A&B Healthcare Week in Review, April 29, 2016

I. REGULATIONS, NOTICES, & GUIDANCE

• On April 27, 2016, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule 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,” to implement Section 101 of the Medicare Access and CHIP Reauthorization Act (MACRA). MACRA made three important changes to how CMS pays health care professionals: (1) ending the Sustainable Growth Rate (SGR) formula; (2) creating a new framework that rewards better care, rather than more care; and (3) combining existing quality reporting systems into one new system. The proposed rule addresses issues such as which health care professionals are eligible for participation in MIPs; the MIPS performance period, category measures, and activities; MIPS composite score methodology and payment adjustments; and how a health care professional can participate in APMs and how incentive payments will work for APM participation. The proposed rule is scheduled to be published in the May 9, 2016 Federal Register, and comments are being accepted through June 27, 2016.
• On April 25, 2016, CMS issued a final rule entitled, “Medicaid and Children’s Health Insurance Program (CHIP) Programs; Medicaid Managed Care, CHIP Delivered in Managed Care, and Revisions Related to Third Party Liability.” According to CMS, this final rule modernizes the Medicaid managed care regulations to reflect changes in the usage of managed care delivery systems. The final rule aligns, where feasible, many of the rules governing Medicaid managed care with those of other major sources of coverage, including coverage through Qualified Health Plans and Medicare Advantage plans; implements statutory provisions; strengthens actuarial soundness payment provisions to promote the accountability of Medicaid managed care program rates; and promotes the quality of care and strengthens efforts to reform delivery systems that serve Medicaid and CHIP beneficiaries. It also ensures appropriate beneficiary protections and enhances policies related to program integrity. This final rule also implements provisions of the Children’s Health Insurance Program Reauthorization Act of 2009 (CHIPRA) and addresses third party liability for trauma codes.
• On April 26, 2016, CMS issued a State Health Officials letter entitled, “FQHC and RHC Supplemental Payment Requirements and FQHC, RHC, and FBC Network Sufficiency under Medicaid and CHIP Managed Care.” The purpose of this letter is to provide guidance on federally-qualified health center (FQHC) and rural health clinic (RHC) payment methodologies under both Medicaid and CHIP managed care delivery systems. This letter also provides guidance on FQHC, RHC, and freestanding birth center (FBC) network sufficiency standards applicable to a Medicaid managed care delivery system. The guidance applies to all Medicaid and CHIP managed care arrangements that provide capitated payment for outpatient services, including comprehensive plans offered by managed care organizations (MCOs) and prepaid ambulatory health plans (PAHPs).
• On April 25, 2016, the Centers for Disease Control and Prevention (CDC) issued an information collection request (ICR) entitled, “Workplace Health In America.” CDC notes that workplaces are becoming important settings for health improvement and risk reduction. By improving the work health environment and helping workers achieve long-term behavior change, employers can diminish employees’ risks for illnesses, enhance their quality of life, improve morale, eliminate unnecessary health care spending, minimize absences from work, reduce accidents, and increase productivity. Furthermore, having a healthy and productive workforce within a supportive work environment can foster greater loyalty among workers, a more committed workforce, and reduced turnover rates. Public Comments are due June 25, 2016.
• On April 26, 2016, the Food and Drug Administration (FDA) issued an ICR entitled, “Requests for Clinical Laboratory Improvement Amendments Categorization.” A guidance document entitled “Guidance for Administrative Procedures for CLIA Categorization” was released on May 7, 2008. The document describes procedures FDA uses to assign the complexity category to a device. Typically, FDA assigns complexity categorizations to devices at the time of clearance or approval of the device. The guidance recommended that manufacturers provide FDA with a copy of the package insert for the device and a cover letter indicating why the manufacturer is requesting a categorization. The guidance also recommended that in the correspondence to FDA the manufacturer should identify the product code and classification as well as reference to the original 510(k) when this is available. Public comments are due June 26, 2016.
