A&B Healthcare Week in Review, February 13, 2015

I. REGULATIONS, NOTICES, & GUIDANCE

• On February 13, 2015, the Centers for Medicare and Medicaid Services (CMS) released a ruling notice entitled “Implementing United States v. Windsor for Purposes of Entitlement and Enrollment in Medicare Hospital Insurance and Supplementary Medical Insurance”. This document announces a CMS Ruling that states the CMS policies for implementing United States v. Windsor, in which the Supreme Court held that section 3 of the Defense of Marriage Act (DOMA), enacted in 1996, is unconstitutional. Section 3 of DOMA defined ‘‘marriage’’ and ‘‘spouse’’ as excluding same-sex marriages and same-sex spouses, and effectively precluded the Federal government from recognizing same-sex marriages and spouses. The CMS ruling announced in this document is applicable beginning February 9, 2015, with respect to appeals pending on, initiated, or reopened in accordance with applicable rules after February 9, 2015, for entitlement and enrollment determinations made on or after June 26, 2013. This ruling does not apply to appeals of entitlement and enrollment determinations made before June 26, 2013. 
• On February 12, 2015, CMS announced a new a new multi-payer payment and care delivery model titled the “Oncology Care Model” (OCM). The OCM encourages participating practices to improve care and lower costs through episode-based, performance-based payments that financially incentivize high-quality, coordinated care. Participating practices will also receive monthly care management payments for each Medicare fee-for-service beneficiary during an episode to support oncology practice transformation, including the provision of comprehensive, coordinated patient care. Said Dr. Patrick Conway, Deputy Administrator for Innovation & Quality: “Based on feedback from the medical, consumer and business communities, we are launching this new model of care to support clinicians’ work with their patients. We aim to provide Medicare beneficiaries struggling with cancer with high-quality care around the clock and to reward doctors for the value, not volume, of care they provide. Improving the way we pay providers and deliver care to patients will result in healthier people.” Physician group practices and solo practitioners that provide chemotherapy for cancer and are currently enrolled in Medicare may apply to participate. Other payers, including commercial insurers, Medicare Advantage plans, state programs, and Medicaid managed care plans, are also encouraged to apply. To be considered, interested payers must submit a letter of intent through the Oncology Care Model inbox at OncologyCareModel@cms.hhs.gov by 5:00 p.m., EDT on March 19, 2015. A CMS fact sheet on the initiative may be found here. The Federal Register notice, which includes additional details for applicants, may be found here. 
• On February 13, 2015, CMS announced that it is extending the timeline for publication of a final rule, “Medicare Program; Reporting and Returning of Overpayments”. Section 6402(a) of the ACA (Enhanced Medicare and Medicaid Program Integrity Provisions) established a new section 1128J(d) of the Social Security Act requiring any person who has received an overpayment to report and return the overpayment to the Secretary, the State, an intermediary, a carrier, or a contractor, as appropriate, at the correct address. Section 1128J(d)(2) requires that an overpayment be reported and returned by the later of—(A) the date which is 60 days after the date on which the overpayment was identified; or (B) the date any corresponding cost report is due, if applicable. In the February 16, 2012 Federal Register (77 FR 9179), CMS published a proposed rule that would implement the provisions of section 1128J(d) of the Act pertaining to Medicare Parts A and B. Today’s notice extends by 1 year (to February 16, 2016) the timeline for publication of a final rule concerning policies and procedures for reporting and returning Part A and B overpayments. “Based on both public comments received and internal stakeholder feedback,” CMS writes, “we have determined that there are significant policy and operational issues that need to be resolved in order to address all of the issues raised by comments to the proposed rule and to ensure appropriate coordination with other government agencies. Specifically, the development of the final rule requires collaboration among both the Department of Health and Human Services' (HHS') Office of the Inspector General and the Department of Justice. Our decision to extend the timeline for issuing a final regulation related to the reporting and returning of Medicare overpayments should not be viewed as a diminution of the Department's commitment to timely and effective rulemaking in this area.”
