Proposed Rules Released Regarding Business Associate Agreements and HITECH Updates to HIPAA

On July 14, 2010, the Federal Register published the “Modifications to the HIPAA Privacy, Security, and Enforcement Rules Under the HITECH Act – Proposed Rules.”  Comments related to the Proposed Rule are due on September 13, 2010 and can be submitted and accessed at www.regulations.gov.

“The proposed modifications to the HIPAA Rules include provisions extending the applicability of certain of the Privacy and Security Rules’ requirements to the business associates of covered entities, establishing new limitations on the use and disclosure of protected health information for marketing and fundraising purposes, prohibiting the sale of protected health information, and expanding individuals’ rights to access their information and to obtain restrictions on certain disclosures of protected health information to health plans.  In addition, the proposed rule adopts provisions designed to strengthen and expand HIPAA’s enforcement provisions.” – HHS

Key provisions of the Proposed Rule regarding Business Associates include:

  • Allowance of additional time to revise Business Associate agreements to bring them into compliance with the HITECH Act, including continued operation under the existing Business Associate agreements for up to one year beyond the compliance date.
  • Subcontractors of Business Associates will be required to enter into business associate agreements with the Business Associate.  Business Associate aware of noncompliance by a subcontractor is required to respond by curing the noncompliance (breach) or terminating the agreement.
  • Business Associates subject to potential civil and criminal penalties.

Key provisions of the Proposed Rule regarding HIPAA include:

  • Many provisions of the HITECH Act took effect on February 18, 2010, however OCR intends to allow 180 days after the final rules come into effect for entities to come into compliance.
  • Authorization requirements for disclosures of PHI in exchange for remuneration.
  • Update to the  marketing rules.
  • Restrictions on disclosures to health plans if the patient pays out-of-pocket.
  • Patient rights to receive electronic copies of their PHI.
  • Updates to the Notice of Privacy Practices.

To read more about the Proposed Rule click here.

If you have questions regarding the Proposed Rule or if you need assistance in drafting a comment please contact Elana Zana.

249 Members of Congress Urge CMS to Revise Meaningful Use and Incentive Eligibility

In a letter submitted to CMS on March 15th, Members of Congress encouraged CMS to revise its proposed definition of meaningful use and the restrictions on the EHR incentive payments.  The letter covered three topics:

1) the definition of Meaningful Use;

2) the definition of Hospital-Based Physician; and

3) the limitation on payments to Multi-Campus hospitals.

Specifically, the letter discussed the application of the meaningful use requirements for both Medicare and Medicaid and urged CMS to relax the restrictions and the broad scope of the definition.  The letter recommends that CMS modify the hospital-based definition to allow incentive payments for physicians that furnish services in hospital-owned ambulatory settings by excluding those physicians from the definition of hospital-based.  Lastly, the letter requests that CMS identify hospitals as discrete facilities regardless of whether the hospital is part of a multi-hospital system operating under the same Medicare provider number.

HHS Issues Proposed Establishment of Certification Programs for Health Information Technology

HHS released today the proposed certification standards for Health Information Technology.  To view these standards click here.  Comments are due May 10, 2010.

Summary of the Rule’s purpose: 

 “This rule proposes the establishment of two certification programs for purposes of testing and certifying health information technology. While two certification programs are described in this proposed rule, we anticipate issuing separate final rules for each of the programs. The first proposal would establish a temporary certification program whereby the National Coordinator would authorize organizations to test and certify Complete EHRs and/or EHR Modules, thereby assuring the availability of Certified EHR Technology prior to the date on which health care providers seeking the incentive payments available under the Medicare and Medicaid EHR Incentives Program may begin demonstrating meaningful use of Certified EHR Technology. The second proposal would establish a permanent certification program to replace the temporary certification program. The permanent certification program would separate the responsibilities for performing testing and certification, introduce accreditation requirements, establish requirements for certification bodies authorized by the National Coordinator related to the surveillance of Certified EHR Technology, and would include the potential for certification bodies authorized by the National Coordinator to certify other types of health information technology besides Complete EHRs and EHR Modules.”

  

HHS has also published a short fact sheet on the proposed rule and FAQ

 
 
 

 

Comments on Meaningful Use and EHR Incentives Proposed Rule Accepted Through March 15th

At the end of the year, CMS finally issued the much anticipated Electronic Health Record Incentive Payments proposed rule, including the definition of “meaningful use.” CMS has also published fact sheets to help distill the information:

Fact Sheet on Medicaid Incentive Payments

Fact Sheet on Medicare Incentive Payments

Fact Sheet on the Definition of Meaningful Use 

Physicians and Hospitals are encouraged to comment on the proposed rule through March 15th.  Some specific hot topics include: the definition of meaningful use, the exclusion of provider-based physicians from incentive payments, calculation for Critical Access Hospital Medicare incentive payments, exclusion of Critical Access Hospitals in Medicaid incentive payments, and the requirements for certified EHR systems. 