• On April 27, 2016, CMS issued an ICR entitled, “Annual Eligibility Redetermination, Product Discontinuation and Renewal Notices.” Section 1321(a) of the ACA provides authority for the Secretary of the Department of Health and Human Services (HHS) to establish standards and regulations to implement the statutory requirements related to Exchanges, Qualified Health Plans (QHPs), and other components of title I of the ACA. Enacted by the Health Insurance Portability and Accountability Act of 1996 (HIPAA), health insurance issuers in the group and individual markets must guarantee the renewability of coverage unless an exception applies. Public comments are due by June 27, 2016.
• On April 28, 2016, CMS issued a guidance entitled, “To Facilitate Successful Re-entry for Individuals Transitioning from Incarceration to Their Communities.” While the Medicaid statute limits payment for services for individuals while residing in correctional institutions, Medicaid coverage can be crucial to ensuring a successful transition following incarceration. Many individuals in the justice-involved population have a high prevalence of long-untreated, chronic health care conditions as well as a high incidence of substance use and mental health disorders. Facilitating enrollment in Medicaid and supporting access to services following incarceration has the potential to make a significant difference in the health of this population and in eligible individuals’ ability to obtain health services that can promote their well-being.
• On April 28, 2016, CMS issued a transmittal entitled, “Making Principal Diagnosis Codes Mandatory for Notice of Election (NOE) to be Accepted.” Currently, NOEs are being accepted without a principal diagnosis present. Contractors report that this occurs on a high percentage of NOEs. A principal diagnosis should be required in order for that NOE to be accepted. This change request requires Medicare systems to return NOEs submitted without a principal diagnosis.
• On April 28, 2016, CMS issued a change request (CR) entitled, “Update to the Common Working File Edits for G9678 - Oncology Care Model Service.” The purpose of this CR is for CMS to update system edits established in CR9341 for the Oncology Care Model (OCM) Monthly Enhanced Oncology Services (MEOS) payment. OCM is a 5-year model, beginning in July 2016, intended to utilize appropriately aligned financial incentives to improve care coordination, appropriateness of care, and access to care for beneficiaries undergoing chemotherapy.
• On April 27, 2016, FDA issued an ICR entitled, “Agency Information Collection Activities; Proposals, Submissions, and Approvals: Postmarket Surveillance.” Section 522 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360l) authorizes FDA to require a manufacturer to conduct postmarket surveillance (PS) of any device that meets the criteria set forth in the statute. The PS regulation establishes procedures that FDA uses to approve and disapprove PS plans. The regulation provides instructions to manufacturers so they know what information is required in a PS plan submission. Public comments are due by June 27, 2016.
• On April 27, 2016, the Office of Management and Budget (OMB) received a final rule for review entitled, “Independent Living Services and Centers for Independent Living.” This proposed rule would update the Independent Living program consistent with its reauthorization in the Workforce Innovation and Opportunity Act. The regulations will include conforming changes to reflect the transition of the program from the Department of Education to HHS Administration for Community Living. The regulations will also address statutory changes such as designated state entities, state plan requirements, additional core service responsibilities with an emphasis on youth and nursing home to community, and indicators of minimum compliance for centers for independent living and Statewide Independent Living Councils.
• On April 29, 2016, CMS issued an ICR entitled, “Advance Beneficiary Notice of Noncoverage (ABN).” The ABN is delivered by Part B paid physicians, providers, practitioners, and suppliers, as well as hospice providers and Religious Non-medical Health Care Institutions paid under Part A. Home health agencies providing items and services under Part A or Part B also use the ABN. Other Medicare institutional providers paid under Part A use other approved notices for this purpose. Public comments are due May 29, 2016.
• On April 29, 2016, CMS issued an ICR entitled, “Medicaid Drug Program - Monthly and Quarterly Drug Reporting Format.” Labelers transmit drug product and pricing data to CMS within 30 days after the end of each calendar month and quarter. CMS calculates the unit rebate amount (URA) and the unit rebate offset amount (UROA) for each new drug application (NDC) and distributes to all State Medicaid agencies. States use the URA to invoice the labeler for rebates and the UROA to report onto the CMS-64. The monthly data is used to calculate Federal Upper Limit (FUL) prices for applicable drugs and for states that opt to use this data to establish their pharmacy reimbursement methodology. Public Comments are due by July 1, 2016.
