A&B Healthcare Week in Review, October 21, 2016

I. Regulations, Notices, & Guidance

• On October 17, 2016, the Food and Drug Administration (FDA) released a proposed rule entitled, Amendments to the Regulation Regarding the List of Drug Products That Have Been Withdrawn or Removed from the Market for Reasons of Safety or Effectiveness. The proposed rule would amend its regulations to revise the list of drug products that have been withdrawn or removed from the market because the drug products or components of such drug products have been found to be unsafe or not effective. Drugs appearing on this list may not be compounded under the exemptions provided by sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). Specifically, the proposed rule would add three entries to this list of drug products: aprotinin, bromocriptine mesylate, and ondanetron hydrochloride. Comments are due by January 3, 2017.
• On October 17, 2016, the FDA issued a final order entitled, Medical Devices; Physical Medicine Devices; Classification of the Upper Extremity Prosthesis Including a Simultaneously Powered Elbow and/or Shoulder With Greater Than Two Simultaneous Powered Degrees of Freedom and Controlled by Non-Implanted Electrical Components. The order classifies the Upper Extremity Prosthesis Including a Simultaneously Powered Elbow and/or Shoulder with Greater Than Two Simultaneous Powered Degrees of Freedom and Controlled by Non-Implanted Electrical Components into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the upper extremity prosthesis including a simultaneously powered elbow and/or shoulder with greater than two simultaneous powered degrees of freedom and controlled by non-implanted electrical components’ classification. The FDA is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. The final order is effective October 18, 2016.
• On October 17, 2016, the Centers for Disease Control and Prevention (CDC) issued a notice with comment period entitled, Proposed Revised Vaccine Information Materials for MMR (Measles, Mumps, and Rubella and MMRV (Measles, Mumps, Rubella, and Varicella) Vaccines. The notice provides the proposed updated version of the measles, mumps, and rubella (MMR) and measles, mumps, rubella, and varicella (MMRV) vaccine information statements. Comments are due by December 19, 2016.
• On October 18, 2016, the Department of Health and Human Services (HHS) issued a notice entitled, Solicitation for Applications from Individuals Interested in Being Appointed to the Chronic Fatigue Syndrome Advisory Committee. HHS is seeking nomination of qualified candidates to be considered for appointment as members of the Chronic Fatigue Syndrome Advisory Committee (CFSAC). CFSAC provides advice and recommendations to the Secretary of HHS, through the Assistant Secretary for Health (ASH), on a broad range of issues and topics related to myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). The appointments of two Committee members are scheduled to end during the 2016 calendar year. Applications are due by November 18, 2016.
• On October 18, 2016, the Office of Management and Budget (OMB) received a final rule from the Centers of Medicare & Medicaid Services (CMS) entitled, CY 2017 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B. The final rule would revise payment policies under the Medicare physician fee schedule, and make other policy changes to payment under Medicare Part B. These changes would apply to services furnished beginning January 1, 2017.
• On October 19, 2016, HHS issued a notice entitled, Request for Comments on Proposed Measures and 2020 Targets for the National Action Plan for Adverse Drug Event Prevention: Inpatient and Outpatient Measures for Reduction of Adverse Drug Events from Anticoagulants, Diabetes Agents, and Opioid Analgesics. The Office of Disease Prevention and Health Promotion (ODPHP) proposes new measures and targets for adverse drug events (ADEs) from anticoagulants, diabetes agents, and opioid analgesics for the National Action Plan for Adverse Drug Event Prevention (ADE Action Plan). Based on input from the Federal Interagency Workgroups for Adverse Drug Events, six national measures and targets for the reduction of ADEs are being proposed. Each drug class highlighted in the ADE Action Plan (anticoagulants, diabetes agents, and opioid analgesics) includes a proposed inpatient and outpatient measure to track national progress in reduction of ADEs from these drug classes. The proposed targets will reflect improvement efforts over a four to six year period since the release of the ADE Action Plan in August 2014. As such, HHS is proposing a baseline year of 2014 for five of the measures and 2016 for one measure. All targets are to be achieved by 2020. HHS seeks comments on the proposed 2020 ADE targets. Comments are due by November 21, 2016.
• On October 20, 2016, the National Institutes of Health (NIH) issued a notice entitled, Notice of Availability of License; Mutant IHD1 Inhibitors Useful for Treating Cancer. The invention Mutant IHD1 Inhibitors Useful for Treating Cancer is owned by an agency of the U.S. Government and is available for licensing and/or co-development in the U.S.
• On October 20, 2016, the FDA issued a notice entitled, Request for Nominations for Voting Members on a Public Advisory Committee; Food Advisory Committee. The FDA is requesting nominations for voting members to serve on the Food Advisory Committee, Office of Regulations, Policy, and Social Sciences, Center for Food Safety and Applied Nutrition. Nominations are due by December 20, 2016.
• On October 20, 2016, HHS issued a notice entitled, Notice of Interest Rate on Overdue Debts. The current rate of 9 5/8%, as fixed by the Secretary of the Treasury, is certified for the quarter ended September 30, 2016. This interest rate will be applied to overdue debt until the Department of Health and Human Services publishes a revision.
• On October 21, 2016, the FDA issued a final order entitled, Medical Devices; Ear, Nose, and Throat Devices; Classification of the Eustachian Tube Balloon Dilation System. The FDA is classifying the Eustachian tube balloon dilation system into class II (special controls). The special controls that will apply to the device are identified in the final order and will be part of the codified language for the Eustachian tube balloon dilation system’s classification. The FDA is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. The order is effective on October 24, 2016.
• On October 21, 2016, the FDA and CMS issued a notice entitled, Program for Parallel Review of Medical Devices. The FDA and CMS are informing the public that the Parallel Review of medical devices pilot program will be fully implemented and extended indefinitely.
• CMS’s final rule with comment period entitled, Medicare Program; Merit-based Incentive Payment System (MIPS) and Alternative Payment Model (APM) Incentive under the Physician Fee Schedule, and Criteria for Physician-Focused Payment Models, has officially been filed for public inspection, triggering the start of the comment period. It appears that comments are due by December 19, 2016, but this will be confirmed for certain in the final Federal Register publication version of the final rule with comment period (scheduled for November 4, 2016).

