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

I. REGULATIONS, NOTICES, & GUIDANCE

• On July 21, 2016, the Centers for Medicare & Medicaid Services (CMS) issued a notice entitled, “Coverage for Contraceptive Services.” CMS is requesting information on whether there are alternative ways (other than those offered in current regulations) for eligible organizations that object to providing coverage for contraceptive services on religious grounds to obtain an accommodation, while still ensuring that women enrolled in the organizations’ health plans have access to seamless coverage of the full range of FDA-approved contraceptives without cost sharing. Public comments are due by September 22, 2016.
• On July 19, 2016, the Center for Consumer Information and Insurance Oversight (CCIIO) issued a manual entitled, “Federally-facilitated Marketplace (FFM) and Federally-facilitated Small Business Health Options Program (FF-SHOP) Enrollment Manual.” This manual is effective as of October 1, 2016. All enrollments made on or after October 1, 2016, should be processed in accordance with the operational requirements set forth in this document. CMS intends to update this Manual regularly, and publish clarifying bulletins between updates. All previous versions of bulletins that have been incorporated into this version of the manual should be considered superseded by this manual.
• On July 15, 2016, CCIIO issued an informational bulletin entitled, “Netting of Payments and Charges under 45 CFR 156.1215.” Under 45 CFR 156.1215, CMS has the authority to net payments owed to issuers and their affiliates operating under the same tax identification number against amounts due to the Federal or State governments from the issuers and their affiliates under the same taxpayer identification number for: (1) advance payments of the premium tax credit and cost-sharing reductions; (2) reconciliation of cost-sharing reductions; (3) Federally-facilitated Exchange user fees and fees for State-based Exchanges utilizing the Federal platform; and (4) risk adjustment, reinsurance, and risk corridors payments and charges.
• On July 18, 2016, the Food and Drug Administration (FDA) issued a notice entitled, “Agency Information Collection Activities; Proposals, Submissions, and Approvals: Bar Code Label Requirement for Human Drug and Biological Products.” FDA previously issued a final rule that requires human drug product and biological product labels to have bar codes. Specifically, the rule requires bar codes on most human prescription drug products and on over-the-counter (OTC) drug products that are dispensed under an order and commonly used in health care facilities. Public comments related to the information collection are due by August 19, 2016.
• On July 15, 2016, CMS issued an informational bulletin entitled, “Annual Re-determination of Medicare Part D Low-Income Subsidy Deemed Status (Re-deeming).” CMS is preparing for the annual redetermination of Medicare Part D low-income subsidy (LIS) deemed status, also known as “re-deeming.” There is information provided to help states understand the process and their role in ensuring that dual eligible beneficiaries have timely, affordable, and comprehensive coverage under the Medicare Part D prescription drug benefit.
• On July 18, 2016, FDA issued a notice entitled, “Protection of Human Subjects -- Informed Consent; Institutional Review Boards.” Some clinical investigations involving children, although otherwise not approvable, may present an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children. Public comments are due September 19, 2016.
• On July 19, 2016, HRSA issued a notice entitled, “National Practitioner Data Bank: Change in User Fees.” HRSA is announcing a decrease in user fees charged to individuals and entities authorized to request information from the National Practitioner Data Bank (NPDB). The new fee will be $2.00 for both continuous and one-time queries and $4.00 for self-queries. The reduction in NPDB user fees is intended to encourage new users while ensuring sufficient funds to the full cost of NPDB operations and retain appropriate cash reserves. The goals of the cash reserves are to mitigate risks, cover operational costs should revenue decrease, and cover the cost of reasonable enhancement and maintenance of the NPDB management system.
• On July 20, 2016, FDA issued a final rule entitled, “Administrative Actions for Noncompliance; Lesser Administrative Actions; Confirmation of Effective Date.” FDA is confirming the effective date of August 17, 2016, for the direct final rule that appeared in the Federal Register of April 4, 2016. The direct final rule amends the regulations describing lesser administrative actions that may be imposed on an Institutional Review Board (IRB) that has failed to comply with applicable regulations. FDA is taking this action to ensure clarity and improve the accuracy of the regulations. This document confirms the effective date of the direct final rule.