• On February 13, 2015, the Food and Drug Administration (FDA) announced that the Agency is seeking information to facilitate development and qualification of biomarkers in areas related to human drug therapeutics. Towards this goal, FDA is encouraging interested groups and individuals to submit information on specific medical and biological areas where novel biomarkers can be identified that would meaningfully advance drug development. FDA encourages respondents to describe evidentiary considerations that are important to qualify these biomarkers for a specific context of use. Details of information that should be provided to the Agency are described in the survey. Comments should be submitted by April 14, 2015. More information may be found here. 
• On February 11, 2015, the Centers for Disease Control and Prevention (CDC) released a general notice entitled “Opportunity To Collaborate in the Evaluation of Simplified Nucleic Acid Tests for Detecting and Quantifying HIV”. CDC is announcing an opportunity for industry and the public to collaborate on a project to evaluate simplified nucleic acid tests. HHS/CDC is interested in evaluating simplified nucleic acid tests that (1) can be used near a patient with rapid turn-around of results (2) can be used to aid in the diagnosis of HIV–1 infection, and (3) have the potential to be used in moderately complex and/or waived laboratories as defined under the Clinical Laboratory Improvement Amendment (CLIA) regulations. Tests of interest include those that use whole blood, serum, plasma, or dried blood spots. Performance will be evaluated relative to HHS/Food and Drug Administration (FDA)-approved qualitative and quantitative nucleic acid tests as well as antibody immunoassays. More than one collaborator may be selected. Formal proposals must be received on or before April 13, 2015. 
• On February 13, 2015, the Departments of Labor, Treasury, and HHS released a Frequently Asked Questions (FAQ) document regarding Supplemental Excepted Benefits. (Most provisions of title XXVII of the Public Health Service Act (PHS Act), part 7 of the Employee Retirement Income Security Act (ERISA) and chapter 100 of the Internal Revenue Service Code do not apply to excepted benefits.) Specifically, this document addresses the question, “Can health insurance coverage that supplements group health coverage by providing additional categories of benefits, be characterized as supplemental excepted benefits?” The FAQ explains that the Departments intend to propose regulations clarifying the circumstances under which supplemental insurance products that do not fill in cost-sharing under the primary plan are considered to be specifically designed to fill gaps in primary coverage. Specifically, the Departments intend to propose that coverage of additional categories of coverage would be considered to be designed to "fill in the gaps" of the primary coverage only if the benefits covered by the supplemental insurance product are not an essential health benefit (EHB) in the State where it is being marketed. 
• On February 9, 2015, FDA released a revised draft guidance for industry entitled “Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Human Prescription Drugs”. This revised draft guidance, when finalized, will assist manufacturers, packers, and distributors of human prescription drugs and biologics with meeting the brief summary requirement for prescription drug advertising and the requirement that adequate directions for use be included with promotional labeling for prescription drugs when print materials are directed toward consumers. FDA is also announcing the withdrawal of the draft guidance for industry entitled ‘‘Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements.’’ Comments on the draft guidance should be submitted by April 10, 2015. More information may be found here. 
• On February 9, 2015, FDA issued a notice entitled “Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communication Devices; Mobile Medical Applications: Guidances for Industry and Food and Drug Administration Staff”. This notice is to inform manufacturers, distributors, and other entities that the Agency does not intend to enforce compliance with regulatory requirements for Medical Device Data Systems (MDDS) and two similar radiology device types due to the low risk they pose to patients and the importance they play in advancing digital health. FDA is also issuing an updated version of the guidance document ‘‘Mobile Medical Applications,’’ originally issued on September 25, 2013, that has been edited to be consistent with the MDDS guidance document. 
• On February 10, 2015, FDA announced the availability of a draft guidance for industry entitled “Individual Patient Expanded Access Applications: Form FDA 3926”. The draft guidance provides for public comment and describes draft Form FDA 3926 (Individual Patient Expanded Access—Investigational New Drug Application (IND)), which, when finalized, FDA intends to make available for licensed physicians to use for expanded access requests for individual patient INDs. Individual patient expanded access allows for the use of an investigational drug outside of a clinical trial for an individual patient who has a serious or immediately life-threatening disease or condition and there is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition. When finalized, draft Form FDA 3926 is intended to provide a streamlined alternative for submitting an Investigational New Drug Application (IND) for use in cases of individual patient expanded access. Comments on the draft guidance should be submitted by April 13, 2015. More information may be found here. 
