Showing posts with label Federal Register. Show all posts
Showing posts with label Federal Register. Show all posts

Tuesday, June 01, 2010

Credentialing and Privileging Telemedicine Physician and Practitioner

Last week the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule revising the conditions of participation (CoPs) for hospitals and critical access hospitals allowing for a new credentialing and privileging process for physicians and practitioners who provide telemedicine services. The proposed rule should make it easier on smaller hospital (especially critical access hospitals) who don't have the in-house medical staff to adequately evaluate and privilege a wide range of specialty physicians who provide services through telemedicine.

The proposed rule was published in the Federal Register on May 26, 2010, and titled, Credentialing and Privileging of Telemedicine Physicians and Practitioners, 75 Fed Reg 29479 (May 26, 2010). Comments on the proposed rule must be submitted by July 26, 2010.

Traditionally the CoPs have required the governing body of the hospital to make all privileging decisions based on the recommendations of its medical staff using specific criteria. Hospitals often use third-party credentialing verification services to assist in compiling the voluminous documents needed to verify credentialing and then have the governing body of the hospital review and sign off on the privileging decision.

The proposed rule points out that there has been a Joint Commission standard policy that allows "privileging by proxy," which has been in direct conflict with CoPs. "Privileging by proxy" allows Joint Commission accredited hospitals to utilize a different methodology to privilege"distant-site" physicians and practitioners. Basically, allowing one Joint Commissioned accredited hospital to accept the privileging decisions of another Joint Commissioned accredited hospital. In the past, hospitals were deemed (deemed status) to meet the CoPs if they were accredited by the Joint Commission. However, changes in the Medicare Improvement for Patients and Providers Act of 2008 (MIPPA) will halt (effective July 15, 2010) the statutory recognition of the Joint Commission's hospital accreditation program and now requires the Joint Commission to meet CMS standards in order to confer Medicare deemed status.

CMS has decided that requiring each hospital to independently privilege providers is a duplicative and burdensome process, especially for small hospitals who often use telemedicine services from larger academic medical centers and hospitals to provide access to needed specialty services. Thus, CMS is proposing in the rule to revise the hospital credentialing and privileging requirements to allow a hospital who obtains telemedicine services by agreement with another hospital that the agreement can specify that the hospital providing the telemedicine services is responsible for credentialing the telemedicine provider and can provide this information to the medical staff of the hospital receiving the telemedicine services who can then rely upon the credentialing and privileging decisions of the hospital providing the telemedicine services.

For a more detailed discussion and understanding of the proposed revisions read the proposed rule in the May 26, 2010, Federal Register.

Monday, May 03, 2010

OCR Request for Information: HIPAA Privacy Rule Accounting of Disclosures under HITECH

Today the Office for Civil Rights (OCR), Department of Health and Human Services issued a Request for Information titled HIPAA Privacy Rule Accounting of Disclosures Under the Health Information Technology for Economic and Clinical Health Act (75 Fed Reg 23214 May 3, 2010). More information at the OCR website.

The Request for Information by OCR seeks comments from health consumers and health care providers/organizations. OCR seeks information on the following areas:
  • Understanding the interests of individuals (health consumers) with respect to learning of such disclosures; and
  • The administrative burden on covered entities (health care providers/organizations) and business associates of accounting for such disclosures.
The Request for Information states that Section 13405(c) of the Health Information Technology for Economic and Clinical Health (HITECH) Act expands an individual’s right under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule to receive an accounting of disclosures of protected health information made by HIPAA covered entities and their business associates. In particular, section 13405(c) of the HITECH Act requires that the HIPAA Privacy Rule be amended to require covered entities to account for disclosures of protected health information to carry out treatment, payment, and health care operations if such disclosures are through an electronic health record.

The Request for Information requests specific comments on the following nine questions:

1. What are the benefits to the individual of an accounting of disclosures, particularly of disclosures made for treatment, payment, and health care operations purposes?

2. Are individuals aware of their current right to receive an accounting of disclosures? On what do you base this assessment?

3. If you are a covered entity, how do you make clear to individuals their right to receive an accounting of disclosures? How many requests for an accounting have you received from individuals?

4. For individuals that have received an accounting of disclosures, did the accounting provide the individual with the information he or she was seeking? Are you aware of how individuals use this information once obtained?

