A&B Healthcare Week in Review, June 24, 2016

I. REGULATIONS, NOTICES, & GUIDANCE

• On June 24, 2016, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule entitled, “Medicare Program; End-Stage Renal Disease Prospective Payment System, Coverage and Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, Durable Medical Equipment, Prosthetics, Orthotics and Supplies Competitive Bidding Program Bid Surety Bonds, State Licensure and Appeals Process for Breach of Contract Actions, Durable Medical Equipment, Prosthetics, Orthotics and Supplies Competitive Bidding Program and Fee Schedule Adjustments, Access to Care Issues for Durable Medical Equipment; and the Comprehensive End-Stage Renal Disease Care Model.” This proposed rule would update and make revisions to the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for calendar year 2017 as well as proposing to implement policies for coverage and payment for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury. This rule also proposes to implement statutory requirements for bid surety bonds and state licensure for the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program (CBP). This proposed rule would expand suppliers’ appeal rights in the event of a breach of contract action by CMS. Finally, this rule announces a request for information related to the Comprehensive ESRD Care Model and future payment models affecting renal care. Public comments must be received by August 23, 2016.
• On June 20, 2016, CMS issued a proposed rule entitled, “Medicaid/CHIP Program; Medicaid Program and Children’s Health Insurance Program (CHIP); Changes to the Medicaid Eligibility Quality Control and Payment Error Rate Measurement Programs in Response to the Affordable Care Act.” This proposed rule would update the Medicaid Eligibility Quality Control (MEQC) and Payment Error Rate Measurement (PERM) programs based on the changes to Medicaid and the Children’s Health Insurance Program (CHIP) eligibility under the Patient Protection and Affordable Care Act (ACA). This proposed rule would also implement various other improvements to the PERM program. Public comments are due by August 20, 2016.
• On June 20, 2016, CMS issued a notice entitled, “Agency Information Collection Activities; Proposals, Submissions, and Approvals: Pre-Claim Review Demonstration For Home Health Services.” CMS seeks to develop and implement a Medicare demonstration project, which CMS believes will help assist in developing improved procedures for the identification, investigation, and prosecution of Medicare fraud occurring among home health agencies (HHAs) providing services to Medicare beneficiaries. Due to the title of “Prior Authorization” used in a prior ICR, which implied that services will be withheld from the beneficiary until an affirmed decision is achieved, this demonstration has been renamed from the “Home Health Prior Authorization Demonstration” to the “Home Health Pre-Claim Review Demonstration,” as home health services are already being provided to the beneficiary when the pre-claim review process begins. Public comments are due July 20, 2016.
• On June 17, 2016, CMS issued a notice entitled, “Alternative Schedule for Payment of Charges for Reconciliation of the Cost-sharing Reduction Portion of Advance Payments for the 2014 and 2015 Benefit Years.” CMS will consider providing flexibility on the payment schedule for the reconciliation of the cost-sharing reduction component of advance payments to assist issuers with cash flow constraints, to ensure they may continue to provide coverage to enrollees through the end of the benefit year. To request such flexibility, an issuer must email CSRrepayment@cms.hhs.gov no later than 11:59 p.m. ET on Tuesday, July 5, 2016.
• On June 17, 2016, CMS issued a transmittal entitled, “Special Provisions for Lab Additional Documentation Requests (ADRs).” The transmittal provides an update for the special provisions for lab ADRs.
• On June 17, 2016, CMS issued a transmittal entitled, “October Quarterly Update to 2016 Annual Update of HCPCS Codes Used for Skilled Nursing Facility (SNF) Consolidated Billing (CB) Enforcement.” This notification provides updates to the lists of Healthcare Common Procedure Coding System (HCPCS) codes that are subject to the consolidated billing provision of the SNF Prospective Payment System (PPS).
• On June 20, 2016, the Health Resources and Services Administration (HRSA) issued a notice entitled, “Children’s Hospitals Graduate Medical Education Payment Program Application and Full-Time Equivalent Resident Assessment Forms.” The Children’s Hospitals Graduate Medical Education (CHGME) Payment Program was enacted to provide Federal support for graduate medical education (GME) to freestanding children’s hospitals. The CHGME Support Reauthorization Act of 2013 included a provision to allow certain newly qualified children’s hospitals to apply for CHGME Payment Program funding. The CHGME Payment Program application forms have been revised to accommodate the new statute. In addition, a payment question included in the CHGME Payment Program application forms has been removed, since the participating children’s hospitals are now required to electronically communicate their financial information to the Payment Management System through the Electronic Handbook.