• On February 10, 2015, FDA announced the availability of a guidance for industry entitled ‘‘Complicated Intra-Abdominal Infections: Developing Drugs for Treatment.’’ The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of complicated intra-abdominal infections (cIAIs). Specifically, this guidance addresses FDA’s current thinking regarding the overall drug development program for the treatment of cIAIs, including clinical trial designs to support approval of drugs. This guidance finalizes the draft guidance of the same name issued October 1, 2012. More information may be found here. 
• On February 10, 2015, HHS announced that an information collection request entitled “Protection of Human Subjects: Assurance Identification/IRB Certification/Declaration of Exemption Form—Extension OMB No. 0990–0263, Assistant Secretary for Health, Office for Human Research Protections.” had been submitted to the Office of Management and Budget (OMB) for review and approval. The Office for Human Research Protections is requesting a three year extension of the Protection of Human Subjects: Assurance Identification/IRB Certification/ Declaration of Exemption Form. That form is designed to promote uniformity among departments and agencies, and to help ensure common means of ascertaining institutional review board certifications and other reporting requirements relating to the protection of human subjects in research. The Federal Policy for the Protection of Human Subjects, known as the Common Rule, requires that before engaging in non-exempt human subjects research that is conducted or supported by a Common Rule department or agency, each institution must: (1) Hold an applicable assurance of compliance [Section 103(a)]; and (2) certify to the awarding department or agency that the application or proposal for research has been reviewed and approved by an IRB designated in the assurance [Sections 103(b) and (f)]. Comments on the extension of the Form are due March 12, 2015. 
• On February 10, 2015, HHS announced that an information collection activity entitled “Protection of Human Subjects: Assurance of Compliance with Federal Policy/IRB Review/IRB Recordkeeping/ Informed Consent/Consent Documentation-Extension—0990–0260, Assistant Secretary for Health, Office for Human Research Protections” had been submitted to OMB for review. Section 491(a) of Public Law 99–158 states that the Secretary of HHS shall by regulation require that each entity applying for HHS support (e.g., a grant, contract, or cooperative agreement) to conduct research involving human subjects submit to HHS assurances satisfactory to the Secretary that it has established an institutional review board (IRB) to review the research in order to ensure protection of the rights and welfare of the human research subjects. Pursuant to the requirement of the Public Law 99–158, HHS promulgated regulations at 45 CFR part 46, subpart A, the basic HHS Policy for the Protection of Human Subjects. The June 18, 1991 adoption of the common Federal Policy (56 FR 28003) by 15 departments and agencies implements a recommendation of the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research which was established on November 9, 1974, by Public Law 95– 622. The Common Rule is based on HHS regulations at 45 CFR part 46, subpart A, the basic HHS Policy for the Protection of Human Subjects. The information collected through the Protection of Human Subjects: Assurance Identification/IRB Certification/Declaration of Exemption Form Protection of Human Subjects: Assurance of Compliance with Federal Policy/IRB Review/IRB Recordkeeping/ Informed Consent/Consent Documentation collection requirement is the minimum necessary to satisfy the assurance, certification, reporting, disclosure, documentation and recordkeeping requirements of Section 491(a) of the Public Health Service Act and HHS Regulations for the protection of human subjects at 45 CFR part 46. 
• On February 10, 2015, HHS announced that an information collection activity entitled “Challenge and Prize Competition Solicitations” had been submitted to OMB for review and approval. Comments are due March 12, 2015. 
