Enforcement of HITECH Business Associate Requirement

The HHS Office of Civil Rights (OCR) has indicated that the agency will be delaying enforcement of the HITECH Act provisions under which Business Associates are required to directly comply with the HIPAA Privacy and Security Rules.  Although the statutory compliance date for the Business Associate requirement is February 17, 2010, Adam Greene, an OCR attorney, "unofficially" indicated in a recent speech that HHS will be exercising its enforcement discretion to not enforce the new provision until after a proposed and final rule on this subject have been promulgated.

HHS Announces Relief for State Part D Drug Cost Expenses

On February 18, 2010, the Department of Health and Human Services (HHS) announced that it will be providing states with an additional $4.3 billion in federal funding to offset the cost of Medicare Part D prescription drug coverage for individuals eligible for both Medicare and Medicaid. The increased aid results from HHS applying the temporary enhanced Federal Medical Assistance Percentage (FMAP) payments authorized by the American Recovery and Reinvestment Act (ARRA) to state “clawback” payments (state payments designed to offset the added expense to Medicare Part D for assuming drug costs for dual eligibles). The temporary adjustment in the clawback payments will apply for the period of October 1, 2008 through December 31, 2010. 

Entities Reporting Breaches of Protected Health Information

The Health Information Technology for Economic and Clinical Health (HITECH) Act, enacted as part of the ARRA, requires covered entities to report to HHS within 60 days of discovery any breaches of protected health information that affect 500 or more individuals. The HHS Office for Civil Rights (OCR) has posted a list of covered entities that have reported such breaches of protected health information, and OCR will continue to update the list as it receives new reports. 

Report on the National Summit on Health Care Fraud

On January 28, 2010, Reed Smith Partner Elizabeth Carder-Thompson, in her capacity as president of the American Health Lawyers Association, attended the National Summit on Health Care Fraud, sponsored by the U.S. Department of Health and Human Services and the U.S. Department of Justice. Ms. Carder-Thompson’s observations on the summit are available on our sister blog, Life Sciences Legal Update

Report on the National Summit on Health Care Fraud

On January 28, 2010, Reed Smith Partner Elizabeth Carder-Thompson, in her capacity as president of the American Health Lawyers Association, attended the National Summit on Health Care Fraud, sponsored by the U.S. Department of Health and Human Services and the U.S. Department of Justice. Ms. Carder-Thompson’s observations on the summit are available on our sister blog, Life Sciences Legal Update.

HHS/DOJ Convene National Summit on Health Care Fraud

On January 28, 2010, HHS Secretary Sebelius and Attorney General Eric Holder are hosting a “National Summit on Health Care Fraud” to discuss innovative ways to eliminate health care fraud, waste, and abuse. The summit, an invitation-only event featuring public and private-sector representatives, is an outgrowth of the Administration’s Health Care Fraud Prevention & Enforcement Action Team (HEAT), announced in May 2009.  At the event, HHS is announcing that the President's proposed FY 2011 budget will include "historic support for anti-fraud efforts."

HHS Resources on State Health IT Laws

HHS has released a number of reports regarding state health information law, business practices, and policy variations.  Specifically, the following materials have been posted:  Report on State Medical Record Access Laws; Report on State Law Requirements for Patient Permission to Disclose Health Information; Releasing Clinical Laboratory Test Results: Report on Survey of State Laws; Report on State Prescribing Laws: Implications for E-Prescribing; and Perspectives on Patient Matching: Approaches, Findings, and Challenges. 

HHS Releases National Health Security Strategy

On January 7, 2010, HHS released the National Health Security Strategy, which sets priorities for government and private activities designed to protect the population’s health during a large-scale emergency, such as bioterrorism, pandemics, and natural disasters. The strategy and accompanying interim implementation guide outline 10 objectives to achieve health security, including goals in such areas as communications, workforce development, integrated health care delivery systems, and access to medical countermeasures.

Expanded Medicare Strike Force Activities

On December 15, 2009, HHS announced the latest expansion of the Medicare Fraud Strike Force, a multi-agency team of federal, state and local officials working to combat Medicare fraud through the use of data analysis techniques and an increased focus on community policing. The Strike Force is now operating in Brooklyn, Tampa and Baton Rouge, joining other teams in Miami, Los Angeles, Detroit, and Houston. Since its inception, the Strike Force has obtained more than 460 indictments for Medicare fraud involving a total of more than $1 billion in claims.

