CMS-2319-P: Proposed HHS Rule on Providing Patients' Greater Access to Test Reports

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On September 14, 2011 HHS Secretary Kathleen Sebelius proposed amendments to the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations and the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule that would allow authenticated patients or their representatives to receive test reports directly from laboratories if requested.

Current law limits a lab’s disclosure of a diagnostic test to three categories of person:

1. The “authorized person”, defined as the individual authorized under State law to order or receive test results.

2. The person responsible for using the test results in the treatment context.

3. The referring lab (in the case of a reference laboratory)

The proposed rule would remove these exceptions for CLIA-certified and CLIA-exempt laboratories from the provision that otherwise guarantees access for individuals to their personal health information.1


Context of the Proposed Rule

The proposed rule comes at the close of a decade that has seen a shift from a model of health care that is provider-centric and paternalistic to a model that is more consumer-driven and empowering.2,3 The impetus for this shift is credited to the Institute of Medicine’s 1999 report “To Err is Human: Building a Safer Healthcare System”.4 In justifying these amendments, the Office of the Secretary provides the following rationale:

“While individuals can obtain test results through the ordering provider, we believe that the advent of certain health reform concepts (for example, individualized medicine and an individual's active involvement in his or her own health care) would be best served by revisiting the CLIA limitations on the disclosure of laboratory test results.”


Implications of the Proposed Rule on Current Process

The rule would guarantee patients access to their test results in the form of their choosing: electronic or otherwise. Additionally, “if it is readily producible in such a form and format”, the individual may elect to receive the information in the electronic format of their choosing. This may have implications for tethered personal health records provided by an institution with its own laboratory, potentially requiring display and download provisions for a patient’s lab data through the patient portal.

The proposed rule does not specify how a patient’s request would be submitted, processed or responded to by the labs; nor does the proposed rule alter the provision that covered entities providing copies of personal health information may charge a reasonable, cost-based fee. The fee should be directly linked to the cost of producing a copy of the information and the cost of any media, such as CDs, for making those copies.


Implications of the Proposed Rule for the States

In general, HIPAA allows for States to have more stringent privacy rules than the federal standard. In the case of the proposed amendment, “more stringent” has been defined to be a State law that “permits greater rights of access or amendment, as applicable". Hence, the proposed changes would effectively preempt any contrary State laws that prohibit the release of personal health information from a covered lab directly to a patient.

As of February 19, 2013, 23 states have no laws addressing the issue and 13 other states expressly forbid this type of disclosure:5

- States That Allow Direct Patient Reporting Without Provider Approval: Delaware, Maryland, New Hampshire, New Jersey, Nevada, Oregon, West Virginia

- States That Prohibit Direct Patient Reporting: Arkansas, Georgia, Hawaii, Illinois, Kansas, Maine, Missouri, Pennsylvania, Rhode Island, Tennessee, Washington, Wyoming

- States That Allow Direct Patient Reporting Only With Provider Approval: California, Connecticut, Florida, Massachusetts, Michigan, New York, Virginia

- States With No Laws on the Issue: Alabama, Alaska, Arizona, Colorado, Idaho, Indiana, Iowa, Kentucky, Louisiana, Minnesota, Mississippi, Montana, Nebraska, New Mexico, North Carolina, North Dakota, Ohio, Oklahoma, South Carolina, South Dakota, Texas, Utah, Vermont


Response to the Proposed Rule

The response to the rule has been generally positive, although at times cautionary.

The National Business Group of Health, representing 347 large employers who voluntarily provide health benefits, “wholeheartedly supports the proposed regulatory changes and strongly urges you to issue a final rule so that patients can gain direct access to their laboratory test results regardless of their state of residence.”6 The group requests that the rule mandate that patients receive the same report as the physician, that any waiting period on accessing the results is limited to 48 hours, and that fees are kept affordable.

