A&B Healthcare Week in Review, July 11, 2014

I. REGULATIONS, NOTICES, & GUIDANCE

• On July 7, 2014, the Food and Drug Administration (FDA) announced an opportunity for the public to comment on a guidance document for industry entitled “Cooperative Manufacturing Arrangements for Licensed Biologics”. The guidance document provides information concerning cooperative manufacturing arrangements applicable to biological products subject to licensure under section 351 of the Public Health Service Act (42 U.S.C. 262). The guidance addresses several types of manufacturing arrangements (i.e., short supply arrangements, divided manufacturing arrangements, shared manufacturing arrangements, and contract manufacturing arrangements) and describes certain reporting and recordkeeping responsibilities, associated with these arrangements, including the following: (1) Notification of all important proposed changes to production and facilities; (2) notification of results of tests and investigations regarding or possibly impacting the product; (3) notification of products manufactured in a contract facility; and (4) standard operating procedures. Comments on these information collection activities are due September 5, 2014.
• On July 7, 2014, FDA announced the availability of a guidance for industry entitled “Neglected Tropical Diseases of the Developing World: Developing Drugs for Treatment or Prevention.” The purpose of the guidance is to assist sponsors in the development of drugs for the treatment or prevention of neglected tropical diseases (NTDs). This guidance represents the FDA's current thinking regarding drug development for the treatment or prevention of NTDs, including clinical trial designs and internal review standards to support approval of drugs. This guidance finalizes the draft guidance issued August 24, 2011. More information may be found here.
• On July 8, 2014, FDA announced that it is reopening the comment period for the notice entitled “Center for Drug Evaluation and Research; Use of Innovative Packaging, Storage, and/or Disposal Systems to Address the Misuse and Abuse of Opioid Analgesics,” published in the Federal Register of April 9, 2014. In the Federal Register of April 9, 2014 (79 FR 19619), FDA announced the establishment of a docket to receive suggestions, recommendations, and comments on innovative packaging, storage and disposal systems, technologies or designs that could be used to prevent or deter misuse and abuse of opioid analgesics by patients and others. In the notice, FDA stated that comments about specific system or technology designs should include a description of the following: (1) Design features and functionality; (2) results of any formative or summative human factors assessments conducted; (3) applications to date, including information on the effectiveness and acceptability of those applications (with literature references or other documentation); (4) recommendations for how the system/technology design could be applied or adapted (either alone and/or in combination with other systems/technologies) to help prevent or deter misuse and abuse, and any limitations of that application; (5) specific problems that could be addressed (e.g., serious complications such as addiction or overdose due to improper dosage and/or administration, improper disposal, accidental use by someone for whom the medication was not prescribed); and (6) to the extent possible, considerations for implementation into routine dispensing and clinical use (e.g., how the solution would impact the workflow in a retail pharmacy). To help FDA prioritize among proposed approaches, the Agency is also interested in receiving feedback about methods that could be used to assess a system or technology's potential abuse-deterrent characteristics and real-world impact (e.g., actual ability to prevent or deter misuse and abuse, effect on access for appropriate patients, patient confidentiality, burden on the healthcare system, feasibility of implementation, whether the design could create unintended medication errors). Finally, FDA is interested in receiving feedback on methods for encouraging further research and development in this area, and, if promising technologies are identified, incentivizing the pharmaceutical industry (e.g. via patent extensions) to adopt such technologies. FDA is reopening the comment period to allow interested persons additional time to submit comments. Comments are now due August 7, 2014.
• On July 8, 2014, FDA’s Office of International Programs (OIP) announced the availability of grant funds for the support of a single source cooperative agreement to the Pan American Health Organization (PAHO) for fostering cooperation and strengthening medical product regulatory systems in the Americas. The goal of the cooperative agreement is to build upon existing cooperation between OIP/FDA and PAHO to foster regulatory collaboration and strengthen regulatory capacity throughout the Americas. The application due date is August 1, 2014, and the anticipated start date is October 1, 2014. More information may be found here.