Use of Technology by Laboratories a Focus of Meaningful Use for Ambulatory Providers

This post was written by Jacqueline Penrod.

The Information Exchange (IE) Workgroup, in a presentation delivered at the December 15, 2009 meeting of the HIT Policy Committee, reported electronic lab ordering and results delivery to be “key elements” of meaningful use, noting that electronic lab results delivery, along with electronic prescribing, will be a “pillar” of the 2011 meaningful use requirements for ambulatory providers. The IE Workgroup reported that widely-varying interpretation of legal requirements “across states and lab sources,” a lack of requirements for messaging and vocabulary standards, and the absence of an ability to monitor and enforce present standards are systemic regulatory issues that must be overcome. To help remedy these challenges, the IE workgroup suggested that CLIA regulatory changes or interpretive guidance, HIT system certification and meaningful use incentives and requirements, and contracting requirements with Health Information Exchanges are potential policy “levers” to encourage increased use of electronic data by these providers.

 

HIT Meaningful Use Workgroup Approximates 2010 Timeline

This post was written by Jacqueline Penrod.

At a meeting of the Health Information Technology (HIT) Policy Committee on December 15, 2009, the Meaningful Use Workgroup provided an update of the approximate timeline for the development of meaningful use criteria. The workgroup intends to conduct informational hearings to inform criteria development for 2013 during the first quarter of 2010 and to refine meaningful use criteria for 2013 during the second and third quarters of the year. Informational hearings addressing barriers and opportunities for the development of HIT at the state level and patient and family engagement will be scheduled for January and February 2010.

Restructuring of the Office of the National Coordinator for HIT

This post was written by Jacqueline Penrod.

Effective December 1, 2009, the Office of the National Coordinator for Health Information Technology reorganized its substructure to “more effectively meet the mission outlined by the Health Information Technology for Economic and Clinical Health (“HITECH”) Act.” The new structure will include five offices, each of which will directly report to the National Coordinator for Health Information Technology. They include: (i) the Office of Economic Modeling and Analysis; (ii) the Office of the Chief Scientist; (iii) the Office of the Deputy National Coordinator for Programs & Policy; (iv) the Office of the Deputy National Coordinator for Operations; and (v) the Office of the Chief Privacy Officer.  

AHRQ Review of Impact of Payment Policy on Clinical Trials

The Agency for Healthcare Research and Quality (AHRQ) has released a "Horizon Scan" entitled "To What Extent do Changes in Third-Party Payment Affect Clinical Trials and the Evidence Base?" The analysis examines the extent to which payment policies may be influencing clinical trial participant recruitment, participation, and retention rates   The report found that several large-scale clinical trials have encountered substantial difficulties due to the deterrent effect of payment policy on participation, with a bigger impact on medical device trials than drug trial. The report called for better coordination among all parties involved in trials, including a strategy covering which costs will be covered and which party will be responsible for such costs.

Off-Label Cancer Therapies

The Agency for Healthcare Research and Quality (AHRQ) has released for public comment its draft Technology Assessment, "Report on the Evidence Regarding Off-Label Indications for Targeted Therapies used in Cancer Treatment." The document reviews the medical literature regarding 19 different drug/diseases indications that, at the time of their selection, were all off-label. The report concludes that for "some diseases, despite limited and/or ambiguous data, the use of an off-label indication may be a reasonable clinical decision." The report suggests additional research in this area.  Comments will be accepted until November 16, 2009 (extended from initial November 9 deadline). 

Comment Opportunity on Health IT/Consumer Preferences Draft Requirements Document

The HHS Office of the National Coordinator (ONC) for Health Information Technology (HIT) has released its Consumer Preferences Draft Requirements Document for public comment. The document is designed to help the HIT Standards Panel identify, harmonize, and facilitate the development of standards that address consumer preferences regarding the use and management of their associated health information. Comments will be accepted until October 16, 2009.

Comparative Effectiveness Grant Opportunity

The Agency for Healthcare Research and Quality (AHRQ) Effective Health Care Program is soliciting applications for a total of $100 million in Recovery Act funding for AHRQ Clinical and Health Outcomes Initiative in Comparative Effectiveness Grants. The purpose of the grants is to conduct large projects in comparative effectiveness aimed at generating new knowledge to help inform decision making in priority areas of clinical care. Research priorities highlighted in the funding announcement include: arthritis and non-traumatic joint disorders; cancer; cardiovascular disease; dementia; depression and other mental health disorders; developmental delays, attention-deficit hyperactivity disorder and autism; diabetes mellitus; functional limitations and disability; infectious diseases including HIV/AIDS; obesity; peptic ulcer disease and dyspepsia; pregnancy including pre-term birth; pulmonary disease/asthma; and substance abuse. Letters of intent are due November 18, 2009.  