• On February 11, 2015, CMS announced an opportunity for the public to comment on an information collection activity entitled “CMS–10433 Initial Plan Data Collection To Support Qualified Health Plan (QHP) Certification and Other Financial Management and Exchange Operations”. As required by the CMS–9989–F, Patient Protection and Affordable Care Act; Establishment of Exchanges and Qualified Health Plans; Exchange Standards for Employers (77 FR 18310) (Exchange Establishment Rule), each Exchange must assume responsibilities related to the certification and offering of Qualified Health Plans (QHPs). In addition to data collection for the certification of QHPs, the reinsurance and risk adjustment programs outlined by the Affordable Care Act, detailed in 45 CFR part 153, as established by CMS–9975–F, Patient Protection and Affordable Care Act; Standards for Reinsurance, Risk Corridors, and Risk Adjustment (77 FR 17220), have general information reporting requirements that apply to issuers, group health plans, third party administrators, and plan offerings outside of the Exchanges. Comments on the proposed information collection activities should be submitted by April 13, 2015. 
• On February 11, 2015, FDA announced that an information collection activity entitled “Food and Drug Administration Recall Regulations” had been submitted to OMB for review. The notice provides a summary of the estimated annual burden hours for recalling firms (manufacturers, processors, and distributors) to comply with the voluntary reporting requirements of FDA’s recall regulations, recognizing that there may be a vast difference in the information collection and reporting time involved in different recalls of FDA’s regulated products. Comments are due March 13, 2015. 
• On February 11, 2015, FDA announced the availability of a draft guidance for industry entitled “Premarket Studies of Implantable Minimally Invasive Glaucoma Surgical Devices”. This leap frog guidance document was developed to notify manufacturers of the recommended non-clinical and clinical studies to support a premarket approval application (PMA) for implantable MIGS devices. Comments should be submitted by May 12, 2015. 
• On February 11, 2015, FDA announced the availability of guidance for industry entitled “Safety Considerations to Mitigate the Risks of Misconnections With SmallBore Connectors Intended for Enteral Applications”. The use of common connector designs, such as Luer connectors, has led to unintended connections between devices that have different intended uses and has resulted in serious and sometimes fatal consequences to patients. This guidance provides recommendations to manufacturers regarding the expectations for design and testing of small-bore connectors intended for enteral applications (‘‘enteral devices’’). FDA is making these recommendations to reduce the risk of unintended connections between enteral and nonenteral devices. 
• On February 11, 2015, FDA released a notice entitled “Availability of Safety and Effectiveness Summaries for Premarket Approval Applications”. FDA is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the Agency’s Division of Dockets Management. 
• On February 11, 2015, FDA announced a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (‘‘FDA Recognized Consensus Standards’’). Specifically, this publication announces the addition of a list of recognized standards that are relevant to safety considerations to mitigate the risks of misconnections with small-bore connectors intended for enteral applications. This publication, entitled ‘‘Modifications to the List of Recognized Standards, Recognition List Number: 039’’ (‘‘Recognition List Number: 039’’), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices. More information may be found here. 
• On February 12, 2015, the Department of Defense (DoD) released a notice entitled “TRICARE, Formerly Known as the Civilian Health and Medical Program of the Uniformed Services (CHAMPUS); Fiscal Year 2015 Mental Health Rate Updates”. This notice provides the updated regional per-diem rates for low-volume mental health providers; the update factor for hospital-specific per-diems; the updated cap per-diem for high-volume providers; the beneficiary per-diem cost-share amount for low-volume providers; and the updated per-diem rates for both full-day and half-day TRICARE Partial Hospitalization Programs for Fiscal Year 2015. The Fiscal Year 2015 rates contained in this notice are effective for services on or after October 1, 2014. 
• On February 12, 2015, FDA announced the availability of draft guidance for industry entitled ‘‘Alcoholism: Developing Drugs for Treatment.’’ The purpose of this guidance is to assist sponsors in the development of drugs for the treatment of alcoholism. Comments should be submitted by April 13, 2015. 
• On February 12, 2015, the Office of the National Coordinator for Health Information Technology (ONC) announced a call for nominations to the Health Information Technology Standards Committee (HITSC) to fill expiring terms of ten (10) current members. The HITSC is charged with making recommendations to the National Coordinator on standards, implementation specifications, and certification criteria for the electronic exchange and use of health information for purposes of adoption, consistent with the implementation of the Federal Health IT Strategic Plan, and in accordance with policies developed by the Health IT Policy Committee. Nominations must be received by 12:00 p.m. on Friday, March 6, 2015. More information may be found here. 
