A&B Healthcare Week in Review, November 11, 2016

I. Regulations, Notices, & Guidance

• On November 7, 2016, the Center for Medicare & Medicaid Services (CMS) issued a proposed notice with comment period entitled, Medicaid Program; Announcement of Medicaid Drug Rebate Program National Rebate Agreement.   The proposed notice with comment period announces changes that would be made to the Medicaid National Drug Rebate Agreement (NDRA) for use by the Secretary of the Department of Health and Human Services (HHS) and manufacturers under the Medicaid Drug Rebate Program (MDRP). CMS is updating the NDRA to incorporate legislative and regulatory changes that have occurred since the agreement was published in the February 21, 1991 Federal Register (56 FR 7049). CMS is also updating the NDRA to make editorial and structural revisions, such as references to the updated Office of Management and Budget (OMB)-approved data collection forms and electronic data reporting. Comments are due by February 7, 2017.
• On November 7, 2016, the Food and Drug Administration (FDA) issued a final rule entitled, Amendments to Regulations on Citizen Petitions, Petitions for Stay of Action, and Submission of Documents to Dockets. The final rule amends certain regulations relating to citizen petitions, petitions for stay of action (PSAs), and the submission of documents to the Agency. In particular, the final rule establishes new regulations to implement certain provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which concern certain citizen petitions and PSAs that involve a request for FDA to take any form of action relating to a pending abbreviated new drug application (ANDA), 505(b)(2) application, or certain applications submitted under the Public Health Service Act. The final rule is effective on January 9, 2017.
• On November 7, 2016, the FDA issued a guidance entitled, Medical Device Reporting for Manufacturers. The guidance is intended to assist medical device manufacturers in meeting applicable reporting and recordkeeping requirements for certain device-related adverse events and malfunctions. Comments may be submitted at any time. 
• On November 7, 2016, the FDA issued a guidance entitled, Non-Inferiority Clinical Trials to Establish Effectiveness. The document provides guidance to sponsors and applicants submitting investigational new drug applications (INDAs), new drug applications (NDAs), biologics licensing applications (BLAs), or supplemental applications on the appropriate use of non-inferiority (NI) study designs to provide evidence of the effectiveness of a drug or biologic. The document includes guidance on when NI studies demonstrating effectiveness of an investigational drug can provide interpretable results, how to choose the NI margin, and how to test the NI hypothesis. Comments may be submitted at any time.
• On November 7, 2016, the FDA issued a draft guidance entitled, Questions and Answers Regarding Food Facility Registration (Seventh Edition). The draft guidance contains 15 sections of updated information relating to the food facility registration requirements in the FD&C Act. Comments are due by February 6, 2017. 
• On November 9, 2016, the FDA issued a draft guidance entitled, Amendment to Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components Intended for Transfusion. The draft guidance, when finalized, is intended to amend the 2010 Chagas Guidance by: expanding the scope to include the collection of blood and blood components for use in manufacturing a product, including donations intended as a component of, or used to manufacture, a medical device; removing the recommendation to ask donors about a history of Chagas disease; and providing a recommendation for a reentry algorithm for donors deferred on the basis of screening test results for antibodies to Trypanosoma cruzi (T. cruzi) or on the basis of answering “yes” to the Chagas screening question. Further, the draft guidance is intended to notify blood establishments that collect blood and 2 blood components that FDA has licensed a supplemental test for antibodies to T. cruzi. The draft guidance does not apply to the collection of Source Plasma. Comments are due by February 8, 2017.
• On November 9, 2016, the FDA issued a draft guidance entitled, Product Labeling for Certain Ultrasonic Surgical Aspirator Devices. The draft guidance provides a specific labeling recommendation to promote the safe and effective use of ultrasonic surgical aspirator devices. The labeling recommendation is being made in light of the risk of tissue dissemination and relates to the use of these devices in the removal of uterine fibroid. Comments are due by January 9, 2017.
• On November 10, 2016, the FDA issued a guidance entitled, FDA’s Voluntary Qualified Importer Program. The guidance describes the Voluntary Qualified Importer Program (VQIP), which provides for expedited review and importation of food offered by importers who voluntarily agree to participate in the program. The guidance describes the eligibility criteria for, and benefits of, participation in VQIP. The guidance also provides information on submitting an application for VQIP participation, obtaining a facility certification for the foreign supplier of a food imported under VQIP, the VQIP user fee, conditions that might result in the revocation of VQIP eligibility, and criteria for reinstatement of eligibility. Comments may be submitted at any time.
• On November 10, 2016, CMS issued a notice entitled, Medicare Program; Medicare Part B Monthly Actuarial Rates, Premium Rate, and Annual Deductible Beginning January 1, 2017. The notice announces the monthly actuarial rates for the aged (age 65 and over) and disabled (under age 65) beneficiaries enrolled in Part B of the Medicare Supplementary Medical Insurance (SMI) program beginning January 1, 2017. In addition, this notice announces the monthly premium for aged and disabled beneficiaries, the deductible for 2017, and the income-related monthly adjustment amounts to be paid by beneficiaries with modified adjusted gross income above certain threshold amounts. The monthly actuarial rates for 2017 are $261.90 for aged enrollees and $254.20 for disabled enrollees. The standard monthly Part B premium rate for all enrollees for 2017 is $134.00, which is equal to 50 percent of the monthly actuarial rate for aged enrollees (or approximately 25 percent of the expected average total cost of Part B coverage for aged enrollees) plus $3.00. (The 2016 standard premium rate was $121.80, which includes the $3.00 repayment amount.) The Part B deductible for 2017 is $183.00 for all Part B beneficiaries. If a beneficiary has to pay an income-related monthly adjustment, they will have to pay a total monthly premium of about 35, 50, 65, or 80 percent of the total cost of Part B coverage plus $4.20, $6.00, $7.80, or $9.60.
• On November 10, 2016, CMS issued a notice entitled, Medicare Program; CY 2017 Part A Premiums for the Uninsured Aged and for Certain Disabled Individuals Who Have Exhausted Other Entitlement. The annual notice announces Medicare’s Hospital Insurance (Part A) premium for uninsured enrollees in calendar year (CY) 2017. This premium is paid by enrollees age 65 and over who are not otherwise eligible for benefits under Medicare Part A (the "uninsured aged") and by certain disabled individuals who have exhausted other entitlement. The monthly Part A premium for the 12 months beginning January 1, 2017, for these individuals will be $413. The premium for certain other individuals as described in this notice will be $227. The notice is effective on January 1, 2017.
• On November 10, 2016, CMS issued a notice entitled, Medicare Program; CY 2017 Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance Amounts. The notice announces the inpatient hospital deductible and the hospital and extended care services coinsurance amounts for services furnished in CY 2017 under Medicare Part A. The Medicare statute specifies the formulae used to determine these amounts. For CY 2017, the inpatient hospital deductible will be $1,316. The daily coinsurance amounts for CY 2017 will be: (1) $329 for the 61st through 90th day of hospitalization in a benefit period; (2) $658 for lifetime reserve days; and (3) $164.50 for the 21st through 100th day of extended care services in a skilled nursing facility in a benefit period. The notice is effective on January 1, 2017.
• On November 10, 2016, the Center for Consumer Information and Insurance Oversight (CCIIO) released a draft bulletin for comment entitled, Timing of Submission and Posting of Rate Filing Justifications for the 2017 Filing Year. The draft bulletin outlines the proposed uniform timeline for submission and public release of information about rate filings for single risk pool coverage. The timelines specified in the draft bulletin apply to the rate filings issuers will submit in 2017 for single risk pool coverage (including both qualified health plans (QHPs) and non-QHPs) with plan or policy years beginning on or after January 1, 2018.  Comments are due by December 1, 2016.