White House Announces Patient Safety and Medical Liability Reform Demonstration

To follow up on President Obama's pledge during his joint session of Congress on health reform, the White House has announced a $25 million HHS demonstration project designed to help states and health care systems improve patient safety and the management of medical liability claims. The three-part initiative will support: (1) competitive grants to states and health systems for implementation and evaluation of evidence-based patient safety and medical liability demonstrations; (2) planning grants and technical assistance; and (3) a rapid review of successful patient safety/medical liability reform initiatives, which will be used to evaluate grant submissions.

Updating Comparative Effectiveness Reviews

The Agency for Healthcare Research and Quality (AHRQ) Effective Health Care Program has issued two reports that examine when AHRQ should update comparative effectiveness reviews (CERs). The first document is a draft research review on "Updating Comparative Effectiveness Reviews". This guidance sets forth a framework for identifying new evidence or evidence not considered in a previous CER, how the update process will be used, and how new data will be incorporated. Comments will be accepted until October 19, 2009. The second document is a final report entitled "Assessment of the Need to Update Comparative Effectiveness Reviews: Report of an Initial Rapid Program Assessment (2005-2009)." This document assesses whether previous CERs need to be updated and prioritizes those CERs for review.

Electronic Health Record Grants

On August 20, 2009, the White House announced it was making almost $1.2 billion in ARRA grant funding available to help hospitals and other providers implement and use electronic health records. Specifically, grants totaling $598 million will be used to establish approximately 70 Health Information Technology Regional Extension Centers to provide technical assistance regarding the selection, acquisition, implementation, and meaningful use of certified electronic health record systems. In addition, a total of $564 million in grants will be made to states and qualified state designated entities to develop or align the policies, procedures, and network systems to assist electronic information exchange within and across states.  

AHRQ Seeks Comments on Patient Registry Guidance

The Agency for Healthcare Research and Quality (AHRQ) is seeking public comment on a series of white papers to support its ongoing project on “Registries for Evaluating Patient Outcomes.”  The white papers, which address interfacing registries with electronic health records, stopping a registry, data linkage, and the use of registries in product safety assessment, eventually will be incorporated into a registries handbook. The public comment period ends on September 15, 2009.

** Note:  The comment period subsequently was extended until September 29, 2009.

NIH Stem Cell Research Guidelines

On July 7, 2009, the National Institutes of Health (NIH) published a notice its final Guidelines for Human Stem Cell Research.” The guidelines, which implement President Obama’s March 9, 2009 Executive Order on federal funding for stem cell research as it pertains to extramural NIH-funded stem cell research, establish policy and procedures under which the NIH will fund such research, and seek to ensure that NIH-funded stem-cell research “is ethically responsible, scientifically worthy, and conducted in accordance with applicable law.” The guidelines are effective July 7, 2009.

AHRQ Issues State-by-State Quality Data

The Agency for Healthcare Research and Quality (AHRQ) has released its annual report on state quality of care, based on data from the 2008 National Healthcare Quality Report. The 2008 “State Snapshots” summarize health care quality by: (1) type of care (preventive, acute and chronic care); (2) setting of care (hospitals, ambulatory, nursing homes and home health care); and (3) clinical areas (cancer, diabetes, heart disease, maternal and child health and respiratory disease). This year the report also includes information regarding the following special focus areas: diabetes, asthma, Healthy People 2010, clinical preventive services, and health disparities. As in previous years, the 2008 report found that no state does well or poorly on all quality measures.

AHRQ Off-Label Drug Use Report

The AHRQ Effective Healthcare Program has released a final research report on "Developing Evidence-Based Research Priorities for Off-Label Drug Use." The report finds that more than 20% of outpatient prescriptions are for off-label use and identifies 14 top-priority drugs that are commonly used for off-label indications with inadequate supporting evidence. The report recommends that future research into off-label drug use focus on drugs used frequently without such evidence, particularly if further concerns are raised by known safety issues, high drug cost, recent market entry, and extensive marketing. Additional research is especially needed in the area of antipsychotic and antidepressant medication. Top priority drugs were quetiapine, warfarin, escitalopram, risperidone, montelukast, bupropion, sertraline, venlafaxine, celecoxib, lisinopril, duloxetine, trazodone, olanzapine, and epoetin alfa.

