A&B Healthcare Week in Review, May 6, 2016

I. REGULATIONS, NOTICES, & GUIDANCE

• On May 6, 2016, the Centers for Medicare & Medicaid Services (CMS) issued an interim final rule entitled, “Patient Protection and Affordable Care Act; Amendments to Special Enrollment Periods and the Consumer Operated and Oriented Plan Program.” The interim final rule establishes provisions that alter the parameters of select special enrollment periods and that revise certain rules governing consumer operated and oriented plans (CO-OPs). This interim final rule amends the eligibility requirements of the special enrollment period for individuals who gain access to new qualified health plans (QHPs) as a result of a permanent move so that this special enrollment period is generally available only to those individuals who had minimum essential coverage prior to their permanent move. CMS is also eliminating the January 1, 2017 implementation deadline for a Health Insurance Marketplace to offer advanced availability of the special enrollment period for certain individuals who gain access to new QHPs as a result of a permanent move; and for offering a new special enrollment period for loss of a dependent or for no longer being considered a dependent due to divorce, legal separation, or death. Furthermore, CMS is amending certain CO-OP governance requirements to provide greater flexibility and facilitate private market transactions that can provide access to needed capital. These amendments will permit a CO-OP to recruit potential directors from a broader pool of qualified candidates. The regulations are effective on May 11, 2016, with the exception of the amendments to 45 CFR 155.420, which are effective on July 11, 2016. Public comments must be received no later than 5:00 p.m. EDT on July 5, 2016.
• On May 3, 2016, CMS issued a final rule entitled, “Medicare and Medicaid Programs: Fire Safety Requirements for Certain Health Care Facilities.” The final rule will amend the fire safety standards for Medicare and Medicaid participating hospitals, critical access hospitals (CAHs), long-term care (LTC) facilities, intermediate care facilities for individuals with intellectual disabilities (ICFIID), ambulatory surgery centers (ASCs), hospices which provide inpatient services, religious non-medical health care institutions (RNHCIs), and programs of all-inclusive care for the elderly (PACE) facilities. Additionally, the final rule will adopt the 2012 edition of the Life Safety Code (LSC) and eliminate references in CMS’ regulations to all earlier editions of the LSC. It will also adopt the 2012 edition of the Health Care Facilities Code, with some exceptions. The regulation is effective July 5, 2016.
• On May 5, 2016, CMS issued an informational bulletin entitled, “Social Security Number Removal Initiative (SSNRI).” CMS issued this bulletin to inform states about the SSNRI. Section 501 of the Medicare Access and CHIP Reauthorization Act (MACRA) of 2015 requires CMS to remove Social Security Numbers from Medicare ID cards and replace existing Medicare Health Insurance Claim Numbers (HICNs) with a Medicare Beneficiary Identifier (MBI). The MBI will be a randomly generated identifier that will not include a social security number or any personally identifiable information (PII). This step is being taken to minimize the risk of identity theft for Medicare beneficiaries and reduce opportunities for fraud. To comply with this statutory requirement, starting in early 2018, CMS will issue new Medicare cards with an MBI to approximately 60 million Medicare beneficiaries, including Dual Eligibles. A HICN will still be assigned to each Medicare beneficiary will still be used for internal data exchanges between CMS and the states, but the new MBI must be used in all interactions with the beneficiary, the provider community, and all external partners.
• On May 2, 2016, CMS issued a notice of new system of record (SOR) entitled, “Privacy Act; Systems of Records.” CMS is proposing to establish a new SOR titled, “CMS Risk Adjustment Data Validation System (RAD-V).” The data collected and maintained in this system will be used to support the audit functions of the risk adjustment program, including validation activities under the risk adjustment data validation program. The RAD-V system will contain PII about individuals who are current or former enrollees in non-grandfathered health plans, including information obtained through the risk adjustment data validation process to establish the relative deviation from the average. Public comments are due June 2, 2016.
• On May 3, 2016, the Food and Drug Administration (FDA) issued a direct final rule entitled, “Standard Preparations, Limits of Potency, and Dating Period Limitations for Biological Products.” FDA is amending the general biological products standards relating to dating periods and also removing certain standards relating to standard preparations and limits of potency. FDA is taking this action to update outdated requirements, and accommodate new and evolving technology and testing capabilities, without diminishing public health protections. This action is part of FDA's retrospective review of its regulations in response to an Executive order. FDA is issuing these amendments directly as a final rule because the Agency believes they are noncontroversial and FDA anticipates no significant adverse comments.
