Health IT Law Blog : Health IT Law Blog : Post & Schell: Law Firm : HIT & Electronic Health Records

On March 24, 2010, the U.S. Drug Enforcement Administration (DEA) released its interim final rule allowing electronic prescriptions of controlled substances.  According to the DEA, e-prescribing of controlled substances will help reduce paperwork, prescription fraud and errors.  Patients are also quite likely to be pleased by this more convenient and accurate way of filling their prescriptions.

According to Healthcare IT News, "ONC, CMS, AHRQ and other HHS staff have worked closely with the [DEA] to develop the policies in the Interim Final Rule."

The Interim Final Rule is classified as a "major rule" and is therefore subject to Congressional review.  The Rule will be published in the Federal Register on March 31, 2010, but you can preview the unofficial version here.

You can also download the unofficial version of the Rule by clicking here.

"E-Rx of controlled substances Interim Final Rule available," Healthcare IT News (March 25, 2010).

• Email This
• Print
• Comments
• Trackbacks
• Share Link

• Javelin Strategy & Research survey found over 275,000 cases of medical identity theft in 2009, with an average price tag greater than $12,000 per incident.  This is twice as many cases as in 2008.  Keeping health information safe is going to be of paramount importance in the next decade, especially considering the steep rise in use of electronic health records. According to Computerworld.com (citing a study by IDC, a research firm), "about a quarter of all Americans -- 77 million people -- already have an EHR, up from 14% from in 2009." By 2015, experts believe the number will reach up to 60%, partially due to the transformation of the health IT industry by the HITECH Act.

• In its comments to CMS regarding the meaningful use NPRM, College of Healthcare Information Management Executives (CHIME) insisted that the present "all or nothing" approach to achieving meaningful use is going to prevent significant numbers of eligible providers from receiving any incentive payments under the HITECH Act.  According to American Medical News:

Among CHIME's suggestions: a gradual implementation process that would allow physicians to qualify for incentives by achieving 25% of meaningful use objectives by 2011, 50% by 2013, 75% by 2015, and 100% by 2017.

'Without an approach that rewards progress or provides sufficient time, organizations with limited resources will likely have little chance of qualifying for payments, thus widening the 'digital divide' in the country,' CHIME wrote.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

Last Thursday, March 18, 2010, from 1:00PM to 2:00PM (EDT), Post & Schell hosted the second webinar in a series examining the effects of meaningful use and other HITECH Act regulations on the healthcare industry. 

The webinar focused on identifying and negotiating the essential elements of HIT agreements, particularly in light of the HITECH Act and related HHS regulations regarding "meaningful use" of "certified EHR technology." Post & Schell's Steve Fox and Vadim Schick, along with Jim Oakes, Principal at Health Care Information Consultants, discussed:

• Warranty, limitation of liability and privacy and security provisions in HIT contracts
• Structuring payments to correspond with certain achievement milestones
• Acceptance testing procedures
• Provisions specific to vendor-financing transactions
• ASP / SaaS models of software licensing

If you missed the presentation, you can listen to the podcast here. You can also view the slides from our presentation here.

This webinar was the second in a series devoted to structuring vendor-provider agreements in the post-HITECH Act world. If you missed our first webinar, A Lawyer's Take on "Meaningful Use," you can still view the slides from that presentation here.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

In a much-anticipated move, the Office of Civil Rights (OCR) within the Department of Health and Human Services has issued an update regarding delays of certain HITECH provisions, while confirming enforcement of others.  Via OCR press release:

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.

You can find about more here.

"HITECH Act Rulemaking and Implementation Update," OCR Press Release (March 18, 2010).

• Email This
• Print
• Comments
• Trackbacks
• Share Link

As if foreshadowing our upcoming webinar on negotiating EHR license agreements in the post-HITECH world, For the Record interviewed our own Steve Fox on this very subject in its February 15, 2010 cover story:

Steve Fox, senior partner and chair of the IT group at the law firm Post & Schell, says such strategies will be critical to an implementation’s ultimate success. For instance, he says vendors’ guarantees that their platform will meet meaningful use thresholds should be discounted.

“I’d be surprised if [satisfying] the final regulations will be achieved by a vendor doing anything,” he says. “Ultimately, it will be up to individual physicians’ offices or provider organization to achieve meaningful use, and in order to do it, they will need that vendor’s help. I have to laugh when I see those guarantees, ‘If you buy our product, you’ll achieve meaningful use,’ because nobody can make that claim. On the other hand, the failure of the vendor’s product can cause you to fail to achieve meaningful use. That’s why it is so important that you have tight provisions in the contract saying that whatever you want that vendor’s product to achieve, it will meet those particular objectives.

“Many vendors use the phrase ‘We don’t know what we don’t know’ as a way to say they can’t try to comply with future regulations, but our position is if you are in the HIT arena, you have to agree up front to comply with whatever they are,” he adds.

 

• Email This
• Print
• Comments
• Trackbacks
• Share Link

On Thursday, March 18, 2010, from 1:00PM to 2:00PM (EDT), Post & Schell will host the next webinar in a series examining the effects of meaningful use and other HITECH Act regulations on the healthcare industry. 

This webinar will focus on identifying and negotiating the essential elements of HIT agreements, particularly in light of the HITECH Act and related HHS regulations regarding "meaningful use" of "certified EHR technology." Post & Schell's Steve Fox and Vadim Schick, along with Jim Oakes, Principal at Health Care Information Consultants, will discuss:

• Warranty, limitation of liability and privacy and security provisions in HIT contracts
• Structuring payments to correspond with certain achievement milestones
• Acceptance testing procedures
• Provisions specific to vendor-financing transactions
• ASP / SaaS models of software licensing

You may view this presentation at your desk. There is no charge or limit to the number of people who may listen to the presentation on the same line. Click here to register. After registering, you will receive log-in information by e-mail.

This webinar is second in a series devoted to structuring vendor-provider agreements in the post-HITECH Act world. If you missed our first webinar, A Lawyer's Take on "Meaningful Use," you can still view the slides from that presentation here.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

ONC announced release of the much-anticipated Notice of Proposed Rulemaking (NPRM) on certification programs.  Via ONC Press Release:

Certification of Health IT will provide assurance to purchasers and other users that an EHR system, or other relevant technology, offers the necessary technological capability, functionality, and security to help them meet the meaningful use criteria established for a given phase. Providers and patients must also be confident that the electronic health IT products and systems they use are secure, can maintain data confidentially, and can work with other systems to share information. Confidence in health IT systems is an important part of advancing health IT system adoption and allowing for the realization of the benefits of improved patient care.

Eligible professionals and eligible hospitals who seek to qualify for incentive payments under the Medicare and Medicaid EHR Incentive Programs are required by statute to use Certified EHR Technology. Once certified, Complete EHRs and EHR Modules would be able to be used by eligible professionals and eligible hospitals, or be combined, to meet the statutory requirement for Certified EHR Technology.
 

• Email This
• Print
• Comments
• Trackbacks
• Share Link