• On February 13, 2015, CMS announced an opportunity for the public to comment on selected information collection activities which have been submitted to OMB for review. They are: 1) Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Survey Mode Experiment; 2) Emergency Department Patient Experience of Care (EDPEC) Survey Mode Experiment; and 3) Laboratory Personnel Report (CLIA) and Supporting Regulations. Comments are due March 16, 2015. More information may be found here.

Event Notices 

• March 9-10, 2015: FDA will convene a meeting of the Advisory Group on Prevention, Health Promotion, and Integrative and Public Health on March 9th and 10th. Topics of discussion for the March 2015 meeting of the Advisory Group will include a welcome from the 19th Surgeon General; an update from the Council; reports from the Prioritization and Collective Impact Working Groups; and the development of recommendations for the Council for the upcoming year. Members of the public who wish to attend must register by 12:00 p.m. EST on March 2, 2015. Individuals should register for public attendance at prevention.council@hhs.gov by providing a full name and affiliation. More information may be found here. 
• March 17, 2015: FDA will convene a meeting of the Arthritis Advisory Committee on March 17th, during which the Committee will discuss biologics license application (BLA) 125544 for CT-P13, a proposed biosimilar to Janssen Biotech Inc.'s REMICADE (infliximab), submitted by Celltrion, Inc. The meeting will take place from 8:00 AM to 5:00 PM at FDA’s White Oak Campus in Silver Spring, Maryland. More information may be found here. 
• April 24, 2015: On February 11, 2015, the Agency for Healthcare Research and Quality (AHRQ) released a notice of public meeting entitled “Meeting for Software Developers on the Common Formats for Patient Safety Data Collection and Event Reporting”. AHRQ coordinates the development of common definitions and reporting formats (Common Formats) that allow healthcare providers to voluntarily collect and submit standardized information regarding patient safety events. In order to support the Common Formats, AHRQ has provided technical specifications to promote standardization by ensuring that data collected by PSOs and other entities are clinically and electronically comparable. The purpose of this notice is to announce a meeting to discuss the Common Formats. This meeting is designed as an interactive forum where software developers and PSOs can provide input on the formats. AHRQ especially requests participation by and input from those entities which have used AHRQ’s technical specifications and implemented, or plan to implement, the formats electronically. The meeting will be held from 10:00 AM to 3:30 PM on Friday April 24th in Rockville, Maryland. 
• April 29, 2015: On April 29, 2015, FDA will convene a meeting of the Cellular, Tissue and Gene Therapies Advisory Committee and the Oncologic Drug Advisory Committee from 8:00 AM to 6:00 PM. The committees will discuss talimogene laherparepvec, Amgen, Inc., biologics license application (BLA) 125518, an oncolytic immunotherapy for the treatment of patients with injectable regionally or distantly metastatic melanoma. 
• May 11, 2015: On February 11, 2015, FDA announced a public meeting and an opportunity for public comment on Patient-Focused Drug Development for functional gastrointestinal (GI) disorders, including irritable bowel syndrome, gastroparesis, chronic persistent symptomatic gastroesophageal reflux despite standard therapeutic interventions, and chronic idiopathic constipation. 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 functional GI disorders on daily life and patient views on treatment approaches. The meeting will be held from 1:00 PM to 5:00 PM at FDA’s White Oak Campus in Silver Spring, Maryland. Registration to attend the meeting must be received by May 1, 2015. More information may be found here. 
• July 31, 2015: On February 12, 2015, the Department of Defense (DoD) announced a meeting of the DoD Medicare-Eligible Retiree Health Care Board of Actuaries. This meeting will be open to the public. It will take place on Friday, July 31, 2015, from 10:00 a.m. to 12:00 p.m., at 4800 Mark Center Drive, Conference Room 18, Level B1, Alexandria, VA 22350. More information may be found here.

