Health Industry Washington Watch : Washington DC Healthcare Industry Law Firm : Reed Smith : Health Industry Washington Watch : Regulations, Medicare/Medicaid, Governmental Organizations

CMS is hosting a National Provider Call on "ICD-10 Implementation Strategies and Planning” on November 17, 2011. The call will include presentations by representatives from CMS, the American Hospital Association, the American Health Information Management Association, and the Centers for Disease Control and Prevention. The session will address, among other things: general ICD-10 requirements and CMS implementation planning; Coding Clinic for ICD-10/AHA's implementation plans; provider and vendor readiness; public health reporting issues; and Medicare claims processing guidance for implementing ICD-10. Registration is required. 

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President Obama has signed into law H.R. 2005, the Combating Autism Reauthorization Act of 2011, which provides funding for surveillance, education, early detection, intervention, and research related to autism, and operation of the Interagency Autism Coordinating Committee.

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On October 12, 2011, the Senate Special Committee on Aging is holding a hearing entitled “A Time for Solutions: Finding Consensus in the Medicare Reform Debate."  Also on October 12, the Senate Health, Education, Labor and Pensions Committee is holding a hearing on "The State of Chronic Disease Prevention."  On October 13, the House Education and the Workforce Subcommittee on Health is holding a hearing on “Regulations, Costs, and Uncertainty in Employer Provided Health Care."

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On September 20, 2011, the House of Representatives approved H.R. 2005 and H.R. 1852.  H.R. 2005, the Combating Autism Reauthorization Act of 2011, provides funding for surveillance, education, early detection, intervention, and research related to autism, and operation of the Interagency Autism Coordinating Committee.  H.R. 1852, the Children's Hospital GME Support Reauthorization Act, provides support to children’s hospitals for pediatric medical residency programs). The Senate Health, Education, Labor and Pensions Committee approved the Senate versions of these bills earlier in the month (S. 958, the Children’s Hospital GME Support Reauthorization Act of 2011, and S. 1094, the Combating Autism Reauthorization Act).

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On September 7, 2011, the Senate Health, Education, Labor and Pensions (HELP) Committee is scheduled to vote on S. 958, the Children's Hospital GME Support Reauthorization Act, and S.1094, the Combating Autism Reauthorization Act.

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A number of Congressional panels have held hearings on health policy issues this month, and more are scheduled, including the following:

• The House Energy and Commerce Committee has held hearings on: reauthorization of the Prescription Drug User Fee Act (PDUFA); the ACA’s Independent Payment Advisory Board (IPAB), which is charged with helping to contain Medicare costs; and legislation addressing children's hospital graduate medical education (GME) costs (H.R. 1852) and autism research (H.R. 2005). On July 20, the panel will hold a hearing on “FDA Medical Device Regulation: Impact on American Patients, Innovation and Jobs." On July 21, the Committee will hold a legislative hearing to review H.R. 1254, the Synthetic Drug Control Act, H.R. 2405, a bill to reauthorize certain provisions of the Public Health Services Act and the Federal Food, Drug, and Cosmetic Act relating to public health preparedness and countermeasure development; and draft legislation entitled the Enhancing Disease Coordination Activities Act.  
• The House Budget Committee held hearings on the IPAB and the sustainability of the Medicare program.
• The House Oversight and Government Reform Committee held a hearing on "Fulfilling A Legal Duty: Triggering A Medicare Plan From The Administration." 
• The Senate Finance Committee held a hearing on “Governors’ Perspectives on Medicaid.” 
• The Senate Homeland Security and Governmental Affairs Committee held a hearing entitled "Harnessing Technology and Innovation to Cut Waste and Curb Fraud in Federal Health Programs." 
• On July 21, the Senate Special Committee on Aging will hold a hearing on reducing Medicare drug costs.
• On July 21, the Senate Judiciary Committee is scheduled to vote on S. 27, the Preserve Access to Affordable Generics Act.
• On August 3, 2011, the Senate Health, Education, Labor and Pensions Committee is scheduled to vote on S. 958, the Children's Hospital GME Support Reauthorization Act, and S.1094, the Combating Autism Reauthorization Act. 

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On June 29, 2011, the Senate Health, Education, Labor and Pensions Committee is scheduled to vote on S. 958, the Children's Hospital Graduate Medical Education (GME) Support Reauthorization Act.  The panel also will consider S.1094, the Combating Autism Reauthorization Act. 

