Health Information Technology
FDA Issues Draft Guidance on Mobile Medical Apps (August 2011)The Food and Drug Administration (FDA) issued draft guidance on how it will oversee mobile medical applications “apps” designed for use on smart phones and other mobile computing devices on July 19. The FDA indicated that it will not regulate the sale or general consumer use of smart phones or tablets. According to a recent study, 500 million users worldwide will be using a health care application by 2015. The draft guidance applies specifically to the following: apps that are used as an accessory to medical devices already regulated by the FDA; and apps that transform a mobile communication device into a regulated medical device by using attachments, sensors or other devices. You can view the full proposal at www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ucm255978.htm. HHS Announces New Approach To Fraud Prevention (July 2011)
Secretary of Health and Human Services Kathleen Sebellius announced that HHS will begin using new analytic technology aimed at identifying fraudulent claims on July 1. According to the Secretary, the technology will be used to analyze the 4.5 million claims that are submitted daily. The new technology uses the same type of predictive modeling that has been used to curb credit and property-casualty insurance fraud. Risk-scoring technology will be applied to each fee-for-service Medicare claim when it is submitted, using real-time data to identify and analyze billing patterns and evaluate the validity of each claim. According to Peter Budetti, Director, CMS Center for Program Integrity, the risk score alone will not result in a denied claim, but will be used to identify which claims need to be looked at more closely. In announcing the new initiative Secretary Sebellius stated, “Suddenly, it is a lot harder for the rotten apple to blend in with the bunch.” "Meaningful Use" Rule Released (July 2010)
CMS announced a final rule defining "meaningful use" of electronic health records (EHR). Physicians and hospitals that attain meaningful use of certified EHR's may qualify for federal bonus payments. The final rule implements provisions contained in the American Recovery and Reinvestment Act of 2009 (ARRA, Pub. L. 111-6). A companion rule was released by the Office of the National Coordinator for Health Information Technology (ONCHIT) to delineate the rules for technology to be certified. The final meaningful use rule is more flexible than the original proposed rule. This is accomplished by dividing Stage 1 meaningful use adoption objectives into "core" objectives and "optional" objectives that can be deferred in 2011 or 2012. Overall, the final rule relaxed the threshold requirements for meeting Stage 1 criteria. According to a fact sheet released by CMS, "Eligible professionals can receive as much as $44,000 over a five-year period through Medicare. For Medicaid, eligible professionals can receive as much as $63,750 over six years. A table that outlines the maximum EHR incentive payment for Medicare eligible professionals appreas on page 4. FCC Proposes Broadband Funding for Healthcare Providers
(April 2010)
The Federal Communications Commission (FCC) has submitted a plan to Congress to revamp its Rural Health Care Program to reimburse healthcare providers for the purchase of broadband services in any location, including urban areas, where the purchase of broadband services is unaffordable. As part of the plan, the FCC is proposing to create a Health Care Broadband Infrastructure Fund. According to a study conducted by the FCC, there are about 3,600 small physician practices in the United States that do not have sufficient access to broadband services to achieve "meaningful use" of electronic health records. In addition, the FCC found that while broadband services may be available, the expense may be cost prohibitive. Proposed Rules on "Meaningful Use" and EHR Certification Released
(February 2010)
The Office of the National Coordinator (ONC) and the Centers for Medicare and Medicaid Services (CMS) published proposed rules establishing criteria for the certification of electronic health records and the definition of "meaningful use" for those EHRs on January 13, respectively. The rules were released in response to provisions contained in the “Health Information Technology for Economic and Clinical Health (HITECH) Act. The HITECH Act was signed into law as part of the American Recovery and Reinvestment Act (ARRA)(Pub. L. No. 111-5). The ARRA provides for Medicare and Medicaid incentive payments to eligible health professionals who make "meaningful use" of certified EHRs. Under the proposed rule, incentive payments for providers could begin as early as 2011. Additional information will be provided in this column in the upcoming months. You may contact Tim McNichol at tmcnichol@acoi.org or by calling toll-free 1-800-327-5183 should you have any questions or wish to share your thoughts on these proposed rules. CMS Announces Delay of Database Requirement (January 2010)