Clinical Trial Technology Assessment

On June 25, 2009, the Agency for Healthcare Research and Quality's (AHRQ) Technology Assessment Program will be releasing a draft technology assessment on “Use of Bayesian Techniques in Randomized Clinical Trials: A CMS Case Study.” Comments on the draft will be accepted until July 10, 2009.

*** Update:  Comment period extended until July 17.

"Meaningful Use" of Electronic Health Records -- Comments Due June 26, 2009

On June 16, 2009, the federal Health Information Technology (HIT) Policy Committee met to begin defining what constitutes "meaningful use" of electronic health records (EHRs) under the American Recovery and Reinvestment Act, which authorizes Medicare and Medicaid incentive payments to eligible health care providers who demonstrate "meaningful use" of a certified EHR.  At the June 16, 2009 meeting, the Committee received recommendations from its Meaningful Use Workgroup on the definition of meaningful use, and the Committee is accepting comments on the Workgroup’s update until June 26, 2009. The Centers for Medicare & Medicaid Services (CMS) expects to issue a proposed rule later this year on the incentive program and the definition of meaningful use, and the public will have another opportunity to comment at that time.

Health Information Technology Extension Program - Comments on Draft Plan Due June 11, 2009

On May 28, 2009, the HHS Office of the National Coordinator for Health Information Technology (ONC) published a notice announcing a draft description of a program establishing regional extension centers to assist providers seeking to adopt and become meaningful users of health information technology, as required under the American Recovery and Reinvestment Act of 2009 (ARRA). While actual ARRA funding awarded per center Is expected to vary based on the number and types of providers proposed to be served and the amount of matching funds proposed by each regional center, the ONC anticipates an average award value on the order of $1 million to $2 million per center, with a maximum award of $10 million. Comments on the draft plan will be accepted until June 11, 2009.

HHS/DOJ Health Fraud Initiative

On May 20, 2009, Attorney General Holder and HHS Secretary Sebelius announced the creation of a new interagency effort, the Health Care Fraud Prevention and Enforcement Action Team (HEAT), to combat Medicare fraud. The HEAT team will include senior officials from Department of Justice (DOJ) and HHS who will build upon existing programs to combat fraud while investing new resources and technology to prevent fraud, waste, and abuse. Strike Force team operations also are being expanded to Detroit and Houston to fight Medicare fraud on a targeted, local basis. Other initiatives include: increasing Medicare provider compliance training; improving data sharing between CMS and law enforcement; and strengthening Medicare Advantage and Medicare Part D program integrity activities.  

HHS ARRA Implementation Plans Released

HHS has released a series of American Recovery and Reinvestment Act (ARRA) Implementation Plans, detailing how the department is addressing key aspects of the legislation. Specifically, the plans highlight the following areas: Improving and Preserving Health Care (including increases in the Medicaid Federal Medical Assistance Percentage); Accelerating the Adoption of Health Information Technology; Strengthening Scientific Research and Facilities; Improving Children and Community Services; Strengthening Community Healthcare Services; Supporting Comparative Effectiveness Research; Promoting Prevention and Wellness; and Improving Accountability and Information Technology Security. The updates include funding tables and discussions of objectives and planned activities, among other features.

Additional Details Released on Obama Budget Proposal

On May 7, 2009, the Obama Administration released its additional details on its proposed federal budget for fiscal year (FY) 2010, the outlines of which were unveiled in February 2009. Overall, the proposed budget would provide a total of $879 billion for the Department of Health and Human Services (HHS) in FY 2010, an estimated $63 billion increase over FY 2009. The Administration continues to advocate the establishment of a $635 billion reserve fund over 10 years to finance health reform, funded by Medicare and Medicaid savings in addition to new revenues. To strengthen Medicare's long-term sustainability, the budget seeks to align incentives toward quality, promote efficiency and accountability, and encourage shared responsibility. Key area for health program reforms include Medicare Advantage payments, hospital payments (including bundling payments to hospitals and certain post-acute providers for services provided within 30 days after discharge from the hospital, reduced payments for certain hospital readmissions, hospital pay-for-performance provisions, and restrictions on specialty hospitals), physician payments, imaging services, home health payments, Medicaid drug prices, among many others. In other areas, the budget stresses improvements in health quality and access to health care, increased funding for Medicare integrity and public health safety efforts.

