Healthcare Week in Review January 22, 2016

A&B Healthcare Week in Review, January 22, 2016

Alston & Bird

I. REGULATIONS, NOTICES, & GUIDANCE

  • On January 21, 2016, the Centers for Medicare and Medicaid Services (CMS) issued a final rule entitled, “Medicaid Program: Covered Outpatient Drugs.” This rule implements provisions of the Affordable Care Act (ACA) pertaining to Medicaid reimbursement for covered outpatient drugs (CODs). This final rule also revises other requirements related to CODs, including key aspects of their Medicaid coverage and payment and the Medicaid drug rebate program, such as a revised definition of average manufacturer price (AMP) and a manufacturer’s “best price,” which are used to determine Medicaid rebates owed by pharmaceutical manufacturers and Federal Upper Limits (FULs) for Medicaid reimbursement for multiple source drugs.
  • On January 22, 2016, CMS published a clarification entitled, “Medicare Program; Explanation of FY 2004 Outlier Fixed-Loss Threshold as Required by Court Rulings.” In accordance with court rulings in cases that challenge the federal fiscal year (FY) 2004 outlier fixed-loss threshold rulemaking under the Inpatient Prospective Payment System (IPPS), this document provides further explanation of certain methodological choices made in the FY 2004 fixed-loss threshold determination.
  • On January 22, 2016, the Department of Health & Human Services (HHS) published a notice entitled, “Annual Update of the HHS Poverty Guidelines.” This notice provides an update of HHS poverty guidelines to account for last calendar year’s increase in prices as measured by the Consumer Price Index (CPI).
  • On January 21, 2016, the CMS Center for Consumer Information and Insurance Oversight (CCIIO) issued guidance entitled, “Final 2017 Actuarial Value Calculator Methodology.” This guidance revises the 2016 version of the Actuarial Value (AV) calculator to incorporate updates in the final 2017 version, released on January 21, 2016. The first part of this document provides background that includes an overview of the regulation that allows HHS to make updates to the AV Calculator as well as the updates that are incorporated into the 2017 AV Calculator. For the second part of the document, we provide a detailed description of the development of the standard population and the AV Calculator methodology. Pursuant to ACA-implementing regulations, HHS requires use of an Actuarial Value (AV) Calculator by issuers of non-grandfathered health insurance plans offered in the individual and small group markets, both inside and outside of the Affordable Insurance Exchanges (also called “Marketplaces”) for the purposes of determining levels of coverage.
  • On January 22, 2016, the Food & Drug Administration (FDA) published a guidance notice entitled, “Postmarket Management of Cybersecurity in Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability.” This draft guidance informs industry and FDA staff of the Agency's recommendations for identifying, addressing, and monitoring cybersecurity vulnerabilities and exploits for postmarket management of medical devices. This draft guidance is neither final nor is it in effect at this time, and is available for viewing here.
  • On January 22, 2016, the FDA published a guidance notice entitled, “Implanted Blood Access Devices for Hemodialysis; Guidance for Industry and Food and Drug Administration Staff; Availability.” In this notice, the FDA announces availability of the guidance entitled “Implanted Blood Access Devices for Hemodialysis.” This guidance was developed to support the reclassification of the implanted blood access devices for hemodialysis into class II (special controls) and to assist industry in preparing premarket notification (510(k)) submissions for implanted blood access devices for hemodialysis. This guidance is available here.
  • On January 19, 2016, the FDA published a request for nominations entitled, “Request for Nominations on the Technical Electronic Product Radiation Safety Standards Committee.” In the notice, FDA requests any industry organizations interested in participating in the selection of voting industry representatives to serve on the Technical Electronic Product Radiation Safety Standards Committee for the Center for Devices and Radiological Health (CDRH) to notify FDA in writing. FDA is also requesting nominations for voting industry representatives to serve on the Technical Electronic Product Radiation Safety Standards Committee. A nominee may either be self-nominated or nominated by an organization to serve as a voting industry representative. Nominations will be accepted for current vacancies effective with this notice.
