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

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. 

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The Government Accountability Office (GAO) has issued a report entitled "Electronic Personal Health Information Exchange: Health Care Entities' Reported Disclosure Practices and Effects on Quality of Care." The report, which was required by the HITECH Act, reviews practices implemented by health information exchange organizations, providers, and other health care entities that disclose electronic personal health information, based on case studies of operational health information exchanges and a selection of each of the exchanges’ participating providers. The health care entities reported that they implement widely-accepted practices for safeguarding personal information to help ensure the appropriate use and disclosure of electronic personal health information for treatment purposes. In addition, both the exchanges and providers reported examples of ways that sharing electronic personal health information has had a positive effect on the quality of care that providers deliver to patients.

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On February 23, 2010, CMS is hosting a teleconference on its January 13, 2010 proposed rule implementing the electronic health record (EHR) incentive payment provisions of the American Recovery and Reinvestment Act of 2009 (ARRA). Among other things, the program will address: eligibility for incentives; what constitutes meaningful use; how to demonstrate meaningful use; and how to submit comments.

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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. 

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This post was written by Jacqueline B. Penrod.

On January 13, 2010, the Office of the National Coordinator for Health Information Technology (ONC) published an interim final rule (the “Standards Rule”) to adopt an initial set of standards, implementation specifications, and certification criteria for health information technology. Designed to be “the first step in an incremental approach . . . to enhance the interoperability, functionality, utility and security of health information technology and to support its meaningful use,” the Standards Rule outlines capability requirements for electronic health records (EHR) systems and establishes standards for the exchange of information between systems. It also provides guidance with respect to maintaining the privacy and security of patient data and adherence to the requirements of the HIPAA Privacy Rule.   The rule is effective February 12, 2010, although comments will be accepted until March 15, 2010. Also on January 13, the Centers for Medicare and Medicaid Services (CMS) published a proposed rule (the “Incentive Rule”) implementing the EHR incentive payments provided for in the American Recovery and Reinvestment Act of 2009 (ARRA). Under the ARRA, hospitals and eligible professionals (EP) may qualify to receive incentive payments under the Medicare fee-for-service, Medicare Advantage, and Medicaid programs if they adopt and meaningfully use certified electronic health technology. Beginning in 2015, hospitals and EPs that do not adopt and meaningfully use such technology will have downward payment adjustments. The Incentive Rule sets forth a broad outline of the manner in which providers will be eligible for EHR incentive payments. It includes the long-awaited initial criteria to determine whether a hospital or EP is a “meaningful user” of certified EHR technology, as well as the methods which will be used to calculate the payments and adjustments. Functionality and clinical quality measures for each type of provider are proposed for each program. The Incentive Rule proposes a three-stage approach to assessing meaningful use of EHR technology, with progressive reliance on and use of electronic medical records. While the criteria for Stage 1 are set forth in detail, the criteria for the remaining two stages are expected to be developed later, taking into account progress in technology and within the health industry. The meaningful use criteria will be updated on a biennial basis; proposed criteria for Stages 2 and 3 are anticipated to be released in 2011 and 2013, respectively. The significant impact that the meaningful use criteria may have on reimbursement for providers warrants close scrutiny. The proposed rule is posted here. CMS will accept comments on the proposed rule until March 15, 2010. Reed Smith is preparing a client bulletin summarizing the Incentive Rule.

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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.

 

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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.

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On November 18, 2009, the House approved H.R. 3014, the Small Business Health Information Technology Financing Act. The bill would create a new Small Business Administration loan guarantee program for the purchase of certain health information technology (IT) by eligible health care professionals in solo and small group practices. Health IT supported by the program would include computer hardware, software, and related technology that supports Medicare’s meaningful electronic health record use requirements. The technology must be purchased by an eligible professional to aid in the provision of health care, including electronic medical records, but it does not include IT whose sole use is financial management, maintenance of inventory of basic supplies, or appointment scheduling. The loan guarantee program would provide a 90% guarantee and loan amounts up to $350,000 for an individual practitioner and $2 million for a group practice. The legislation now moves to the Senate for further consideration.