• On May 3, 2016, FDA issued an information collection request (ICR) entitled, “Market Claims in Direct-to-Consumer Prescription Drug Print Ads.” In the notice, FDA indicates that the marketing literature divides product attributes into intrinsic and extrinsic. Intrinsic cues are physical characteristics of the product, whereas extrinsic cues are product-related but not part of the product. Research has found that both intrinsic and extrinsic cues can influence perceptions of product quality. Consumers may rely on product cues in the absence of explicit quality information. The objective quality of prescription drugs is not easily obtained from promotional claims in direct-to-consumer (DTC) ads; thus consumers may rely upon extrinsic cues to inform their decisions. Public comments are due June 3, 2016.
• On May 2, 2016, CMS issued a notice entitled, “Medicare Program; Announcement of Requirements and Registration for the MIPS.” The notice launched a challenge related to the new Merit-based Incentive Payment System (MIPS) program, which will assist CMS in accelerating the transition from the traditional fee-for-service (FFS) payment model to a system that rewards health care providers for giving high-quality care. This challenge will address one of the most important aspects of CMS’ programs, which is educating and providing outreach to the potential 1.2 million MIPS eligible clinicians. The deadline for Phase I submissions is on July 15, 2016.
• On May 5, 2016, CMS issued an ICR entitled, “Medicare Part D Reporting Requirements and Supporting Regulations; Medicare Self-Referral Disclosure Protocol.” Data collected via Medicare Part D Reporting Requirements will be an integral resource for oversight, monitoring, compliance and auditing activities necessary to ensure quality provision of the Medicare Prescription Drug Benefit to beneficiaries. Sponsors should retain documentation and data records related to their data submissions. Data will be validated, analyzed, and utilized for trend reporting by the Division of Clinical and Operational Performance (DCOP) within the Medicare Drug Benefit and C & D Data Group. If outliers or other data anomalies are detected, DCOP will work in collaboration with other Divisions within CMS for follow-up and resolution. Public comments are due on July 6, 2016.
• On May 2, 2016, the Office of Management and Budget (OMB) received for review a CMS final rule entitled, “Medicare Shared Savings Program; Accountable Care Organizations (ACOs)--Revised Benchmark Rebasing Methodology.” This final rule would address changes to the Medicare Shared Savings Program, specifically a revised benchmarking methodology, which affects Medicare payments to providers of services and suppliers participating in Accountable Care Organizations (ACOs) under the Medicare Shared Savings Program. These changes would apply to existing ACOs and approved ACO applicants participating in the program beginning January 1, 2017.
• On May 3, 2016, CMS issued a notice entitled, “Healthy Indiana Program (HIP) 2.0 Beneficiaries Survey.” CMS is requesting emergency approval to field the beneficiary surveys and to conduct key informant interviews and focus groups. The clearance is particularly important for decisions about the renewal of precedent-setting waivers of Medicaid policy that assure important beneficiary protections regarding coverage and access to care. Public comments are due June 3, 2016.
• On May 3, 2016, FDA issued a draft guidance entitled, “Developing Direct-Acting Antiviral Drugs for Treatment.” The purpose of this draft guidance is to assist sponsors in all phases of development of direct-acting antiviral (DAA) drugs for the treatment of chronic hepatitis C. This draft guidance revises the draft guidance of the same name that was issued on October 23, 2013. Public comments are due July 3, 2016.
• On May 3, 2016, FDA issued a draft guidance entitled, “Special Protocol Assessment.” This draft guidance provides information about the procedures and general policies adopted by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) for special protocol assessment (SPA). This draft guidance is intended to improve the quality of Requests for SPAs and accompanying submission materials, and the quality of the resulting interaction between sponsors and the FDA. This draft guidance revises the guidance for industry entitled “Special Protocol Assessment” issued May 17, 2002. Public comments are due July 3, 2016.
• On May 3, 2016, the Centers for Disease Control and Prevention (CDC) issued a request for nominations entitled, “Requests for Nominations: Breast and Cervical Cancer Early Detection and Control Advisory Committee.” The Committee provides advice and guidance to the Secretary of the Department of Health and Human Services (HHS), and the Director of CDC, regarding the early detection and control of breast and cervical cancer. The committee makes recommendations regarding national program goals and objectives; implementation strategies; program priorities, including surveillance, epidemiologic investigations, education and training, information dissemination, professional interactions and collaborations, and policy. Nominations must be submitted by June 24, 2016.