• On July 8, 2014, the National Institutes of Health (NIH) issued a request for Office of Management and Budget (OMB) approval for the following proposed collection: “Specimen Resource Locator, Existing Collection in Use without OMB Control Number, National Cancer Institute (NCI), National Institutes of Health (NIH).” The National Cancer Institute's (NCI) Cancer Diagnosis Program has developed, and is expanding, a searchable database: Specimen Resource Locator (SRL). The SRL allows scientist in the research community and the NCI to locate specimens needed for their research. The SRL will list all NCI supported repositories and their links. This administrative submission is an on-line form that will collect information to manage and improve a program and its resources for the use of all scientists. This submission does not involve any analysis. Responses are due within 30 days.
• On July 9, 2014, FDA announced a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews. This publication, entitled “Modifications to the List of Recognized Standards, Recognition List Number: 036”, will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
• On July 9, 2014, FDA issued draft guidance for industry entitled “Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products”. The draft guidance document provides sponsors of virus or bacteria-based gene therapy products (VBGT products) and oncolytic viruses or bacteria (oncolytic products) with recommendations on how to conduct shedding studies during preclinical and clinical development. Comments must be received by November 19, 2014 before the Agency begins work on the final version of guidance. More information may be found here.
• On July 9, 2014, FDA issued a notice issued a notice entitled “Certification to Accompany Drug, Biological Product, and Device Applications or Submissions” which announces an opportunity for the public to comment on the requirements for certain FDA applications or submissions to be accompanied by a certification, Form FDA 3674, to ensure all applicable statutory requirements have been met. Comments are due September 8, 2014.
• On July 9, 2014, FDA issued a “Request for Notification From Industry Organizations Interested in Participating in the Selection Process for a Nonvoting Industry Representative and Request for Nominations for Nonvoting Industry Representatives on the Cellular, Tissue, and Gene Therapies Advisory Committee”. FDA is requesting that any industry organizations interested in participating in the selection of a nonvoting industry representative to serve on the Cellular, Tissue, and Gene Therapies Advisory Committee for the Center for Biologics Evaluation and Research notify FDA in writing. FDA is also requesting nominations for a nonvoting industry representative to serve on the Cellular, Tissue, and Gene Therapies Advisory Committee. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current or upcoming vacancies effective with this notice. Submissions are due August 8, 2014.
• On July 9, 2014, the Department of Health and Human Services (HHS) issued a 30 day notice of submission of information collection approval from OMB and a request for comments entitled “Communications Testing for Comprehensive Communication Campaign for HITECH ACT”. The Office of the National Coordinator for Health Information Technology (ONC) is requesting an approval by OMB on an extension, to a previously approved generic clearance titled Communications Testing for Comprehensive Communication Campaign for HITECH ACT, 0955-0005, for collecting information through a variety of research methods for the purpose of developing and testing communications involving health information technology and health information privacy.
• On July 10, 2014, FDA issued a final rule entitled “Tobacco Products, User Fees, Requirements for the Submission of Data Needed To Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products”. The final rule requires domestic tobacco product manufacturers and importers to submit information needed to calculate the amount of user fees assessed under the Federal Food, Drug, and Cosmetic Act. The United States Department of Agriculture (USDA) has been collecting this information and providing FDA with the data FDA needs to calculate the amount of user fees assessed to tobacco product manufacturers and importers. USDA intends to cease collecting this information starting in fiscal year 2015 (October 2014). Consistent with the requirements of the FD&C Act, the final rule requires the submission of this information to FDA instead of USDA. The rule is effective August 11, 2014.
