A&B Healthcare Week in Review, October 8, 2016

I. Regulations, Notices, & Guidance

• On October 3, 2016, the Food and Drug Administration (FDA) issued a final order entitled, Medical Devices; Exemption From Premarket Notification; Method, Metallic Reduction, Glucose (Urinary, Nonquantitative) Test System in a Reagent Tablet Format. The final order denies a petition requesting exemption from the premarket notification requirements for method, metallic reduction, glucose (urinary, nonquantitative) devices that are in a reagent tablet format and are classified as class II devices as urinary glucose (nonquantitative) test system. 
• On October 4, 2016, the National Institutes of Health (NIH) issued a notice entitled, Prospective Grant of Exclusive Patent License: Development of Anti-CD70 Chimeric Antigen Receptors for the Treatment of CD70 Expressing Cancers. The NIH is contemplating the grant of an Exclusive Patent License to Kite Pharma, Inc.  Comments are due October 19, 2016.
• On October 4, 2016, the Office of Management and Budget (OMB) received a final rule from the Department of Veterans Affairs (VA) entitled, Copayments for medications beginning January 1, 2017. The final rule proposes to amend the VA’s regulations concerning copayments charged to certain veterans for medication required on an outpatient basis to treat non-service connected conditions.
• On October 4, 2016, the FDA issued a notice entitled, Request for Nominations for Voting Members for the Patient Engagement Advisory Committee. The FDA is requesting additional nominations for members to serve on the Center for Devices and Radiological Health’s (CDRH) Patient Engagement Advisory Committee. The Committee provides relevant skills and perspectives in order to improve communication of benefits, risks and clinical outcomes, and increase integration of patient perspectives into the regulatory process for medical devices. The call is open until November 18, 2016.
• On October 5, 2016, the NIH issued a notice entitled, Prospective Grant of Exclusive Patent License: Development of a NANOG-based therapeutic for cancer. The NIH is contemplating the grant of an Exclusive Patent License to Inova Health System. Comments are due October 20, 2016.
• On October 5, 2016, the FDA issued a guidance entitled, Tropical Disease Priority Review Vouchers. The guidance finalizes the draft guidance of the same name issued October 2008 and provides clarification of the FDA’s interpretation of the priority review voucher section in the Federal Food, Drug, and Cosmetic Act (FD&C Act) added by the Food and Drug Administration Amendments Act (FDAAA).
• On October 5, 2016, the FDA issued a guidance entitled, Head Lice Infestation: Developing Drugs for Topical Treatment. The purpose of the guidance is to assist sponsors in the clinical development of drugs for the treatment of head lice infestation. This guidance addresses the Agency’s current thinking regarding the overall development program and clinical trial designs of drugs to support approval of an indication for topical treatment of head lice infestation.
• On October 5, 2016, the FDA issued a final rule entitled, Abbreviated New Drug Applications and 505(b)(2) Applications. The final rule implements portions of Title XI of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) that pertain to provision of notice to each patent owner and the new drug application (NDA) holder of certain patent certifications made by applicants submitting 505(b)(2) applications or abbreviated new drug applications (ANDAs); the availability of 30-month stays of approval on 505(b)(2) applications and ANDAs that are otherwise ready to be approved; submission of amendments and supplements to 505(b)(2) applications and ANDAs; and the types of bioavailability and bioequivalence data that can be used to support these applications. This final rule also amends certain regulations regarding 505(b)(2) applications and ANDAs to facilitate compliance with and efficient enforcement of the FD&C Act.
• On October 6, 2016, CMS issued a State Release 178 entitled, Prescribed Drugs, Covered Outpatients Drugs, FFP, Federal Financial match, FFP Eligibility. The State Release defines “prescribed drug” and “covered outpatient drug” for purposes of Medicaid.
• On October 7, 2016, the FDA issued a guidance entitled, Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use. The guidance describes studies and criteria that FDA recommends be used when submitting premarket notifications (510(k)s) for self-monitoring blood glucose test systems (SMBGs) intended for over-the-counter (OTC) home use by lay-users.
• On October 7, 2016, the FDA issued a guidance entitled, Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use. The guidance describes studies and criteria that FDA recommends be used when submitting premarket notifications (510(k)s) for blood glucose monitoring systems (BGMSs) which are for prescription point-of-care use in professional healthcare settings.