• On May 3, 2016, CDC issued a request for nominations entitled, “Healthcare Infection Control Practices Advisory Committee.” The Committee provides advice and guidance regarding the practice of infection control and strategies for surveillance, prevention, and control of healthcare-associated infections, antimicrobial resistance, and related events in settings where healthcare is provided, including hospitals, outpatient settings, LTC facilities, and home health agencies. Nominations must be submitted by August 15, 2016.
• On May 2, 2016, CMS issued a bulletin entitled, “Policy-Based Payments: Reversal of January 2016 – April 2016 Adjustments in the May and June Payment Cycles.” The bulletin modifies the March 22, 2016 guidance entitled, “Policy-Based Payments: April 2016 Transition of All Issuers to Policy-based Payments and Subsequent Adjustments Only in Cases of Extreme Variation Between Policy-based Payments and the Manual Payment Process Guidance.” Consistent with the March 22, 2016 guidance, all Marketplace issuers were transitioned to policy-based payments for the April, 2016 payment cycle, and CMS is ending adjustments to the calculated policy-based payment amount to the manual workbook submitted payment amount (except in cases of extreme (>25%) variation) in the May 2016 payment cycle. This guidance sets forth the approach CMS will take to smooth the cash-flow implications of this transition for issuers whose total adjustments for January through April were net-positive.
• On May 3, 2016, CMS issued Frequently Asked Questions (FAQs) entitled, “Incarceration and the Marketplace.” These FAQs provide guidance on the definition of “incarcerated,” and “incarceration pending the disposition of charges” for the purposes of eligibility for enrollment in a QHP through the Marketplace. The information in this document applies to all Federally-facilitated Marketplaces and to State-based Marketplaces that rely on the federal eligibility and enrollment platform. State-based Marketplaces that do not rely on the federal eligibility and enrollment platform may adopt the policies set forth in this document, or other reasonable ones consistent with applicable law.
• On May 3, 2016, the HHS Office of the Inspector General (OIG) issued a notice entitled, “OIG Advisory Opinion No. 16-05,” regarding the use of a “preferred hospital” network as part of Medicare Supplemental Health Insurance (“Medigap”) policies, whereby [name redacted] would indirectly contract with hospitals for discounts on the otherwise-applicable Medicare inpatient deductibles for its policyholders and, in turn, would provide a premium credit of $100 to policyholders who use a network hospital for an inpatient stay.
• On May 4, 2016, CDC issued a notice entitled, “Million Hearts® Hypertension Control Challenge.” This notice invites comment on the Million Hearts® Hypertension Control Challenge, program designed to identify clinical practices and health systems that have been successful in achieving high rates of hypertension control and to develop models for dissemination. Public comments are due by July 4, 2016.
• On May 5, 2016, CMS issued an ICR entitled, “End Stage Renal Disease (ESRD) Network Semi-Annual Cost Report Forms and Supporting Regulations; Organ Procurement Organization’s (OPOs) Health Insurance Benefits Agreement and Supporting Regulations; CMS Innovation Partners Program Applications and Surveys.” The Medicare and Medicaid Programs final conditions for coverage for Organ Procurement Organizations (OPOs) require OPOs to sign agreements with CMS in order to be reimbursed and perform their services. The information provided on this form serves as a basis for continuing the agreements with CMS and the OPOs for participation in the Medicare and Medicaid programs for reimbursement of service. Public comments are due June 6, 2016.
• On May 5, 2016, FDA issued a notice entitled, “Charter Renewals: Pharmacy Compounding Advisory Committee.” FDA announced the renewal of the Pharmacy Compounding Advisory Committee by the Commissioner of Food and Drugs. The Commissioner has determined that it is in the public interest to renew the Pharmacy Compounding Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until April 25, 2018.
• On May 6, 2016, the Government Accountability Office (GAO) issued a notice on terms of appointments entitled, “Change in Medicaid and CHIP Payment and Access Commission Terms.” In accordance with the Children's Health Insurance Program Reauthorization Act (CHIPRA) of 2009, the GAO Comptroller General appoints the 17 members of the Medicaid and CHIP Payment and Access Commission (MACPAC). This notice announces the extension of all current members for an additional 4 months.
• On May 6, 2016, FDA issued a notice entitled, “Charter Renewals: Anesthetic and Analgesic Drug Products Advisory Committee.” FDA announced the renewal of the Anesthetic and Analgesic Drug Products Advisory Committee by the Commissioner of Food and Drugs. The Commissioner has determined that it is in the public interest to renew the Anesthetic and Analgesic Drug Products Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until May 1, 2018.

