A&B Healthcare Week in Review, December 19, 2014

I. REGULATIONS, NOTICES, & GUIDANCE

• On December 19, 2014, the Internal Revenue Service (IRS), the Employee Benefits Security Administration (EBSA), and the Centers for Medicare and Medicaid Services (CMS) published proposed rules entitled “Amendments to Excepted Benefits”. This document contains proposed rules that would amend the regulations regarding excepted benefits under the Employee Retirement Income Security Act of 1974, the Internal Revenue Code, and the Public Health Service Act related to limited wraparound coverage. Excepted benefits are generally exempt from the requirements that were added to those laws by the Health Insurance Portability and Accountability Act and the Patient Protection and Affordable Care Act (ACA). The proposed rule will be published in the Federal Register on December 23, 2014, and comments will be due 30 days thereafter. 
• On December 17, 2014, the Food and Drug Administration (FDA) released a proposed rule entitled “Electronic Distribution of Prescribing Information for Human Prescription Drugs, Including Biological Products”. FDA is proposing to amend its prescription drug and biological product labeling regulations to require electronic distribution of the prescribing information intended for health care professionals, which is currently distributed in paper form on or within the package from which a prescription drug or biological product is dispensed. FDA is also proposing that prescribing information intended for health care professionals will no longer be permitted to be distributed in paper form with the package from which a prescription drug or biological product is dispensed, except as provided by this regulation. We are proposing these actions to help ensure that the most current prescribing information is publicly accessible for the safe and effective use of human prescription drugs. Comments are due March 18, 2015. 
• On December 18, 2014, FDA announced the availability of a guidance for industry entitled ‘‘Providing Regulatory Submissions in Electronic Format—Standardized Study Data.’’ The guidance announced in this document is being issued in accordance with the Food and Drug Administration Safety and Innovation Act (FDASIA), which amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to require that certain submissions under the FD&C Act and Public Health Service Act (PHS Act) be submitted in electronic format, beginning no earlier than 24 months after issuance of final guidance on that topic. The guidance describes how FDA plans to implement the requirements for the electronic submission of standardized study data contained in certain submissions under new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), and investigational new drug applications (INDs). This finalizes the revised draft guidance that was issued on February 6, 2014. 
• On December 18, 2014, FDA announced the availability of a guidance for industry entitled ‘‘Providing Regulatory Submissions in Electronic Format—Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act.’’ The guidance announced in this notice sets forth FDA’s interpretation of the Food and Drug Administration Safety and Innovation Act (FDASIA), which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to require that certain submissions under the FD&C Act and the Public Health Service Act be submitted in electronic format, beginning no earlier than 24 months after issuance of a final version of a guidance document specifying the format for such electronic submissions. This guidance describes how FDA interprets and plans to implement the electronic submission requirements and finalizes the draft guidance that was issued on February 6, 2014. 
• On December 15, 2014, the United States Office of Personnel Management (OPM) issued a proposed rule to amend the system for assessing the annual performance of health plans contracted under the Federal Employees Health Benefits (FEHB) Program. The purpose of this rule is to measure and assess all FEHB plan performance (experience-rated and community-rated) through the use of a common, objective, and quantifiable performance assessment for the 2016 plan year. OPM must receive comments on or before January 14, 2015. More information may be found here. 
• On December 17, 2014, FDA announced that a proposed collection of information entitled “Fast Track Drug Development Programs: Designation, Development, and Application Review” had been submitted to the Office of Management and Budget (OMB) for review and clearance. Comments are due January 20, 2014. 
• On December 18, 2014, FDA announced that an information collection entitled “Draft Guidance for Industry, Researchers, Patient Groups, and Food and Drug Administration Staff on Meetings With the Office of Orphan Products Development” had been submitted to OMB for review and clearance. Comments are due January 20, 2014. 
• On November 18, 2014, FDA announced that an information collection entitled “Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics” had been submitted to OMB for review and clearance. Comments are due January 20, 2014. 
• On December 16, 2014, FDA announced that an information collection activity entitled “Requirements for Submission of Bioequivalence Data” had been submitted to OMB for review. Comments are due January 15, 2014. 
• On December 17, 2014, OPM issued a direct final rule to discontinue the annual determination of the Medically Underserved Areas (MUAs) for the Federal Employees Health Benefits (FEHB) Program. This rule is effective January 1, 2015; comments are due February 17, 2015. More information may be found here.