• On July 11, 2014, FDA announced the availability of draft guidance for industry entitled “Abbreviated New Drug Application Submissions; Amendments and Easily Correctable Deficiencies Under the Generic Drug User Fee Amendments”. The guidance document is intended to assist applicants in preparing to submit to FDA amendments to abbreviated new drug applications (ANDAs) or prior approval supplements (PASs) under the Federal Food, Drug, and Cosmetic Act, by explaining how the Generic Drug User Fee Amendments of 2012 (GDUFA) performance metric goals apply to these submissions. When finalized, this guidance will replace the December 2001 guidance for industry entitled “Major, Minor, and Telephone Amendments to Abbreviated New Drug Applications” in consideration of the new amendment review tier system and performance goals under GDUFA. Comments must be received by September 9, 2014 before the Agency begins work on the final version of guidance. More information may be found here.
• On July 11, 2014, FDA announced the availability of draft guidance for industry entitled “Abbreviated New Drug Application Submissions-Prior Approval Supplements Under the Generic Drug User Fee Amendments of 2012”. This draft guidance is intended to assist applicants preparing to submit to FDA prior approval supplements (PASs) and amendments to PASs for abbreviated new drug applications (ANDAs). It describes FDA's performance metric goals for PASs and clarifies how FDA will handle a PAS and amendments to a PAS for an ANDA subject to the GDUFA performance metric goals. Comments must be received by September 9, 2014 before the Agency begins work on the final version of guidance. More information may be found here.
• On July 11, 2014, FDA announced the availability of draft guidance for industry entitled “Reporting Drug Sample Information Under Section 6004 of the Affordable Care Act.” Under the Affordable Care Act (ACA), the Secretary of Health and Human Services has delegated authority to FDA to issue guidance to identify the information to be submitted under section 6004 and oversee and make arrangements for the collection of such information. FDA is issuing this draft guidance to provide information to assist persons submitting drug sample information under ACA section 6004, and to advise industry of an updated compliance policy. This draft guidance revises the draft compliance policy guide issued on April 3, 2012. Comments must be received by October 9, 2014 before the Agency begins work on the final version of guidance. More information may be found here.
• On July 11, 2014, FDA announced that it had submitted to OMB a guidance for industry entitled “Guidance for Industry on Establishing That a Tobacco Product Was Commercially Marketed in the United States as of February 15, 2007”. This guidance provides information on how a manufacturer may establish that a tobacco product was commercially marketed in the United States as of February 15, 2007. Grandfathered tobacco products are not considered new tobacco products and thus are not subject to premarket review. Comments are due August 11, 2014.
• On July 11, 2014, the Centers for Medicare and Medicaid Services (CMS) released the following information collection activities for public comment: 1) Solicitation for Applications for Medicare Prescription Drug Plan 2015 Contracts; 2) Part C—Medicare Advantage and 1876 Cost Plan Expansion Application; 3) Generic Clearance for Medicaid and CHIP State Plan, Waiver, and Program Submissions; and 4) Executive Summary Form for Research Identifiable Data. Comments on these information collection activities are due September 9, 2014. More information may be found here.
• On July 11, 2014, CMS announced that the following information collection activities had been submitted to OMB for review: 1) Reconciliation of State Invoice and Prior Quarter Adjustment Statement; 2) Medicaid Drug Rebate Program Forms; and 3) The Predictive Learning Analytics Tracking Outcome (PLATO TM). Comments are due August 11, 2014. More information may be found here.
• On July 11, 2014, HHS issued a notice informing the public that the Office of Inspector General (OIG) is considering revising the Non-Binding Criteria for Implementing Permissive Exclusion Authority Under Section 1128(b)(7) of the Social Security Act (62 FR 67392, December 24, 1997), and is soliciting input from the public for OIG to consider in developing the revised criteria. In considering possible revisions to the criteria, OIG is soliciting comments, recommendations, and other suggestions from concerned parties on how best to revise the criteria to address relevant issues and to provide useful guidance to the health care industry. The issues OIG is considering include, but are not limited to: (1) Whether there should be differences in the criteria for individuals and entities and (2) whether and how to consider a defendant's existing compliance program. Reponses are due September 9, 2014. More information may be found here.