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A number of Congressional panels have held hearings recently on health policy issues, including: a Senate Judiciary Crime Subcommittee hearing entitled "Responding to the Prescription Drug Epidemic: Strategies for Reducing Abuse, Misuse, Diversion, and Fraud";  House Energy and Commerce hearings on interstate health insurance purchasing and creation of an interoperable public safety network; and a Joint Economic Committee hearing on innovation and job growth in the life sciences industry.  In addition, three hearings are scheduled for June 2: a House Oversight and Government Reform Health Care Subcommittee hearing on "Pathway to FDA Medical Device Approval: Is There a Better Way?"; a House Small Business Healthcare Subcommittee hearing entitled "Not What the Doctor Ordered: Health IT Barriers for Small Medical Practices"; and an Energy and Commerce Health Subcommittee hearing on the “Patient Protection and Affordable Care Act’s Effects on Maintaining Health Coverage and Jobs: A Review of the Health Care Law's Regulatory Burden."

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A number of Congressional panels have held hearings this month on health policy issues, including Senate Health, Education, Labor and Pensions (HELP) Committee hearings entitled “First, Do No Harm: Improving Health Quality and Patient Safety” and "Diverting Non-Urgent Emergency Room Use: Providing Better Care and Lower Costs." Both the House Energy & Commerce Subcommittee on Health and the House Ways and Means Committee have examined reform of the Medicare Sustainable Growth Rate/physician fee schedule formula. In addition, the House Education and the Workforce Committee held a hearing on "Policies and Priorities of the U.S. Department of Health and Human Services." Looking ahead, on May 17, the HELP Committee has scheduled a hearing on “Strengthening Medical and Public Health Preparedness and Response.”

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On April 13, 2011, the House of Representatives approved H.R. 1217, a bill to repeal the ACA’s Prevention and Public Health Fund, which is a discretionary fund for investment in prevention and public health programs. The bill now moves to the Senate, where it is unlikely to be considered. The White House also has issued a statement opposing the bill.

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On April 5, 2011, the House Energy and Commerce Committee approved a series of health policy bills, including H.R. 1217, a bill to repeal the Prevention and Public Health Fund (a discretionary fund for investment in prevention and public health programs); and H.R. 1213, a bill to repeal mandatory funding provided to states to establish American Health Benefit Exchanges under the ACA. The full House is scheduled to vote on H.R. 1217 on April 13, 2011.

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On February 15, 2011, the House Energy and Commerce Health Subcommittee approved a number of health policy bills, including H.R. 358 (relating to coverage of abortion services under the ACA); H.R. 528, the Neglected Infections of Impoverished Americans Act of 2011 (requiring the HHS Secretary to study the epidemiology and impact of neglected parasitic infectious disease associated with poverty); and H.R. 570 (to amend the Dental Emergency Responder Act to enhance the roles of dentists and allied dental personnel in the nation's disaster response framework).  In addition, on February 16, the House Judiciary Committee approved  H.R. 5, the Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2011. The legislation would set conditions for lawsuits arising from health care liability claims, including limits on noneconomic and punitive damages.

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On January 4, 2011, President Obama signed into law S. 3036, the National Alzheimer's Project Act, which establishes a National Alzheimer’s Project within HHS and an advisory council on Alzheimer’s research, care, and services to coordinate related research, health care, and treatment efforts.

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On December 15, 2010, President Obama signed into law H.R. 4994, the “Medicare and Medicaid Extenders Act of 2010.” The new law averts a 25% Medicare physician fee schedule cut previously scheduled to take effect January 1, 2011 under the statutory “sustainable growth rate” formula. The law also continues a variety of expiring Medicare provisions and makes other health policy changes, funded primarily through a change in limits on recoveries of excessive tax credits provided to subsidize insurance premiums under the ACA. A CMS summary of the new law with additional implementation details is available here. In addition, on December 18, the President signed into law the “Red Flag Program Clarification Act of 2010,” which is intended to clarify that health care providers and other non-financial businesses are not subject to the Federal Trade Commission’s (FTC) “Red Flag” identity theft rule simply because they extend credit to patients who do not pay for all services at the time services are received. The President also has signed into law H.R. 2941, to reauthorize and enhance Johanna's Law to increase public awareness and knowledge with respect to gynecologic cancers, and S. 3199, the “Early Hearing Detection and Intervention Act.” More information on these bills is available here. 

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HHS has issued its final “Strategic Framework on Multiple Chronic Conditions.” The initiative is designed to represent a “paradigm shift” from a focus on individual chronic diseases to one that uses a multiple chronic conditions approach. HHS highlights the health care resource implications associated with MCCs, since 66% of the country’s total health care spending goes toward care for the roughly quarter of Americans with MCCs (e.g., arthritis, chronic respiratory conditions, diabetes, heart disease, hypertension, and mental health conditions). The framework provides options for HHS to strengthen coordination of its efforts internally and collaboration with stakeholders externally. The framework has four overarching goals: to provide better tools to caregivers; to maximize the use of proven self-care management and other services by individuals with MCCs; to foster health care and public health system changes to improve the health of individuals with MCCs; and to facilitate research in this area. Each of these goals includes several key objectives and strategies to guide HHS’s efforts.