A collective of executives, academics and physicians also put forth a public response the rule, firmly supporting the changes, and viewing them as a core necessity to achieving patient engagement, fulfilling the promise of electronic records, and maximizing healthcare quality and patient safety.7

Although supporting the rule, physician groups have been more cautionary. The College of American Pathologists, fearing a disruption of the physician-patient relationship, desires that labs not be required to release test results to a patient in advance of release of those results to the ordering physician outside of emergency circumstances. They also support the maintenance of the current 30-day time-frame in which to respond to patients’ requests to inspect and copy results.8 The American College of Physicians warns of issues with misinterpretation, “both unwarranted concerns and inappropriate reassurances”, and cautions that lab data may not be reliable when taken out of context. They propose that text such as the following be amended to all released reports:9

“Note: Lab test results are reported as a positive or negative, or more often they show whether or not your results fall within a normal range. Normal values vary from person to person and normal test results may not exclude a health problem. Abnormal values also don't always indicate the presence of disease. Some laboratory tests are precise, reliable indicators of specific health problems, while others only provide more general information about your health condition. These laboratory results are just part of the information you and your physician/other health care professional (add name and phone number, according to the laboratory’s records) should use to make decisions about your health care.If you do not have a follow-up appointment with your physician in the near future, you should contact him/her if you have any questions about this report or your treatment plan.”

The Office of Legislative Research in Connecticut (OLR), a state that allows this type of reporting only with provider approval, expresses concerns with the pre-empting of state legislation, explaining that this prohibition is “designed to protect the patient by insuring proper explanation and interpretation of laboratory findings, and avoiding possible harmful misinterpretations.”5 The OCR proposes the following alterations to the rule:

1. Limit the types of tests patients can directly access.

2. Require provider notification before labs release test results to patients.

3. Implement a waiting period before labs release test results to give physicians and opportunity to discuss results prior to their release.


The concept of a waiting period or “embargo” has been echoed by several commentators, even prior to the proposed changes.10,11

The topic has also been the subject of an editorial in the Journal of the American Medical Association,10 and a recent topic of debate in the Society of General Internal Medicine Forum.12,13,14 Dave deBronkart, one of the debaters and an online patient empowerment advocate, while calling for greater care in the linking of educational material to lab results and a greater attention to the display format of labs, still admits that a strong relationship with a clinician is paramount for interpretive accuracy. His goal is not to advocate for a world where patients “go it alone”, but rather a world where the patients are on a more egalitarian footing as it comes to their health.


References

1. CLIA Program and HIPAA Privacy Rule; Patients' Access to Test Reports: Department of Health and Human Services, Centers for Medicare and Medicaid Services. Federal Register. 2011 Sep 14;76(178):1–13. [1]

2. Eysenbach G, Diepgen TL. The role of e-health and consumer health informatics for evidence-based patient choice in the 21st century. Clin. Dermatol. 2001;19(1):11–7.

3. Runy LA. Consumers in control. How the Net will reshape health care. Hosp Health Netw. 2000. pages suppl4–7.

4. To Err Is Human: Building a Safer Health System: Institute of Medicine [Internet]. nap.edu. [cited 2012 Mar 5]. Available from: [2]

5. Dube N. Direct Patient Access to Lab Test Results [Internet]. Connecticut Office of Legislative Research. [cited 2013 Mar 10]. Available from: [3]

6. Darling H. Re: RIN 0938-AQ38, CLIA Program and HIPAA Privacy Rule; Patients' Access to Test Reports [Internet]. National Business Group on Health. [cited 2013 Mar 10]. Available from: [4]

7. Angrist M, Bobe J, Barth-Jones DC, Campos H, Chopra A, Bechtel C, et al. A Consensus Letter
to the HHS Office of Civil Rights and the Centers for Medicare and Medicaid Services on the Need to Finalize the Proposed Rule to
Expand the Rights of Patients to Access their Test Results [Internet]. 2012 [cited 2013 Mar 10]. Available from: [5]

8. Re: CMS-2319-P [Internet]. College of American Pathologists. 2011 [cited 2013 Mar 10]. Available from: [6]

9. Hatton D. [Internet]. American College of Physicians. 2011 [cited 2013 Mar 10]. Available from: [7]

10. Davis Giardina T, Singh H. Should patients get direct access to their laboratory test results? An answer with many questions. JAMA. 2011 Dec 14;306(22):2502–3.

11. Wiljer D, Urowitz S, Apatu E, DeLenardo C, Eysenbach G, Harth T, et al. Patient accessible electronic health records: exploring recommendations for successful implementation strategies. J. Med. Internet Res. 2008;10(4):e34.

12. Delbanco T, Walker J. Benefits from Destroying the Black Box (or Are We Opening Pandora’s Box?). SGIM Forum. 2012 Feb 1;35(2):2, 12, 14–5.

13. deBronkart D. Let Patients Help. SGIM Forum. 2012 Feb 1;35(2):5, 13.

14. Olson D. Patient Access to Electronic Records: Not Now. SGIM Forum. 2012 Feb 1;35(2):4, 12.

Submitted by Trevor Jamieson