• On June 20, 2016, the Substance Abuse and Mental Health Services Administration (SAMHSA) issued a notice entitled, “Opioid Drugs in Maintenance and Detoxification Treatment of Opioid Dependence--42 CFR part 8 (OMB No. 0930-0206) and Opioid Treatment Programs (OTPs) – Revision.” Regulations require that Opioid Treatment Programs (OTPs) be certified. “Certification”' is the process by which SAMHSA determines that an OTP is qualified to provide opioid treatment under the Federal opioid treatment standards established by the Secretary of HHS. To become certified, an OTP must be accredited by an SAMHSA-approved accreditation body. Public comments are due by July 20, 2016.
• On June 20, 2016, the Food and Drug Administration (FDA) issued a final guidance entitled, “Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices.” This guidance explains the circumstances in which it may be appropriate to extrapolate existing medical device data to support pediatric device indications in premarket approval applications (PMAs), humanitarian device exemptions (HDEs) and de novo requests. This guidance also describes FDA’s approach for determining whether extrapolation may be appropriate and the factors that should be considered within a statistical model for extrapolation. Extrapolation may be appropriate when there are few differences in safety or effectiveness of the proposed device when used in adult as compared to the intended pediatric populations and the adult data are of high quality for borrowing.
• On June 20, 2016, the National Institutes of Health (NIH) issued a notice entitled, “Policy on the Use of a Single Institutional Review Board for Multi-Site Research.” NIH is issuing this policy on the use of a single Institutional Review Board (IRB) for multi-site research to establish the expectation that a single IRB (sIRB) of record will be used in the ethical review of non-exempt human subjects research protocols funded by the NIH that is carried out at more than one site in the United States. The policy will take effect May 25, 2017.
• On June 20, 2016, Agency for Healthcare Research and Quality (AHRQ) issued a notice entitled, “AHRQ ACTION III – Measurement for Performance Improvement in Physician Practices.” This two-year project is an important first step to understanding fully measurement for performance improvement in medical groups. This exploratory research is expected to set the stage for informing future research and policy discussions, both of which could ultimately have a more direct impact on providers, payers, and patients. Public comments are due July 20, 2016.
• On June 21, 2016, National Institute of Mental Health (NIMH) issued a notice entitled, “Availability of Biological Samples to Evaluate the Technical Performance of Inflammatory Markers.” NIMH seeks information about the availability of data and existing biological specimens (plasma and cerebrospinal fluid (CSF)) obtained from healthy controls and clinically well-characterized individuals with mental illnesses (bipolar disorder, major depressive disorder, post-traumatic stress disorder, schizophrenia). This information will be used to identify biobanks of existing samples that could potentially be sourced to assess the technical performance of a panel of inflammation-related proteins, and to identify gaps in the availability of samples for the mental illnesses listed above. All responses must be submitted via email to biospecimens2@mail.nih.gov by August 4, 2016.
• On June 21, 2016, FDA issued a final rule entitled, “Exceptions Applicable to Certain Human Cells, Tissues, and Cellular and Tissue-Based Products.” FDA is issuing this final rule to amend certain regulations regarding donor eligibility, including the screening and testing of donors of particular human cells, tissues, and cellular and tissue-based products (HCT/Ps), and related labeling. This final rule is in response to the enhanced understanding in this area and in response to comments from stakeholders regarding the importance of embryos to individuals and couples seeking access to donated embryos. Public comments are due by August 21, 2016.
• On June 21, 2016, the Internal Revenue Service (IRS) and the Department of the Treasury issued a final regulation entitled, “Modification of Treatment of Certain Health Organizations.” This document contains final regulations that provide guidance to Blue Cross and Blue Shield organizations, and certain other organizations, on computing and applying the medical loss ratio and the consequences for not meeting the medical loss ratio threshold. The final regulations reflect the enactment of a technical correction to section 833(c)(5) of the Internal Revenue Code by the Consolidated and Further Continuing Appropriations Act of 2015. The final regulations affect Blue Cross and Blue Shield organizations, and certain other organizations involved in providing health insurance.
