OCR Update on Issuance of HIPAA HITECH Rulemaking

Update from Office for Civil Rights (OCR) on issuance of the Notice of Proposed Rulemaking (NPRM) implementing changes to HIPAA under the Health Information Technology for Economic and Clinical Health Act (HITECH). Health care organizations and health lawyers have been anxiously awaiting rules implementing and interpreting the changes because the effective date for many of the HITECH requirements was February 17, 2010. Of particular interest has been whether or not health care organizations are required to amend business associate agreement.

The notice seems to indicate that the the date for compliance and enforcement may be delayed since it states that the NPRM "will provide specific information regarding the expected date of compliance and enforcement." However, covered entities and business associates need to weigh the risks of not complying with the new requirements while waiting for further clarification from OCR.

The notice states:

OCR will implement important privacy and security provisions of the Health Information Technology for Economic and Clinical Health (HITECH) Act through notice and comment rulemaking, as required by the Administrative Procedure Act. These provisions include: business associate liability; new limitations on the sale of protected health information, marketing, and fundraising communications; and stronger individual rights to access electronic medical records and restrict the disclosure of certain information. OCR continues work on a Notice of Proposed Rulemaking (NPRM) regarding these provisions. Although the effective date (February 17, 2010) for many of these HITECH Act provisions has passed, the NPRM and the final rule that follows will provide specific information regarding the expected date of compliance and enforcement of these new requirements.

However, interim final rules implementing HITECH Act provisions in two areas have already been issued and are currently in effect: enforcement and breach notification. New civil money penalty amounts apply to HIPAA Privacy and Security Rule violations occurring after February 17, 2009. Covered entities and business associates must comply now with breach notification obligations for breaches that are discovered on or after September 23, 2009. OCR announced previously that it would use its enforcement discretion not to impose fiscal sanctions with regard to breaches discovered before February 22, 2010. Since that date has passed, OCR will enforce the Breach Notification Interim Final Rule, including with the possible imposition of sanctions, as it does with the HIPAA Privacy and Security Rule requirements.

WV HIT Funding Under HITECH: WVHIN Gets $7.8M and WV REC gets $6M

Health and Human Services Secretary Sebelius and the National Coordinator for Health Information Technology, David Blumenthal, announced the HITECH funding under the ARRA for State Health Information Exchanges (HIEs) and Regional Extension Center (RECs) across the country.

The White House Press Release provides a detailed list of HIEs and RECs receiving grants. Inormation is also available via the HHS News Release, Sebelius, Solis Announce Nearly $1 Billion Recovery Act Investments in Advancing Use of Health IT, Training Works for Health Jobs of the Future.

West Virginia will receive the following funding:

• West Virginia Department of Health and Human Resources in conjunction with the West Virginia Health Information Network HIE Award: $7,819,000

• West Virginia Health Improvement Institute, Inc. REC ward:$6,000,000

More information about the health information technology programs and awards can be found on the Office of National Coordinator HIT Website.

• State Health Information Exchange Cooperative Agreement Program

• Health Information Technology Extension Program

State Attorney General HIPAA HITECH Enforcement

My health law colleague, David Harlow, covers the news today on the first HIPAA enforcement action taken by a state attorney general under the new HITECH provision of American Recovery and Reinvestment Act of 2009 (ARRA).

David's post, HIPAA enforcement by state attorney general: The shape of things to come, provides a good summary of the announcement by the Connecticut Attorney General. More information via the Connecticut Attorney General press release.

The lawsuit filed by the Connecticut Attorney General Richard Blumenthal (coincidentally brother of David Blumenthal, National Coordinator of Health Information Technology) alleges that a health insurer, Health Net of Connecticut, Inc., failed to promptly notify the AG and other officials of a missing portable computer disk drive that contained unencrypted protected health information, Social Security numbers and bank accounts for approximately 446,000 individuals. The lawsuit also named UnitedHealth Group Inc. and Oxford Health Plans, LLC who acquired ownership of Health Net of Connecticut. The action also seeks a court order against Health Net to encrypt all information held on electronic devices.

Since the early days of HIPAA implementation and compliance there has largely been a lack of real enforcement efforts. The new provisions under HITECH allowing state attorney generals to file HIPAA enforcement actions on behalf of the public bring a new era of enforcement against health care providers who are unfortunate to have a health data breach and fail to properly respond to such breach in a timely manner.

David offers some good advice and takeaway points to health care providers and others who regularly handle health information. It is not enough to have policies and procedures in place but to regularly monitor whether they are being followed. Today's health data is liquid and it can flow in many directions. Providers need to understand where and how data is stored, used and transferred.

CMS and ONC Issue Rules on Proposing a Definition of Meaningful Use and Setting Standards for EHR Incentive Program

Yesterday the Centers for Medicare & Medicare Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) issued two regulations laying the foundation for improving quality, efficiency and safety through meaningful use of certified electronic health record (EHR) technology.

