PRIOR PRINTER'S NO. 381 PRINTER'S NO. 476 THE GENERAL ASSEMBLY OF PENNSYLVANIA HOUSE BILL No.409 Session of 2025 INTRODUCED BY KOSIEROWSKI, HILL-EVANS, VENKAT, DONAHUE, SANCHEZ, FREEMAN, NEILSON, RABB, WARREN, GIRAL, PROBST, STEELE, OTTEN, D. WILLIAMS, MAYES, KENYATTA, GUENST, MERSKI, BOYD, CURRY, GREEN AND WEBSTER, JANUARY 29, 2025 AS REPORTED FROM COMMITTEE ON HEALTH, HOUSE OF REPRESENTATIVES, AS AMENDED, FEBRUARY 5, 2025 AN ACT Amending the act of October 24, 2018 (P.L.719, No.112), entitled "An act providing for notification of patient test results to be sent directly to a patient or the patient's designee; and providing for duties of the Department of Health ," further providing for definitions, for test results and for duties of Department of Health. The General Assembly of the Commonwealth of Pennsylvania hereby enacts as follows: Section 1. Sections 2, 3 and 4 of the act of October 24, 2018 (P.L.719, No.112), known as the Patient Test Result Information Act, are amended to read: Section 2. Definitions. The following words and phrases when used in this act shall have the meanings given to them in this section unless the context clearly indicates otherwise: "Chronic condition." An illness that frequently recurs or persists for a period in excess of three months. "Diagnostic imaging service." A medical imaging test 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 performed on a patient that is intended to diagnose the presence or absence of a disease, including, but not limited to, a malignancy. The term does not include a nonimaging study, including an electrocardiogram, standard electrocardiogram treadmill stress test, cardiac monitor, pulmonary function test or similar test. "Diagnostic radiograph." A projectional radiograph that acquires an image or digital image with x-rays to produce a high contrast, two-dimensional image, otherwise known as an x-ray. "Health care practitioner." As defined in section 103 of the act of July 19, 1979 (P.L.130, No.48), known as the Health Care Facilities Act. ["Significant abnormality." A finding by a diagnostic imaging service of an abnormality or anomaly which would cause a reasonably prudent person to seek additional or follow-up medical care within three months. ] Section 3. Test results. [(a) General rule.-- When, in the judgment of the entity performing a diagnostic imaging service, a significant abnormality may exist, the entity performing the diagnostic imaging service shall directly notify the patient or the patient's designee by providing notice that the entity has completed a review of the test performed on the patient and has sent results to the health care practitioner who ordered the diagnostic imaging service. The notice shall include all of the following: (1) The name of the ordering health care practitioner . (2) The date the test was performed. (3) The date the results were sent to the ordering health care practitioner . 20250HB0409PN0476 - 2 - 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 (4) The following statements: You are receiving this notice as a result of a determination by your diagnostic imaging service that further discussions of your test results are warranted and would be beneficial to you. The complete results of your test or tests have been or will be sent to the health care practitioner that ordered the test or tests. It is recommended that you contact your health care practitioner to discuss your results as soon as possible. (5) The contact information necessary for the patient to obtain a full report. ] (a.1) W ritten notice at time of service.--The entity performing the diagnostic imaging service shall provide written notice to the patient or the patient's designee at the time of the diagnostic imaging service. The notice shall include the following statement: Your test results will be made available to you once the results are ready. You can access your test results online through your electronic health record (EHR) patient portal. If you do not have access to your online patient portal, you can request that your test results be delivered to you by mail. You may be charged a reasonable fee for the administrative costs of mailing the test results. (b) Exceptions.--The following shall be exempted from the requirements of subsection [ (a)] (a.1): (1) Routine obstetrical ultrasounds used to monitor the development of a fetus. (2) Diagnostic imaging services performed on a patient 20250HB0409PN0476 - 3 - 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 who is being treated on an inpatient basis [ or] in an emergency [room] department or observation unit of a hospital. (3) Diagnostic radiographs. (4) Diagnostic imaging services performed on a patient with a chronic condition if the patient has previously received notice of the chronic condition. (5) Diagnostic imaging services test results provided to a patient or a patient's designee at the time of the test. [(c) Time.--Except as provided under subsection (d)(2)(v), no later than 20 days after the date the results were sent to the ordering health care practitioner as provided under subsection (a)(3), the entity performing the diagnostic imaging service shall provide the patient or patient's designee with the notice under subsection (a) . (d) Method of transmittal.-- (1) The notice under subsection (a) shall be provided in a manner deemed acceptable by the patient or the patient's designee. (2) A notice provided under subsection (a) shall be presumed to comply with this act if: (i) mailed in a properly addressed and stamped letter through the United States Postal Service; (ii) sent electronically by e-mail; (iii) sent by automatic alert from an electronic medical record system that the notice under subsection (a) has been posted to the patient's electronic medical record that is presently viewable; (iv) sent by facsimile; or (v) provided directly to the patient at the time of 20250HB0409PN0476 - 4 - 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 service, so long as the patient acknowledges the receipt of the results and signs the patient's medical record accordingly. (e) Construction.-- (1) Nothing in this act shall be construed to require an entity to provide a patient or patient's designee the notice under subsection (a) if the results are provided to the patient or patient's designee by the health care practitioner at the time of the test. (2) Nothing in this act shall be construed to prohibit an entity from providing a patient with: (i) the summary of a diagnostic imaging service report, otherwise known as an impression or conclusion; or (ii) the complete results of the diagnostic imaging service provided to the ordering health care practitioner.] (f) Disclosure of test results.-- Except as provided under subsection (g), the following test results and any other related results shall not be disclosed to a patient as part of the patient's electronic health record, and in the case of a clinical laboratory test result or pathology report shall not be disclosed by the person or entity that administers and controls the patient's electronic health record, until one full business day has elapsed after the results are finalized, unless the ordering health care practitioner directs the release of the results before the end of that period: (1) Pathology reports or , radiology reports OR CLINICAL LABORATORY TESTS that have a reasonable likelihood of showing a finding of malignancy. 20250HB0409PN0476 - 5 - <-- 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 (2) Tests that could reveal genetic markers. (g) Exception.-- The prohibition under subsection (f) shall not apply if the test results are provided to a patient or the patient's designee at the time of the test. (h) Policies and procedures.--A health care facility , clinical laboratory or an entity performing a diagnostic imaging service shall develop and implement policies and procedures for providing patient test results in accordance with this section. (i) Face-to-face requirements.--Nothing in this act shall be construed to repeal any law of this Commonwealth that requires a health care practitioner to conduct a face-to-face meeting or counseling session with a patient prior to a test result being disclosed to the patient or being posted in the patient's electronic health record. Section 4. Duties of Department of Health. (a) Reviews and complaints.-- The Department of Health shall[: (1) in accordance with law, conduct compliance reviews as part of the inspection performed by the department or an accrediting organization and investigate complaints filed relating to the requirements of section 3; and (2) establish a complaint procedure, which shall be made available on the department's publicly accessible Internet website.] conduct compliance reviews on health care facilities and clinical laboratories licensed or permitted LICENSED by the department. (b) Limitation.--The Department of Health shall limit the scope of the compliance reviews under subsection (a) to determining whether policies and procedures have been developed and implemented in accordance with section 3(h). 20250HB0409PN0476 - 6 - <-- <-- <-- 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 Section 2. This act shall take effect in 60 days. 20250HB0409PN0476 - 7 - 1