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On December 2, 2010, HHS released “Healthy People 2020,” which sets forth new 10-year goals and objectives for national health promotion and disease prevention. The document includes a greater focus on identifying, measuring, tracking, and reducing health disparities through a “determinants of health” approach that examines the range of personal, social, economic, and environmental factors that influence health status. New topic areas for 2020 include, among others, genomics, healthcare-associated infections, and health incident preparedness.  HHS also announced a contest for technology application developers to design platform-neutral applications to provide Healthy People stakeholders (e.g., professionals and advocates) with easy access to a comprehensive suite of information resources to maximize their success in achieving Health People objectives. The application deadline is March 7, 2011. 

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The House and Senate have approved S. 3199, the Early Hearing Detection and Intervention Act, and S. 3036, the National Alzheimer's Project Act, clearing the measures for the President. On December 1, 2010, the Senate Health, Education, Labor and Pensions Committee approved, with amendments, H.R. 2941, to reauthorize and enhance Johanna's Law to increase public awareness and knowledge with respect to gynecologic cancers. The Senate version of the bill now must be reconciled with an earlier version of the measure approved by the House in September.

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The HHS Health Information Technology Policy Committee’s Quality Measures Workgroup is seeking comments on clinical quality measures enabled for use within electronic health record systems. The Workgroup has identified “measure concepts” in the areas of Patient and Family Engagement, Clinical Appropriateness/Efficiency, Care Coordination, Patient Safety, and Population and Public Health. The Workgroup now is requesting detailed examples of measures relevant to each measure concept; comments are due December 23, 2010. 

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This post was written by Paul Sheives.

FDA seeks comments on the agency’s draft document, “Strategic Priorities FY 2011–2015.” The documents lists four key strategic priorities: (1) advancing regulatory science and innovation; (2) strengthening the safety and integrity of the global supply chain; (3) strengthening compliance and enforcement activities to support public health; and (4) expanding efforts to meet the needs of special populations. Also listed are four strategic program goals: (1) advancing food safety and nutrition; (2) promoting public health by advancing the safety and effectiveness of medical products; (3) establishing an effective tobacco regulation, prevention, and control program; and (4) managing for organizational excellence and accountability. FDA is accepting written comments on the document until November 1, 2010. 

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The House and Senate have approved the following health policy bills, which now await the President’s signature: H.R. 2923, the Combat Methamphetamine Enhancement Act; S. 1674, the Improving Access to Clinical Trials Act (to provide for an exclusion under the Supplemental Security Income program and Medicaid for compensation of individuals who participate in clinical trials for rare diseases or conditions); and S. 3751, the Stem Cell Therapeutic and Research Reauthorization Act. In addition, the House recently approved the following bills, which still await Senate action: H.R. 3470, Nationally Enhancing the Wellbeing of Babies through Outreach and Research Now (NEWBORN) Act (which would authorize funding for infant mortality pilot programs in areas with high rates of infant mortality); H.R. 5809, the Safe Drug Disposal Act (which would provide for takeback disposal of controlled substances in certain instances); H.R. 5756, the Training and Research for Autism Improvements Nationwide Act; H.R. 3199, the Emergency Medic Transition Act (to provide grants to state emergency medical service departments to provide expedited training of veterans with prior medical training); H.R. 1745, the Family Health Care Accessibility Act (to provide liability protections for volunteer practitioners at health centers); H.R. 5710, the National All Schedules Prescription Electronic Reporting Reauthorization Act; H.R. 6012, to direct the HHS Secretary to review utilization of diabetes screening benefits and establish a related outreach program; H.R. 1362, the National MS and Parkinson's Disease Registries Act; H.R. 1995, the Diabetes in Minority Populations Evaluation Act; H.R. 5986, the Neglected Infections of Impoverished Americans Act; H.R. 758, the Pediatric Research Consortia Establishment Act; H.R. 5354, the Gestational Diabetes Act; H.R. 1347, the Concussion Treatment and Care Tools Act; H.R. 2408, the Scleroderma Research and Awareness Act; H.R. 2818, the Methamphetamine Education, Treatment, and Hope Act; H.R. 1032, the Heart Disease Education, Analysis Research, and Treatment for Women Act; H.R. 1230, the Acquired Bone Marrow Failure Disease Research and Treatment Act; H.R. 2941, to reauthorize and enhance Johanna’s Law to increase public awareness and knowledge with respect to gynecologic cancers; H.R. 5462, the Birth Defects Prevention, Risk Reduction, and Awareness Act; and H.R. 1210, the Arthritis Prevention, Control, and Cure Act. Note that Congress has adjourned until November 15, 2010 (after the mid-term elections).