The Centers for Medicare and Medicaid Services (CMS) announced that it will delay from January 1 until April 5, 2010, implementation of a policy requiring physicians and other Medicare Part B providers to enroll in the Provider Enrollment, Chain, and Ownership System (PECOS) database. Under the policy, Medicare will not pay claims for services when the referring or ordering physician is not in the PECOS database by April 5. CMS estimates that approximately 200,000 physicians are not in the PECOS database at this time. According to CMS, providers who have not updated their Medicare enrollment record information since 2003, when PECOS started, need to update their records. If a physician has no changes to his or her enrollment, he or she still needs to submit an initial enrollment application to establish a record in PECOS. Additional information on enrollment in the PECOS system may be found at http://www.cms.hhs.gov/MedicareProviderSupEnroll/01_Overview.asp#TopOfPage. This issue was addressed at the December meeting of CMS’ Practicing Physician Advisory Committee (PPAC). ACOI and PPAC member Joseph A. Giaimo, DO, and other PPAC members called for a further delay of implementation of the rule to allow for additional education by CMS and to allow for greater preparation by the physician community. Electronic Health Information Breach Notification Rules Issued (September 2008)
The Federal Trade Commission and the Department of Health and Human Services issued rules requiring the notification of consumers when the security of their health information is breached. The HHS interim final rule is applicable to healthcare providers, health plans, and other entities covered by the Health Insurance Portability and Accountability Act (HIPAA). The FTC rules apply to non-HIPAA covered entities. Both rules implement provisions of the Health Information Technology For Economic and Clinical Health (HITECH) Act which was enacted into law as part of the American Recovery and Reinvestment Act of 2009 (ARRA)(Pub. L. 111-5). Under the HHS rule, breaches involving fewer than 500 individuals must be reported to the individuals and to the Secretary of HHS annually. Breaches involving more than 500 individuals must immediately be reported to the media, the individuals and to HHS. The rules also include guidance on encryption and destruction technologies that would best protect health information. According to a statement released by HHS, �To determine when information is �unsecured� and notification is required by the HHS and FTC rules, HHS is also issuing in the same document as the regulations an update to its guidance specifying encryption and destruction as the technologies and methodologies that render protected health information unusable, unreadable, or indecipherable to unauthorized individuals.� Entities subject to the regulations that secure health information as specified by the guidance through encryption or destruction are relieved from the breach notification requirements set forth in the rules. Additional information on the HHS rule and the security of medical records is available at www.hhs.gov/ocr/privacy. Grant Money Announced for the Advancement of Health
Information Technology (September 2008)
Vice President Joe Biden and Secretary of Health and Human Services Kathleen Sebelius announced the availability of $1.2 billion in grant money on August 20. The grants are intended to help healthcare providers implement and use electronic health records by establishing technical assistance centers and national health information networks. Grants totaling $598 million will be used to create approximately 70 �Health Information Technology Regional Extension Centers� intended to provide hands-on technical assistance to support the adoption and use of certified electronic health record systems. $564 million in grants will be provided to states and other entities to create state or regional data exchanges. Additional information on the grant programs is available at www.healthit.hhs.gov. ACOI Comments on Development of �Meaningful Use� Definition for HIT (July 2009)
The ACOI along with other physician organizations sent a letter to David Blumenthal, M.D., National Coordinator for Health Information Technology, on June 26 in response to a request for comment on the definition of �meaningful use� of electronic health records (EHRs). The �American Recovery and Reinvestment Act� (ARRA)(Pub. L. No. 111-5) authorizes CMS to provide financial incentives to eligible physicians for meaningful use of EHRs. The incentive payments will begin in 2011 with reductions in reimbursement beginning in 2015 for those who do not adopt EHRs. The letter to Dr. Blumenthal expressed support for the efforts underway and highlighted the need for caution in light of the ambitious timetable put forth. The submitted comments suggested that the �meaningful use� definition include: �1) guiding key principles that we believe are critical to achieving the goal of widespread adoption of EHRs and other health information technology, and to ensuring patient access to quality and timely care; and 2) an achievable and predictable pathway toward meaningful use, including a set of program specifications for meeting the 2011 incentive payment timeframe and beyond.� The ACOI continues to work to ensure that efforts by the federal government to facilitate the adoption of HIT are done in an efficient and effective manner. Online Pharmacy Legislation Sent to the President�s Desk (October 2008)
The House and Senate approved the �Ryan Haight Online Pharmacy Consumer Protection Act� (H.R. 6353) on September 23 and 30, respectively. The legislation amends the Controlled Substances Act to prohibit the delivery, distribution, and dispensing of controlled substances over the Internet without a valid prescription. H.R 6353 sets forth specific guidelines that must be followed by online pharmacies in relation to controlled substances and requires an in-person exam by a physician before prescription drugs can be dispensed by an online pharmacy. The legislation, named after a California high school student who died after overdosing on Vicodin obtained through an Internet pharmacy, is expected to be signed into law by the President.