• On June 21, 2016, CMS issued a notice entitled, “Affordable Care Act Implementation FAQs.” This set of Frequently Asked Questions (FAQs) addresses Marketplace coverage information that may be included in the Consolidated Omnibus Budget Reconciliation Act (COBRA) election notice.
• On June 22, 2016, FDA issued a notice of availability entitled, “International Conference on Harmonisation: Electronic Transmission of Postmarket Individual Case Safety Reports for Drugs and Biologics, etc.” FDA is announcing the availability of its FDA Adverse Event Reporting System (FAERS) Regional Implementation Specifications for the International Conference on Harmonisation (ICH) E2B(R3) Specification.
• On June 22, 2016, FDA issued a notice entitled, “Invitation to Participate in Account Management Pilot for the Import Trade Auxiliary Communication System.” FDA is announcing that it intends to conduct a pilot program to test and evaluate a new Import Trade Auxiliary Communication System (ITACS) Account Management function. To be considered for participation in this ITACS pilot, please send an email to at itacssupport@fda.hhs.gov with the subject line “ITACS Pilot Participation Request” by July 6, 2016.
• On June 21, 2016, FDA issued a withdrawal of notice entitled, “Guidance for Industry on Nonproprietary Naming of Biological Products; Withdrawal.” FDA is withdrawing the proposed collection of information that published on June 2, 2016, at this time.
• On June 21, 2016, OMB received a final rule for review entitled, “Expanding Uses of Medicare Data by Qualified Entities.” According to OMB, under the Medicare Access and CHIP Reauthorization Act (MACRA), this final rule would implement statutory requirements that expand the permissible uses of Medicare claims data that is obtained by qualified entities in accordance with applicable information, privacy, security and disclosure laws. In doing so, this rule would explain how qualified entities may create non-public analyses and provide or sell such analyses to authorized users, as well as how qualified entities may provide or sell combined data, or provide Medicare claims data alone at no cost, to certain authorized users. This rule would also implement certain privacy and security requirements and impose assessments on qualified entities in the case of a violation of a data use agreement.
• On June 22, 2016, CMS issued an MLN Matters® Article entitled, “Recovering Overpayments from Providers Who Share Tax Identification Numbers.” The article is intended for providers of services and suppliers who share the same Tax Identification Number (TIN) even though they may have different National Provider Identifiers or other billing numbers used to bill Medicare.
• On June 23, 2016, CMS issued a transmittal entitled, “July Quarterly Update for 2016 Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Fee Schedule.” The DMEPOS Fee Schedule is updated on a quarterly basis, when necessary, to implement fee schedule amounts for new codes and correct any fee schedule amounts for existing codes. The recurring update notification applies to chapter 23, section 60 of the Pub. 100-04 Medicare Claims Processing Manual.
• On June 23, 2016, CMS issued a notice entitled, “Consumer Research Supporting Outreach for Health Insurance Marketplace.” CMS is requesting reapproval for two surveys that aid in understanding levels of awareness and customer service needs associated with the Health Insurance Marketplace established by the ACA. Public comments are due by July 23, 2016.
• On June 23, 2016, HRSA issued a request for nominations entitled, “Requests for Nominations: Advisory Commission on Childhood Vaccines.” HRSA is requesting nominations to fill vacancies on the Advisory Commission on Childhood Vaccines (ACCV). The agency will receive nominations on a continuous basis.
• On June 24, 2016, FDA issued a guidance entitled, “Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment; Draft Guidance for Industry; Extension of the Comment Period.” FDA is extending the comment period for the notice of availability, published in the Federal Register of May 4, 2016, announcing the draft guidance for industry entitled “Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment.” Public comments are due by July 19, 2016.
• On June 24, 2016, FDA issued a guidance entitled, “Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 043.” The guidance will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices. The Agency will receive written comments concerning this document at any time.
• On June 24, 2016, FDA issued a guidance entitled, “Quality Metrics Technical Conformance Guide--Technical Specifications Document.” The guidance provides technical recommendations for the submission of quality metric data. Public comments are due by September 24, 2016.

