, 2016.
• On June 1, 2016, FDA issued a notice entitled, “Agency Information Collection Activities; Proposals, Submissions, and Approvals: Guidance for Industry on Nonproprietary Naming of Biological Products.” The guidance describes FDA’s current thinking on the need for biological products licensed under the Public Health Service Act (PHS Act) to bear a nonproprietary name that includes an FDA designated suffix. There is a need to clearly identify biological products to facilitate pharmacovigilance and, for the purposes of safe use, to minimize inadvertent substitution. Public comments are due July 1, 2016.
• On June 1, 2016, CMS issued a notice entitled, “Warning Signs- Plan or Policy Non-Quantitative Treatment Limitations (NQTLs) that Require Additional Analysis to Determine Mental Health Parity Compliance.” The Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA), as amended by the Affordable Care Act (ACA), generally requires that group health plans and health insurance issuers offering group or individual health insurance coverage ensure that the financial requirements and treatment limitations on Mental Health or Substance Use Disorder (MH/SUD) benefits they provide are no more restrictive than those on medical or surgical (med/surg) benefits.
• On June 2, 2016, FDA issued a guidance entitled, “Charging for Investigational Drugs Under an Investigational New Drug Application--Questions and Answers.” The guidance provides information for industry, researchers, physicians, institutional review boards (IRBs), and patients about the implementation of FDA’s regulation on charging for investigational drugs under an investigational new drug application (IND) for the purpose of either clinical trials or expanded access for treatment use. FDA received a number of questions concerning its implementation of the charging regulation. FDA is providing guidance in a question and answer format to address the most frequently asked questions about charging for investigational drugs under an IND.
• On June 2, 2016, FDA issued a draft guidance entitled, “E18 Genomic Sampling and Management of Genomic Data; International Council for Harmonisation.” The draft guidance pertains to genomic sampling and the management of genomic data in clinical studies. The focus of this draft guidance is on the general principles of collecting, processing, transporting, storing, and disposing of genomic samples or data. The technical aspects of genomic sampling and research are also discussed when appropriate, recognizing the rapidly evolving technological advances in these areas. The draft guidance is intended to provide harmonized principles of genomic sampling and of managing genomic data in clinical studies. Public comments are due by August 2, 2016.
• On June 2, 2016, FDA issued a guidance entitled, “Expanded Access to Investigational Drugs for Treatment Use--Questions and Answers.” The guidance provides information for industry, researchers, physicians, institutional review boards (IRBs), and patients about the implementation of FDA’s regulations on expanded access to investigational drugs for treatment use under an investigational new drug application (IND). FDA received a number of questions concerning implementation of its expanded access regulations and is providing guidance in a question and answer format to address the most frequently asked questions.
• On June 2, 2016, FDA issued a guidance entitled, “Individual Patient Expanded Access Applications: Form FDA 3926.” The guidance describes Form FDA 3926 (Individual Patient Expanded Access--Investigational New Drug Application (IND)), which is available for licensed physicians to use for expanded access requests for individual patient INDs. Individual patient expanded access allows for the use of an investigational new drug outside of a clinical investigation, or the use of an approved drug where availability is limited by a risk evaluation and mitigation strategy (REMS), for an individual patient who has a serious or immediately life-threatening disease when there is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.
• On June 2, 2016, CMS issued an MLN Matters® Article entitled, “Updated Information on the Intravenous Immune Globulin (IVIG) Demonstration.” In the article, CMS informs providers that a new Medicare contractor, Noridian Healthcare Solutions, LLC, will replace NHIC as the implementation support contractor for the IVIG demonstration as of July 1, 2016. This article also reminds suppliers of the 2016 payment rate for demonstration service code Q2052. The 2016 payment rate is $336.05.
• On May 31, 2016, CMS issued a correcting amendment to a final rule entitled, “Medicare and Medicaid Programs; Electronic Health Record Incentive Program-Stage 3 and Modifications to Meaningful Use in 2015 through 2017; Corrections and Correcting Amendment.” This document corrects certain technical and typographical errors that appeared in the October 16, 2015, final rule with comment period titled "Medicare and Medicaid Programs; Electronic Health Record Incentive Program—Stage 3 and Modifications to Meaningful Use in 2015 through 2017."
• On June 3, 2016, CMS issued a notice entitled, “Announcement of Requirements and Registration for “A Bill You Can Understand” Design and Innovation Challenge: Help Patients Understand Their Medical Bills and the Financial Aspect of Health; Correction.” This document corrects technical errors that appeared in the notice published in the May 10, 2016, Federal Register entitled “Announcement of Requirements and Registration for ‘‘A Bill You Can Understand’’ Design and Innovation Challenge: Help Patients Understand Their Medical Bills and the Financial Aspect of Health.”