5. With respect to treatment, payment, and health care operations disclosures, 45 CFR 170.210(e) currently provides the standard that an electronic health record system record the date, time, patient identification, user identification, and a description of the disclosure. In response to its interim final rule, the Office of the National Coordinator for Health Information Technology received comments on this standard and the corresponding certification criterion suggesting that the standard also include to whom a disclosure was made (i.e., recipient) and the reason or purpose for the disclosure. Should an accounting for treatment, payment, and health care operations disclosures include these or other elements and, if so, why? How important is it to individuals to know the specific purpose of a disclosure— i.e., would it be sufficient to describe the purpose generally (e.g., for ‘‘for treatment,’’ ‘‘for payment,’’ or ‘‘for health care operations purposes’’), or is more detail necessary for the accounting to be of value? To what extent are individuals familiar with the different activities that may constitute ‘‘health care operations?’’ On what do you base this assessment?

6. For existing electronic health record systems:
(a) Is the system able to distinguish between ‘‘uses’’ and ‘‘disclosures’’ as those terms are defined under the HIPAA Privacy Rule? Note that the term ‘‘disclosure’’ includes the sharing of information between a hospital and physicians who are on the hospital’s medical staff but who are not members of its workforce.
(b) If the system is limited to only recording access to information without regard to whether it is a use or disclosure, such as certain audit logs, what information is recorded? How long is such information retained? What would be the burden to retain the information for three years?
(c) If the system is able to distinguish between uses and disclosures of information, what data elements are automatically collected by the system for disclosures (i.e., collected without requiring any additional manual input by the person making the disclosure)? What information, if any, is manually entered by the person making the disclosure?
(d) If the system is able to distinguish between uses and disclosures of information, does it record a description of disclosures in a standardized manner (for example, does the system offer or require a user to select from a limited list of types of disclosures)? If yes, is such a feature being utilized and what are its benefits and drawbacks?
(e) Is there a single, centralized electronic health record system? Or is it a decentralized system (e.g., different
departments maintain different electronic health record systems and an accounting of disclosures for treatment,
payment, and health care operations would need to be tracked for each system)?
(f) Does the system automatically generate an accounting for disclosures under the current HIPAA Privacy Rule (i.e., does the system account for disclosures other than to carry out treatment, payment, and health care
operations)?
i. If yes, what would be the additional burden to also account for disclosures to carry out treatment, payment, and health care operations? Would there be additional hardware requirements (e.g., to store such accounting information)? Would such an accounting feature impact system performance?
ii. If not, is there a different automated system for accounting for disclosures, and does it interface with the electronic health record system?

7. The HITECH Act provides that a covered entity that has acquired an electronic health record after January 1, 2009 must comply with the new accounting requirement beginning January 1, 2011 (or anytime after that date when it acquires an electronic health record), unless we extend this compliance deadline to no later than 2013. Will covered entities be able to begin accounting for disclosures through an electronic health record to carry out treatment, payment, and health care operations by January 1, 2011? If not, how much time would it take vendors of electronic health record systems to design and implement such a feature? Once such a feature is available, how much time would it take for a covered entity to install an updated electronic health record system with this feature?

8. What is the feasibility of an electronic health record module that is exclusively dedicated to accounting for disclosures (both disclosures that must be tracked for the purpose of accounting under the current HIPAA Privacy Rule and disclosures to carry out treatment, payment, and health care operations)? Would such a module work with covered entities that maintain decentralized electronic health record systems?

9. Is there any other information that would be helpful to the Department regarding accounting for disclosures
through an electronic health record to carry out treatment, payment, and health care operations?

Written comments to OCR must be submitted on or before May 18, 2010.

Friday, March 26, 2010

DEA Interim Final Rule on Electronic Prescribing of Controlled Substances

On March 24, 2010, the Drug Enforcement Administration (DEA) released the Interim Final Rule with Request for Comments on Electronic Prescribing of Controlled Substances.

The Interim Final Rule outlines the procedures for health care providers to electronically prescribe controlled substances. The DEA has revised its regulations to provide practitioners with the option of writing prescriptions for controlled substances electronically and permit pharmacies to receive, dispense and archive these electronic prescriptions.

The Interim Final Rule will be officially published in the Federal Register on Wednesday, March 31, 2010 and will include a 60 day comment period.

Sunday, May 06, 2007

Justia's RSS Federal Register

Do you have a need to monitor the federal rules, proposed rules and orders on a particular topic or particular agency? If so, Justia's Regulation Tracker to the rescue. A very useful tool for those of us in the highly regulated world of health care.

Thanks to Tom Mighell at inter alia I just learned about this new feature. I've added a couple of test RSS feeds on topics that I regularly try to monitor. You can also browse by government agency. I've been using Justia's federal court filings RSS feeds for a while to monitor cases filed in the Southern and Northern Districts of West Virginia but wasn't aware of this new federal rule tracker.