Health Information Technology Legislation Introduced (October 2008)
Representative Pete Stark, Chairman of the House Ways and Means Subcommittee on Health, introduced the �Health-e Information Technology Act of 2008� (H.R. 6898) on September 15. The legislation requires the Secretary of Health and Human Services to create standards for interoperable health information technology (HIT) systems no later than October 2011; establishes in statute the Office of the National Coordinator for Health Information Technology; and provides incentives to physicians through Medicare for the adoption of certified electronic health records, among other things. Incentive payments to physicians could total $40,000 over five years under H.R. 6898. The incentives would be phased out and payments under the Medicare system would be reduced for those who do not use qualified HIT systems within a set time frame. The legislation has been referred to three House Committees where no additional action is expected for the remainder of this year. It appears that the legislation will be reintroduced at the beginning of the next congress in early 2009.
HIT Legislation Advances in the House of Representatives (August 2008)
The House of Representatives Committee on Energy and Commerce approved the �Protecting Records, Optimizing Treatment, and Easing Communication through Healthcare Technology Act of 2008� (H.R. 6357) by voice vote on July 23. The legislation, drafted to advance the adoption of health information technology (HIT), would create in statute the Office of the National Coordinator for Health Information Technology and would provide $569 million in grants and loans to providers for the adoption of HIT. The financial assistance would be directed largely toward small and rural providers as well as those practicing in underserved areas. Prior to approval by the Committee, an amendment was adopted in the form of a substitute to address some of the privacy concerns that have been expressed with regard to patient records. The House Committee on Ways and Means, which also has jurisdiction over health information technology, is expected to consider its own legislation when Congress returns from the August recess. Action on HIT legislation in the U.S. Senate continues to be stalled.
HIT Legislation Advances in the House of Representatives (July 2008)
The House of Representatives Committee on Energy and Commerce, Subcommittee on Health, approved the �Protecting Records, Optimizing Treatment, and Easing Communication through Healthcare Technology Act of 2008� (H.R. 6357) by voice vote on June 24. The legislation, drafted to advance the adoption of health information technology (HIT), would create in statute the Office of the National Coordinator for Health Information Technology and would provide grants for the adoptions of HIT, among other things. The full Committee on Energy and Commerce is expected to consider the legislation later this summer. H.R. 6357 is similar to the �Wired for Health Care Quality Act� (S. 1693), which has been stalled in the Senate over privacy concerns. Similar concerns are expected to be raised prior to consideration and approval by the full House of Representatives..
CMS Announces New Electronic Email Update Service (December 2007)
The Centers for Medicare and Medicaid Services (CMS) recently announced a new email update service that delivers Medicare information to fee-for-service providers and others directly to their desks via email. The new service allows you to choose the subjects on which you receive information to have sent to your selected email account. In order to see a full listing of the resources available and to sign up for the email update service, visit the CMS website at www.cms.hhs.gov..
Senate Committee Approves HIT Legislation (July 2007)
The Senate Health, Education, Labor and Pensions Committee (HELP) approved by voice vote the �Wired for Health Care Quality Act� (S. 1693) on June 27. The legislation does the following: requires government purchases of health information technology (HIT) to comply with basic standards and sets forth a mechanism to establish the standards; authorizes funds to create grant and loan programs to assist in the development and adoption of HIT; and, codifies the Office of the National Coordinator for Health Information Technology (ONCHIT), among other things. Similar legislation was approved by both the U.S. Senate and the U.S. House of Representatives in the previous Congress, but the two chambers were not able to resolve their differences prior to the adjourning.
Several physician groups, including the ACOI, have raised questions regarding some provisions of the legislation. Specifically, there are concerns that portions of S. 1693 could result in unintended consequences including, but not limited to, a reduction in the availability of health care services for patients. As a result, the ACOI is continuing to work with legislators, their staffs and other physician organizations to improve the provisions of this legislation.