Event Notices

• August 12-13, 2014: FDA announced a public meeting entitled “2014 Scientific Meeting of the National Antimicrobial Resistance Monitoring System.” The purpose of the meeting is to discuss progress made in achieving the goals of the National Antimicrobial Resistance Monitoring System (NARMS) Strategic Plan: 2012-2016. The meeting will be held August 12th and 13th from 8:00 AM to 5:00 PM at FDA’s White Oak Campus in Silver Spring, Maryland. More information may be found here.
• September 26, 2014: On July 8, 2014, FDA announced a public meeting and an opportunity for public comment on Patient-Focused Drug Development for idiopathic pulmonary fibrosis. 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 idiopathic pulmonary fibrosis on daily life as well as patient views on treatment approaches for idiopathic pulmonary fibrosis. The meeting will take place from 1:00 PM to 5:00 PM on September 26th at FDA’s White Oak Campus in Silver Spring, Maryland; registration must be received by September 10th. More information may be found here.
• September 22, 2014: On July 9, 2014, FDA announced a public meeting and an opportunity for public comment on Patient-Focused Drug Development for Hemophilia A, Hemophilia B, von Willebrand Disease, and Other Heritable Bleeding Disorders. The meeting will be held on September 22, 2014 from 9:00 AM to 5:00 PM at FDA’s White Oak Campus in Silver Spring, Maryland. The public meeting is intended to provide FDA with patients' perspectives on the impact on daily life of Hemophilia A, Hemophilia B, von Willebrand Disease, and other heritable bleeding disorders. FDA also is seeking patients' perspectives on the available therapies for these disorders. More information may be found here.

II. LEGISLATION & COMMITTEE ACTION

U.S. Senate

• On July 9, 2014, Senators Patty Murray (D-WA) and Mark Udall (D-CO) introduced the Protect Women’s Health from Corporate Interference Act in response to last week’s Supreme Court ruling in Burwell v. Hobby Lobby Stores, Inc. The 5-4 ruling held that HHS’ preventive care mandates regarding contraceptive coverage issued under the ACA violate the Religious Freedom Restoration Act (RFRA) when applied to closely held, for-profit corporations that hold sincere religious beliefs against such coverage. The measure would ban employers from refusing to cover any health coverage, including contraceptive coverage, guaranteed to their employees and dependents under federal law, with an exemption for houses of worship and religious non-profits. A bill summary may be found here. In the House, Representatives Diana DeGette (D-CO), Louise Slaughter (D-NY), and Jerrold Nadler (D-NY), introduced companion legislation.
• On July 11, 2014, Senators Chuck Grassley (R-IA) and Ron Wyden (D-OR) announced that they have requested detailed pricing information on a costly new Hepatitis C drug, Sovaldi, from the drug’s manufacturer, Gilead Sciences, Inc. Wyden and Grassley issued a letter to Gilead which states: “Given the impact Sovaldi’s cost will have on Medicare, Medicaid and other federal spending, we need a better understanding of how your company arrived at the price for this drug. In order for a marketplace to function properly, it must be competitive, fair, and transparent. It is unclear how Gilead set the price for Sovaldi. That price appears to be higher than expected given the costs of development and production and the steep discounts offered in other countries. An efficient market needs informed consumers to keep costs down.”

