Hepatitis C Screening Act Frequently Asked Questions
Below are responses to questions submitted by Hospital and Healthsystem Association of Pennsylvania (HAP) members. These responses have been vetted by HAP legal counsel. Please note that HAP shared these responses with the Pennsylvania Department of Health (DOH) but DOH declined to respond. That said, these responses represent HAP’s current legal interpretation based on plain reading of the law as well as research on past PA laws and similar laws in other states.
- When will the Hepatitis C Screening Act go into effect?
The Hepatitis C Screening Act is effective September 18, 2016.
- What are the key provisions of the Act?
- A Hepatitis C screening test or Hepatitis C diagnostics test must be offered to every individual born between 1945 and 1965 receiving health services as an inpatient in a hospital, or receiving primary care services in the outpatient department of hospital, healthcare facility or physician’s office.
- If an individual accepts the offer of the Hepatitis C screening test and the screening test is reactive, the health care provider must offer the individual follow-up health care or refer the individual to a health care provider who can provide follow-up health care. The follow-up health care must include a Hepatitis C diagnostic test.
- The offer of testing must be culturally and linguistically appropriate.
- What is the difference between a Hepatitis C screening test and a Hepatitis C diagnostic test?
- The initial Hepatitis C screening test is a test that detects the presence of Hepatitis C antibodies in the blood. A reactive result on a Hepatitis C screening test is interpreted as a presumptive positive for Hepatitis C antibodies in the blood. This means a person may have been infected with the Hepatitis C virus at some point in time. It does not mean they are currently infected. There are laboratory based (i.e., EIA) and point of care (i.e., rapid test) Hepatitis C antibody screening tests.
- The Hepatitis C diagnostic test (also known as an HCV RNA test) is a laboratory test that detects the presence of the Hepatitis C virus in the blood. The presence of Hepatitis C virus in the blood indicates current Hepatitis C infection.
Scope of requirements related to offering test
- Does the Act require that hospitals offer screening to patients in the Emergency Department?
No, patients in a hospital emergency department are not hospital inpatients and are not receiving primary care services. The Act only requires providers to offer testing to inpatients and patients receiving primary care services in outpatient settings (e.g. clinics, etc.).
- Are hospitals required to offer screening to observation patients?
No, the Act only requires testing to be offered to inpatients and patients receiving primary care services in outpatient settings (e.g. clinics, etc.).
- Does the Act require that hospitals offer screening for patients in “specialty” outpatient areas such as the cancer center?
No, specialty outpatient areas are not providing primary care services to patients. The Act covers inpatients and patients receiving primary care services in outpatient settings (e.g. clinics, etc.).
- What about patients coming into the hospital for an endoscopy or other interventional radiology procedures, are hospitals required to offer screening for those patients?
No, these patients are not hospital inpatients. The Act covers inpatients and patients receiving primary care services in outpatient settings (e.g. clinics, etc.).
- Does the Act require gynecology clinics to offer this screening or is it only a family medicine or internal medicine primary care clinics?
Based on Hospital and Healthsystem Association of Pennsylvania’s (HAP) reading of the Act, the definition of primary care is broad and could conceivably include gynecologists. Although HAP has not found any references in DOH regulations to primary care that expressly include or exclude gynecology, there is precedent for including OB/GYNs as primary care providers in other areas of the law.
- Are hospitals required to offer screening to patients coming in for outpatient specialist visits (for example, neurology and surgery)?
No, specialty outpatient services are not primary care services. The Act covers inpatients and patients receiving primary care services in outpatient settings (e.g. clinics, etc.).
- What about Urgent Care services? Are urgent care services considered “primary care services?”
Yes, HAP recommends that providers implement policies to offer screening to patients seeking urgent care services delivered under a primary care physician license.
- The Act provides three exclusions to the requirement that a Hepatitis C screening test be offered, including when the health care practitioner reasonably believes the patient: 1) is being treated for a life threatening emergency, 2) has previously been offered or has been the subject of a Hepatitis C screening test, or 3) lacks capacity to consent. How recent must the previous screening be to qualify for the exception (for example, last year, 1 month, ever…)?
The plain reading of the statutory language implies that if a provider has a reasonable belief that the patient has ever been offered screening before or that the patient has ever been screened before, then the exception applies.
- Does the Act require providers to offer Hepatitis C screening to patients receiving outpatient laboratory work (for example, blood draws)?
No, the plain reading of the Act limits the requirement to offering screening to patients receiving primary care services in outpatient settings.
- If a patient is positive for Hepatitis C according to their written medical history, can the patient be excluded for the screening requirement?
Yes, a positive Hepatitis C diagnosis that was confirmed by a Hepatitis C diagnostic test is evidence of a previous screening and would qualify under the three exception criteria outlined in the Act.