Event Notices

• May 25 & 26, 2016, the Advisory Committee on Interdisciplinary, Community-Based Linkages (ACICBL) will convene a public meeting. The purpose of the ACICBL meeting is to continue discussions on the next report on enhancing community-based clinical training. The Advisory Committee focuses on the targeted program areas and disciplines for Area Health Education Centers, geriatrics, allied health, chiropractic, podiatric medicine, social work, graduate psychology, and rural health.
• June 1, 2016, FDA will convene a public workshop entitled “Quantitative Assessment of Assumptions to Support Extrapolation of Efficacy in Pediatrics.” The objective of the workshop is to discuss quantitative and qualitative approaches for verifying assumptions pertaining to disease and therapeutic response similarity between adults and children. The workshop will also provide a forum for discussion on the use of modeling and simulation for systematic assessment of extrapolation assumptions.
• June 9, 2016, CMS will convene a forum entitled, “Marketplace Year 3: Issuer Insights & Innovation.” The forum will explore novel techniques that health insurance companies are using to serve Marketplace consumers, including: consumer engagement, provider contracting, and care coordination.
• June 16, 2016, CMS will convene the 2016 Medicare Advantage and Prescription Drug Plan Audit & Enforcement Conference & Webcast. The agenda will be available a week prior to the meeting. Participants may register here.
• July 20, 2016, CMS will convene a public meeting with the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC). This meeting will specifically focus on obtaining the MEDCAC’s recommendations regarding treatment strategies for patients with lower extremity chronic venous disease.

II. CONGRESSIONAL LEGISLATION & COMMITTEE ACTION

U.S. Senate

• The Senate has adjourned and will reconvene on Monday, May 9, 2016.

House of Representatives

• The House has adjourned and will reconvene on Tuesday, May 10, 2016.
• On May 2, 2016, House Republicans sent a letter to acting CMS Administrator, Andy Slavitt, expressing concerns that the Medicare Part B drug payment demo program would “unnecessarily disrupt care” for sick seniors who depend on Medicare. “CMS’ proposed Medicare experiment would impose cuts in Phase I that will severely harm patient access to needed drugs,” they wrote. “Under CMS’ Medicare drug experiment, numerous physicians would face acquisition costs that exceed the Medicare payment amount for certain drugs. This policy will make it harder for patients to receive the drugs they need and especially hurt seniors who depend on doctors in smaller practices or those who live in rural areas.” They urged CMS to withdraw the proposed rule.
• On May 4, 2016, House Energy and Commerce Committee Chairman Fred Upton (R-MI) and House Ways and Means Committee Chairman Kevin Brady (R-TX) issued additional subpoenas to HHS seeking to obtain documents regarding the Affordable Care Act’s (ACA’s) cost-sharing reduction (CSR) program. House Republicans allege that the Obama Administration is illegally making the payments to health insurers on behalf of the recipients without a legal appropriation from Congress.