HHS Report on Rural Health Care

On May 4, 2009, HHS released a report entitled Hard Times in the Heartland: Health Care in Rural America.” The report focuses on health care challenges facing rural communities, including high relative out-of-pocket health costs and fewer primary care physicians and specialists per resident. HHS argues that health reform is needed to bring affordable, high quality health care to rural areas.

HHS Emergency Care Coordination Center

HHS has established the Emergency Care Coordination Center (ECCC) to support the US government’s coordination of in-hospital emergency medical care activities and to improve the delivery of daily emergency medical care and emergency behavioral health care. ECCC activities will include promotion of clinical and systems-based emergency medical care research, and the development of government-stakeholder partnerships to translate validated, evidence-based research into daily clinical practice. 

HHS Report on Need for Health Reform

On March 30, 2009, HHS released a report entitled The Costs of Inaction,” which cites the high cost of health care, diminished access to care, and persistent gaps in health care quality as reasons to pass health reform legislation this year. Highlights of the report include the following:

  • The U.S. spent approximately $2.2 trillion on health care in 2007, or $7,421 per person, totaling 16.2% of gross domestic product (GDP).
  • Health care costs doubled from 1996 to 2006, and are projected to rise to 25% of GDP in 2025 and 49 percent in 2082.
  • An estimated 87 million people were uninsured at some point in 2007 and 2008. More than 80% of the uninsured are in working families.
  • Up to 98,000 Americans die each year as a result of medical errors.

Gene Patents & Licensing Practices

The HHS Secretary's Advisory Committee on Genetics, Health, and Society has published a notice soliciting comments on a draft report on “Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests.'' Comments will be accepted until May 15, 2009; comment submission information is available here.

Federal Coordinating Council for Comparative Effectiveness Research

On March 19, 2009, HHS announced the members of the Federal Coordinating Council for Comparative Effectiveness Research. The Council was authorized by the American Recovery and Reinvestment Act (ARRA) as part of a major expansion of federal efforts to compare the effectiveness of different medical treatments, including both infrastructure changes and an infusion of $1 billion in funding for comparative effectiveness research. The Council is charged with helping to coordinate and guide investments in comparative effectiveness research, advising the President and Congress on federal comparative effectiveness research infrastructure needs, and reviewing federal agency organizational expenditures for comparative effectiveness research. The Council must report to the President and Congress by June 30, 2009 on current federal comparative effectiveness research and recommendations for research conducted under ARRA funding. The members of the Council are as follows:

  • Anne Haddix, chief policy officer, Office of Strategy and Innovation, Centers for Disease Control and Prevention;
  • Thomas Valuck, Medical Officer and Senior Adviser, CMS Center for Medicare Management;
  • Peter Delany, Director, Office of Applied Studies, Substance Abuse and Mental Health Services Administration;
  • Carolyn Clancy, Director, Agency for Healthcare Research and Quality;
  • Deborah Parham Hopson, Associate Administrator, HIV/AIDS Bureau, Health Resources and Services Administration;
  • David Hunt, Chief Medical Officer, Office of the National Coordinator for Health Information Technology;
  • James Scanlon, Acting Assistant Secretary for Planning and Evaluation, HHS;
  • Elizabeth Nabel, Director, National Heart, Lung, and Blood Institute, National Institutes of Health;
  • Garth Graham, Deputy Assistant Secretary for Minority Health, Office of Minority Health, HHS;
  • Jesse Goodman, Acting Chief Medical Officer, Food and Drug Administration, and Director, FDA Center for Biologics Evaluation and Research;
  • Michael Marge, Acting Director, Office on Disability, HHS;
  • Neera Tanden, Counselor, Office of the Secretary, HHS;
  • Joel Kupersmith, Chief Research and Development Officer, Department of Veterans Affairs;
  • Michael Kilpatrick, Director of Strategic Communications for the Military Health System, Department of Defense; and
  • Ezekiel Emanuel, Special Advisor for Health Policy, Office of Management and Budget

In a related development, the Institute of Medicine is accepting public comments on priorities for comparative effectiveness research under the ARRA.  Stakeholders can submit answers to a questionnaire through March 27, 2009.

