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PAMED Seeks Clarification on Patient Test Results Law from Pa. Department of State

Last Updated: Sep 10, 2019

physician-senior-patientOne of the biggest regulatory issues on the minds of many Pennsylvania physicians involves the Patient Test Results Information Act and how the state plans to enforce compliance with the new law.

The law – known as Act 112 of 2018 – requires entities performing a diagnostic imaging service to directly notify the patient or patient’s designee when, in the judgment of the entity performing the test, a significant abnormality may exist.

Although Act 112 took effect on Dec. 23, 2018, the Pa. Department of Health (DOH) delayed enforcement of the law for one year to allow time for facilities to develop policies to address the new law. Enforcement will begin on Dec. 23, 2019.

PAMED Advocacy for Physicians on Act 112

In response to physician concerns about Act 112, the Pennsylvania Medical Society (PAMED) has recently taken these steps:

  • On Sept. 3, 2019, we reached out to the Pa. Department of State via letter, requesting a meeting to discuss implementation of the Patient Test Results Information Act. According to recently issued DOH guidance on Act 112 (see below for more details on DOH guidance on Act 112 compliance), any Act 112-related complaints against entities not licensed by DOH will be referred to the appropriate state licensure board for investigation and enforcement. In our letter, we asked to meet with the Department of State to gain a better understanding of how it will enforce Act 112 and establish procedures for handling complaints.
  • PAMED is currently advocating with lawmakers with the goal of amending Act 112. We believe that using the term “significant abnormality” to trigger patient notification is problematic because a significant abnormality is difficult, if not impossible, to define and may ultimately cause confusion for patients. We are pursuing amendments to the law to take into consideration the need for clarity, clinical relevance, and what is in the best interest of patients. 

DOH Guidance on Act 112 Compliance

DOH has issued clarifying guidance on Act 112 implementation and compliance. Licensed facilities will need to establish a policy addressing requirements of the law. The policy must include:

  • How and when patients will be notified if a significant abnormality is identified on a diagnostic test;
  • What information must be provided in the notification; and
  • What services the facility offers that fall within the Act’s definition of “diagnostic imaging services.”

DOH will also require a licensed facility’s policies to verify that a patient’s test result notification will contain each of the following items:

  • The name of the ordering health care practitioner
  • The date the test was performed
  • The date the results were sent to the ordering health care practitioner

For entities that are not required to be licensed per the state’s Health Care Facilities Act, DOH will refer any Act 112-related complaints to the appropriate agency, including the Pa. Department of State’s licensing boards.

Read DOH’s clarifying guidance as well as answers to FAQs here.

PAMED Resources on Act 112

We offer a Quick Consult fact sheet with additional information on the patient test results law. You’ll find details such as what is required to be in the notice, exceptions under the law, and acceptable methods of communication to the patient. Get the fact sheet.

PAMED members with questions can also contact our Knowledge Center at 855-PAMED4U (855-726-3348) or KnowledgeCenter@pamedsoc.org.


7 comments

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  1. Mark Tilyou | Aug 23, 2019

    ENOUGH ALREADY

    We have too many regs now.  Any little slip up with any new (and old) reg. will abcsoltely get the attention of the regulators.

    These people dont care how much good you do but they will punish you- thats what they do.  These people have had their

     power rush and will in a heart beat tell you that you must be guilty of something and any excuse to get their toe in the door

    and ultimately cause you harm.  We need to grow some and get these govt admin types out of our lives so we can do our job.

  2. Danae Powers | Dec 10, 2018

    Communicating the complex reality of clinical practice to a legislature/ regulatory agency  that thinks in black and white boiler plate language is a challenge. It is interesting that in the past it was much easier for a physician to communicate test results to a patient - especially the ones that needed follow up. Then we got HIPAA, EHR, ICD - X, physician extenders, prior authorization, required CME mandates that specified hoops and jumps, onerous credentialing regs, yada yada yada and docs spending less than 40% of their time in direct patient care -  and the communication time for critical results is disappearing. 

    what could possibly go wrong with even more micromanagement?

     

    Danae Powers

     

  3. PAMED Staff | Dec 06, 2018

    Thank you for your comment, Dr. Ehrenberger.  

    On her website, Rep. Quinn states, “I know three people, and have heard of too many others, who would likely be alive today if their early test results were communicated to them. Getting the information of a diagnosis to a patient can be as important as the diagnosis itself. It is my intention to ensure that despite the burdens on and the excessive paperwork in our physicians’ offices, communication of a significant abnormality will save lives.”

  4. Kristen Ehrenberger | Nov 22, 2018
    This does seem like unnecessary extra paperwork. I couldn't find any info on why Marguerite Quinn proposed the bill. Personal experience of a missed or delayed diagnosis?
  5. Steve Karp | Nov 16, 2018

    The point of my comment was, without any background information or knowledge of this Act, to draw out an inevitable boilerplate legal mumbo jumbo response, the ramifications of which practicing physicians have to contend with every day. Unfortunately the practice of medicine has become the practice of law. As a mild tongue in cheek response to this absurdity, see my article in the archives of American Thinker.

    Though voluminous comments I can make to the prepared statement above, it's interesting that cancer patients are excluded, likely at the behest of the Susan G Komen foundation, the nexus of politico-legal medicine. Also note it took a tortured response four times longer than my comment, but still suffering from foot in mouth disease, in an attempt to circle the wagons. The question remains 'cui bono'? Certainly not the patient.

  6. Michael Siget | Nov 16, 2018

    Thank you for your comments. 

    PAMED has a dedicated government relations team that lobbies on physicians’ behalf before the legislature.  PAMED’s attorneys work closely with the government relations team to provide legal input regarding the organization’s legislative efforts. PAMED’s attorneys also develop related resources for PAMED and its members to provide information on legislation that will affect physicians, thus the FAQ document that was published.  The document published is intended to provide information on the various aspects of Act 112.  

    Please note that state boards cannot exert any authority over the legislature or block the legislature from enacting legislation.  The state boards were created by the legislature and were given defined authority over the practice of medicine.  However, the legislature is the governmental body that determines what areas the state boards can regulate.  While the state boards can express views on legislation, they are prohibited from lobbying the legislature for or against pending legislation.  Further, Act 112 deals with the Department of Health, not the state boards.  

    As the FAQ document indicates, diagnostic imaging services are not required to provide the results of the tests to the patient, such as a diagnosis of cancer.  What those entities must do is provide a notice to the patient concerning follow-up with the ordering health care practitioner so that the ordering health care practitioner can discuss the test results and follow-up care with the patient.  In addition, “significant abnormality” is a defined term in the act and is provided in the FAQ document.  

    If you have any further questions or would like to discuss this further, feel free to call PAMED and you will be put in touch with the appropriate person.

  7. Steve Karp | Nov 16, 2018
    When is the attorney for the PA medical society going to represent PA physicians and pressure the state medical board to exert their authority to block the state legislature from enacting laws which interfere with medical practice? What if the tests 'abnormality' is not clinically relevant or the radiologist does not have sufficient clinical information? "ma'am you have cancer. Oops not really it's just the button on your blouse.' Was abnormality defined in the law?

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