The two regulations are part of the implementation of the EHR incentive programs for physicians and hospitals enacted under the HITECH provisions of the American Recovery and Reinvestment Act of 2009 (ARRA). CMS issued a proposed rule outlining the proposed provisions governing the EHR incentive programs, including defining the central concept of “meaningful use” of EHR technology. ONC issued an interim final regulation setting forth the initial standards, implementation specifications, and certification criteria for EHR technology.

For more details see the following CMS Press Release. Also, CMS has issued Fact Sheets on the proposed regulations:

• CMS Proposes Requirements for the Electronic Health Records (EHR) Medicaid Incentive Payment Program
  
• CMS Proposed Requirements for the Electronic Health Records (EHR) Medicare Incentive Program
  
• CMS Proposes Definition of Meaningful Use of Certified Electronic Health Records (EHR) Technology

Below are links to complete copies of the rules. Once they are published in the Federal Register I will update with the specific Fed Reg details. Some light reading for the New Year!

Medicare and Medicaid Programs; Electronic Health Record Incentive Program
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Proposed rule.
SUMMARY: This proposed rule would implement the provisions of the American Recovery and Reinvestment Act of 2009 (ARRA) (Pub. L. 111-5) that provide incentive payments to eligible professionals (EPs) and eligible hospitals participating in Medicare and Medicaid programs that adopt and meaningfully use certified electronic health record (EHR) technology. The proposed rule would specify the-- initial criteria an EP and eligible hospital must meet in order to qualify for the incentive payment; calculation of the incentive payment amounts; payment adjustments under Medicare for covered professional services and inpatient hospital services provided by EPs and eligible hospitals failing to meaningfully use certified EHR technology; and other program participation requirements. Also, as required by ARRA the Office of the National Coordinator for Health Information Technology (ONC) will be issuing a closely related interim final rule that specifies the Secretary’s adoption of an initial set of standards, implementation, specifications, and certification criteria for electronic health records. ONC will also be issuing a notice of proposed rulemaking on the process for organizations to conduct the certification of EHR technology.

Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology
AGENCY: Office of the National Coordinator for Health Information Technology,
Department of Health and Human Services.
ACTION: Interim final rule.
SUMMARY: The Department of Health and Human Services (HHS) is issuing this interim final rule with a request for comments to adopt an initial set of standards, implementation specifications, and certification criteria, as required by section 3004(b)(1) of the Public Health Service Act. This interim final rule represents the first step in an incremental approach to adopting standards, implementation specifications, and certification criteria to enhance the interoperability, functionality, utility, and security of health information technology and to support its meaningful use. The certification criteria adopted in this initial set establish the capabilities and related standards that certified electronic health record (EHR) technology will need to include in order to, at a minimum, support the achievement of the proposed meaningful use Stage 1 (beginning in 2011) by eligible professionals and eligible hospitals under the Medicare and Medicaid EHR Incentive Programs.

HIPAA Enforcement Meets HITECH: HIPAA Administrative Simplification: Enforcement Rule

On October 30, 2009, the Secretary of the Department of Health and Human Services (HHS) issued the HIPAA Administrative Simplification: Enforcement Interim Final Rule, 45 CFR Part 160 (74 Federal Register 56123, October 30, 2009).

This new rule was developed and adopted by HHS to conform the enforcement regulations under HIPAA to the revisions made to HIPAA under the Health Information Technology for Economic and Clinical Health Act (HITECH), which was part of the American Recovery and Reinvestment Act of 2009 (ARRA).

The rule amends the HIPAA enforcement regulations to include the imposition of tiered ranges for civil money penalty amounts based upon an increasing culpability associated with the violation. A full chart of the violation categories and related amounts can be found in the rule.

The interim final rule is effective on November 30, 2009. Comments on the rule can be made prior to December 29, 2009.

Congressional Members Concerned About HHS Inclusion of "Harm Standard" In Breach Notification Rule

Members of the U.S. House of Representative submitted an October 1, 2009 letter of concern to Secretary Sebelius and the Department of Health and Human Services (HHS) concerning inclusion of a "harm standard" in the recently released(August 24, 2009) Interim Final Rule - Breach Notification for Unsecured Protected Health Information (45 CFR Part 160 and 164) 74 Fed. Reg. 42740.

HHS in developing the Interim Final Rule interpreted the term "compromises" as meaning that a threshold substantial harm standard should be included when determining whether a breach of data has occurred. However, the Members indicate in their letter that they considered whether a "harm standard" should be a part of the legislation and decided not to include such a standard. The letter urges HHS to revise and repeal the harm standard provisions included in the Interim Final Rule.

The letter was submitted by Rep. Henry Waxman, Rep. Charles Rangel, Rep. John Dingell, Rep. Frank Pallone, Jr., Rep. Pete Stark and Rep. Joe Barton.

Tip to Alan Goldberg, health care attorney and American Health Lawyer Association HIT Listserve Moderator, who posted a copy of the letter.

