A&B Healthcare Week in Review, September 16, 2016

I. Regulations, Notices, & Guidance

• On September 16, 2016, the National Institutes of Health (NIH) issued a final rule entitled, Clinical Trials Registration and Results Information Submission. The final rule details the requirements for submitting registration and summary results information, including adverse event information, for specified clinical trials of drug products (including biological products) and device products and for pediatric post market surveillances of a device product to ClincialTrials.gov.
• On September 16, 2016, the NIH issued a notice entitled, NIH Policy on the Dissemination of NIH-Funded Clinical Information. The notice provides an overview of the policy, which establishes the expectation that all investigators conducting clinical trials funded in whole or in part by the NIH will ensure that these trials are registered at ClinicalTrials.gov.
• On September 16, 2016, the Food and Drug Administration (FDA) issued a draft guidance entitled, S9 Nonclinical Evaluation for Anticancer Pharmaceuticals – Questions and Answers; International Council for Harmonisation. The draft Q&A’s guidance provides recommendations for nonclinical studies for the development of pharmaceuticals, including both small molecule and biotechnology derive produced, intended to treat patients with cancer.
• On September 16, 2016, the FDA issued a guidance entitled, Recommendations for Microbial Vectors Used for Gene Therapy. The guidance document provides investigational new drug application (IND) sponsors with recommendations concerning IND submissions for microbial vectors used for gene therapy (MVGTs) in early phase clinical trials.
• On September 16, 2016, the FDA issued a notice requesting comment entitled, International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; 4-Methylethcathinone and Eleven Other Substances. The FDA is requesting comments concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use of 12 drug substances. Comments are due by September 30, 2016.
• On September 15, 2016, the FDA issued a guidance entitled, Qualification of Biomarker--Total Kidney Volume in Studies for Treatment of Autosomal Dominant Polycystic Kidney Disease. The guidance provides a qualified context of use (COU) for total kidney volume (TKV), measured at baseline, to be used as a prognostic enrichment biomarker to select patients with autosomal dominant polycystic kidney disease (ADPKD) at high risk for a “progressive decline” in renal function. The guidance also describes the experimental conditions and constraints for which this biomarker is qualified through the Center for Drug Evaluation and Research (CDER) Biomarker Qualification Program.
• On September 14, 2016, the Office of Management and Budget (OMB) received a final rule from the Centers of Medicare & Medicaid Services (CMS) entitled, Merit-Based Incentive Payment System (MIPS) and Alternative Payment Models (APMs) in Medicare Fee-for-Service. The proposed rule would implement provisions of the Medicare Access and CHIP Reauthorization Act (MACRA) related to MIPS and APMs.  Section 101 of MACRA authorizes a new MIPS, which repeals the Medicare sustainable growth rate and improves Medicare payments for physician services.  MACRA consolidates the current programs of the Physician Quality Reporting System, the Value-Based Modifier, and the Electronic Health Records Incentive Program into one program, MIPS, that streamlines and improves on the three distinct incentive programs.  Additionally, MACRA authorizes incentive payments for providers who participate in eligible APMs.

Event Notices

• October 24, 2016: the FDA announced a regional public meeting entitled, Health Canada and U.S. Food and Drug Administration Joint Public Consultation on International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The goal of the meeting is to provide information and receive comments on the current activities of ICH, as well as the upcoming ICH meetings in Osaka, Japan.
• October 20, 2016: the FDA announced a public meeting to discuss proposed recommendations for the reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years 2018 through 2022.
• October 14, 2016: the FDA announced a public meeting entitled, Progress Toward Implementing the Product Identification Requirements of the Drug Supply Chain Security Act. The meeting is intended to provide members of the pharmaceutical distribution supply chain and other interested stakeholders an opportunity to share information with FDA about the efforts underway to implement the Drug Supply Chain Security Act's (DSCSA's) product identification requirements, including the use of product identifiers to enhance tracing at the product level.
• October 13, 2016: CMS announced a call entitled, IMPACT Act: Data Elements and Measure Development Call. During the call, CMS will discuss how data elements are used in measure development.
• October 1, 2016: the Department of Health and Human Services (HHS) announced that the Substance Abuse and Mental Health Services Administration (SAMHSA) will hold a public hearing. The hearing will discuss the training requirements for nurse practitioners (NPs) and physician assistants (PAs) that have been stipulated in the Comprehensive Addiction and Recovery Act (CARA).