• On July 20, 2016, FDA issued a notice entitled, “Charter Renewals: Science Board to the Food and Drug Administration.” FDA is announcing the renewal of the Science Board to the FDA by the Commissioner of FDA. The Commissioner has determined that it is in the public interest to renew the Science Board to the FDA for an additional 2 years beyond the charter expiration date. The new charter will be in effect until June 26, 2018.
• On July 19, 2016, the Office of Management and Budget (OMB) received a proposed rule for review entitled, “Medicaid Supplemental Payment and Accountability.” According to OMB, this proposed rule would promote transparency by establishing new reporting requirements for states to provide to CMS certain information on supplemental payments to Medicaid providers, including supplemental payments approved under either Medicaid state plan or demonstration authority. 194 Supplemental payments to federally qualified health centers, rural health clinics, and Indian providers are not included in the reporting requirements nor are payments known as pass through or wrap-around payments included in this proposed rule. Disproportionate share hospital payments are also not subject to the reporting requirements of this proposed rule.
• On July 20, 2016, OMB received for review the “CY 2018 Notice of Benefit and Payment Parameters.”
• On July 19, 2016, OMB received a final rule for review entitled, “FY 2017 Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities.” According to OMB, this annual final rule would update the payment rates used under the prospective payment system for Skilled Nursing Facilities for fiscal year 2017.
• On July 19, 2016, OMB received a final rule for review entitled, “FY 2017 Inpatient Rehabilitation Facility Prospective Payment System.” According to OMB, This annual final rule updates the prospective payment rates for inpatient rehabilitation facilities (IRFs) for fiscal year 2017.
• On July 20, 2016, CMS issued an MLN Matters® Article entitled, “Protecting Patient Personal Health Information.” The article is intended for physicians, including physician group practices that are covered entities under the Health Insurance Portability and Accountability Act (HIPAA) using electronic systems to store Personal Health Information (PHI) of their Medicare patients.
• On July 21, 2016, the Drug Enforcement Administration (DEA) issued a notice entitled, “Proposed Adjustments to the Aggregate Production Quotas for Schedule I and II Controlled Substances and Assessment of Annual Needs: List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2016.” DEA proposes to adjust the 2016 aggregate production quotas for several controlled substances in schedules I and II of the Controlled Substances Act and assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. Public comments are due August 22, 2016.
• On July 21, 2016, DEA issued a notice entitled, “Proposed Aggregate Production Quotas for Schedule I and II Controlled Substances and Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2017.” DEA proposes to establish the 2017 aggregate production quotas for controlled substances in schedules I and II of the Controlled Substances Act and assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. Public comments are due August 22, 2016.
• On July 21, CMS issued both State and Manufacturer Releases entitled, “Reporting of Managed Care Drug Utilization Data, Reporting of MCO Utilization Data, MCO Drug Utilization, State Drug Utilization Data, SDUD, Reporting of State Drug Utilization Data, Reporting of SDUD, Labeler, Monitoring of Drug Utilization Data, Labeler Monitoring of SDUD, State Drug Utilization Data to CMS, SDUD, Reported to CMS, Best Price Not Greater than AMP.” The releases detail specific Medicaid drug rebate program data related issues that are important to states and manufacturers. Among other things, the releases: 1) delay until July 1, 2017 the requirements for states to comply with “date of service” rebate reporting for Medicaid Managed Care (MCO) prescription claims; 2) encourage labelers to proactively monitor state-reported drug utilization data for both timeliness and accuracy in order to ensure that the drug utilization data reported to CMS matches the drug utilization data reported on state rebate invoices; and 3) remind labelers to not report a “best price” that is greater than AMP.
• On July 21, 2016, CCIIO issued an FAQ entitled, “Annual Income Threshold Adjustment FAQ.” As part of the ongoing effort to improve the consumer experience in the Marketplace, CMS is implementing a change that will allow more consumers to get their household income immediately verified by the Marketplace when they submit an application. The change will reduce the number of consumers who have to follow-up and submit documentation to verify their household income while maintaining important program integrity controls. These FAQs provide details about this change in the Federally-facilitated Marketplaces (FFM), as well as guidance on what this means for State-based Marketplaces.
• On July 22, 2016, HRSA issued a notice entitled, “Health Center Program.” The Bureau of Primary Health Care (BPHC) is awarding funds to health centers transitioning to value-based models of care, improving the use of information in decision making, and increasing engagement in delivery system transformation.