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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.  

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This post was written by Jacqueline Penrod.

On December 15, 2009, the HHS Office of the National Coordinator’s HIT Policy Committee will meet to hear reports from its workgroups, including the Meaningful Use Workgroup. Likewise, the HIT Standards Committee will meet on December 18, 2009 to discuss updates from its workgroups. 

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The Health Information Technology (HIT) Policy Committee will be meeting October 27 and October 28 to focus on HIT issues for specialists, smaller physician practices, and small community hospitals that may not be adequately addressed by the initial HIT-enabled quality measures that focus on primary care providers. Also, the HIT Standards Committee’s Implementation Workgroup will hold a hearing October 29 on the HIT “adoption experience.”

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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.

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The Health Information Technology (HIT) Standards Committee is meeting October 14, 2009 to discuss reports from its Clinical Operations, Clinical Quality, and Privacy and Security Workgroups and hear expert testimony on HIT security.  In addition, the HIT Policy Committee's Information Exchange Workgroup is meeting October 20, 2009 to focus on the electronic exchange of laboratory information.

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On September 1, 2009, CMS issued guidance to state Medicaid directors on the American Recovery and Reinvestment Act (ARRA) provisions allowing payment to providers who adopt and become meaningful users of electronic health records. Specifically, CMS has outlined allowable state expenses related to the administration of the provider incentive payments. CMS will publish proposed regulations to formally implement this policy later this year. 

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On August 24, 2009, the Department of Health and Human Services (HHS) issued an interim final rule with comment period to implement an American Recovery and Reinvestment Act of 2009 provision requiring notification of breaches of unsecured protected health information. For purposes of determining what information is “unsecured protected health information,” HHS also is updating its guidance specifying the technologies and methodologies that render protected health information unusable, unreadable, or indecipherable to unauthorized individuals. The interim final rule is effective September 23, 2009. HHS will accept comments on the interim final rule until October 23, 2009, while comments on information collection requirements associated with the rule are due by September 8, 2009. In a related development, on August 25, 2009, the Federal Trade Commission (FTC) published a final rule that requires vendors of personal health records and related entities to notify consumers when the security of their individually identifiable health information has been breached, in compliance with the ARRA. The FTC rule is effective September 24, 2009, and full compliance is required by February 22, 2010. A Reed Smith analysis of the FTC rule is posted here, and a summary of the HHS rule is available here.   

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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.  

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On August 27, 2009, the HHS Office of the National Coordinator for Health Information Technology (ONC) will be hosting a technical assistance webcast on the ONC Health Information Technology Extension/Regional Centers Cooperative Agreement Program Funding Opportunity Announcement. 

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The HHS Office of the National Coordinator for Health Information Technology (ONC) has announced several upcoming meetings as part of its efforts to implement the Federal Health IT Strategic Plan. First, the HIT Policy Committee's Certification/Adoption Workgroup is meeting on July 14 and 15, 2009 to hear testimony from stakeholder groups, such as purchasers, vendors, and users, on the electronic health information certification process. In addition, the HIT Policy Committee is meeting on July 16, 2009 to discuss the preliminary draft definition of “Meaningful Use.” Finally, on July 21, 2009, the HIT Standards Committee is meeting to discuss the certification process.

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CMS has announced a website dedicated to information on the health information technology provisions in the American Recovery and Reinvestment Act of 2009, including information on Medicare and Medicaid incentives for electronic health records adoption. 

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A number of Congressional panels have held hearings recently on health policy issues, including the following:

• An Energy and Commerce Oversight and Investigations Subcommittee hearing on "Terminations of Individual Health Policies by Insurance Companies.”
• A Senate Homeland Security and Governmental Affairs Subcommittee on Oversight hearing on S. 372, the "Whistleblower Protection Enhancement Act of 2009."
• An Energy and Commerce Health Subcommittee hearing entitled "Medical Devices: Are Current Regulations Doing Enough for Patients?"