II. Congressional Legislation & Committee Action

U.S. Senate

• On September 15, 2016, the Senate Homeland Security and Governmental Affairs Committee held a hearing entitled, “The State of Health Insurance Markets.” The witnesses included The Honorable Mary Taylor, Lieutenant Governor and Director, Ohio Department of Insurance (ODI); P. Wieske, Deputy Commissioner, Office of the Commissioner of Insurance State of Wisconsin (OCIW); The Honorable  Nick Gerhart, Commissioner, Iowa Insurance Division (IID); and The Honorable  Mike Kreidler, Commissioner, Office of the Insurance Commissioner State of Washington (OICW).
• On September 14, 2016, the Senate Special Aging Committee held a hearing entitled, “Maximizing Social Security Benefits.” The witnesses included Mr. Charles Jeszeck, Director, Education, Workforce, and Income Security, U.S. Government Accountability Office; Ms. Virginia P. Reno, Deputy Commissioner For Retirement and Disability Policy, U.S. Social Security Office; Mr. William Meyer, Chief Executive Officer, Social Security Solutions, Inc.; and Ms. Sita Nataraj Slavov, Professor of Public Policy and Visiting Scholar, Schar School of Policy and Government at George Mason University and American Enterprise Institute.
• On September 14, 2016, the Senate Veterans’ Affairs Committee held a hearing entitled, “The Future of the VA: Examining the Commission on Care Report and VA’s Response.” The witnesses included Honorable Robert A. McDonald, Secretary of Veterans Affairs, U.S. Department of Veteran Affairs; Ms. Nancy M. Schilchting, Chairperson, Commission on Care; Honorable Thomas E. Harvey, Esq.; Mr. Jeff Steele, Assistant Director, Legislative Division, The American Legion; Ms. Joy J. Ilem, National Legislative Direct, Disabled American Veterans; Ms. Lauren Agustine, Senior Legislative Associate, Iraq and Afghanistan Veterans of America; Ms. Rene A. Campos, Deputy Director, Government Relations, Military Officers Association of America; Mr. Carlos Fuentes, Deputy Director, National Legislative Service, Veterans of Foreign Wars; and Mr. Rick Weidman, Executive Director for Policy and Government Affairs, Vietnam Veterans of America.

House of Representatives

• On September 14, 2016, the House Oversight and Government Reform Committee held a hearing entitled, “Examining the Affordable Care Act’s Premium Increases.” The witnesses included Mr. Chris Carlson, Principal, Oliver Wyman; Mr. Kurt Giesa, Partner, Head of Actuarial Healthcare Practice, Oliver Wyman; Mr. Al Redmer, Jr., Commissioner, Maryland Insurance Administration; Dr. Mandy Cohen, M.D., MPH, Chief Operating Office and Chief of Staff, Office of the Administrator, U.S. Department of Health and Human Services (HHS); and Mr. Topher Spiro, Vice President, Health Policy, Center for American Progress.
• On September 14, 2016, the House Energy and Commerce Health and Oversight and Investigations Subcommittees held a joint hearing entitled, “Affordable Care Act Outlook and Oversight.” The witnesses included Mr. Chris Carlson, Principal, Oliver Wyman; Mr. Kurt Giesa, Partner, Head of Actuarial Healthcare Practice, Oliver Wyman; Mr. Al Redmer, Jr., Commissioner, Maryland Insurance Administration; Dr. Mandy Cohen, M.D., MPH, Chief Operating Office and Chief of Staff, Office of the Administrator, U.S. Department of Health and Human Services (HHS); and Mr. Topher Spiro, Vice President, Health Policy, Center for American Progress.
• On September 14, 2016, the House Ways and Means Health Subcommittee held a hearing entitled, “Spurring Health Care Innovation.” The witnesses included Mr. Michael Gallup, President, TeleTracking Technologies; Mr. Jared Short, Chief Operating Office, Cambia Health Solutions; Mr. Paul Black, Chief Executive Officer, Allscripts; and Mr. Greg Long, Chief Medical Officer, Senior Vice President, Systems of Care, Thedacare.