Event Notices

• October 27, 2016:  The Medicaid and CHIP Payment and Access Commission will hold their next meeting on October 27, 2016. An agenda and additional information can be found here.
• October 31, 2016: HHS announced a meeting of the Technical Advisory Panel on Medicare Trustee Reports. The Panel will discuss the long-term rate of change in health spending and may make recommendations to the Secretary on how the Medicare Trustees might more accurately estimate health spending in the short and long run. The Panel’s discussion is expected to be very technical in nature and will focus on the actuarial and economic assumptions and methods by which Trustees might more accurately measure health spending. 
• November 2, 2016: The Physician-Focused Payment Model Technical Advisory Committee (PTAC) announced a webinar entitled, Overview of the Physician-Focused Payment Model Technical Advisory Committee. The webinar will be hosted by Chair Dr. Jeffrey Bailet and Vice Chair Elizabeth Mitchell. The webinar will provide important background information about the history and purpose of the PTAC and highlight key upcoming dates in the submissions process.
• November 14, 2016: CMS announced a listening session to solicit input from stakeholders regarding our implementation of section 704 of the Comprehensive Addiction and Recovery Act of 2016 (CARA), which includes provisions to permit Part D sponsors to establish drug management programs for at-risk beneficiaries under which Part D sponsors may limit such beneficiaries’ access to frequently abused drugs to certain prescribers and pharmacies. 
• November 16, 2016: PTAC announced a webinar entitled, How to Submit to the Physician-Focused Payment Model. This webinar will be hosted by PTAC member Mr. Harold Miller. Registration for the event is not yet open.
• November 28-29, 2016: HHS announced a meeting of the Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA). The Committee will hear the findings from the HHS sponsored RAND study, “Toward a Sustainable Blood Supply in the United States: An Analysis of the Current System and Alternatives for the Future.” The ACBTSA Subcommittee on Blood System Sustainability will present their response to the study, and the full Committee will discuss and develop appropriate recommendations for HHS consideration. Additional topics that are pertinent to the mission of the Committee may be added to the agenda. 