Event Notices

• August 15, 2016, FDA announced a public meeting to discuss proposed recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA) for fiscal years (FYs) 2018 through 2022.
• August 24, 2016, the Substance Abuse and Mental Health Services Administration’s (SAMHSA) announced a public meeting with the Center for Substance Abuse Treatment (CSAT) National Advisory Council (NAC).
• September 26, 2016, the Department of Health and Human Services (HHS) announced a public meeting of the Advisory Group on Prevention, Health Promotion, and Integrative and Public Health.
• October 6, 2016, FDA announced a public workshop entitled, “Pre-Clinical Evaluation of Red Blood Cells for Transfusion.” The purpose of the public workshop is to discuss new methodologies for pre-clinical evaluation of the safety and efficacy of red blood cell transfusion products.

II. CONGRESSIONAL LEGISLATION & COMMITTEE ACTION

U.S. Senate

• The Senate has adjourned and will reconvene on Tuesday, September 6, 2016.

House of Representatives

• The House has adjourned and will reconvene on Tuesday, September 6, 2016.

III. REPORTS, STUDIES, & ANALYSES

• On July 20, 2016, CMS’ Center for Program Integrity (CPI) released the Annual Report to Congress on the Medicare and Medicaid Integrity Programs for Fiscal Years (FYs) 2013 and 2014, which found that from October 1, 2012 through September 30, 2014 (FY 2013 and FY 2014), every dollar invested in CMS’s Medicare program integrity efforts saved $12.40 for the Medicare program. The report highlights CMS’s significant achievements in reducing potentially fraudulent and improper payments. Total savings from program integrity efforts were nearly $42 billion over the two-year period covered by the report.
• On July 20, 2016, the Congressional Budget Office (CBO) released a Cost Estimate of, “H.R. 5613, Continuing Access to Hospitals Act of 2016.” Because CBO expects that H.R. 5613 would not change how CMS enforces the direct supervision requirement, CBO estimates that enacting H.R. 5613 would not affect direct spending or revenues. Additionally, CBO estimates that enacting H.R. 5613 would not increase net direct spending or on-budget deficits in any of the four consecutive 10-year periods beginning in 2027.
• On July 20, 2016, CBO released a Cost Estimate of, “H.R. 5458, Veterans TRICARE Choice Act of 2016.” The staff of the Joint Committee on Taxation (JCT) estimates that the legislation would reduce revenues by $97 million over the 2017-2026 period. CBO estimates that effects on direct spending and spending subject to appropriation would be insignificant in any year and in total over the 2017-2026 period.
• On July 21, 2016, the HHS Office of the Inspector General (OIG) released a report entitled, “Adverse Events in Rehabilitation Hospitals: National Incidence Among Medicare Beneficiaries.” This report is part of a series on adverse events in health care settings, defined as harm resulting from medical care. OIG found that an estimated 29 percent of Medicare beneficiaries experienced adverse or temporary harm events during their rehab hospital stays, resulting in temporary harm; prolonged stays or transfers to other hospitals; permanent harm; life-sustaining intervention; or death. OIG recommend that CMS raise awareness of patient safety issues in rehab hospitals and seek to reduce patient harm. This effort should include: (1) collaboration to create and disseminate a list of potential adverse events that occur in rehab hospitals and (2) the addition of information about potential adverse events in quality guidance to rehab hospitals. CMS concurred with the recommendations.
• On July 21, 2016, the OIG released a report entitled, “FDA is Issuing More Postmarketing Requirements (PMRs), but Challenges with Oversight Persist.” OIG found that FDA continues to have problems with its data management system and work processes, which hinder its ability to track PMRs. OIG recommended that FDA should determine the reasons why some PMRs have been delayed for years, and take action as appropriate. FDA implemented the recommendation to determine the reasons some PMRs have been delayed.
• On July 21, 2016, CBO released a Cost Estimate of, “S. 849, Advancing Research for Neurological Diseases Act of 2016.” CBO estimates that implementing S. 849 would cost $152 million over the 2017-2021 period, assuming appropriation of the necessary amounts. CBO also estimates that enacting the legislation would not increase net direct spending or on-budget deficits in any of the four consecutive 10-year periods beginning in 2027.
• On July 21, 2016, CBO released a Cost Estimate of, “H.R. 5659, Expanding Seniors Receiving Dialysis Choice Act of 2016.” The bill would transfer responsibility for the costs of acquiring organs for kidney transplants from Medicare Advantage plans to the fee-for-service portion of Medicare. Payments to MA plans would be adjusted to reflect that shift. Thus, CBO estimates that this provision would not have a significant effect on federal spending.