III. Reports, Studies, & Analyses 

• On September 16, 2016, the Office of Inspector General (OIG) released a report entitled, Ohio Made Incorrect Medicaid Electronic Health Record Incentive Payments. The report found that the Ohio Department of Medicaid made incorrect Medicaid electronic health record (EHR) incentive payments totaling $526,000 to 10 hospitals. The incorrect payments included both overpayments and underpayments, for a net overpayment amount of $524,000.
• On September 16, 2016, the OIG released a report entitled, Oklahoma Made Incorrect Medicaid Electronic Health Record Incentive Payments to Hospitals. The report found that the Oklahoma Health Care Authority did not always pay EHR incentive program payments to eligible hospitals in accordance with Federal and State requirements for program years 2012 and 2012. Specifically, the Oklahoma Care Authority overpaid seven hospitals a total of $1.1 million and underpaid four hospitals a total of $402,000, for a net overpayment of $680,000.
• On September 15, 2016, the OIG released a report entitled, West Virginia Made Incorrect Medicaid Electronic Health Record Incentive Payments to Hospitals. The report found that from July 1, 2011 through December 31, 2013, the West Virginia Department of Health and Human Resources, Department of Medical Assistance Services paid $50.3 million to 42 eligible hospitals in West Virginia for Medicaid EHR incentive payments.
• On September 15, 2016, the OIG released a report entitled, Kansas Correctly Invoiced Rebates to manufactures for Most Physician-Administered Drugs Dispensed to Enrollees of Medicaid Managed-Care Organizations. The report found that although the Kansas Department of Health and Environment, Division of Health Care Finance generally complied with Federal Medicaid requirements for invoicing manufacturers for rebates for physician-administered drugs dispensed to enrollees of Medicaid managed-care organizations (MCOs), it did not invoice all rebate-eligible physician-administered drugs dispensed to enrollees of MCOs. Specifically, the State agency did not invoice manufacturers for rebates totaling $63,000 ($36,000 Federal share). These errors occurred because the State agency's internal controls did not always ensure that it invoiced manufacturers to collect rebates.
• On September 15, 2016, the Government Accountability Office (GAO) released a report entitled, Long-Term Care Workforce: Better Information Needed on Nursing Assistants, Home Health Aides, and Other Direct Care Workers. The report found that direct care workers who provide long-term services and supports (LTSS) numbered an estimated 3.27 million in 2014, or 20.8% of the nation’s health workforce.
• On September 15, 2016, the Congressional Budget Office (CBO) issued a cost estimate on H.R. 954, CO-OP Consumer Protection Act of 2016. Along with the CBO, the Joint Committee on Taxation (JCT) estimates that the legislation would reduce revenues by $4 million over the 2016-2026 period. JCT also estimates that H.R. 954 would reduce direct spending by less than $500,000 over the 2016-2026 period, reflecting very small changes in subsidies for insurance purchased through health insurance marketplaces. JCT estimates that legislation would increase federal budget deficits by $4 million over the 2016-2026 period.
• On September 15, 2016, the GAO released a report entitled, Hospices Should Improve Their Election Statements and Certifications of Terminal Illness. The report found that hospice election statements lacked required information or had other vulnerabilities.
• On September 14, 2016, the GAO released a report entitled, Health Care: Results of Recent Undercover Resting for Patient Protection and Affordance Care Act Coverage, and Review of Market Concentration in the Private Markets. The report found that the federal and selected state health-care Marketplace’s eligibility determination and enrollment processes were vulnerable to fraud. Furthermore, the study found that enrollment in the private health-insurance market was concentrated among a small number of health insurance companies in most states in 2014, including in the newly established Exchanges.
• On September 13, 2016, the OIG issued a report entitled, Medicaid Fraud Control Units Fiscal year 2015 Annual Report. OIG found that fraud control units recovered $744 million overall in criminal and civil fraud, abuse and neglect cases over the course of the year. Investigations into fraud, abuse and neglect at nursing homes resulted in 40 criminal convictions and 20 settlements and judgements in FY 2015.
• On September 13, 2016, the House Energy and Commerce Committee released a report entitled, Implementing Obamacare: A Review of CMS’ Management of the State-Based Exchanges. The report chronicles the failures of state exchanges established under Obamacare.
• On September 12, 2016, the GAO issued a report entitled, Generic Drugs Under Medicare: Part D Generic Drug Prices Declined Overall, but Some Had Extraordinary Price Increases. The report found that drug prices declined overall under Medicare Part D since 2010. Specifically, generic drug prices fell 50% from the first quarter of 2010 through the second quarter of 2015.
• On September 12, 2106, the GAO issued a report entitled, Patient Protection and Affordable Care Act: Most Enrollees Reported Satisfaction with Their Health Plans, Although Some Concerns Exist. The report found that most enrollees who obtained their coverage through the health insurance exchanges were satisfied overall with their qualified health plans (QHP) during the first few years that exchanges operated. Specifically, most QHP enrollees who obtained their coverage through the exchanges reported overall satisfaction with their plans in 2014 through 2016.
• On September 12, 2016, the GAO issued a report entitled, Patient Protection and Affordable Care Act: Final Result of Undercover Testing of the Federal Marketplace and Selected State Marketplaces for Coverage Year 2015. The report found that the Marketplace eligibility determination and enrollment process for qualified health plans remained vulnerable to fraud for the 2015 coverage year. Simultaneously, the GAO issued a report entitled, Patient Protection and Affordable Care Act: Result of Undercover Enrollment Testing for the Federal Marketplace and a Selected State Marketplace for the 2016 Coverage Year. The report found that the Marketplace eligibility determination and enrollment process for qualified health plans, remained vulnerable to fraud for the 2016 coverage year as well.
• On September 12, 2016, the Internal Revenue Service (IRS) issued a report entitled, Individual Income Tax Return 2014. The report found that American paid nearly $1.7 billion in individual mandate fines through about 8.1 million tax returns in 2014.
• On September 12, 2016, the CBO issued a cost estimate of H.R. 670, Special Needs Trust Fairness and Medicaid Improvement Act. The CBO estimates that enacting H.R. 670 would reduce direct spending, on net, by $5 million over the 2017-2026 period. CBO estimates that enacting the legislation would not increase net direct spending or on-budget deficits in any of the four consecutive 10-year periods beginning in 2027.