In addition, on June 24, 2009, the House Small Business Regulations and Healthcare Subcommittee is holding a hearing on "Health Information Technology and the New Challenges Faced by Solo and Small Group Healthcare Practices." Also on June 24, the Senate Homeland Security and Governmental Affairs Committee is holding a hearing on "Type 1 Diabetes Research: Real Progress and Real Hope for a Cure."

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On June 24, 2009, the House Small Business Regulations and Healthcare Subcommittee is holding a hearing on "Health Information Technology and the New Challenges Faced by Solo and Small Group Healthcare Practices."

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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.

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The second meeting of the HIT Standards Committee will take place on June 23, 2009. The meeting, which will include presentations from the HIT Standards Committee Workgroups, is a web-based meeting with teleconference dial-in.

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On June 16, the HIT Policy Committee is holding its second public meeting.

 

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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.

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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.

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Senate Finance Committee Chairman Max Baucus and Ranking Member Chuck Grassley released a lengthy policy paper on April 28, 2009 discussing options for reducing health care costs and improving quality in the health care delivery system, including significant Medicare payment reform proposals. Key areas addressed in the paper include the following:  

• Promoting Quality Care – Policy options to promote quality in the Medicare program include: establishing value‐based purchasing programs for hospitals, home health, and SNFs by FY 2012; expanding programs leading to value‐based purchasing for doctors, IRFs, and LTCHs; tying Medicare Advantage payments to quality of care; and restricting utilization of diagnostic imaging services.
• Fostering Care Coordination and Provider Collaboration – Policy options to enhance care management efforts include: establishing Medicare payment incentives for hospitals that reduce preventable hospital readmissions; providing a single bundled Medicare payment for acute and post‐acute episodes of care; establishing Medicare pilot programs of patient‐centered care coordination models for the chronically ill ; making reforms to Medicare physician reimbursement rates.
• Infrastructure Investments – Potential health delivery infrastructure investments include:  additional efforts to support widespread adoption and meaningful use of health information technology (beyond ARRA provisions); the development of quality measures; the establishment of a independent institute to conduct comparative effectiveness research; and improvements to health care workforce training.
• Transparency– Policy options to promote transparency include: requiring drug and device manufacturers to report publicly certain payments to physicians; establishing new restrictions on specialty hospitals; and expanding information for consumers on nursing home quality. 
• Other Health Care Delivery Options – Among other things, the plan calls for various steps to promote primary care (including providing primary care practitioners and targeted general surgeons with a 5% Medicare payment bonus) and expanded efforts to fight Medicare fraud and abuse.

The the deadline for public comments is May 15, 2009. The document is the first of three sets of potential option papers, each covering a different topic area that members will discuss before a bipartisan “Chairman’s Mark” on comprehensive health care reform is developed. Policy option papers on increasing health care coverage and financing health care reform will be released following future roundtable discussions on those topics. Note that the Finance Committee held its roundtable discussion on access to health care coverage on May 5, 2009, so an options paper on that topic should be available in the near future. In addition, on May 12, the Senate Finance Committee is holding its third roundtable discussion, this one focusing on financing comprehensive health care reform.

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The Office of the National Coordinator for Health Information Technology has announced the first meeting of the HIT Policy Committee on May 11, 2009. In addition, the first meeting of the HIT Standards Committee is scheduled for May 15, 2009. Both Committees were established by the ARRA to help guide the expansion of federal health IT efforts.

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CMS has released the 2009 Data Submission Specifications for use in the 2009 Physician Quality Reporting Initiative (PQRI) Electronic Health Record test.

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The “Federal Health Architecture” within HHS has announced the availability of “CONNECT” software to help public and private health information technology systems communicate to the Nationwide Health Information Network (NHIN), a federal initiative to facilitate the electronic exchange of health information. 