II. LEGISLATION & COMMITTEE ACTION

U.S. Senate

• On February 10, 2015, the Senate Health, Education, Labor and Pensions (HELP) Committee convened a hearing entitled “The Reemergence of Vaccine-Preventable Diseases: Exploring the Public Health Successes and Challenges”. During the hearing Members and witnesses discussed the recent resurgence of vaccine-preventable diseases, particularly a measles outbreak that originated in Southern California in late December. Many have attributed the outbreak to the growing number of individuals who are declining to vaccinate their children. The sole witness for Panel I was Anne Schuchat, MD (RADM, USPHS), Director, National Center for Immunization and Respiratory Diseases (NCIRD), Centers for Disease Control and Prevention (CDC). Witnesses for Panel II included Mark Sawyer, MD, Professor of Clinical Pediatrics, Division of Infectious Diseases, University of California San Diego and Rady Children’s Hospital; Tim Jacks, DO, FAAP, Parent. Pediatrician, and Every Child By Two Immunization Champion; and Kelly L. Moore, MD, MPH, Director, Immunization Program, Tennessee Department of Health. More information on the hearing may be found here. More information on the hearing may be found here.

House of Representatives

• On February 11, 2015, the House Energy and Commerce Subcommittee on Health convened a hearing entitled “Examining ICD-10 Implementation”. Witnesses for the hearing included Edwin M. Burke, MD, Beyer Medical Group; Rich Averill, Director of Public Policy, 3M Health Information Systems; Sue Bowman, Senior Director, Coding Policy and Compliance, American Health Information Management Association (AHIMA); Kristi A. Matus, Chief Financial and Administrative Officer, Athena Health; William Jefferson Terry, MD, Mobile Urology Group, testifying on behalf of the American Urological Association (AUA); Carmella Bocchino, Executive Vice President of Clinical Affairs and Strategic Planning, America’s Health Insurance Plans (AHIP); and Dr. John Hughes, Professor of Medicine, Yale University. During the hearing Subcommittee Chairman Joe Pitts (R-PA) characterized the International Classification of Diseases, 9th Revision (ICD-9) code set as an outdated system that does not capture the data needed to track changes in modern medical practice and healthcare, and he noted that the United States currently lags behind most of the rest of the world, which already uses ICD-10. “Many providers and payers, including the Centers for Medicare and Medicaid Services, have already made considerable investments in the ICD-10 transition,” Pitts said, “and any further delay will entail additional costs to keep ICD-9 systems current, to re-train employees, and to prepare, again, for the transition.” More information on the hearing may be found here.
  • On February 11, 2015, the House Energy and Commerce Subcommittee on Oversight and Investigations convened a hearing entitled “Federal Efforts on Mental Health: Why Greater HHS Leadership Is Needed." This hearing was part of the Subcommittee’s examination, ongoing since January 2013, of mental health programs and resources with the aim of ensuring that Federal dollars devoted to mental health are reaching the over 11 million American adults with serious mental illness (SMI) and helping them to obtain the most effective care. In particular, this hearing examined the findings of a recent report of the GAO, “Mental Health: HHS Leadership Needed to Coordinate Federal Efforts Related to Serious Mental Illness,” GAO-15-113. Witnesses for the hearing included Linda T. Kohn, Ph.D., Director, Health Care, U.S. Government Accountability Office; and Richard G. Frank, Ph.D., Assistant Secretary for Planning and Evaluation. More information on the hearing may be found here.
• On February 12th, the House Energy and Commerce Committee advanced six public health bills (see below) by voice vote. More information may be found here.
  • HR 639 — A bill to amend the Controlled Substances Act with respect to drug scheduling recommendations by the Secretary of Health and Human Services, and with respect to registration of manufacturers and distributors seeking to conduct clinical testing.
  • HR 648 — A bill to amend title XII of the Public Health Service Act to reauthorize certain trauma care programs, and for other purposes.
  • HR 647 — A bill to amend title XII of the Public Health Service Act to reauthorize certain trauma care programs, and for other purposes.
  • HR 734 — A bill to amend the Communications Act of 1934 to consolidate the reporting obligations of the Federal Communications Commission in order to improve congressional oversight and reduce reporting burdens.