II. LEGISLATION & COMMITTEE ACTION

U.S. Senate

• On Saturday December 13, 2014, the Senate passed a $1.014 trillion spending measure—often referred to as a “Cromnibus” bill because it combines the scope of an omnibus spending bill with a shorter-term continuing resolution, or CR, for the Department of Homeland Security—to fund the federal government through September 2015. The House had passed the Consolidated and Further Continuing Appropriations Act two days earlier, and President Obama signed the bill into law on December 16th. Included in the 1,603 page bill is a provision that bars CMS from using program management appropriations for the ACA risk corridors program and requires risk corridors to be budget neutral. Additionally, the Cromnibus rescinds $10 million in appropriations for the ACA’s Independent Payment Advisory Board (IPAB). The package also contains emergency Overseas Contingency Operations funding to combat the Islamic State of Iraq and the Levant (ISIL), and emergency funding to address the domestic and international Ebola crisis. A summary of the bill may be found here. 
• On December 15, 2014, the Senate confirmed President Obama’s nominee Vivek Murthy M.D., M.B.A. to be United States Surgeon General of the Public Health Service. Murthy is an attending physician at Brigham and Women’s Hospital and an instructor at Harvard Medical School. In 2011 Murthy was appointed by President Barack Obama to the National Advisory Group on Prevention, Health Promotion, and Integrative and Public Health. 
• On December 16, 2014, the Senate passed a bill (H.R. 5771) to extend certain expiring tax provisions through 2014 for individuals, businesses, and the energy sector.

House of Representatives 

• On December 16, 2014, the Democratic staff of the House Energy and Commerce Committee released a report detailing the district-specific impact if the Supreme Court rules against providing federal tax credits to consumers who receive ACA insurance coverage through federally facilitated health care exchanges (King v. Burwell). The report finds that for the more than 13 million Americans that are expected to receive tax credits on the federal exchange in 2016, a total of approximately $65 billion in tax credits are at risk.

III. REPORTS, STUDIES, & ANALYSES

• On December 16, 2014, CMS released interim results from a study on beneficiary access to pharmacies offering preferred cost sharing. The study found that 1,203 plans across 43 parent organizations offer preferred cost-sharing arrangements at network pharmacies. The average retail pharmacy network of those plans consisted of 66,986 total pharmacies, of which14,380 pharmacies were found to offer preferred cost-sharing (approximately 20%). The results suggest that most beneficiaries have convenient access to a preferred cost sharing pharmacy, although some plans did not provide convenient access in urban areas. In urban areas not meeting the 90% standard (n=641, 54% of total), some plans were shown to provide extremely low levels of convenient access to a pharmacy with preferred cost-sharing. Specifically, 16% of plans provide convenient access to fewer than 30% of their urban beneficiaries. CMS concludes that “…these findings reinforce CMS’ concern that plans are offering access to pharmacies with lower cost-sharing in a way that may be misleading to beneficiaries, in violation of CMS requirements.” CMS will provide plans with their individual results, and will hold discussions with outlier organizations.
• On December 16, 2014, the National Center on Health Statistics released health coverage estimates from the National Health Interview Survey from January through June 2014. The study finds that in the first 6 months of 2014, 38.0 million persons of all ages (12.2%) were uninsured at the time of interview, 54.0 million (17.3%) had been uninsured for at least part of the year prior to interview, and 27.3 million (8.7%) had been uninsured for more than a year at the time of interview. Among adults aged 18–64, the percentage who were uninsured at the time of interview decreased from 20.4% in 2013 to 17.0% in the first 6 months of 2014. Among adults aged 19–25, the percentage who were uninsured at the time of interview decreased from 26.5% in 2013 to 20.1% in the first 6 months of 2014.

IV. OTHER HEALTH POLICY NEWS

• On December 15, 2014, Tennessee Governor Bill Haslam (D) released his Insure Tennessee plan, a two year pilot Medicaid expansion program. Under the program, Tennesseans 21 to 64 years old will be offered a choice of the Healthy Incentives Plan or the Volunteer Plan. The Volunteer Plan would provide a health insurance voucher to participants that would be used to participate in their employer’s health insurance plan. The voucher, valued at slightly less than the average TennCare per-enrollee cost, can be used to pay for premiums and other out-of-pocket expenses associated with participation in an individual’s employer sponsored private market plan. Participants in the Healthy Incentives Plan may choose to receive coverage through a redesigned component of the TennCare program, which would introduce Healthy Incentives for Tennesseans (HIT) accounts, modeled after Health Reimbursement Accounts (HRAs), which can be used to pay for a portion of required member cost-sharing. More information on the pilot program may be found here. 
• On December 16, 2014, CMS announced the recipients of 11 Model Test and 21 Model Design awards under the second round of the State Innovation Models initiative on December 16, 2014. In round two, the State Innovation Models initiative is providing approximately $665 million over the next four years to support state-led, multi-payer health care payment and service delivery models. More information may be found here. 
• On December 18th and 19th, the Medicare Payment Advisory Commission (MedPAC) convened a series of meetings in Washington, DC to discuss Medicare payment policy issues. Sessions covered payment updates and adequacy, as well as an update on the status of Medicare Advantage. More information, including presentations and transcripts as they become available, may be found here.