  • On January 21, 2016, the Health Resources & Services Administration (HRSA) published a request for nominations entitled, “Advisory Council on Blood Stem Cell Transplantation; Request for Nominations for Voting Members.” In this public notice, HRSA nominations of qualified candidates to fill expected vacancies on the Advisory Council on Blood Stem Cell Transplantation (ACBSCT). The ACBSCT advises and makes recommendations to the HHS Secretary on broad Program policy in areas such as the necessary size and composition of the adult donor pool available through the Program and the composition of the National Cord Blood Inventory; requirements regarding informed consent for cord blood donation; accreditation requirements for cord blood banks; the scientific factors that define a cord blood unit as high quality; public and professional education to encourage the ethical recruitment of genetically diverse donors and ethical donation practices; criteria for selecting the appropriate blood stem source for transplantation; Program priorities; research priorities; and the scope and design of the Stem Cell Therapeutic Outcomes Database.
  • On January 21, 2016, HRSA published a request for nominations entitled, “Advisory Committee on Organ Transplantation Request for Nominations for Voting Members.” HRSA requests nominations to fill vacancies on the Advisory Committee on Organ Transplantation (ACOT).
  • On January 19, 2016, the Centers for Disease Control and Prevention (CDC) published a request for information entitled, “Request for Information on Development of a Performance Test Protocol for Closed System Transfer Devices That Incorporate Air-Cleaning Technology To Provide Worker Protection During Pharmacy Compounding and Administration of Hazardous Drugs.” The National Institute for Occupational Safety and Health (NIOSH) of CDC requests information for the development of a test protocol to evaluate the performance of closed system drug-transfer devices (CSTDs) that adopt air-cleaning technologies. CSTDs are generally available in two design types: (1) One that uses a physical barrier to block the unintended release of drug into the surrounding environment or the intake of environmental contaminants into the sterile drug pathway and (2) one that uses air cleaning or filtration technologies to prevent the unintended release of drug into the surrounding environment or the intake of environmental contaminants into the sterile drug pathway. A draft protocol titled, “A Vapor Containment Performance Protocol for Closed System Transfer Devices Used During Pharmacy Compounding and Administration of Hazardous Drugs,” was developed by NIOSH to evaluate how protective the physical barrier-type CSTD devices were as an indicator of how effective they would be at preventing hazardous drug escape from the closed system. This RFI seeks information from the public regarding the feasibility of developing a protocol applicable to CSTDs using air cleaning or filtration technologies and to request information from stakeholders on this topic.
  • On January 19, 2016, the CDC published a request for information entitled, “Request for Information on NIOSH Center for Direct Reading and Sensor Technologies: Sensors for Emergency Response Activities.” CDC requests information to enhance the value of the NIOSH Center for Direct Reading and Sensor Technologies and is seeking input regarding specific issues on the availability, capability, suitability, barriers, limitations, and opportunities for current or future direct reading devices and sensor technologies that can be utilized for emergency response. This RFI is intended to inform the planning of a document to evaluate current and future sensor technologies used in emergency response.
  • On January 19, 2016, CMS published an information collection notice entitled, “Agency Information Collection Activities: Submission for OMB Review; Comment Request.” CMS announces an opportunity for the public to comment on CMS' intention to collect information from the public under a revision of a currently approved information collection on the Evaluation of the Graduate Nurse Education Demonstration Program.
  • On January 20, 2016, the CDC published 5 information collection notices, on the following topics: Partnerships for Community Health (PICH) and Racial and Ethnic Approaches to Community Health (REACH); Annual Survey of Colorectal Cancer Control Activities Conducted by States and Tribal Organizations; the Behavioral Risk Factor Surveillance System (BRFSS); the Pregnancy Risk Assessment Monitoring System (PRAMS); and the Asthma Information and Reporting System (AIRS).
  • On January 20, 2016, CMS published an information collection notice entitled, “Agency Information Collection Activities: Submission for OMB Review; Comment Request.” In this notice, CMS announces an opportunity for the public to comment on CMS' intention to collect information from the public under an extension of a currently approved information collection concerning Consumer Assistance Program Grants.
  • On January 21, 2016, the CDC published information collection notices on the following topics: Monitoring and Coordinating Personal Protective Equipment (PPE) in Healthcare to Enhance Domestic Preparedness for Ebola Response; and Measuring Perceived Self-Escape Competencies among Underground Mineworkers.