 

National Health IT Coordinator Named

On March 20, 2009, HHS announced the selection of David Blumenthal, M.D., M.P.P. as the Obama Administration's choice for National Coordinator for Health Information Technology. As the National Coordinator, Dr. Blumenthal will lead the implementation of a nationwide interoperable, privacy-protected health information technology infrastructure, as called for in the American Recovery and Reinvestment Act. Dr. Blumenthal most recently served as a physician and director of the Institute for Health Policy at the Massachusetts General Hospital/Partners HealthCare System in Boston.


 

Provider Conscience Rights Rule Blocked

On March 10, 2009, HHS proposed to rescind a controversial Bush Administration rule issued December 19, 2009 that implements and enforces certain federal nondiscrimination statutes protecting the conscience rights of health care providers and other entities. The Obama Administration is reviewing this rule to ensure its consistency with current Administration policy and to reevaluate the necessity for regulations in this area. Comments on the notice will be accepted until April 9, 2009. 

No Delay in HIPAA Code Set/Standard Rules

The Obama Administration has been reviewing regulations issued late in the Bush Administration, including HHS final rules published January 16, 2009 that mandate the use of updated diagnosis and procedure codes (the ICD-10-CM rule) and updated standards for electronic health care and pharmacy transactions under the Health Insurance Portability and Accountability Act of 1996 (HIPAA). The Administration has decided not to delay implementation of these final rules or reopen the rules for comment.

HHS Office of Recovery Act Coordination

HHS has announced the creation of the Office of Recovery Act Coordination to help ensure the timely and transparent distribution of an estimated $137 billion in American Recovery and Reinvestment Act (ARRA) funds managed by HHS. Dennis Williams will lead the new office and serve as the HHS Deputy Assistant Secretary for Recovery Act Coordination. As of March 11, 2009, HHS has distributed $3 billion in ARRA funds to support a variety of policies and programs, including community health centers and state Medicaid programs. In a related development, NIH has announced the availability of $1.5 billion in ARRA grants to fund scientific research, construction and improvement of research facilities, and the purchase of scientific equipment. 

HIT Standards Committee and HIT Policy Committee Nominations (Due March 16, 2009)

On March 12, 2009, HHS published a notice soliciting nominations of members for the HIT Standards Committee and HIT Policy Committee, both of which are established by the American Recovery and Reinvestment Act of 2009.  The HIT Standards Committee is charged with making recommendations to the National Coordinator for Health Information Technology on standards, implementation specifications, and certification criteria for the electronic exchange and use of health information for purposes of health information technology adoption.  The HIT Policy Committee makes recommendations to the National Coordinator on the implementation of a nationwide health information technology infrastructure. Nominations for both committees are due by March 16, 2009.

HHS Report on Medical Identity Theft

HHS has issued a report on medical identity theft, which includes a discussion of policy and technical approaches to the prevention, detection, and remediation of medical identity theft. 

AHRQ Web Site for Medical Therapeutics Information

The Agency for Healthcare Research and Quality's Centers for Education and Research on Therapeutics (CERTs) has launched a new educational web site offering clinicians and consumers expert information on drugs, biological products, and medical devices from a federally-sponsored network of leading research centers. The Clinician-Consumer Health Advisory Information Network (CHAIN) also provides access to informational resources developed from research conducted by CERTS and intended for use in improving health care quality, safety, and effectiveness.

AHRQ Study of Impact of Third-Party Payment on Clinical Trials

On January 9, the Agency for Healthcare Research and Quality's (AHRQ) Technology Assessment Program posted for review a draft technology assessment entitled “Horizon Scan: To What Extent Do Changes in Third-Party Payment Affect Clinical Trials and the Evidence Base?”  Comments will be accepted until January 23, 2009.

Healthcare Associated Infections Action Plan

The Department of Health and Human Services (HHS) has released its “Action Plan to Prevent Healthcare-Associated Infections,” which establishes a set of five-year national prevention targets to reduce health care-associated infections (HAIs). 

HIPAA Privacy Rule and the Electronic Exchange of Health Information

On December 15, 2008, the HHS Office for Civil Rights announced new guidance on how the HIPAA Privacy Rule can facilitate electronic health information exchange in a networked environment. In addition, the guidance addresses electronic access by an individual to his or her protected health information and how the Privacy Rule may apply to the use of personal health records.  