IV. Other Health Policy News

• On September 15, 2016, CMS released a Pre-claim Review Demonstration for Home Health Services Frequently Asked Questions. The FAQs address questions related to whether certain branch locations and HHAs are included in the demonstration given their location/populations served, the requirement to include an NPI on claims, the preferred timing of RAP submissions, PCR review submission processes, and how to manage uncooperative certifying physicians.
• On September 15, 2016, U.S. Senators Tammy Baldwin (D-WI) and John McCain (R-AZ) and U.S. Representative Jan Schakowsky (D-IL) introduced the Fair Drug Pricing Act. The legislation would impose new transparency requirements on drug manufactures whose products are facing specified increase in price.
• On September 13, 2016, CMS released a blog post by Principal Deputy Administrator and Chief Medical Officer, Patrick Conway, M.D. The blog post provides data, which shows that efforts made by CMS to lower hospital readmission has worked. The data shows that all states, but one have seen Medicare 30-day readmission rates fall; in 43 states, readmission rates fell by more than 5%; and in 11 states, readmission rates fell by more than 10%.
• On September 12, 2016, more than a dozen House Energy and Commerce Committee Republicans sent a letter to HHS questioning what they see, as the misclassification of the EpiPen in the Medicaid Drug Rebate Program. The authors requested that the OIG open an independent inquiry into CMS’ oversight of the program.
• On September 12, 2016, leaders of the House Ways and Means Committee, House Energy and Commerce Committee, and the Senate Finance Committee sent a letter to CMS and Acting Administrator Andrew Slavitt, expressing concerns about fraudulent Medicare spending despite the Agency’s recent efforts to prevent improper payments before they are sent out the door.