ARRA - HITECH: Health Care Information Breach Notification Regulations Now In Effect

Have you had a health data security breach? Do you know what a health data breach is? Are you required to notify individuals impacted by the breach? Do you have to notify federal agencies of such breach?

Read on for more information regarding the Office for Civil Right (OCR) and Federal Trade Commission (FTC) regulations requiring health care providers and other health data business vendors to assess and in some cases notify and report health information data breaches under the new federal law created by ARRA-HITECH.

The new regulations went into effect on September 23, 2009 and September 24, 2009, respectively, with a full compliance date of February 22, 2010. Health care providers covered under HIPAA and third party users of health information, including personal health record (PHR) companies and vendors, PHR related entities, health 2.0 companies and other third party health data service providers, should examine the regulations and understand the impact on their business.

The regulations require entities to develop internal compliance processes to act upon and advise individuals of data breaches that pose a significant risk of financial, reputational or other harm to the affected individual. The OCR regulations apply mainly to covered entities and business associates under HIPAA and the FTC regulations apply mainly to PHR vendors and PHR related entities. The regulations define a "breach" and set forth the time frames and scope of notification required. The regulations require the tracking and reporting of such data breaches to OCR and FTC. Also, OCR has published separate guidance specifying the technology and methods that will render health information unusable, unreadable and undecipherable as defined under ARRA-HITECH.

OCR has provided a summary of the breach notification rule on its website. OCR has also published instructions for reporting breaches to the HHS Secretary. The instructions include details for reporting "Breaches Affecting 500 or More Individuals" and "Breaches Affecting Fewer than 500 Individuals." OCR will also maintain a list of reported breaches that impact 500 or more individuals. The FTC also has a section on its website providing information on its health breach notification rule.

Below are links to the full regulation text:

• OCR Interim Final Rule - Breach Notification for Unsecured Protected Health Information (45 CFR Part 160 and 164) 74 Fed. Reg. 42740 (Aug 24, 2009).
  

• OCR Guidance Specifying the Technologies and Methodologies That Render Protected Health Information Unusable, Unreadable, or Indecipherable to Unauthorized Individuals for Purposes of the Breach Notification Requirements Under Section 13402 of Title XIII (Health Information Technology for Economic and Clinical Health Act) of the American Recovery and Reinvestment Act of 2009; Request for Information 74 Fed. Reg. 19006 (April 27, 2009).
  

• Federal Trade Commission: Health Breach Notification Rule: Final Rule -- Issued Pursuant to the American Recovery and Reinvestment Act of 2009 -- Requiring Vendors of Personal Health Records and Related Entities To Notify Consumers When the Security of Their Individually Identifiable Health Information Has Been Breached (16 CFR Part 318) 74 Fed. Reg. 42962 (Aug 25, 2009). The FTC has also issued a Breach Notification Form.

UPDATE (July 29, 2010):

Today the OCR/HHS issued a statement that the OCR Interim Final Rule listed above and published on August 24, 2010, is being withdrawn from the Office of Management and Budget (OMB). The full notice published on the OCR website states:

Breach Notification Final Rule Update

The Interim Final Rule for Breach Notification for Unsecured Protected Health Information, issued pursuant to the Health Information Technology for Economic and Clinical Health (HITECH) Act, was published in the Federal Register on August 24, 2009, and became effective on September 23, 2009. During the 60-day public comment period on the Interim Final Rule, HHS received approximately 120 comments.

HHS reviewed the public comment on the interim rule and developed a final rule, which was submitted to the Office of Management and Budget (OMB) for Executive Order 12866 regulatory review on May 14, 2010. At this time, however, HHS is withdrawing the breach notification final rule from OMB review to allow for further consideration, given the Department’s experience to date in administering the regulations. This is a complex issue and the Administration is committed to ensuring that individuals’ health information is secured to the extent possible to avoid unauthorized uses and disclosures, and that individuals are appropriately notified when incidents do occur. We intend to publish a final rule in the Federal Register in the coming months.

West Virginia's Statewide Health Information Technology Strategic Plan

Over the past several months I have been involved with a group in developing West Virginia's statewide strategic plan for health information technology.

The final draft of the West Virginia Health Information Technology Statewide Strategic Plan, September 2009 is now available for review and comment. Additional comments and feedback on the strategic plan are welcome.

The strategic plan is a part of West Virginia's efforts to position itself as a national leader in implementing and adopting health information technology to improve our health care system. The strategic plan will be a part of the the state's efforts to submit applications to the Office of the National Coordinator for Health Information Technology (ONC) for funding under the State Health Information Exchange Cooperative Agreement Program and the Health Information Technology Extension Program: Regional Centers Cooperative Agreement Program, both programs developed under the American Recovery and Reinvestment Act of 2009, Title XIII - Health Information Technology, Subtitle B.

The project has been lead by the Adoption of Health Information Technology Workgroup under the West Virginia Health Improvement Institute. Both private and public stakeholders from across West Virginia have collaborated and provided input into the development of the strategic plan.