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 October 17, 2016, the Office of Inspector General (OIG) released a report entitled, Children’s Health Insurance Program Enrollment Using the Express Lane Eligibility Option Did Not Always Meet Federal Requirements. The report found that States generally determined Children's Health Insurance Program (CHIP) eligibility using the Express Lane Eligibility (ELE) option in accordance with Federal requirements. From the OIG’s sample of 120 beneficiaries, States correctly determined eligibility for 110 beneficiaries. The OIG found no eligibility errors in four of the eight States reviewed; however, four States did not determine eligibility for seven beneficiaries in accordance with Federal requirements. On the basis of the OIG’s sample, they estimated that 148,375 beneficiaries were eligible, but 6,998 were potentially ineligible. The OIG also estimated that Federal and State CHIP payments on behalf of eligible beneficiaries totaled $196.9 million, and Federal and State CHIP payments made on behalf of potentially ineligible beneficiaries totaled $10.6 million. The OIG attributes the enrollment of potentially ineligible beneficiaries to State-specific eligibility determination errors.
• On October 17, 2016, the OIG released a report entitled, Medicaid Enrollment Using the Express Lane Eligibility Option Did Not Always Meet Federal Requirements. The report found that States generally determined Medicaid eligibility using the ELE option in accordance with Federal requirements. From the OIG’s sample of 157 beneficiaries, States correctly determined eligibility for 133 beneficiaries. The OIG found no errors in 6 of the 10 States reviewed; however, 4 States did not determine eligibility for 17 beneficiaries in accordance with Federal requirements. On the basis of the OIG’s sample, they estimated that 731,365 beneficiaries were eligible, but 86,672 were potentially ineligible. The OIG also estimated that Federal and State Medicaid payments on behalf of eligible beneficiaries totaled $1.5 billion, and Federal and State Medicaid payments made on behalf of potentially ineligible beneficiaries totaled $284.1 million. The OIG attributes the enrollment of potentially ineligible beneficiaries to State-specific eligibility determination errors. 
• On October 17, 2016, the OIG released a report entitled, State Use of Express Lane Eligibility for Medicaid and CHIP Enrollment. The report found that Medicaid and the CHIP provide health insurance coverage for certain low-income children, yet millions of eligible children are still uninsured. This report is being issued concurrently with two OIG audits that fulfill a Congressional mandate to assess whether State agencies met Federal requirements in making eligibility determinations using ELE and developing eligibility error rates.
• On October 17, 2016, the Government Accountability Office (GAO) released a report entitled, Medicare: CMS’s Round 2 Durable Medical Equipment and National Mail-order Diabetes Testing Supplies Competitive Bidding Programs. The report found that the number of beneficiaries receiving durable medical equipment (DME) items covered under the competitive bidding program (CBP) generally decreased after implementation of two CBP phases that began July 1, 2013—round 2 and the national mail-order program for diabetes testing supplies. 
• On October 19, 2016, the OIG released a report entitled, Virginia Did Not Always Make Correct Medicaid Claim Adjustments. The report found that the Virginia Department of Medical Assistance Services (State agency) did not always use the correct Federal medical assistance percentage (FMAP) when processing claim adjustments reported on Form CMS-64. The State agency used the current FMAP on the date the adjustment was made. In doing so, the State agency repaid to the Federal Government a higher amount than it received for the original claim. Furthermore, when the State agency submitted the revised claim, it received a higher FMAP payment than it should have received. Taking into consideration both of the errors, the net effect resulted in no overpayment or underpayment. The State agency agreed with the OIG’s finding and concurred with the OIG’s recommendation.
• On October 19, 2016, the OIG released a report entitled, Michigan Improperly Received Medicaid Reimbursement for School-Based Health Services. The report found that the Michigan Department of Health and Human Services (the State agency) did not always comply with Federal requirements when using a random moment time study (RMTS) to claim direct medical service costs related to Medicaid school-based health services (SBHS). Specifically, the RMTS methodology did not meet acceptable standards because the sample universe from which the State agency selected the sample items was incomplete. The sample universe did not contain all the job titles of the employees whose salaries and wages were allocated on the basis of the sample results. As a result, the State agency received unallowable Federal reimbursement totaling $954,000 for services provided during State fiscal year 2011. 
• On October 19, 2016, the OIG released a report entitled, Hundreds of Millions in Medicare Payments for Chiropractic Services Did Not Comply With Medicare Requirements. The report found that most Medicare payments for chiropractic services did not comply with Medicare requirements. On the basis of the OIG’s sample results, the OIG estimated that $358.8 million, or approximately 82 percent, of the $438.1 million paid by Medicare for chiropractic services was unallowable. These overpayments occurred because CMS's controls were not effective in preventing payments for medically unnecessary chiropractic services.
• On October 19, 2016, the GAO released a report entitled, Breast Cancer Education; HHS Has Implemented Initiatives Aimed at Young Women. The report found that the CDC has led federal efforts to respond to four areas specified in the Young Women’s Breast Health Education and Awareness Requires Learning Young Act of 2009 (EARLY Act). CDC reported spending nearly $37 million between fiscal years 2010 to 2016 on multiple efforts across the four areas specified in the act. 
• On October 20, 2016, CMS released a report entitled, Computation of Annual Liability Insurance (Including Self-Insurance), No-Fault Insurance, and Workers’ Compensation Settlement Recovery Threshold. The report found that the average cost of collecting conditional payments for liability insurance (including self-insurance, no-fault insurance, and workers’ compensation settlements was approximately $421 for fiscal year (FY) 2015.

IV. Other Health Policy News 

• On October 17, 2016, Vice President Joe Biden issued the administration’s plan for how the Cancer Moonshot initiative will be launched.
• On October 19, 2016, CMS released Frequently Asked Questions on Pre-Claim Review Demonstration for Home Health Services. The FAQ’s address questions related to the pre-claim review demonstration that was announced on June 8, 2016.