Event Notices

• June 28&29, 2016, FDA announced a meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee.
• July 14&15, 2016, the Centers for Disease Control and Prevention (CDC) announced a meeting of the Healthcare Infection Control Practices Advisory Committee (HICPAC). The agenda will include updates on CDC’s activities for prevention of healthcare associated infections (HAIs), updates on antimicrobial stewardship, an update on Draft Guideline for Prevention of Infections in Healthcare Personnel, and an update from the workgroup for considerations on endoscope reprocessing.

II. CONGRESSIONAL LEGISLATION & COMMITTEE ACTION

U.S. Senate

• On June 23, 2016, the Senate Special Committee on Aging convened a hearing entitled, “The Right Care at the Right Time: Ensuring Person-Centered Care for Individuals with Serious Illness.” The witnesses included Dr. Atul Gawande, Executive Director, Ariadne Labs; Dr. Katherine Pope, Spectrum Medical Group; Co-Founder, Hospice of Southern Maine; Dr. Kate Lally, Chief of Palliative Care, Care New England Health System; Amy Berman, Senior Program Officer, The John A. Hartford Foundation.
• On June 21, 2016, Senate Judiciary Subcommittee on Antitrust, Competition Policy and Consumer Rights convened a hearing entitled, “The CREATES Act: Ending Regulatory Abuse, Protecting Consumers, and Ensuring Drug Price Competition.” The witnesses included Mr. Alden Abbott, Deputy Director of the Edwin Meese III Center for Legal and Judicial Studies and John, Barbara, and Victoria Rumpel Senior Legal Fellow at the Heritage Foundation; Professor Robin Feldman, Harry & Lillian Hastings Professor Of Law and Director of The Institute For Innovation Law at UC Hastings College Of Law; Mr. Peter O. Safir, Senior Counsel at Covington & Burling; Ms. Beth Zelnick-Kaufman, Assistant General Counsel for Amneal Pharmaceuticals; Mr. George Slover, Senior Policy Counsel for Consumers Union; and Dr. Nitin Damle, President of the American College of Physicians.
• On June 22, 2016, the Senate Veterans' Affairs Committee convened a hearing entitled, “Examining the Progress and Challenges in Modernizing Information Technology at the Department of Veterans Affairs.” The witnesses included Dr. David J. Shulkin, Under Secretary For Health, Department of Veterans Affairs; Valerie C. Melvin, Director Of Information Management, U.S. Government Accountability Office.

House of Representatives

• On June 22, 2016, House Republicans released a Health Care White Paper entitled, “A Better Way: Our Vision for a Confident America.” The proposal is built on five principles: (1) Repeal the ACA; (2) Provide all Americans with more choices, lower costs, and greater flexibility; (3) Protect the nation’s most vulnerable; (4) Spur innovation in health care; and (5) Protect and preserve Medicare.
• On June 21, 2016, the House passed by voice vote H.R. 5860, the Small Business Healthcare Relief Act, which was introduced by Rep. Mike Thompson (D-CA) and Rep. Charles W. Boustany (R-LA). H.R. 5860 would allow small businesses to use pre-tax dollars for assistance to employees purchasing policies in the individual market and except certain health reimbursement arrangements from group health plan requirements.
• On June 21, 2016, Rep. Michael Burgess (R-TX) and Rep. Gene Green (D-TX) introduced bipartisan legislation aimed at making health care more affordable by promoting greater transparency around the costs of health care services for patients. The Health Care Price Transparency Promotion Act of 2016 calls upon the states to establish and maintain laws requiring disclosure of information on hospital charges, to make such information available to the public, and to provide individuals with information about estimated out-of-pocket costs for health care services.
• On June 23, 2016, the House approved the Military Construction and Veterans Affairs and Zika Response Appropriations Act final Conference Report that includes a $1.1 billion plan to fight the Zika virus. The bill passed by a 239-171 vote. The legislation now needs to be approved by the Senate, before heading to the President’s desk for final approval.