III. REPORTS, STUDIES, & ANALYSES

• On May 6, 2016, GAO released a report entitled, “Improved Guidance Needed to Better Support Efforts to Screen Managed Care Providers.” GAO found that the selected states and Medicaid managed care plans face significant challenges in screening providers for eligibility to participate in the Medicaid program. Based on information the Agency received from two selected states and 16 selected plans, GAO found that the states and plans used information that was fragmented across 22 databases managed by 15 different federal agencies to screen providers. GAO recommends that CMS (1) consider additional databases used in screening, (2) collaborate with the Social Security Administration to improve access to the Death Master File, (3) coordinate with other agencies to develop a common identifier across databases, and (4) provide state Medicaid programs with guidance that establishes expectations and best practices on sharing provider screening data among states and plans. HHS concurred with the recommendations.
• On May 3, 2016, the Congressional Budget Office (CBO) issued a report entitled, “Cost Estimate of H.R. 4641.” H.R. 4641 would require the Secretary of HHS to establish a task force to review and modify best practices for the treatment of pain. CBO estimated that implementing H.R. 4641 would cost $2 million over the 2016-2021 period, assuming appropriation of the estimated amounts, mostly to cover administrative expenses associated with the task force. CBO also estimated that enacting H.R. 4641 would not increase net direct spending or on-budget deficits in any of the four consecutive 10-year period beginning in 2027.
• On May 5, 2016, CBO issued a report entitled, “Cost Estimate of H.R. 5052, Opioid Program Evaluation Act.” H.R. 5052 would direct the Department of Justice (DOJ) and HHS to enter into agreements with the National Academy of Sciences to evaluate the effectiveness of a proposed grant program to be administered by DOJ to combat opioid abuse. CBO estimated that implementing H.R. 5052 would cost about $4 million over the 2016-2021 period, assuming enactment—through separate legislation—of a grant program to combat opioid abuse.

IV. OTHER HEALTH POLICY NEWS

• On May 4, 2016, the Physician-Focused Payment Model Technical Advisory Committee (PTAC) held its second meeting. MACRA established the PTAC to provide comments and recommendations to the Secretary of HHS on physician payment models. The Committee received information about MACRA implementation and payment models currently being tested by the Center for Medicare & Medicaid Innovation (CMMI) within CMS. The purpose of the meeting was to discuss and invite public comment on criteria for alternative payment models (APMs) and the draft PTAC proposal review process. CMS staff noted that, as defined by MACRA, Advanced APMs must meet the following criteria: (1) the APM requires participants to use certified electronic health records (EHR) technology; (2) the APM bases payment on quality measures comparable to those in the MIPS quality performance category; and (3) the APM either needs to require APM entities to bear more than nominal financial risk for monetary losses or be a Medical Home Model expanded under CMMI authority. Additional comments may be submitted to the PTAC at PTAC@hhs.gov before noon (EDT) on May 13, 2016.
• On May 5, 2016, CMS hosted a webinar on Medicare Advantage and Prescription Drug Plan. The purpose of this webinar was to provide important new information for the Medicare Advantage and Prescription Drug Plan Sponsoring Organizations, CMS staff and other CMS partners, staff level operations, mid-level management and senior executives regarding updates to existing Medicare policies, new policies, policy updates, and technology updates; provide enrollment and eligibility understanding for various Medicare beneficiaries; and how to fight fraud and abuse within the Medicare program. The session topics included: Building Effective Relationships with Your Account Managers; Encounter Data Update; Reporting of National and Contract Level Quality Scores by Race and Ethnicity; Medicare Prescription Drug Benefit Manual (PDBM) Chapter 6, The Part D Formularies Awaken; Effective Strategies for Addressing Overutilization and Abuse of Prescription Drugs in Medicare Part D; pharmacy benefit manager (PBM) Migration: Lessons Learned in Part D; and Combatting Fraud, Waste and Abuse (FWA) in Medicare Parts C and D.
• On May 5, 2016, CMS announced the third annual release of the Physician and Other Supplier Utilization and Payment public use data to increase transparency in the Medicare program. The Physician and Other Supplier Utilization and Payment data contains summarized information on Part B services and procedures provided to Medicare beneficiaries by physicians and other healthcare professionals. The data includes payment and submitted charges, or bills, for services and procedures provided by each physician or supplier. It allows for comparisons by physician, specialty, location, types of medical services and procedures delivered, Medicare payment, and submitted charges.