  • HR 212 — Drinking Water Protection Act
  • HR 471 — Ensuring Patient Access and Effective Drug Enforcement Act
• On February 12, 2015, the House Science, Space, and Technology Committee convened a hearing entitled "Can Americans Trust the Privacy and Security of their Information on HealthCare.gov?" Witnesses for the hearing included Michelle De Mooy, Deputy Director, Consumer Privacy, Center for Democracy and Technology; and Morgan Wright, Principal, Morgan Wright, LLC. More information on the hearing may be found here. 
• On February 12, 2015, the House passed the America’s Small Business Tax Relief Act of 2015 (H.R. 636), which makes permanent a number of tax extenders worth a combined $79.2 billion over ten years. The measure was approved by a vote of 272-142.

III. REPORTS, STUDIES, & ANALYSES

• This week the Government Accountability Office (GAO) released its 2015 update of the “High Risk List”, which calls attention to the agencies and program areas that are high risk due to their vulnerabilities to fraud, waste, abuse, and mismanagement or are most in need of broad reform. This year, GAO added two new risk areas: 1) managing risks and improving Veterans Affairs (VA) healthcare; and 2) improving the management of information technology acquisitions and operations. Medicare has been designated a high-risk program since 1990 (the first year in which the list was published), while Medicaid was added to the list in 2003. The report is published at the beginning of each new Congress.
• On February 11, 2015, the Kaiser Family Foundation released a research brief entitled “Cost-Sharing Subsidies in Federal Marketplace Plans”. For people with low and modest incomes, the ACA provided for reduced cost sharing if enrollees select a plan from the silver tier in the federal or state marketplace. Using data downloaded from the Data.HealthCare.gov 2015 QHP Landscape file, “Health plan information for individuals and families”, researchers analyzed the average cost-sharing amounts for standard silver plans and for the cost-sharing variants for each category of enrollee cost sharing. Researchers observed a general pattern of declining average cost-sharing amounts in each service category as the actuarial value of the variants increases. For example, for plans with a combined deductible for medical and prescription expenses, the average annual deductible amount is $2,559 for standard silver plans, $2,078 for CSR73 plans, $737 for CSR87 plans, and $229 for CSR94 plans. The brief concludes that reduced cost-sharing can meaningfully reduce the financial burden of receiving medical care.
• On February 11, 2015, Avalere released an analysis which finds that some Exchange plans place all drugs used to treat complex diseases (i.e. HIV, cancer, and multiple sclerosis) on the highest drug formulary cost-sharing tier. Specifically, in five of the 20 classes of drugs analyzed, plans placed all drugs in a class on the specialty tier. In the Protease Inhibitor and Multiple Sclerosis Agents classes, 29 and 51 percent of plans respectively place all drugs, including available generics, on the highest tier. Moreover, a subset of plans in each of 10 drug classes placed all single-source branded drugs in a class on a specialty tier. Specifically, in 8 of the 10 classes, 2015 exchange plans were more likely than 2014 plans to assign all single-source branded drugs to the highest cost sharing tier. “Enrolling in a plan that places all medications for a particular disease on the specialty tier can mean significant out-of-pocket costs for consumers, particularly if they do not qualify for cost sharing reductions,” said Caroline Pearson, Vice President at Avalere. “Plans that place some drugs in a class on lower tiers may allow consumers to find lower cost alternatives.” 
• On February 9, 2015, the Urban Institute released an analysis entitled “Characteristics of Those Eligible for Cost-Sharing Reductions and Premium Tax Credits Under the Affordable Care Act”. The ACA created cost-sharing reductions (CSRs) to help people with very modest incomes pay for out-of-pocket costs after selecting a marketplace health plan. This assistance is separate from the tax credits provided to help cover the cost of insurance premiums and is designed to help cover otherwise unaffordable deductibles, co-pays and co-insurance. The authors find that if all those eligible enroll in a plan by 2016, they would save, on average, $479 per year on things like co-pays, deductibles and co-insurance. By 2016, 13.8 million individuals with very modest incomes will be eligible for CSRs if they enroll in a health plan. Of the 13.8 million people eligible for CSRs, the analysis finds, 47.9 percent live in the South; 48.9 percent are single adults without children; and 60.0 percent are White, non-Hispanics.