Event Notices

• October 25, 2016: the Department of Health and Human Services (HHS) announced a public meeting of the Secretary’s Advisory Committee on Human Research Protections (SACHRP). An agenda will be posted here prior to the meeting.
• October 31, 2016: the FDA announced a public workshop entitled, Center for Devices and Radiological Health Veteran Amputee Devices. The purpose of the workshop is to engage all stakeholders involved in the research and development, and marketing of prosthetic limb medical devices used by veteran amputees.
• October 31, 2016: the FDA announced a public meeting entitled, Pre-Market Evaluation of Abuse-Deterrent Properties of Opioid Drug Products. The meeting is intended to give the FDA the opportunity to discuss, and seek public input from stakeholders on, the approach to testing FDA recommended in its draft guidance “General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products.” The meeting will also provide an opportunity to discuss FDA’s efforts to develop standardized in vitro testing methodologies for evaluating the abuse deterrence of opioid drug products.
• November 2, 2016: the FDA announced a public meeting entitled, Medical Device User Fee Amendments. The purpose of the meeting is to discuss proposed recommendations for the reauthorization of the Medical Device User Fee Amendments (MDUFA) for fiscal years (FYs) 2018 through 2022.
• November 3, 2016: the FDA announced a public advisory committee meeting of the Pharmacy Compounding Advisory Committee (PCAC). The committee intends to discuss five bulk drug substances nominated for inclusion on the section 503A Bulks List. FDA will discuss the following nominated bulk drug substances: Glycolic acid, trichloroacetic acid, kojic acid, diindolylmethane, and vasoactive intestinal peptide. The chart in this document describes which use(s) FDA reviewed for each of the five bulk drug substances being discussed at this advisory committee meeting.
• November 8, 2016: the FDA announced a public workshop entitled, Workshop on Promoting Semantic Interoperability of Laboratory Data. The purpose of the workshop is to receive and discuss input from stakeholders regarding proposed approaches to facilitate the adoption and implementation of interoperability standards in a manner that enables consistent, accurate, and harmonized descriptions of in vitro diagnostic tests and results.
• November 9, 2016: the FDA announced a public advisory committee meeting of the Microbiology Devices Panel of the Medical Devices Advisory Committee. The committee will discuss and make recommendations regarding the reclassification of quantitative Cytomegalovirus (CMV) viral load devices from class III (Premarket approval) to class II (510(k)).

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 3, 2016, the Office of Inspector General (OIG) released a study entitled, Changing How Medicare Pays for Clinical Diagnostic Laboratory Tests: An Update to CMS’s Progress. The study provides a progress update on CMS’s implementation of Medicare’s new congressionally mandated payment system for laboratory tests.
• On October 3, 2016, the OIG released a study entitled, Medicare Payments for Clinical Diagnostic Laboratory Tests in 2015: Year 2 of Baseline Data. The study found Medicare Part B paid $7 billion for lab tests in 2015, a total that did not change from 2014. The top 25 lab tests by Medicare payments totaled $4.1 billion in 2015, slightly less than in 2014. Payments for two categories of tests changed significantly from 2014 to 2015, among all tests as well as among the top 25 tests. Among all tests, Medicare payments for drug tests increased by 19 percent and payments for molecular pathology tests decreased by 44 percent. 
• On October 4, 2016, the Congressional Budget Office issued a cost estimate on H.R. 5122, a bill to prohibit further action on the proposed rule regarding testing of Medicare Part B prescription drug models. The CBO estimates that enacting H.R. 5122 would increase direct spending by $395 million over the 2017-2026 period. That estimate includes the savings that would be lost if the proposed demonstration was blocked, offset in part by additional savings that would result from CMMI’s ability to mitigate that loss by replacing the blocked demonstration with other projects, some of which would reduce federal spending.
• On October 6, 2016, the U.S. Government Accountability Office (GAO) released a report entitled, Skilled Nursing Facilities: CMS Should Improve Accessibility and Reliability of Expenditure Data. The report found that CMS has not taken key steps to make expenditure data from skilled nursing facilities readily accessible to public stakeholders or to ensure their reliability. 
• On October 6, 2016, the OIG released a report entitled, Not All Internal Controls Implemented by CDC Were Effective in Ensuring That World Trade Center Health program Pharmacy and medical Claims Were Paid According to Federal Requirements. The report found that not all of the CDC's internal controls were effective in ensuring that claims for the World Trade Center Health Program (WTCHP) pharmacy benefits and medical services were paid in accordance with Federal requirements. The OIG determined that the internal controls for reimbursing claims for pharmacy benefits and medical services were not always effective in ensuring that New York (NY) Metro area members' primary prescription drug insurance was billed by pharmacies to maintain the WTCHP as the secondary payer (2 claims), Nationwide Network prescribers of members' prescription drugs were WTCHP-authorized (2 claims), prescription refills were authorized (1 claim), and pharmacy benefit and medical service claims were reimbursed at or below appropriate payment rates (2 claims).
• On October 7, 2016, the OIG released a report entitled, Medicare Improperly Paid Providers Million of Dollars for Incarcerated Beneficiaries Who Received Services During 2013 and 2014. The report found that CMS's policies and procedures generally prevented improper payments in cases when CMS's data systems identified a beneficiary as incarcerated at the time that a claim was processed. However, CMS's policies and procedures did not allow CMS to detect and recoup improper payments on a post payment basis when CMS's data systems did not identify a beneficiary as incarcerated at the time that a claim was processed. 
• On October 6, 2016, the OIG released a report entitled, Medicare’s Policies and Procedures Identified Almost All Improper Claims Submitted for Deceased Individuals and Recouped Almost All Improper Payments Made for These Claims for January 2013 Through October 2015. The report found that for the audit period the OIG identified $426,000 in improper payments for 427 Medicare claims and $1.5 million in potentially improper payments for 1,047 Medicare claims with dates of service that were after the individuals' dates of death. These improper and potentially improper payments represented 0.0002 percent of the total Parts A and B payments made during this period. In addition, these claims represented only 0.15 percent of the Medicare claims in which the Enrollment Database (EDB) had been updated with date-of-death information after the claims had been processed and paid.
• On October 7, 2016, the OIG released a report entitled, Indian Health Service Hospitals: Longstanding Challenges Warrant Focused Attention to Support Quality Care. The report found that Indian Health Service Hospitals face continual increases in the number of American Indians and Alaska Natives using their services, yet they provide a narrow scope of medical services and limited access to specialists and community support (e.g., nursing homes and home health). 
• On October 7, 2016, the OIG released a report entitled, Indian Health Service Hospitals: More Monitoring Needed to Ensure Quality Care. The report found that Indian Health Service Hospitals may be missing opportunities to identify and remediate quality problems in their hospitals because they performed limited oversight regarding quality care and compliance with Medicare Hospital Conditions of Participation (CoPs).