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A number of Congressional panels have held hearings recently on health policy issues, including the following:

• A House Ways and Means Committee hearing on reforming the health care delivery system to encourage better coordination and higher quality care, such as through bundled payments, health information technology, and value-based purchasing.
• House Energy and Commerce hearings on "Institutional Review Boards that Oversee Experimental Human Testing for Profit" (Oversight Subcommittee), "Making Health Care Work for American Families” (Health Subcommittee), and the "Protecting Consumer Access to Generic Drugs Act of 2009," which would prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market (Commerce Subcommittee). 
• A House Appropriations Subcommittee on Labor-HHS hearing on “Pathways to Health Reform: Implementing the National Strategy to Reduce Healthcare-Associated Infections.”
• A Senate Health, Education, Labor and Pensions Committee hearing addressing insurance market reform in national health reform.
• A Finance Committee hearing on the "Role of Long-Term Care in Health Reform."
• A Senate Commerce Committee hearing on deceptive health insurance industry practices. 

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The GAO has announced the appointment of 13 members to the Health Information Technology Policy Committee, a new advisory body established by the ARRA. The panel is charged with making recommendations on creating a policy framework for the development and adoption of a nationwide health information technology infrastructure, including standards for the exchange of patient medical information. Note that additional members will be appointed by HHS, Congress, and the President. 

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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.

 

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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.

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This post was written by Karl A. Thallner, Jr., Carol C. Loepere, Debra A. McCurdy, Brad M. Rostolsky, Jacqueline B. Penrod, and Amie E. Schaadt.

On February 17, 2009, President Obama signed into law H.R. 1, the American Recovery and Reinvestment Act (the “ARRA”). The sweeping $790 billion economic stimulus package includes a number of health care policy provisions. Reed Smith's Health Care Memorandum summarizes the major health policy provisions of the Act.

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On February 13, 2009, the House and Senate approved the conference report to accompany H.R. 1, the American Recovery and Reinvestment Act.  President Obama signed the bill into law on February 17, 2009.  The $790 billion economic stimulus package includes a number of health care policy provisions.  Among other things, the final agreement includes:

• $19 billion to accelerate the adoption of health information technology systems;
• Strengthened federal privacy and security provisions to protect personally-identifiable health information;
• Approximately $87 billion in additional federal matching funds over two years to help states maintain their Medicaid programs in the face of state budget shortfalls;
• $1.1 billion to support comparative effectiveness research;
• $1 billion for a new Prevention and Wellness Fund; and
• Provisions to help unemployed workers maintain health insurance coverage under the Consolidated Omnibus Budget Reconciliation Act (COBRA) law.
• A provision blocking a fiscal year 2009 reduction in Medicare payments to teaching hospitals related to capital payments for indirect medical education;
• A provision blocking a fiscal year 2009 Medicare payment cut to hospice providers related to a wage index payment add-on;
• Technical corrections to the Medicare, Medicaid, and SCHIP Extension Act of 2007 related to Medicare payments for long-term care hospitals;
• A temporary increase in states’ annual disproportionate share hospital allotments;
• An extension of moratoria on Medicaid regulations for targeted case management, provider taxes, and school-based administration and transportation services through June 30, 2009, and a new moratorium on a Medicaid regulation related to hospital outpatient services through June 30, 2009;
• An extension of Transitional Medical Assistance and the Qualified Individual program; and
• Medicaid prompt payment requirements for nursing facilities and hospitals.

Information on the versions of the measure approved earlier by the House and Senate is available here.    

Update:  On February 17, 2009, President Obama signed into law H.R. 1, the American Recovery and Reinvestment Act (the “ARRA”).  Reed Smith's Health Care Memorandum summarizes the major health policy provisions of the Act.

 

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The House and Senate currently are drafting major economic stimulus legislation that include a number of health care provisions. Although the details of the House and Senate versions vary, both the House and Senate packages would provide, on a temporary basis, approximately $87 billion additional federal matching funds to help states maintain their Medicaid programs during the economic downturn. Both plans also would expand federal health information technology efforts, including providing increased Medicare and Medicaid payments to certain providers using certified health information technology and establishing new privacy and security protections for health information, and increase federal funding of comparative effectiveness research, among many other things. The House of Representatives is set to vote on the bill this week. Senate panels are currently marking up various titles of the Senate package. Details on the Senate Finance Committee’s health-related provisions are available here. 