House of Representatives

• On July 9, 2014, the House Energy and Commerce Health Subcommittee held a hearing entitled “21st Century Cures: Modernizing Clinical Trials”. Witnesses for the hearing included Roy S. Herbst, MD, PhD, Chief of Medical Oncology, Yale Cancer Center; Sundeep Khosla, MD, Director Center for Clinical and Translational Science, Mayo Clinic; Jay P. Siegel, MD Chief Biotechnology Office and Head, Scientific Strategy and Policy, Johnson & Johnson; William V. Murray, President and CEO, Medical Device Innovation Consortium; Robert J. Meyer, MD Director, Virginia Center for Translational and Regulatory Sciences (VCTRS), University of Virginia School of Medicine; Paula Brown Stafford, MPH, President, Clinical Development, Quintiles; and Aaron S. Kesselheim, M.D., J.D., M.P.H., Assistant Professor of Medicine at Harvard Medical School, Director, Program on Regulation, Therapeutics, and Law, PORTAL Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital. More information on the hearing may be found here.
• On July 9, 2014, the House Oversight and Government Reform Subcommittee on Government Operations held a hearing entitled “Examining Solutions to Close the $106 Billion Improper Payments Gap”. During the hearing Members and witnesses discussed the rate of improper payments across all government programs, as well as solutions to reduce waste, fraud, and abuse. Witnesses for the hearing included The Honorable John Koskinen, Commissioner, Internal Revenue Service (IRS); Ms. Beth Cobert, Deputy Director for Management, Office of Management and Budget (OMB); Ms. Beryl H. Davis, Director, Financial Management and Assurance, Government Accountability Office (GAO); Dr. Shantanu Agrawal, M.D., Deputy Administrator and Director, Center for Program Integrity (CPI), Center for Medicare and Medicaid Services (CMS), Department of Health and Human Services (HHS); and Mr. Mark Easton, Deputy Chief Financial Officer, Department of Defense (DoD). More information on the hearing may be found here.
• On July 9, 2014, the Senate Special Aging Committee held a hearing entitled “Improving Audits: How We Can Strengthen the Medicare Program for Future Generations”. Witnesses for the hearing included Alan Weil, Editor-in-Chief, Health Affairs; Steve Stang, National Partner-in-Charge, Health Care Assurance Services; Walter Gorski, Principal, Gorski Healthcare Group LLC; Jessica Meeske, Pediatric Dental Specialists of Greater Nebraska and American Dental Association; Diana Haramboure, Senior Vice President and Chief Administrative Office, First Coast Service Options; Margaret Hambleton, Vice President and Corporate Compliance Officer, Dignity Health; Kathleen King, Director of Healthcare at the Government Accountability Office; Chad Janak, Vice President, Audit Operations, Connolly Healthcare; and Mindy Hatton, Senior Vice President and General Counsel, American Hospital Association. The Committee released a report of the same title, which may be accessed here. More information on the hearing may be found here.
• On July 10, 2014, the House Oversight and Government Reform Subcommittee on Energy Policy, Health Care and Entitlements held a hearing entitled “Medicare Mismanagement Part II: Exploring Medicare Appeals Reform”. The sole witness for the hearing was Nancy J Griswold, Chief Administrative Law Judge (ALJ), Office of Medicare Hearings and Appeals (OMHA), US Department of Health and Human Services (HHS). OMHA administers the nationwide Administrative Law Judge hearing program for Medicare claims and entitlement appeals under sections 1869 and 1155 of the Social Security Act. In January of this year, OMHA announced that it had suspended action on new requests for hearings filed by hospitals, nursing homes, and providers. In a memo to appellants detailing the decision, OMHA estimated that the suspension would last approximately two years, but clarified that claims filed directly by beneficiaries would continue to be reviewed. More information on the hearing may be found here.
• On July 11, 2014, the House Energy and Commerce Subcommittee on Health held a hearing entitled “21st Century Cures: Incorporating the Patient Perspective”. The sole witness for Panel I was Dr. Janet Woodcock, MD, Director of the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA). Witnesses for Panel II included Richard F. Pops, Chairman and CEO, Alkermes; Robert J. Beall, Ph.D., President and CEO, Cystic Fibrosis Foundation; Pat Furlong, Founding President and CEO, Parent Project Muscular Dystrophy; Leonard Lichtenfeld, M.D., Deputy Chief Medical Officer, American Cancer Society (ACS); and Marshall Summar, M.D., Director, Scientific Advisory Committee, National Organization for Rare Disorders. More information on the hearing may be found here.