Legislation Approved to Advance Health Information Technology (June 2007)
The U.S. House of Representatives took an important step in the advancement of health information technology (HIT) by approving the �10,000 Trained by 2010 Act�(H.R. 1467) on Wednesday, June 6. The Act, which is crafted to promote research and training in HIT, authorizes four grants totaling $99.6 million to be administered through the National Science Foundation (NSF). Specifically, the legislation authorizes $37.2 million to improve and expand university HIT education programs, $29.2 million for two-year colleges to expand or create associate degree programs in HIT, $18.6 million for universities to establish centers for informatics research and $14.6 million for basic HIT research. The legislation must be considered by the Senate before it goes to the President�s desk for his signature.
Internal Revenue Service Issues Memorandum on Electronic Health Records (May 2007)
The Internal Revenue Service (IRS) issued guidance pertaining to handling examination and exemption application cases for not-for-profit hospitals that provide financial assistance to staff physicians for the attainment and utilization of electronic health records (EHRs) on May 11. The directive is in response to regulations published by the U.S. Department of Health and Human Services (HHS) in August 2006 that allow hospitals to provide EHR software and technical support to medical staff physicians without violating the federal anti-kickback law and the physician self-referral law. The IRS directive allows not-for-profit hospitals to enter into Health IT Subsidy agreements without jeopardizing their tax-exempt status as long as several conditions are met. For further information, you may visit the IRS website at www.irs.gov/charities/index.html.
CMS and OIG Issue Final Rules to Promote Adoption of HIT (September 2006)
The Centers for Medicare and Medicaid Services (CMS) and the Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued final rules to support the adoption of electronic prescribing and electronic health records technology on August 8, 2006. The rules take effect on October 10, 2006. The final rules create new exceptions to the �Physician Self Referral Act� (commonly referred to as the Stark Law) and safe harbors to the �Anti-Kickback Statute,� two key federal fraud and abuse laws.
The exceptions and safe harbors created in the final rules establish the conditions under which entities may donate to physicians interoperable electronic health records software, information technology and training services. In addition, the exceptions and safe harbors establish the conditions under which hospitals and certain other entities may provide physicians with hardware, software, or information technology and training services necessary and used solely for electronic prescribing. The rules associated with the promotion of electronic prescribing are required by the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) signed into law on December 8, 2003. The electronic health record technology exception and safe harbor will expire on December 31, 2013. For additional information you may contact Tim McNichol at tmcnichol@acoi.org or by calling toll-free 1-800-327-5183
U.S. House of Representatives Approves HIT Legislation (August 2006)
The U.S. House of Representatives approved the �Health Information Technology Promotion Act of 2006� (H.R. 4157) by a vote of 270 � 148 with 14 members not voting on July 27. The legislation, among other things, would establish in statute the Office of the National Coordinator of Health Information Technology (NCHIT) within the Department of Health and Human Services (HHS); would require health plans, providers and others to adopt the 10th revision of the International Classification of Diseases (ICD-10) no later than October 1, 2010; would require the development of voluntary guidelines for interoperability by August 31, 2009; and would authorize $20 million a year in fiscal years 2007 and 2008 in grants to help providers adopt information technology.
Approval of H.R. 4157 follows the adoption of the �Wired for Health Care Quality Act� (S. 1418) approved by the U.S. Senate on November 18, 2005. The two bills will now go to a conference committee where efforts will be made to reconcile significant differences in the two bills. Sticking points for the conference committee will include funding for adoption of information technology and conflicting views on privacy.
HIT Legislation Considered by US House Subcommittees (June 2006)
Both the U.S. House of Representatives Ways and Means and Energy and Commerce Health Subcommittees have considered and favorably reported the �Health Information Technology Promotion Act of 2005� (H.R. 4157). The legislation was introduced by Representatives Nancy Johnson (R-CT) and Nathan Deal (R-GA). H.R. 4157 would establish in statute the Office of the National Coordinator of Health Information Technology (NCHIT) within the Department of Health and Human Services (HHS) as well as address self-referral and anti-kickback statutes, among other things. Additional consideration of this legislation is expected later this month by the full committees and perhaps the House of Representatives.
H.R. 4157 follows the adoption of the �Wired for Health Care Quality Act� (S. 1418) by the U.S. Senate on November 18, 2005. S. 1418 was introduced by Senators Michael Enzi (R-WY), Edward Kennedy (D-MA) and others. Should the House approve H.R. 4157, the legislative differences of the bills will have to be resolved in a conference committee prior to going to the President�s desk for his signature. For additional information on this or other legislation you may contact Tim McNichol at tmcnichol@acoi.org or by calling toll-free 1-800-327-5183.