Discontinuation of Human Subject Participation in Research.

On December 1, 2008, the HHS Office for Human Research Protections (OHRP), Office of Public Health and Science, announced it is requesting public comments on a draft guidance document entitled “Guidance on Important Considerations for When Participation of Human Subjects in Research is Discontinued.” The draft document is intended primarily for institutional review boards (IRBs), investigators, and funding agencies that may be responsible for the review or oversight of human subject research conducted or supported by HHS. OHRP will accept comments on the draft until January 30, 2009. In a related development, the FDA released guidance on “Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials,” which clarifies FDA's position that it is critical that data be retained from trial participants who decide to discontinue participation in a clinical study of an investigational product, who are withdrawn by their legally authorized representative, as applicable, or who were discontinued from participation by the clinical investigator. This Level 1 guidance is being issued for immediate implementation to prevent the potential loss of important clinical trial data.; if comments are received, the agency will review the comments and revise the guidance if appropriate. 

Guidance on Engagement of Institutions in HHS-Funded Human Subjects Research

The HHS Office for Human Research Protections has released its “Guidance on Engagement of Institutions in Human Subjects Research.” The guidance document describes whether certain scenarios would result in an institution being considered engaged in a human subjects research project, and addresses institutional review boards' review considerations for cooperative research in which multiple institutions are engaged in the same non-exempt human subjects research project. The guidance is intended primarily for IRBs, research administrators and other relevant institutional officials, investigators, and funding agencies that may be responsible for the conduct, review and oversight of human subject research that is conducted or supported by the U.S. Department of Health and Human Services. 

AHRQ Technology Assessments for Public Comment

The AHRQ's Technology Assessment Program develops systematic reviews and health technology assessments at the request of CMS in order to inform national Medicare coverage policies. AHRQ has announced that beginning October 15, 2008, it will post draft Technology Assessment Program reports for public comment on its website.  In a related development, on October 14, 2008, AHRQ has announced that it will be releasing for public comment a draft White Paper on "Potential Conflict of Interest in the Production of Drug Compendia" on October 22, and comments will be accepted on the draft until November 5, 2008.

HIPAA Guidance Documents

The Department of Health and Human Services (HHS) has published two new HIPAA Privacy Rule guidance documents that discuss when a health care provider may share a patient’s health information with the patient’s family, friends, or others involved in the patient’s care. One guide is designed for health care providers and the other is aimed at consumers.

Emergency Assistance in Hurricane Areas

HHS Secretary Michael Leavitt has declared that a public health emergency exists in Louisiana, Texas, Mississippi, and Alabama as a result of Hurricane Gustav. The declaration triggers waivers of certain Medicare, Medicaid, and SCHIP rules in the affected states. In a related development, on September 3, 2008 HHS announced implementation of the “Disaster Case Management” demonstration program providing case managers to help Hurricane Gustov victims obtain a wide range services, ranging from emergency food and shelter to health care services. 

OIG Report on Medicaid Fraud Control Units

The Office of Inspector General (OIG) of the Department of Health and Human Services has released the FY 2007 State Medicaid Fraud Control Unit (MFCU) Annual Report. In FY 2007, MFCUs recovered more than $1.1 billion in court-ordered restitution, fines, civil settlements, and penalties. They also obtained 1,205 convictions and there were 607 successful civil actions. Moreover, they were responsible for 805 OIG exclusions from participation in federal health care programs. The report is posted here.

Electronic Health Records (EHR) Demonstration

On June 10, 2008, HHS announced the 12 communities that will participate in a national Medicare demonstration project that provides incentive payments to physicians for using certified EHRs to improve the quality of patient care. The project will include up to 1,200 primary care physician practices in the following areas: Alabama; Delaware; Jacksonville, FL; Georgia; Maine; Louisiana; Maryland/Washington, DC; Oklahoma; Pittsburgh, PA; South Dakota (multi-state); Virginia; and Madison, WI. Total payments under the demonstration for all five years may be up to $58,000 per physician or $290,000 per practice. CMS will begin working with partners in four Phase I communities over the coming months to develop site-specific recruitment strategies, and recruitment of physician practices will start in the fall. For Phase II sites, these activities will begin in 2009.  