IV. Other Health Policy News 

• On October 3, 2016, the Centers for Medicare & Medicaid Services (CMS) announced that they have awarded $13.4 million in funding over four years to six new Pediatric Quality Measures Program (PQMP) grantees focused on implementing new pediatric quality measures developed by the PQMP Centers of Excellence (COE).
• On October 3, 2016, CMS issued a fact sheet announcing refinements to the design of the second year of the Medicare Advantage Value-Based Insurance Design (MA-VBID) model. CMS announced that in the second year of the model, beginning January 1, 2018, CMS will: open the model test to new applicants; conduct the model test in three new states - Alabama, Michigan, and Texas; add rheumatoid arthritis and dementia to the clinical categories for which participants may offer benefits; make adjustments to existing clinical categories; and change the minimum enrollment size for some MA and MA-PD plan participants.
• On October 3, 2016, the Center for Medicare & Medicaid Innovation Center (CMMI) announced the participants in the Part D Enhanced Medication Therapy Management (MTM) model. This Enhanced MTM model offers an opportunity and financial incentives for basic stand-alone Part D Prescription Drug Plans (PDPs) in selected regions to offer innovative MTM programs in lieu of the standard CMS MTM model.
• On October 4, 2016, the OIG issued an investigative advisory on Medicaid fraud and patient harm involving personal care services. Within the investigative advisory, OIG identifies concerns about fraud and patients harm that build upon those outlined in a Portfolio report issued in November 2012. OIG recommends that CMS implement the following key unimplemented recommendations from OIG's Personal Care Services (PCS) Portfolio: 1) establish minimum Federal qualifications and screening standards for PCS workers, including background checks; 2) require States to enroll or register all PCS attendants; 3) assign them unique numbers; 4) require that PCS claims identify the dates of service and the PCS attendant who provided the service; and 5) consider whether additional controls are needed to ensure that PCS are allowed under program rules and are provided.
• On October 5, 2016 CMS issued a fact sheet entitled, Pre-Claim Review Demonstration of Home Health Services – Early Data from Illinois. The fact sheet provides early statistics based on the initial data coming in from Illinois.
• On October 5, 2016, CMS Acting Administrator, Andrew M. Slavitt sent a letter to Senator Amy Klobuchar (D-MN) whereby he stated that companies that incorrectly classify drugs in Medicaid are liable for False Claims Act penalties.