IV. OTHER HEALTH POLICY NEWS

• On July 18, 2016, Republicans released their 2016 Republican Party Platform and convened in Cleveland, Ohio for the Republican National Convention. In the document, the Republicans outline their goals to repeal the Affordable Care Act (ACA); foster personal responsibility while increasing preventive services to promote healthy lifestyles; achieve a free market in healthcare and ensure competition; and reform the FDA so “that the FDA no longer wastes U.S. taxpayer and innovators’ resources because of bureaucratic red tape and legal uncertainty.”
• On July 21, 2016, Humana announced that the company will exit Health Insurance Exchanges in eight states in 2017. The company will only offer individual plans in 156 counties in 11 states; however, Humana has not provided that details on which exchanges it is leaving.
• On July 21, 2016, the U.S. Department of Justice announced a law suit to block two health insurance mergers —Anthem Inc.’s $48 billion takeover of rival health insurer Cigna Corp. and Aetna Inc.’s $37 billion bid for Humana Inc.—arguing that the mergers would decrease competition in the Marketplace. "For most Americans, health insurance is not luxury but a necessity," Attorney General Loretta Lynch said. "Health insurance can mean the difference between life and death. If the big five were to become the big three, not only would the bank accounts of American people suffer, but the American people themselves."
• On July 21, 2016, the CDC announced that the Agency will begin making awards totaling nearly $60 million to states, cities, and territories to support efforts to protect Americans from Zika virus disease and adverse health outcomes that can result from Zika infection, including the serious birth defect microcephaly. “Local, state and territorial health departments are on the front lines in the fight against Zika,” said CDC Director Tom Frieden. “These CDC funds will strengthen state and territorial capacity to respond to Zika virus, an increasingly concerning public health threat for pregnant women and babies. We hope Congress will provide the additional resources we need to fully support the Zika response.”
• On July 21, 2016, CMS announced 516 awardees in 47 states, Puerto Rico, and the District of Columbia to help reduce the risks for heart attacks and strokes among millions of Medicare fee-for-service beneficiaries. The health care practitioners participating in the Million Hearts® Cardiovascular Disease Risk Reduction Model will work to decrease cardiovascular disease risk by assessing an individual patient’s risk for heart attack or stroke and applying prevention interventions.
• On July 21, 2016, CMS released the Data Brief: Evaluation of National Distributions of Overall Hospital Quality Star Ratings. CMS has been posting quarterly hospital quality star ratings based on patients’ experience of care on the Hospital Compare website since April 16, 2015. To continue the efforts to make quality of care information more readily available, CMS developed an Overall Hospital Quality Star Rating (Star Rating) that reflects comprehensive quality information about the care provided at the nation’s hospitals.