Emergency Declared/Rules Waived in Iowa and Indiana

On June 16, 2008, HHS declared a public health emergency in response to flooding in Iowa and Indiana. This declaration allows CMS to waive certain documentation and other requirements to enable providers to care for Medicare beneficiaries who have been evacuated. Among other things, for institutional providers treating evacuated patients in flood areas, the CMS will waive certain critical access hospital patient limits, the skilled nursing facility (SNF) three-day prior hospitalization requirement and benefit limits; disregard evacuated patients in calculating the 25-day average length of stay for long-term care hospitals, and not count evacuated patients in determining compliance with the 60 percent inpatient rehabilitation facility rule. For patients in the community, CMS will allow evacuees to receive home health services in alternative sites, waive rules preventing early refills of Medicare Part D prescriptions, and work to assist beneficiaries replace DME. CMS also will waive certain Emergency Medical Treatment and Labor Act (EMTALA) rules, allow beneficiaries in health plans to go out of network, and make emergency arrangements for ESRD care. Details regarding the emergency policies are available here.

Emergency Preparedness Grants, Draft Guidance Developments

On June 3, 2008, HHS announced that it has made available nearly $1.1 billion to continue assisting public health departments, hospitals and other health care organizations respond to public health and medical emergencies resulting from terrorism, pandemic influenza, and other naturally occurring emergencies. In a related development, HHS has released three draft guidance documents. designed to assist in preparation for an influenza pandemic. The documents address: (1) the Use and Purchase of Facemasks and Respirators by Individuals and Families for Pandemic Influenza Preparedness; (2) Antiviral Drug Use during an Influenza Pandemic; and (3) Proposed Considerations for Antiviral Drug Stockpiling by Employers In Preparation for an Influenza Pandemic. Comments will be accepted until July 3, 2008.

Federal Health IT Strategy

On June 3, 2008, the Department of Health and Human Services (HHS) Office of the National Coordinator (ONC) for Health Information Technology released the ONC-Coordinated Federal Health IT Strategic Plan: 2008-2012.  The plan has two primary goals: (1) to enable the transformation to higher quality, more cost-efficient, patient-focused health care through electronic health information access and use by care providers, and by patients and their designees; and (2) to enable the appropriate, authorized, and timely access and use of electronic health information to benefit public health, biomedical research, quality improvement, and emergency preparedness. To reach these goals, the plan calls for the facilitation of the electronic exchange and use of health information, while protecting the privacy and security of patient health information; promotion of interoperability of health information systems; support for nationwide deployment of electronic health records; and the establishment of collaborative decision-making.

DMEPOS Competitive Bidding Developments

In preparation for implementation of the first phase of the Medicare DMEPOS competitive bidding program on July 1, 2008, CMS has been posting new educational resources on its web site. Recent publications include new "tip sheets" for grandfathered suppliers and referral sources (e.g., providers and home health agencies) and an educational article explaining new Medicare manual instructions related to the bidding program.

OIG Report on Unimplemented Recommendations

The HHS Office of Inspector General (OIG) has issued its “Compendium of Unimplemented Office of Inspector General Recommendations.” This publication is a compilation of significant monetary and nonmonetary recommendations that the OIG believes has the potential to result in cost savings and improvements to HHS program efficiency and effectiveness if enacted.

Nursing Home Developments

CMS has released its "2008 Action Plan for (Further Improvement of) Nursing Home Quality”. The major components of the plan include: increasing consumer awareness and assistance; improving the nursing home survey and enforcement processes; promoting quality improvement in key areas such as reducing the use of restraints and decreasing the prevalence of preventable pressure sores; expanding partnerships to promote quality care; and expanding value-based purchasing. In a related development, CMS announced that it is expanding its “Nursing Home Compare” website to designate whether a facility has ever been on CMS’s “special focus facility” (SFF) list. SFF facilities have been determined by CMS to have failed to improve quality significantly after being given the opportunity to do so.

IPPS Relative Weights

In the FY 2009 Medicare IPPS proposed rule published April 30, CMS stated that it had contracted with RAND and RTI to consider a variety of potential refinements to relative weights. While these reports were not available when the rule was issues, the findings are now posted on the CMS website. CMS will accept comments on these reports through June 19.

Medicare "Incident To" Services

CMS has made extensive changes to the Medicare Benefits Policy Manual provisions to clarify policies related to Part B services provided “incident to” the services of physicians." While CMS maintains that the update "represents no significant change in Medicare policy,” CMS has made numerous edits to clarify current policy and provide consistency to the extent local interpretations of these rules has differed. Click here for details.