• On April 25, 2016, CMS issued a Special Edition (SE) MLN Matters® article entitled, “Medicare Policy Clarified for Prolonged Drug and Biological Infusions Started Incident to a Physician's Service Using an External Pump.” Medicare pays for drugs and biologicals which are not usually self-administered by the patient and furnished “incident to” physicians’ services rendered to patients while in the physician’s office or the hospital outpatient department. CMS provides that, since the prolonged drug and biological infusions started incident to a physician's service using an external pump should be treated as an incident to service, it cannot be billed on suppliers’ claims to Durable Medical Equipment Medicare Administrative Contractors (DME MACs).
• On April 26, 2016, the Indian Health Service (IHS) issued a notice entitled, “Medical Professionals Recruitment and Continuing Education Programs: New Limited Competition Cooperative Agreement.” IHS is accepting competitive cooperative agreement applications for the Medical Professionals Recruitment and Continuing Education Program until June 27, 2016. The purpose of this IHS cooperative agreement is to enhance medical professional recruitment and continuing education programs, services and activities for American Indian and Alaska Native (AI/AN) people. The agency wants to facilitate continuing medical education for AI/AN physicians, through annual meetings and other venues that are culturally competent and sensitive.
• On April 28, 2016, CMS issued an ICR entitled, “Notice of Research Exception under the Genetic Information Nondiscrimination Act; Consumer Experience Survey Data Collection.” Under the Genetic Information Nondiscrimination Act of 2008 (GINA), a plan or issuer may request (but not require) a genetic test in connection with certain research activities so long as such activities comply with specific requirements. The Secretary of Labor or the Secretary of HHS is required to be notified if a group health plan or health insurance issuer intends to claim the research exception permitted under Title I of GINA. Public comments are due by June 28, 2016.
• On April 28, 2016, CMS issued an ICR entitled, “Probable Fraud Measurement Pilot; Information Collection for Transparency in Coverage Reporting by Qualified Health Plan Issuers; Medicare Current Beneficiary Survey.” CMS is seeking OMB approval of the collections required for a probable fraud measurement pilot, which would establish a baseline estimate of probable fraud in payments for home health care services in the fee-for-service (FFS) Medicare program. CMS and its agents will collect information from HHAs, the referring physicians and Medicare beneficiaries selected in a national random sample of home health claims. Public comments are due by May 28, 2016.
• On April 28, 2016, CMS issued a final notice entitled, “Medicare and Medicaid Programs: Approval of the Institute for Medical Quality's Ambulatory Surgical Center Accreditation Program.” This final notice announced CMS’ decision to approve the Institute for Medical Quality (IMQ) for recognition as a national accrediting organization for ambulatory surgical centers (ASCs) that wish to participate in the Medicare or Medicaid programs. An ASC that participates in Medicaid must also meet the Medicare conditions for coverage (CfCs) as required under CMS regulations.
• On April 28, 2016, FDA issued a notice entitled, “Center for Biologics Evaluation and Research eSubmitter Program: Electronic Submission of Postmarketing Adverse Event Reports for Human Vaccine Products.” FDA announced the availability a Vaccine Adverse Event Reporting System (VAERS) eSubmitter program for the electronic submission of postmarketing individual case safety reports (ICSRs) and ICSR attachments of adverse events for human vaccine products. The VAERS eSubmitter program is a free software program for voluntary use that is intended to help persons subject to mandatory postmarketing requirements for vaccines including applicants, manufacturers, packagers, and distributors to electronically submit ICSRs and ICSR attachments.
• On April 22, 2016, the Office of Personnel Management (OPM) received a proposed rule for review entitled, “Federal Employees Health Benefits Program; Tribes and Tribal Organizations.” OPM proposes to amend the Federal Employees Health Benefits (FEHB) regulations at 5 CFR part 890 to include enrollments for eligible employees of tribes and tribal organizations under the provisions of the ACA.
• On April 28, 2016, CMS issued a SE MLN Matters® article entitled, “Medicare Coverage of Substance Abuse Services.” This article summarized the available substance abuse services and provided reference links to other online Medicare information with further details about these services.