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On January 16, 2009, HHS published a final rule announcing updated HIPAA electronic transaction standards, including updated versions of the health care transactions standard (i.e., for claims, remittance, and eligibility requests) and the pharmacy claims transactions standard. The rule also adopts a standard for Medicaid pharmacy subrogation transactions, through which state Medicaid agencies recoup payments for pharmacy services when a third party payer has primary financial responsibility. The compliance date is January 1, 2012 (although small health plans have an additional year to comply with the Medicaid pharmacy subrogation standard). Separately, HHS published a notice announcing the Secretary’s recognition of certain Healthcare Information Technology Standards Panel Interoperability Specifications and the standards they contain as ‘‘Interoperability Standards’’ for health information technology.

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CMS has announced the launch of the Medicare Personal Health Record (PHR) Choice Pilot in Arizona and Utah to allow Medicare area beneficiaries to maintain their health record information electronically.  

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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. 

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On January 27, the Senate Judiciary Committee is holding a hearing on “Health IT: Protecting Americans' Privacy in the Digital Age.” The hearing will be webcast.

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The HHS Office of Inspector General (OIG) has issued a report on the top management and performance challenges facing the HHS. Key areas identified by the OIG include: Medicare Part D oversight (including drug pricing and rebates, fraud and abuse safeguards, and access to accurate information); Medicare integrity (including DME fraud and competitive bidding); Medicare Advantage; Medicaid and State Children’s Health Insurance program integrity (including prescription drug fraud and pharmacy reimbursement); quality of care (including pay-for-performance, “never events,” and transparency of ownership and performance); emergency preparedness and response; oversight of food, drugs, and medical devices (including food safety and security, drug and medical device safety, and transparency of provider financial interests); grants management; integrity of information systems and the implementation of health information technology; and ethics program oversight and enforcement.

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The Senate Health, Education, Labor and Pensions Committee has scheduled a hearing on "Investing in Health IT: A Stimulus for a Healthier America" on January 15, 2009.  

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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.  

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On November 12, 2008, Senate Finance Committee Chairman Max Baucus released a white paper entitled "Call to Action: Health Reform 2009." The document details Senator Baucus’ goals for health care reform in the broad areas of coverage, quality, and cost. Highlights of the lengthy plan include the following.  

• Ensuring Health Coverage for All Americans. The Baucus plan seeks universal health insurance coverage by supplementing the current employer-based system with a nationwide insurance pool called the Health Insurance Exchange. Premium subsidies would be available to qualifying families and small businesses. While the Exchange is being created, individuals aged 55 to 64 could buy in to Medicare, and access would be expanded to Medicaid and the State Children’s Health Insurance Program (CHIP). Once affordable health insurance options are available, all individuals would be required to have insurance coverage. 
• Improving Value by Reforming the Health Care Delivery System. Among other things, the plan calls for strengthening the role of primary care and chronic care management; refocusing payment incentives toward quality and value; and encouraging providers in different settings to collaborate in a way that improves quality and saves money (e.g., gainsharing). As part of the payment reforms, Baucus calls for overhaul of the Medicare physician fee schedule formula, greater surveillance of high-growth services, expanded use of pay-for-performance methodologies, and global payments for services provided to a patient during hospitalization and post-discharge. The Baucus plan also seeks to improve the health care infrastructure by supporting comparative effectiveness research through a new Health Care Comparative Effectiveness Research Institute and by promoting the adoption of health information technology. 
• Financing a More Efficient Health Care System. The Baucus plan seeks to prevent Medicare fraud, waste, and abuse through: more stringent enrollment criteria; enactment of payment methodologies that discourage waste (such as the DMEPOS competitive bidding program); encouraging provider and supplier compliance; vigilant government oversight of government health programs; and strong punishment for program abuses. The plan also seeks to increase transparency in the health system by mandating disclosure of gifts and other transfers of value made by drug and device companies to physicians and other health care professionals; increasing scrutiny of physician self-referrals (including a focus on physician-owned hospitals); and requiring public reporting and disclosure of health care price and quality information. With regard to private plans in Medicare, the Baucus plan also would address overpayments to Medicare Advantage (MA) plans, promote performance measures for Part D prescription drug plans and the application of pay-for-performance principles to these plans, and extend Medicaid price discounts to the drugs used by the dual-eligible population in the Part D program. In addition, the plan addresses long-term care reforms, including policies to continue to shift care from institutional settings to home and community settings, malpractice reform, and reforms of the tax code designed to make incentives more efficient, distribute benefits more fairly, and promote smarter consumer spending of health care dollars.