III. REPORTS, STUDIES, & ANALYSES

• On July 10, 2014, the Government Accountability Office (GAO) issued a study entitled “Early Effects of Medical Loss Ratio Requirements and Rebates on Insurers and Enrollees”. GAO was asked to review the effects of the ACA minimum loss ratio (MLR) requirements on insurers and enrollees and how rebates would change if agent and broker payments were excluded from the MLR formula. The ACA established federal MLR standards for the percentage of premiums private insurers must spend on their enrollees' medical care claims and activities to improve health care quality, as opposed to what they spend on administrative (“non-claims”) costs. GAO determined that more than three quarters of insurers met or exceeded the standards in 2011 and in 2012, and the median MLRs among all insurers were 88 percent. The report finds that insurers' MLRs and their spending on claims and non-claims costs varied across different insurance markets. Specifically, insurers in the large group market had higher median MLRs and spent a higher share of their premiums on enrollees' claims and less on non-claims costs, compared to insurers in the individual and small group markets. GAO found that most of the eight insurers it interviewed reported that factors other than the PPACA MLR requirements affected their business practices since 2011. All eight insurers reported that they increased their premium rates since 2011 and that they based these decisions on a variety of factors, such as trends in medical care claims, competition with other insurers, and other requirements. Three of the eight insurers stated that the MLR requirements were one among several factors that influenced their decisions about premium rates.
• The July issue of Health Affairs focuses on “Using Big Data to Transform Care”. Featured abstracts include:
  • Big Data In Health Care: Using Analytics To Identify And Manage High-Risk And High-Cost Patients: Authors present six key examples of clear opportunities to reduce costs through the use of big data: high-cost patients, readmissions, triage, de-compensation, adverse events, and treatment optimization for diseases affecting multiple organ systems. The article discusses the types of insights that are likely to emerge from clinical analytics, the types of data needed to obtain such insights, and the infrastructure—analytics, algorithms, registries, assessment scores, monitoring devices, and so forth—that organizations will need to perform the necessary analyses and to implement changes that will improve care while reducing costs.
  • Implementing Electronic Health Care Predictive Analytics: Considerations And Challenges: This article describes some of the considerations and challenges of implementing electronic health care predictive analytics, including the need to ensure patients’ privacy, establish a health system monitoring team to oversee implementation, incorporate predictive analytics into medical education, and make sure that electronic systems do not replace or crowd out decision making by physicians and patients.
  • Leveraging The Big-Data Revolution: CMS Is Expanding Capabilities To Spur Health System Transformation: Historically, CMS has faced technological challenges in storing, analyzing, and disseminating the data it generates because of its volume and privacy concerns. However, rapid progress in the fields of data architecture, storage, and analysis—the big-data revolution—over the past several years has given CMS the capabilities to use data in new and innovative ways. Authors describe the different types of CMS data being used both internally and externally, and highlight a selection of innovative ways in which big-data techniques are being used to generate actionable information from CMS data more effectively.
• A new Commonwealth Fund survey finds that in the wake of the ACA’s first open enrollment period, significantly fewer working-age adults are uninsured than just before the sign-up period began, and many have used their new coverage to obtain needed care. The results indicate that the uninsured rate for people ages 19 to 64 declined from 20 percent in the July-to-September 2013 period to 15 percent in the April-to-June 2014 period. An estimated 9.5 million fewer adults were uninsured. Young men and women drove a large part of the decline: the uninsured rate for 19-to-34-year-olds declined from 28 percent to 18 percent, with an estimated 5.7 million fewer young adults uninsured. By June, the survey shows, 60 percent of adults with new coverage through the marketplaces or Medicaid reported they had visited a doctor or hospital or filled a prescription; of these, 62 percent said they could not have accessed or afforded this care previously.
• This week the Office of Inspector General (OIG) issued a report entitled “Questionable Billing for Medicare Part B Clinical Laboratory Services”. OIG found that in 2010, over 1,000 labs exceeded the thresholds (i.e., had unusually high billing) for 5 or more measures of questionable billing for Medicare lab services. Almost half of the labs that exceeded the thresholds for five or more measures of questionable billing—compared to 13 percent of all labs—were located in California and Florida, areas known to be vulnerable to Medicare fraud. Some labs that exceeded the thresholds for fewer than five measures also exhibited billing that may warrant further review. OIG found that Medicare allowed $1.7 billion across all labs for claims associated with questionable billing. OIG recommended that CMS: 1) review the labs identified as having questionable billing and take appropriate action, 2) review existing program integrity strategies to determine whether these strategies are effectively identifying program vulnerabilities associated with lab services, and 3) ensure that existing edits prevent claims with invalid and ineligible ordering-physician numbers from being paid. CMS concurred with all recommendations.