Event Notices

• November 29 – 30, 2016: HHS announced an advisory meeting of the National Committee on Vital and Health Statistics. The Committee will focus on legislatively mandated reports and activities such as the 12th Report to Congress, the next Affordable Care Act (ACA) Review Committee hearing, and requirements set forth in ACA section 10109. Additional areas where the Committee potentially could focus its attention in 2017 and beyond also will be discussed and considered for inclusion in its work plan. Additionally, the Committee will hear input from HHS officials on the Committee’s proposed work plan and potential areas in which Committee expertise and input would be useful for the Department. Completion of reports and recommendations undertaken earlier in 2016 will also be discussed.
• December 6, 2016: HHS announced a meeting of the Health IT Standards Committee. The Committee will hear reports from its workgroups/task forces and updates from the Office of the National Coordinator for Health Information Technology (ONC) and other federal agencies.
• December 6, 2016: HHS announced a meeting of the Health IT Policy Committee. The committee will hear reports from its task forces and updates from ONC and other federal agencies.
• February 2, 2017: The FDA announced a public workshop entitled, Ninth Annual Sentinel Initiative Public Workshop. The workshop will bring the stakeholder community together to discuss a variety of topics on active medical product surveillance. Topics will include an update on the state of FDA’s Sentinel Initiative, including an overview of the current state of Sentinel System safety surveillance activities, and uses of the Sentinel System accomplished in 2016. In addition, panelists will discuss the future of the Sentinel System and opportunities to expand its medical product surveillance capabilities. This workshop will also engage stakeholders to discuss current and emerging Sentinel Initiative projects.
• February 14, 2017: CMS announced a Town Hall meeting on the FY 2018 applications for new medical services and technologies add-on payments.

II. Congressional Legislation & Committee Action

U.S. Senate

• The Senate has adjourned and will reconvene on Monday, November 14, 2016.

House of Representatives

• The House has adjourned and will reconvene on Monday, November 14, 2016.

III. Reports, Studies, & Analyses  

• On November 10, 2016, the Office of Inspector General (OIG) released a report entitled, Public Summary Report: New York Implemented Security Controls Over Its Health Insurance Exchange Web Site and Database But Could Improve Security Controls. The report provides an overview of the results of the OIG’s audit of the information security controls at New York's health insurance exchange, New York State of Health (New York marketplace). Although the OIG did not identify evidence that the vulnerabilities in the New York marketplace’s Web site had been exploited, exploitation could have resulted in unauthorized access to and disclosure of personally identifiable information, as well as disruption of critical marketplace operations.

IV. Other Health Policy News

• On November 7, 2016, Senators Chuck Grassley (R-IA) and Elizabeth Warren (D-MA) announced that they will introduce the Over-the-Counter Hearing Aid Act of 2016. The bill will make certain types of hearing aids available over the counter.
• On November 10, 2016, CMS released Medicaid and CHIP Managed Care Final Rule Frequently Asked Questions. The FAQs address common questions related to the Medicaid and CHIP Managed Care Final Rule.
• On November 10, 2016, the OIG released their Fiscal Year 2017 HHS OIG Work Plan. The Work Plan summarizes new and ongoing reviews and activities that the OIG plans to pursue with respect to HHS programs and operations during the current fiscal year and beyond.
• On November 10, 2016, CCIIO released a letter entitled, Draft 2018 Letter to Issuers in the Federally-facilitated Marketplaces. The letter provides issuers seeking to offer QHPs, including stand-alone dental plans, in the Federally-facilitated Marketplaces (FFMs) or the Federally-facilitated Small Business Health Options Programs (FF-SHOPs) with operational and technical guidance to help them successfully participate in any such Marketplace in 2018. Unless otherwise specified, references to the FFMs include the FF-SHOPs.