Health care reform promises to be a high-profile issue for the new Congress and the incoming Obama Administration. The broad scope of the Baucus white paper suggests that Congress intends to focus beyond access to insurance or the immediate problem of fixing the Medicare physician fee schedule and examine fundamental policy questions concerning how to promote quality and value throughout the health system at a time of limited federal resources.

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CMS is sponsoring a conference on October 6 and 7, 2008 in Boston to educate stakeholders about the new electronic-prescribing (“e-prescribing”) initiatives included in MIPPA. Pre-registration is required. 

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On August 22, 2008, HHS proposed new code sets to be used by the public and private sectors for reporting diagnoses and inpatient procedures in health care transactions under the Health Insurance Portability and Accountability Act (HIPAA) effective October 1, 2011. Specifically, the proposed rule would adopt the International Classification of Diseases, Tenth Revision, Clinical Modification (ICD–10–CM) for diagnosis coding, and the International Classification of Diseases, Tenth Revision, Procedure Coding System (ICD–10–PCS) for inpatient hospital procedure coding. These new codes would replace the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD–9–CM) Volumes 1 and 2, and the International Classification of Diseases, Ninth Revision, Clinical Modification (CM) Volume 3 for diagnosis and procedure codes, respectively. HHS believes the adoption of the ICD-10 code set will: support value-based purchasing by accurately defining services and providing specific diagnosis and treatment information; support comprehensive reporting of quality data; ensure more accurate payments for new procedures; result in fewer rejected and improper claims; and facilitate comparisons to international data. While HHS expects the transition to the new codes to save billions of dollars in the long-term, short-term implementation costs (training, productivity losses, and systems changes) could reach hundreds of millions of dollars. HHS will accept comments on the proposed rule, including the cost/benefit assumptions, until October 21, 2008. 

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On August 22, 2008, HHS published a proposed rule that would adopt updated versions of the standards for electronic transactions under the Health Insurance Portability and Accountability Act of 1996 (HIPAA). The rule also would adopt a transaction standard for Medicaid Pharmacy Subrogation and two standards for billing retail pharmacy supplies and professional services, and would clarify who the “senders” and “receivers” are in the descriptions of certain transactions. HHS will accept comments on the proposed rule until October 21, 2008.  

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CMS is sponsoring a conference on October 6 and 7, 2008 in Boston, Massachusetts, to educate stakeholders about the new eprescribing initiatives included in the Medicare Improvements for Patients and Providers Act of 2008 (“MIPPA”).    While there is no registration fee, space is limited.  For questions, please call 1-888-883-3734 x 820, or send an e-mail to registrar@e-prescribeconference.com. 
 

Featured keynote speakers include: 

• Mike Leavitt, Secretary of Health and Human Services
• Kerry Weems, Acting Administrator, Centers for Medicare & Medicaid Services
• David J. Brailer, MD, PhD, Chairman, Health Evolution Partners, Former National Coordinator for Health Information Technology

Conference registration is now open.

 

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On July 23, 2008, the House Committee on Energy and Commerce approved H.R. 6357, the “Protecting Records, Optimizing Treatment, and Easing Communication through Healthcare Technology Act of 2008.” The legislation seeks to promote nationwide adoption of a Health Information Technology (HIT) infrastructure and encourage the use of an electronic health record for each person in the United States by 2014. H.R. 6357 would: make permanent the Office of the National Coordinator for Health Information Technology; establish incentives for exchanging health information electronically; and provide safeguards to protect the privacy of an individual’s health information. The bill also would extend federal privacy law to entities that do business with providers, such as quality review organizations and entities that store and manage a provider’s electronic health information.