Event Notices

• May 3, 2016, CMS will host a webinar entitled Overview of the Quality Payment Program Proposed Rule. The webinar is scheduled from 12:00pm - 1:00pm EDT. This listening session is an opportunity for stakeholders to provide CMS early feedback on proposed policy for the Quality Payment Program. Registration information is available here.
• May 4, 2016, CMS will host a webinar entitled The Merit-Based Incentive Payment System (MIPS) in the Quality Payment Program. The webinar is scheduled from 12:00pm - 1:00pm EDT. This listening session is an opportunity for stakeholders to provide CMS early feedback on proposed policy for the Quality Payment Program. Registration information is available here.
• May 4, 2016, the Physician-Focused Payment Model Technical Advisory Committee will convene a public meeting. The Committee will have initial discussions about how physician-focused payment models proposals will be submitted and reviewed by the Committee after the Secretary of HHS establishes criteria for physician-focused payment models through rulemaking. There will be time allocated for public comment on a draft proposal review document. The public may attend the meeting in-person or listen by phone via audio teleconference. Registration is required in order to attend in-person or by phone.
• May 10, 2016, CMS will host an MLN Connects Event, entitled MACRA Listening Session: Quality Payment Program Proposed Rule from 2:00pm - 3:00pm EDT. This listening session is an opportunity for stakeholders to provide CMS early feedback on proposed policy for the Quality Payment Program. CMS will not consider feedback during the call as formal comments on the rule. Registration information is available here.
• May 17 &18, 2016, HHS will hold a webinar with the Chronic Fatigue Syndrome Advisory Committee (CFSAC). The agenda can be found here.
• September 27, 2016, FDA will hold a public meeting and an opportunity for public comment on Patient-Focused Drug Development for patients who have received an organ transplant. Patient-Focused Drug Development is part of FDA’s performance commitments made as part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). The public meeting is intended to allow FDA to obtain patient perspectives on the impact of receiving an organ transplant on daily life and patient views on treatment approaches; the input from this public meeting will help in developing topics for further discussion. FDA is also interested in discussing issues related to scientific challenges in developing drugs to manage organ transplantation. Registration information can be found here.