To view some of the submitted comments so far go to: www.regulations.gov.

The American Hospital Association also encourages hospitals to send out this comment letter.

If you are interested in drafting your own comment and require some assistance please contact Elana Zana or Dave Schoolcraft.

CMS Teleconference on HITECH Act and EHR Proposed Regulations

CMS hosted a teleconference today to review the proposed Medicare & Medicaid EHR Incentive regulations.  The presentation provides a good overview of the eligibility for incentive payments as well as the definition of meaningful use.  CMS has posted its presentation and will be posting an audio recording of the presentation here

Public comments on the proposed rule will be accepted until 5 PM on March 15, 2010.  To view comments already submitted to CMS go to: www.regulations.gov and put in the Keyword or ID: CMS-2009-0117-0002.  Persons or entities that wish to comment may do so on electronically by submitting the comments to www.regulations.gov and refer to file code CMS-0033-P.  If you want assistance drafting these comments please contact Elana Zana or David Schoolcraft.

Regional Extension Centers & State HIE Awards Announced

On Friday, HHS announced the Regional Extension Center (“REC”) awards and the State Health Information Exchange (“HIE”) awards.  The funding for these programs comes from the Recovery Act and is part of the EHR initiative.  The State HIE money is aimed at facilitating state-wide health information exchange.  The purpose of the RECs is to assist health professionals in implementing health information technology and EHRs. 

The State of Washington received $11.3 million for HIE and Qualis Health was awarded the Washington REC designation and approximately $12.8 million dollars.  The State of Washington will work with OneHealthPort in implementing the State HIE strategies. 

To read the HHS press release click here.

To read Dr. David Blumenthal’s (ONC) blog article regarding the awards click here.

HHS Issues Meaningful Use & EHR Incentive Payment Proposed Regulations

The much awaited proposed regulations regarding the ARRA incentive funds and “meaningful use” have finally been released. HHS has issued the proposed rules for the Medicare & Medicaid Programs & EHR Incentive Program (556 pages) and the Health Information Technology Initial Set of Standards, Implementation, Specifications and Certification Criteria for EHR Technology, including the definition of meaningful use (136 pages).

HHS has also released fact sheets to assist in destilling the proposed requirements.  To view these fact sheets click here.

More information regarding the various contents of these regulations will follow in subsequent blog posts.  If you have specific questions please contact Elana Zana or David Schoolcraft.

Health Information Exchange

Earlier this month Dr. David Blumenthal, National Coordinator for Health Information Technology, published a letter describing the benefits of health information exchange.  In his letter, Dr. Blumenthal highlights four aims of health information exchange in the HITECH Act:

  • It squarely tackles commercial barriers
  • It tackles the economic barriers
  • It tackles the technical barriers
  • It provides building blocks for information exchange across jurisdictions 

In Washington,  OneHealthPort has been designated the lead organization for Washington Health Information Exchange.  Approximately $11.3 Million of federal funding is expected during the first quarter of 2010 for Washington based health information exchange activities. 

To read Dr. Blumenthal’s letter in its entirety please click here.

HIT Policy Committee Meeting Re: Meaningful Use for Specialists & Smaller Practices/Hospitals

The Office of the National Coordinator published this recent announcement:

The HIT Policy Committee will be holding a two-day meeting, October 27 and October 28, focusing on specialists, smaller physician practices, small community hospitals, etc. The Recovery Act requires not just adoption of health information technology (HIT) but also meaningful use of the information to improve care. To demonstrate meaningful use, the Policy Committee has chosen to focus on HIT-enabled quality measures that are both process and outcomes oriented. Most of the initial measures proposed for 2011 focused on primary care providers because of the availability of those measures. This hearing seeks input from various groups that may not be adequately addressed by the initial measures proposed, such as specialists, non-physician practitioners, smaller physician practices, safety net providers, and small community hospitals.

For more information click here.

Final Meaningful Use Matrix

Recently, Dr. David Blumenthal, the National Coordinator for Health Information Technology, issued a press release regarding “meaningful use” and the recommendations of the HIT Policy Committee.  The HIT Policy Committee was charged with making recommendations regarding the definition of meaningful use and certification and adoption standards.  As part of its recommendation, the HIT Policy Committee submitted a matrix of health outcomes and objectives to be achieved in 2011, 2013 and 2015.  To view the matrix click here.

The health outcome policy priorities described in the matrix include:

  • Improve quality, safety, efficiency, and reduce health disparities;
  • Engage patients and families;
  • Improve care coordination;
  • Improve population and public health; and
  • Ensure adequate privacy and security protections for personal health information.

Though the date is still to be determined, the HIT Policy Committee plans on having an informational hearing regarding its recommendations in October.  HHS plans on releasing the proposed rule in December and will have a public comment period in early 2010.