IV. OTHER HEALTH POLICY NEWS

• On July 7, 2014, HHS Secretary Sylvia Mathews Burwell announced $83.4 million in ACA funding to support primary care residency programs in 60 Teaching Health Centers across the nation. The Teaching Health Center Program expands residency training in community-based settings. Residents will be trained in family medicine, internal medicine, pediatrics, obstetrics and gynecology, psychiatry, geriatrics, and general dentistry. “The Affordable Care Act supports the training of new primary care physicians through the Teaching Health Center program,” Secretary Burwell said. “Today’s announcement demonstrates the continued growth of this program to help prepare even more physicians to provide primary care in communities across the country.” A list of awards (asterisk indicates new awardees) is available here; more information on the Teaching Health Centers program may be found here.
• On July 7, 2014, the HHS National Coordinator for Health IT (ONC) announced the launch of the EHR Innovations for Improving Hypertension Challenge, a part of the Million Hearts® initiative, which seeks to prevent one million heart attacks and strokes by 2017. The challenge asks healthcare professionals and other caregivers to submit the tools they use to improve patient care to reduce high blood pressure. The deadline for submissions is October 6th, and winners will be announced on October 28th. “We are excited that with this challenge we will be able to share the best practices that many physicians and their teams are using to help patients improve their blood pressure and reduce their risk of heart attack and stroke,” said Janet Wright, MD, executive director of Million Hearts.
• On July 8, 2014, HHS announced the availability of $100 million in ACA funding to support an estimated 150 new health center sites across the country in 2015. More information on the funding opportunity may be found here.
• On July 9, 2014, HHS announced new prospective awardees to test innovative care models through the Health Care Innovation Awards (HCIA), bringing the total amount of funding to approximately $360 million for 39 recipients spanning 27 states and the District of Columbia. The awards range from an expected $2 million to $23.8 million over a three year period, and round out the anticipated recipients for round two of the Health Care Innovation Awards program. Examples include projects to promote better care for persons living with HIV/AIDS, reduce unnecessary use of emergency departments, improve pediatric dental care, promote prevention and management of cardiovascular disorders, and to improve care coordination in rural areas. More information about the program and prospective recipients may be found here.
• On July 11, 2014, HHS announced that Medicaid enrollment continues to show continued growth across the country, particularly in states that expanded their Medicaid programs under the ACA. As of the end of May, 6.7 million more individuals were enrolled in Medicaid or the Children’s Health Insurance Program (CHIP) as compared to the baseline period from July through September 2013, an increase of 11.4 percent. That includes more than 920,000 additional people enrolled in May as compared to April in the 48 states and the District of Columbia that reported data. This month, for the first time, HHS is also reporting separately the total number of children enrolled in Medicaid and CHIP for those states that are reporting the relevant data for each month in 2014. The full report may be found here.

This advisory is published by Alston & Bird LLP’s Health Care practice area to provide a summary of significant developments to our clients and friends. It is intended to be informational and does not constitute legal advice regarding any specific situation. This material may also be considered attorney advertising under court rules of certain jurisdictions.