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Congressional committees have held numerous hearings on health policy issues recently, including the following: 

• The House Oversight and Government Reform Committee held a hearing July 24, 2008, entitled, "The Medicare Drug Benefit:  Are Private Insurers Getting Good Discounts for the Taxpayer?" At the hearing, the Committee released a staff report that charges that prices paid for drugs used by the dual eligible beneficiaries under Medicare Part D are significantly higher than Medicaid prices for the same drugs. According to the report, the higher prices for the top 100 drugs resulted in a windfall of $1.7 billion for drug manufacturers in 2006 and $2 billion in 2007.   Separately, on July 24, the Joint Economic Committee held a hearing entitled "Small Market Drugs, Big Price Tags: Are Drug Companies Exploiting People With Rare Diseases?" 

• On July 24, the House Ways and Means Health Subcommittee held a hearing on options to encourage the adoption and use of a fully interoperable health information technology system. On July 15, the panel considered health care reform lessons learned at the state level. 
  
• The House Energy and Commerce Subcommittee on Health held a hearing July 22 on “State Fiscal Relief: Protecting Health Coverage in an Economic Downturn.”  The Subcommittee on Oversight and Investigations held a hearing July 24 on "Long-Term Care Insurance: Are Consumers Protected for the Long Term?"  Likewise, the House Small Business Committee held a hearing July 23 on "The Impact of Predators in Long-Term Care on Small Business Operators." 
  
• The House Budget Committee held a hearing July 16 entitled "Getting Better Value in Health Care."  Likewise, on July 17, the Senate Finance Committee held a hearing entitled "The Right Care at the Right Time: Leveraging Innovation to Improve Health Care Quality for All Americans."  
  
• The Senate Special Aging Committee held a hearing July 23 to examine person-centered health care at nursing homes.
  
• On July 22, the House Homeland Security Committee held a hearing on "Emerging Biological Threats and Public Health Preparedness: Getting Beyond Getting Ready." . The Committee also met to focus on the “Training of First Responders in Rural Communities." In addition, the House Agriculture Committee held a hearing July 23 on health care in rural areas.

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On August 13, 2008, CMS is holding a national provider conference call on the 2008 Physician Quality Reporting Initiative (PQRI). The call will provide information on the PQRI provisions in MIPPA, the e-prescribing measure for 2008 PQRI and proposed measures for 2009 PQRI, MIPPA incentives for electronic prescribing, and registry reporting for 2008.  Registration information is available here.

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On June 25, 2008, the House Energy and Commerce Subcommittee on Health approved H.R. 6357, the “Protecting Records, Optimizing Treatment, and Easing Communication through Healthcare Technology Act of 2008” or the PRO(TECH)T Act. The legislation is designed to promote the nationwide adoption of an HIT infrastructure and encourage the use of an electronic health record for each person in the United States by 2014. H.R. 6357 makes permanent the Office of the National Coordinator for Health Information Technology. It also would establish incentives for doctors, hospitals, insurers, and the government to exchange health information electronically, such as grants and loans to facilitate the widespread adoption of qualified health information technology. Additionally, it would provide safeguards to protect the security and privacy of an individual’s health information, including requiring notification when personal health information is breached.

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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.  

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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.

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On June 3, 2008, the Senate Finance Committee is holding a hearing on "Rising Costs, Low Quality in Health Care: The Necessity for Reform." On June 4, 2008, the House Energy and Commerce Health Subcommittee is holding a hearing on Committee Chairman John Dingell’s draft legislation designed to encourage the adoption of health information technology and strengthen privacy protections for patients. 

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CMS is conducting a demonstration project testing the use of internet-based personal health records for Medicare beneficiaries in South Carolina.

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