Event Notices

  • January 28 - 29, 2016: The Medicaid and CHIP Payment and Access Commission (MACPAC) will convene a meeting at the Horizon Ballroom of the Ronald Reagan and International Trade Center, 1300 Pennsylvania Ave NW, Washington, DC . The agenda is available here and discussed in more detail below.
  • March 25, 2016: CMS has announced a public conference to discuss potential improvements to the HHS Risk Adjustment methodology for the 2018 benefit year and beyond. More information on the announcement may be found here.

II. CONGRESSIONAL LEGISLATION & COMMITTEE ACTION

U.S. Senate

  • On January 20, 2016, the Senate Health, Education, Labor, and Pensions (HELP) Committee held a hearing on “Improving the Federal Response to Challenges in Mental Health Care” Witnesses for this hearing: Brian Hepburn, Executive Director, National Association of State Mental Health Program Directors; Penny Blake, Emergency Nurses Association; William Eaton, Professor, Department of Mental Health, Johns Hopkins Bloomberg School of Public Health; and Hakeem Rahim, CEO, Live Breathe LLC, Let’s Talk Mental Illness, National Alliance on Mental Illness.
  • On January 21, 2016, the Senate Finance Committee convened a hearing entitled “CO-OPs: A Review of the Financial and Oversight Controls,” to examine the management failures of the ACA’s Consumer Operated and Oriented Plans (CO-OPs) and its impact on consumers, patients and taxpayers. The sole witness is Andy Slavitt, Acting Administrator of CMS.
  • On January 20, 2016, Senate HELP Committee Chairman Lamar Alexander (R-TN) and Ranking Member Patty Murray (D-WA) released draft legislation that would aim to reduce administrative burdens relating to health information technology (IT) and electronic health record (EHR) utilization and improve interoperability of health IT systems, among other health IT-focused policy changes.
  • On January 19, 2016, the Senate HELP Committee announced its schedule for considering a number of biomedical innovation bills. On February 9th, the Committee will consider a number of bills focused on advancing therapies for rare diseases and medical rehabilitation research. On March 9th, the Committee will markup legislation aimed at “modernizing” the FDA and National Institutes of Health (NIH). More information about the schedule is available here.

House of Representatives

  • The House of Representatives was not in session this week, in order to accommodate a one-week district work period. The House is expected to reconvene on January 25th to conduct legislative business. More information about the House Floor Schedule may be found here.

III. REPORTS, STUDIES, & ANALYSES

  • On January 19, 2016, the Congressional Budget Office (CBO) issued a preliminary summary of the Budget and Economic Outlook: 2016 to 2026. In the preliminary summary, CBO projects that the 2016 federal deficit will be rough $130 billion higher than previously estimated, due largely to un-offset revenue reductions resulting from so-called “tax extender” legislation that was enacted in December and slower than anticipated economic growth. Medicare, Medicaid, Children’s Health Insurance Program (CHIP), and Health Insurance Exchange premium tax credit subsidy expenditures are projected to be $104 billion higher in 2016 than they were in 2015.
  • On January 19, 2016, the Government Accountability Office (GAO) released a report entitled, “Additional Oversight Needed of CMS's Demonstration to Coordinate the Care of Dual-Eligible Beneficiaries.” In this report, GAO examined (1) how integrated care organizations—which are health plans or other entities—are implementing care coordination for dual-eligible beneficiaries and (2) what, if any, challenges organizations have encountered in implementing care coordination and the extent to which CMS oversees these care coordination activities. GAO recommends that CMS develop new comparable measures and align existing measures to strengthen oversight of care coordination. HHS proposed actions that it plans to take in response to GAO’s recommendations, as discussed in the report.
  • On January 20, 2016, the HHS-Office of the Inspector General (HHS-OIG) issued a report entitled, “National Background Check Program for Long Term Care Employees: Interim Report.” HHS-OIG found that 25 States that are receiving ACA grants to implement background checks for prospective long-term health care employees reported having achieved varying levels of program implementation. Specifically, some States have not obtained legislation that would enable them to conduct background checks. Other States have not yet implemented processes to collect fingerprints and monitor criminal history information after individuals begin employment. Only 6 of the 25 States have submitted to CMS data sufficient to calculate the percentage of prospective employees who were disqualified because of their background checks. In these six States, 3 percent of prospective employees were disqualified from employment. Of the remaining 19 States, 11 States were not yet submitting data reports and 8 States had data gaps that prevented the calculation of disqualification rates.

IV. OTHER HEALTH POLICY NEWS

  • On January 19, 2016, CMS announced in a blog post that the agency would eliminate and modify certain Special Enrollment Periods (SEPs) for qualified health plan (QHP) coverage under the ACA, outside of the normal Open Enrollment process. Among other things, the announcement indicates that the following SEPs would be eliminated: (1) consumers who enrolled with too much in advance payments of the premium tax credit because of a redundant or duplicate policy; (2) consumers who were affected by an error in the treatment of Social Security income for tax dependents; (3) lawfully present non-citizens who were affected by a system error in determination of their advance payments of the premium tax credit; (4) lawfully present non-citizens with incomes below 100 percent of the federal poverty limit who experienced certain processing delays; (5) consumers who were eligible for or enrolled in Consolidated Omnibus Budget Reconciliation Act (COBRA) coverage and not sufficiently informed about their coverage options; and (6) consumers who were previously enrolled in the ACA's Pre-Existing Condition Health Insurance Program.
  • On January 21, 2016, MACPAC announces its agenda for its January 28th public meeting. MACPAC will hold sessions on the following topics: Design Considerations for the Future of Children’s Coverage: Focus on Affordability; Affordability for Children in Separate CHIP versus Employer-Sponsored Insurance; the Commission’s Work on Children’s Coverage and Next Steps; Functional Assessment Tools for Medicaid Long-Term Services and Supports Eligibility and Care Planning; Providers Serving Medicaid Patients; a Historical Review of Proposals to Reform Medicaid; Addressing Growth in Federal Medicaid Spending: Selected Financing Alternatives. More information may be found here.
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