Event Notices

• June 20, 2016, FDA announced a public workshop entitled, “openFDA Public Workshop.” The purpose of the public workshop is to provide a forum for the openFDA system user community to engage in a robust interactive discussion and provide feedback to FDA regarding openFDA's platform, application programming interfaces (APIs), downloadable harmonized datasets, and possible enhancements to the openFDA platform, as well as to view the demonstration of various applications (apps) specifically developed for utilization of openFDA data.
• June 22, 2016, CMS announced a meeting of the Advisory Panel on Outreach and Education (APOE) entitled, “Health Insurance Marketplace, Medicare, Medicaid, and Children's Health Insurance Program.”
• June 22, 2016, HHS announced a public meeting of the National Advisory Council on the National Health Service Corps.
• June 23, 2016, FDA announced a public advisory committee meeting of the Pharmacy Compounding Advisory Committee.
• June 25-29, 2016, FDA announced a conference entitled, “Collaborating to Strengthen Food, Drug, and Medical Device Safety Systems.” This conference is intended to provide information about FDA drug and device regulation to the regulated industry.
• July 18, 2016, CMS announced a public meeting of the Advisory Panel on Clinical Diagnostic Laboratory Tests. The purpose of the Panel is to advise the Secretary of HHS and the Administrator of CMS on issues related to clinical diagnostic laboratory tests.
• August 3 & 4, 2016, HHS announced a public webcast to address import and export permit regulations for infectious biological agents, infectious substances, and vectors; and import and export permit exemptions. Registration instructions may be found here.

II. CONGRESSIONAL LEGISLATION & COMMITTEE ACTION

U.S. Senate

• The Senate has adjourned and will reconvene on Monday, June 6, 2016.

House of Representatives

• The House has adjourned and will reconvene on Tuesday, June 7, 2016.
• On May 31, 2016, House Committee on Energy and Commerce Chairman Fred Upton (R-MI) and House Committee on Ways and Means Chairman Kevin Brady (R-TX) sent a letter to HHS regarding a nearly yearlong effort to obtain information regarding the source of funding for the Basic Health Program (BHP). “Since June 2015, the Committee on Energy and Commerce and the Committee on Ways and Means have sought information from your department about the implementation and source of funding for the BHP,” wrote Upton and Brady. “Today, almost a year later, your Department has failed to provide meaningful answers to our questions. Your refusal to provide the requested documents and information raises serious concerns about the Department’s willingness to be accountable for the lawful execution of laws passed by Congress.”

III. REPORTS, STUDIES, & ANALYSES

• On May 31, 2016, the Congressional Budget Office (CBO) issued a report entitled, “Cost Estimate of H.R. 4981, Opioid Use Disorder Treatment Expansion and Modernization Act.” H.R. 4981 would permit nurse practitioners and physician assistants who meet certain criteria to apply for waivers administered by the Substance Abuse and Mental Health Services Administration (SAMHSA). Those waivers would allow them to prescribe buprenorphine products to patients with opioid dependency. Additionally, the bill would permit pharmacists to fill only part of a prescription for certain drugs upon the request of the prescribing physician or the patient. CBO estimates that enacting H.R. 4981 would reduce net direct spending by $37 million over the 2017-2026 period. Section 3 of the bill would increase direct spending by $85 million while section 5 would decrease direct spending by $122 million. H.R. 4981 also would have a discretionary cost of about $2 million; any such spending would be subject to the availability of appropriated funds.
• On June 3, 2016, CBO issued a report entitled, “H.R. 5273, Helping Hospitals Improve Patient Care Act of 2016.” H.R. 5273 would modify Medicare payment rules for certain hospital outpatient departments and some hospital inpatient services, increase the number of beds for long-term care hospitals (LTCHs), extend a demonstration involving rural community hospitals, modify meaningful use standards for some physicians practicing in ambulatory surgical centers, and delay CMS’ authority to terminate certain Medicare Advantage (MA) contracts. CBO estimates that enacting H.R. 5273 would increase direct spending by $50 million over the 2017-2021 period but decrease direct spending by $14 million over the 2017-2026 period.
• On May 31, 2016, HHS Office of the Inspector General (OIG) issued a report entitled, “Spring 2016 Semiannual Report to Congress.” The semiannual reports are intended to keep the Secretary of HHS and Congress fully and currently informed of significant findings and recommendations by the OIG. The Semiannual Report provides a review of recent reports and recommendations from OIG, as well as a summary of recent enforcement actions.
• On June 1, 2016, the Government Accountability Office (GAO) issued a report entitled, “Medicare: Utilization and Expenditures for Complex Wheelchair Accessories.” GAO found that the Medicare fee-for-service (FFS) program spent millions of dollars annually to furnish wheelchairs and wheelchair accessories to Medicare beneficiaries. GAO also found that the top accessory--a combination tilt and recline power seating system--accounted for an estimated $56 million, or 35 percent, of total expenditures on accessories used with these chairs.

IV. OTHER HEALTH POLICY NEWS

• On June 2, 2016, GAO announced the appointment of five new members to the Medicare Payment Advisory Commission (MedPAC), as well as the reappointment of one current member. The newly appointed members are Amy Bricker, RPh, Vice President, Supply Chain Strategy, Express Scripts, Inc.; Brian DeBusk, PhD, CEO, DeRoyal Industries; Paul Ginsburg, PhD, Leonard Schaeffer Chair in Health Policy Studies, Brookings Institution, and Professor of Health Policy, University of Southern California; Bruce Pyenson, FSA, MAAA, Principal and Consulting Actuary, Milliman, Inc.; and Pat Wang, JD, CEO, Healthfirst. Their terms will expire in April 2019. The reappointed member, whose term will also expire in April 2019, is Jon Christianson, Ph.D., Professor of Health Policy and Management at the University of Minnesota's School of Public Health in Minneapolis, Minnesota. He will continue to serve as Vice Chair.
• On June 2, 2016, Blue Cross and Blue Shield of North Carolina (BCBSNC) filed a suit against the federal government in the United States Court of Federal Claims over the government's failure to make the risk corridor payments for 2014 as promised under the ACA’s Section 1342. BCBSNC alleges that the federal government underpaid the company by approximately $130 million for 2014 alone.