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Congressional panels have held several health policy hearings recently, including the following: 

• A House Science and Technology Subcommittee on Technology and Innovation Committee hearing on "Standards for Health IT: Meaningful Use and Beyond"; 
• A House Energy and Commerce Subcommittee on Health hearing on “Cutting Waste, Fraud, and Abuse in Medicare and Medicaid”; 
• A House Veterans Affairs Subcommittee hearing on “Veterans Health Administration Contracting and Procurement Practices”; 
• A Senate Appropriations Committee hearing on "Defending Against Public Health Threats"; and 
• A House Oversight and Government Reform Committee hearing entitled "From Molecules to Minds: The Future of Neuroscience Research and Development."

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On September 16, 2010, the House Energy and Commerce Subcommittee on Health approved with amendments the following bills: H.R. 758, the Pediatric Research Consortia Establishment Act; H.R. 1032, the Heart Disease Education, Analysis Research, and Treatment for Women Act; H.R. 1210, the Arthritis Prevention, Control, and Cure Act of 2009; H.R. 1230, the Bone Marrow Failure Disease Research and Treatment Act of 2009; H.R. 1347, the Concussion Treatment and Care Tools Act of 2009; H.R. 1362, the National MS and Parkinson's Disease Registries Act; H.R. 1995, the Eliminating Disparities in Diabetes Prevention Access and Care Act of 2009; H.R. 2408, the Scleroderma Research and Awareness Act; H.R. 2818, the Methamphetamine Education, Treatment, and Hope Act of 2009; H.R. 2941, Johanna’s Law Reauthorization (to educate women and healthcare providers about gynecologic cancers); H.R. 2999, the Veterinary Public Health Workforce and Education Act; H.R. 5354, the Gestational Diabetes Act of 2009; H.R. 5462, the Birth Defects Prevention, Risk Reduction, and Awareness Act of 2010; H.R. 5986, the Neglected Infections of Impoverished Americans Act of 2010; H.R. 6012, To direct the HHS Secretary to review uptake and utilization of diabetes screening benefits and establish an outreach program with respect to such benefits, and for other purpose; H.R. 6081, the Stem Cell Therapeutic and Research Reauthorization Act of 2010; and H.R. 6109, the Health Data Collection Improvement Act. The legislation now awaits full Committee consideration.

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On May 20, 2010, HHS published a proposed rule to amend the Department’s regulations regarding the responsibility of applicants to promote objectivity in research for which Public Health Service (PHS) funding is sought. The proposed revisions are intended to expand and add transparency to investigator disclosure of significant financial interests and enhance regulatory compliance and effective institutional oversight and management of investigators’ financial conflicts of interests. HHS is proposing these changes in light of the increasingly complex interactions among the government, research institutions, and private sector entities involved with biomedical and behavioral research. HHS will accept comments on the proposed rule until July 20, 2010.

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HHS has published a notice announcing the availability of an interagency working group draft “Strategic Framework on Multiple Chronic Conditions (MCCs).” The draft plan addresses approaches to improving the health of individuals with concurrent multiple chronic conditions (e.g., arthritis, chronic respiratory conditions, diabetes, heart disease, hypertension, and mental health conditions) by providing options for HHS to strengthen coordination of its efforts internally and collaboration with stakeholders externally. The framework has four overarching goals: to provide better tools to caregivers; to maximize the use of proven self-care management and other services by individuals with MCCs; to foster health care and public health system changes to improve the health of individuals with MCC; and to facilitate research in this area. Each of these goals includes several key objectives and strategies to guide HHS’s efforts. HHS is accepting stakeholder comments on the draft framework until June 18, 2010.

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A number of recent Congressional hearings focused on health policy issues, including the following:

• A Senate Homeland Security and Governmental Affairs Committee hearing on CMS contract management.
• A Senate Aging Committee hearing on “Aging in Place: The National Broadband Plan and Bringing Health Care Technology Home.”
• A Senate Health Education Labor and Pensions Committee hearing on “Protection from Unjustified Premiums.”
• A House Appropriations Subcommittee on Agriculture, Rural Development, FDA, and Related Agencies hearing on drug safety.
• A House Energy and Commerce Health Subcommittee on "Antibiotic Resistance and the Threat to Public Health."

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