II. CONGRESSIONAL LEGISLATION & COMMITTEE ACTION

U.S. Senate

• On April 27, 2016, the Senate Special Committee on Aging convened a hearing entitled, “Valeant Pharmaceuticals' Business Model: the Repercussions for Patients and the Health Care System.” The Committee received testimony from Berna Heyman, a Wilson Disease Patient and Retired Associate Dean of Libraries at William & Mary; Dr. Frederick K. Askari, M.D. PhD, Associate Professor and Director of the Wilson Disease Center of Excellence at the University of Michigan Health System; Dr. Richard Fogel M.D., FACC, FHRS, Chief Clinical Officer at St. Vincent; Bill Ackman, Founder and Chief Executive Officer of Pershing Square Capital Management LP; J. Michael Pearson, Chief Executive Officer of Valeant Pharmaceuticals International, Inc.; and Howard Schiller, Director, Former Chief Financial Officer, and Former Interim Chief Executive Officer of Valeant Pharmaceuticals International, Inc.
• On April 28, 2016, the Senate Committee on Finance convened a hearing entitled, “Mental Health in America: Where Are We Now?” The witnesses included Brandon Marshall, Executive Chairman and Co-founder of Project 375; Margaret Bennington-Davis, Chief Medical Officer for Health Share of Oregon; Douglas Thomas, Director of the State of Utah's Division of Substance Abuse and Mental Health; and Linda Rosenberg, CEO of the National Council for Behavioral Health.
• On April 27, 2016, Senate Committee on Finance’s Ranking Member Ron Wyden (D-OR) introduced a bill to protect seniors in Medicare from high out-of-pocket costs in Part D plans. The bill, called the “Reducing Existing Costs Associated with Pharmaceuticals for Seniors Act of 2016” (RxCAP), would eliminate all cost-sharing for beneficiaries above the current out-of-pocket threshold of about $7,500. “Escalating drug prices are increasingly straining the budgets of families in Oregon and across the country, particularly seniors in Medicare who often have to take multiple costly medications to stay healthy,” Sen. Wyden said. “It defies common sense that protection from high out-of-pocket costs exists for almost all other types of health coverage, but not for traditional Medicare.”
• On April 28, 2016, Senate Democrats from the Senate Committee on Finance wrote a letter to CMS about their concerns with the Part B Drug Payment Model and requested changes to the proposed rule. They suggested that CMS should resolve the following issues before moving forward with the model: (1) beneficiaries’ access to Part B medications and quality of care; (2) potential impact on site of service; and (3) interaction with existing delivery and payment reform models. Senate Republicans from the Senate Committee on Finance issued a separate letter urging CMS to withdraw the rule immediately.

House of Representatives

• On April 27, 2016, the House Energy and Commerce Committee convened a full committee markup of H.R.4641, to provide for the establishment of an inter-agency task force to review, modify, and update best practices for pain management and prescribing pain medication, and for other purposes; H.R.3680, the "Co-Prescribing to Reduce Overdoses Act of 2015"; H.R.3691, the "Improving Treatment for Pregnant and Postpartum Women Act"; H.R.1818, the "Veteran Emergency Medical Technician Support Act"; H.R.3250, the "DXM Abuse Prevention Act"; H.R.4969, the "John Thomas Decker Act of 2016"; H.R.4586, "Lali's Law"; H.R.4599, the "Reducing Unused Medications Act of 2016"; H.R.4978, the "Nurturing and Supporting Healthy Babies Act"; H.R.4976, the "Opioid Review Modernization Act"; the "Opioid Use Disorder Treatment Expansion and Modernization Act"; and the "Examining Opioid Treatment Infrastructure Act of 2016."
• On April 28, 2016, the House Judiciary Committee convened a hearing entitled, “Oversight of the False Claims Act.” The witnesses included Dennis Burke, President& CEO, Good Shepherd Health Care System; Larry Thompson, Professor in Corporate and Business Law, University of Georgia; Neil Getnick, Partner, Getnick & Getnick LLP; and Jonathan Diesenhaus, Partner, Hogan Lovells US LLP.
• On April 29, 2016, House Energy and Commerce Chairman Fred Upton (R-MI), House Ways and Means Committee Chairman Kevin Brady (R-TX), and 32 Republican Committee Members sent a letter to CMS Acting Administrator Andy Slavitt regarding a new agency rule that will affect how health care plans are designed and sold on the Exchanges. In the letter, the Members express concern that the rule will harm patients by increasing the government’s role in health care, limiting choices, and stifling innovation: “We are concerned CMS’s policies will continue a pattern of allowing Washington bureaucrats to pick winners and losers by propping up plans that meet arbitrary requirements, instead of preserving choice and encouraging consumers to select plans that will best meet their unique needs.”