III. REPORTS, STUDIES, & ANALYSES

• On June 22, 2016, the Board of Trustees of the Federal Hospital Insurance and Federal Supplementary Medical Insurance Trust Funds released the 2016 Medicare Trustees Report. According to the report, the ACA requires the Independent Payment Advisory Board (IPAB) to submit proposals to the President the year following a determination that the projected rate of growth in Medicare spending per beneficiary exceeds a target growth rate. Since 2013, the Chief Actuary at CMS has been required to determine the projected and target growth rates. If the Chief Actuary makes a determination that the projected Medicare per capita growth rate exceeds the per capita target growth rate in the implementation year, the Chief Actuary is required to establish a savings target for that year. As in prior years, the 2016 determination is that the target growth rate has not been exceeded and IPAB has not been triggered.
• On June 20, 2016, the Government Accountability Office (GAO) released a report entitled, “Federal Autism Activities: Agencies Are Encouraging Early Identification and Providing Services, and Recent Actions Could Improve Coordination.” GAO found that specific actions were taken to help respond to the individual intervention needs of children with autism. GAO identified about 8,200 young children with autism in five states enrolled in Medicaid or CHIP and found that speech, language, and audiology services were the most common overall; however, the types of services commonly received varied, depending on the age of the child.
• On June 22, 2016, HHS Office of the Inspector General (OIG) released a report entitled, “Nationwide Analysis of Common Characteristics in OIG Home Health Fraud Cases.” OIG identified a substantial number of providers-over 500 HHAs and over 4,500 physicians-that were outliers in comparison to their peers nationally with respect to multiple characteristics commonly found in OIG-investigated cases of home health fraud. OIG simultaneously released a report entitled, “Alert: Improper Arrangements and Conduct Involving Home Health Agencies and Physicians.” OIG found that home health services are vulnerable to fraud, waste, and abuse. The federal government has obtained criminal convictions and reached civil settlements with several HHAs, individual physicians, and heads of home-visiting physician companies that defrauded Medicare by, among other conduct, making (or accepting) payments for patient referrals, falsely certifying patients as homebound, and billing for medically unnecessary services or for services that were not rendered.
• On June 22, 2016, OIG released a report entitled, “High Part D Spending on Opioids and Substantial Growth in Compounded Drugs Raise Concerns.” OIG found that Medicare spending for Part D drugs has continued to rise by more than $10 billion a year. OIG also found that in particular, compounded topical drugs rose more than 3,400 percent since 2006. OIG will continue to conduct investigations and reviews to help address the ongoing problems created by opioid abuse and the emerging problems linked to compounded drugs.
• On June 21, 2016, GAO released a report entitled, “Controlled Substances: DEA Should Take Additional Actions to Reduce Risks in Monitoring the Continued Eligibility of Its Registrants.” The Drug Enforcement Administration (DEA) has established controls for determining registrant eligibility to handle and prescribe controlled substances. However, GAO found limitations in DEA's controls to help ensure that individual registrants are and remain eligible and do not present issues that may increase the risk of illicit diversion. GAO is making five recommendations to DEA to help ensure practitioners are and remain eligible and that those who pose an increased risk of illicit diversion are identified. DEA stated it appreciated the intent of GAO's recommendations, but raised concerns about its legal authority to take some of the actions. GAO's recommendations include having DEA seek legal authority as needed, and remain valid.

IV. OTHER HEALTH POLICY NEWS

• On June 20, 2016, HHS announced a major initiative to help small practices prepare for the Quality Payment Program. HHS will award $20 million to fund on-the-ground training and education for Medicare clinicians in individual or small group practices of 15 clinicians or fewer. These funds will help provide hands-on training tailored to small practices, especially those that practice in historically under-resourced areas including rural areas, health professional shortage areas, and medically underserved areas.
• On June 20, 2016, the U.S. Supreme Court ruled to affirm a lower court ruling allowing the U.S. Patent and Trademark Office's Patent Trial and Appeal Board to continue using a broader standard than federal courts when it comes to interpreting patent claims in Cuozzo Speed Technologies v. Lee. The decision could reportedly make it harder for pharmaceutical manufacturers of brand-name drugs to protect their patents.
• On June 23, 2016, the American Enterprise Institute (AEI) and the Schaeffer Initiative for Innovation in Health Policy, a collaboration between the USC Leonard D. Schaeffer Center for Health Policy & Economics and the Brookings Institution, convened a session entitled, “The 2016 Medicare Trustees Report: One year closer to Independent Payment Advisory Board (IPAB) cuts?” The discussion focused on the new 2016 Medicare Trustees Report (2016 Report) released on June 22, 2016. Medicare’s Chief Actuary Paul Spitalnic summarized the key findings, which was followed by a panel of experts who discussed the potential consequences of the report on policy actions that might be taken to improve the program's fiscal condition.