IV. OTHER HEALTH POLICY NEWS

• On February 9, 2015, the HHS released a report outlining the impact of advanced premium tax credits on premiums in the Health Insurance Marketplaces. According to the Department, almost 6.5 million individuals in the 37 states using the HealthCare.gov platform are estimated to qualify for an average of $268 per person/month in advanced premium tax credits. Among consumers who are signed up for 2015 coverage to date in the 37 HealthCare.gov states, 8 in 10 could choose a plan with a premium of $100 or less after tax credits, based on available options. According to the report, on average, premium tax credits reduced consumers’ monthly premiums by 72 percent. In addition, the average monthly premium for 2015 coverage dropped from $374 before tax credits to $105 after tax credits, among 6.5 million consumers in the 37 state using the HealthCare.gov platform who selected a plan with tax credits. Monday’s report also includes state-by-state figures. This analysis includes plan selections from Nov. 15 through Jan. 30. 
• On February 12, 2015, CMS announced that it will unveil Nursing Home Compare (NHC) 3.0, an expanded NHC 5-Star Quality Rating System for Nursing Homes on the CMS Nursing Home Compare website, on February 20th. CMS announced that it will add two quality measures (QMs) for antipsychotic medication use; raise standards for nursing homes to achieve a high rating on all publicly reported measures; adjust staffing algorithms to more accurately reflect staffing levels; and create a plan for State Survey Agencies to conduct specialized, onsite surveys of a sample of nursing homes across the U.S. that assess adequacy of resident assessments and the accuracy of information reported to CMS that is used in calculating quality measures used in the rating system. “The changes in ratings reflect that CMS raised the bar for performance that should be recognized as high quality and anticipates nursing homes will make quality improvements to achieve these higher standards,” said a CMS statement. “However, the changes in the quality measures star ratings released in February do not necessarily indicate a change in the quality of care provided.” 
• On February 9, 2015, Pennsylvania Governor Tom Wolf (D) announced that the state will pursue a traditional Medicaid expansion under the ACA, and that the Governor would withdraw from federal consideration the “alternative” expansion plan (known as “Healthy PA”) proposed by his Republican predecessor Tom Corbett. “Today is the first step toward simplifying a complicated process and ensuring hundreds of thousands of Pennsylvanians have greater access to the health insurance they need,” said Wolf. “Our approach will alleviate confusion, remove unnecessary red tape, and streamline the system so that people can see a doctor when they are sick and health care professionals have more time to concentrate on providing quality care.” Also of note, the same day the Wyoming Senate rejected a bill that would have expanded Medicaid in the state by a vote of 11 to 19. 
• On February 11, 2015, CMS announced that Hospital Engagement Network funding will be made available—as part of the CMS Partnerships for Patients initiative—to national, regional, or state hospital associations large health care organizations that hold corporate ownership and operational control of a group of hospitals that consist of at least 25 hospitals, or national affinity organizations that will support hospitals in the efforts to reduce preventable hospital acquired conditions and readmissions. “Hospital Engagement Networks are one part of an overall effort to deliver better care, spend dollars more wisely, and improve health through the Affordable Care Act,” CMS writes. “Initiatives like the Partnership for Patients, Accountable Care Organizations, Quality Improvement Organizations, and others have helped reduce hospital readmissions in Medicare by nearly 8 percent between January 2012 and December 2013 – translating into 150,000 fewer readmissions – in addition to quality improvements mentioned above.” More information on the solicitation may be found here.
• On February 10, 2015, the United States Court of Appeals for the Ninth Circuit ruled that St. Luke’s Health System Inc. must divest Saltzer Medical, a large physician group, because the 2012 merger of the two Nampa, Idaho-based entities violated § 7 of the Clayton Act (Saint Alphonsus Med. Ctr.—Nampa Inc. v. St. Luke's Health Sys., Ltd., 9th Cir., No. 14-35173, 2/10/15). Section 7 of the Clayton Act bars mergers whose effect “may be substantially to lessen competition, or to tend to create a monopoly.”