III. REPORTS, STUDIES, & ANALYSES

• On April 28, 2016, the HHS Office of the Inspector General (OIG) released a report entitled, “Enhanced Enrollment Screening of Medicare Providers: Early Implementation Results.” This study examines CMS’ early implementation of new screening tools intended to prevent illegitimate providers from enrolling in Medicare. OIG found that providers submitted fewer enrollment applications to CMS in the post-implementation period. OIG found that there was also an increase in the rate of applications that CMS returned to providers and a higher rate of approvals (lower rate of denials) among CMS’ enrollment determinations. OIG recommends that CMS (1) monitor contractors to determine whether they are verifying information on enrollment and revalidation applications as required; (2) validate that contractors are appropriately considering site visit results when making enrollment decisions; (3) revise and clarify site visit forms so that they can be more easily used by inspectors to determine whether a facility is operational; and (4) ensure that CMS’ enrollment data system contains the complete and accurate data needed to execute and evaluate the Agency’s enrollment-screening enhancements. CMS concurred with all five recommendations
• On April 25, 2016, OIG released a report entitled, “Review of Medicare Contractor Information Security Program Evaluations for Fiscal Year 2014.” OIG notes that CMS contracted with PricewaterhouseCoopers (PwC) to evaluate information security programs at the MACs, using a set of agreed-upon procedures. PwC found that the total number of gaps identified at the MACs increased from the previous year. PwC also found that deficiencies remain in all of the Federal Information Security Management Act of 2002 (FISMA) control areas tested, including high- and medium-risk gaps repeated from the previous year.
• On April 28, 2016, the Government Accountability Office (GAO) released a report entitled, “Department of Defense (DOD) Is Meeting Most Mental Health Care Access Standards, but It Needs a Standard for Follow-up Appointments.” GAO found that while DOD has increased the number of available mental health providers in both direct and purchased care in recent years, DOD data indicate that the military services still face shortages for certain providers, such as psychiatrists. Additionally, GAO found that only an estimated 37 percent of civilian mental health providers were accepting any new TRICARE patients. GAO recommended that DOD establish an access standard for mental health follow-up appointments and regularly monitor data on these appointments. DOD concurred with GAO's recommendation.
• On April 28, 2016, GAO released a report entitled, “Indian Health Service (IHS): Actions Needed to Improve Oversight of Patient Wait Times.” GAO found that the lack of systematic, agency-wide oversight of the timeliness of primary care appointments prevents IHS from knowing the extent to which it is meeting the goal of providing accessible primary care services to AI/AN people and is also inconsistent with federal internal control standards. GAO recommended that IHS (1) communicate specific agency-wide standards for patient wait times, and (2) monitor patient wait times in its federally operated facilities, and ensure corrective actions are taken when standards are not met.

IV. OTHER HEALTH POLICY NEWS

• On April 29, 2016, CMS announced that this year for the first time, consumers will have the option to select “Simple Choice plans”. According to CMS, these are plans that have a uniform set of features – enabling consumers to compare plans on fewer important plan factors like monthly premiums and providers in the plan’s network with the confidence of knowing that the benefits won’t vary from plan to plan. CMS expects these plans “will be a core part of the shopping experience on HealthCare.gov this year. To improve decision making, Simple Choice plans will display prominently in Plan Compare, with clear visual cues that show consumers the plans that are easy to compare vs. the ones that should be researched for differences. Consumers also will be able to choose to only see these types of plans, if they want to quickly compare them.”
• On April 29, 2016, CMS also announced that, in the 2017 Open Enrollment period, the Agency will pilot the display of star ratings using a 5-star rating scale. The pilot will be in several selected states that use the HealthCare.gov platform. During this period, CMS will continue testing consumer use and experience and improve the display of quality rating information. We also have provided the opportunity for state-based Marketplaces to choose to display quality rating information on their websites in the 2017 Open Enrollment period.
• On April 27, 2016, CMS added six new quality measures to its consumer-based Nursing Home Compare website. Three of these six new quality measures are based on Medicare-claims data submitted by hospitals, which is significant because this is the first time CMS is including quality measures that are not based solely on data that are self-reported by nursing homes. These three quality measures measure the rate of rehospitalization, emergency room use, and community discharge among nursing home residents. The measures will be implemented in July 2016.