- Instead of making the offer, does the Act allow hospitals to just let patients know that testing is available if they want it?
No. Letting a patient know that testing is available is not an offer of testing. An example of an offer would be, "We are routinely offering Hepatitis C testing to all persons born between 1945 and 1965. Would you like to be tested for Hepatitis C?"
- Can a facility or provider covered by the law refer a patient out for testing if the patient accepts the offer for a screening or diagnostic test?
In general, it is expected that covered facilities and providers have the capacity to provide the Hepatitis C screening test. Hepatitis C screening testing should be handled the same way any other routine test is provided in the same facility or office. If it is the facility’s policy to give a patient a lab slip to have routine lab tests, including the Hepatitis C screening test, conducted at an off-site draw station after discharge, this is acceptable.
If a patient accepts the offer of the Hepatitis C screening test and the screening test is reactive, as stated in the Act, the health care provider may refer the patient to a health care provider who can provide follow-up health care which includes a Hepatitis C diagnostic test.
Provision of Test Results
- What happens if the patient's Hepatitis C screening test is reactive?
As stated in the Act, any patient with a reactive screening test result must either be offered follow-up health care or referred to a health care provider that can provide follow-up health care. The follow-up health care must include Hepatitis C diagnostic testing.
- Does the Act allow a facility/provider to test for Hepatitis C and have the test results sent to another provider to be provided back to the patients?
No. The facility conducting the test is responsible for provision of results and follow-up health care or a referral for follow-up health, including a Hepatitis C diagnostic test.
Follow-up Health Care for Patients who Screen Reactive for Hepatitis C
- The Act requires that providers ordering Hepatitis C testing provide or refer for follow-up health care for those who test reactive. If providers make a referral, does a provider have to make an actual appointment?
Referrals should be made using the current process in place at the facility or provider office.
- Do hospitals need to document that the Hepatitis C reactive patient kept the referral for follow-up health care?
No, the Act does not require confirmation that the referral was kept.
Billing and Reimbursement
- Does the law require insurance companies to pay for the Hepatitis C test? What if the patient doesn't have insurance?
No, the law does not require insurance companies to pay for the test. However, the U.S. Preventive Services Task Force (USPSTF) issued a B grade categorization on screening for Hepatitis C among persons born between 1945 and 1965. The USPSTF recommendation means that Hepatitis C screening among this population will be covered by most public and private insurance. The Affordable Care Act requires that most private insurance plans cover USPSTF A or B recommended services without cost sharing. Medicaid Managed Care plans must also cover these services.
Cursory review of Medicare coverage and certain private insurance policies reveals that payment is available for a one-time screening ordered by primary care practitioners in certain primary care outpatient settings. Inpatient coverage does not appear readily available.
Per HAP’s discussions with Department of Human Services, HAP has confirmed that Pennsylvania Medical Assistance Program covers Hepatitis C testing.
Persons with private insurance should refer to their policy or contact their insurance carrier for additional information. If a patient accepts the offer of a test but lacks insurance or has insurance that may not pay for the test, providers should follow their normal protocol for any other test that might be ordered and may not be covered.
- Are hospitals required to absorb the screening cost as part of the inpatient Medicaid DRG payment?
No. Hospitals may bill Medicaid separately for screening and testing costs.
- The Act provides an exclusion for patients being treated for life-threatening emergency (critically ill patient / trauma patient). Should an exclusion under these circumstances and others have to be documented? Other exclusions?
Absent DOH regulation or additional guidance, it is highly recommended that hospitals develop compliance policies that document an exclusion for offering testing when the patient is experiencing a life-threating emergency or the other two exclusions as well as situations where an individual refuses to take a test or the individual is referred for follow-up care to another health care provider with or without a test being provided.
- What does it mean to “offer” screening?
The Act requires that a hospital or provider ask the patient if he or she wants the screening (yes/no). The offer of testing must be culturally and linguistically appropriate and the Act authorizes the DOH to promulgate regulations on what qualifies as “culturally and linguistically appropriate.” In addition, offering the test does not imply that hospitals must perform the test at no cost to the patient if the patient decides to undergo testing. Hospitals may bill for this service.
- Does the Act require documentation that the offer was made?
No, there is no requirement in the law requiring formal documentation that the offer of a Hepatitis C screening test was made. However, for internal tracking and quality assurance purposes, providers may want to document that the offer was made.
- Is it enough to take the patient’s word that they have already been screened, or does the Act require additional documented results of screening required?
Additional documentation of prior screening is strongly recommended. In a situation where a patient verbally informs the health care provider that he or she has previously been screened, the provider should document this response. Providers may want to check in the patient’s EHR for results of previous screening test.
- Does the Act require documentation if a patient declines testing?
Patients always have the option to decline testing. They may do so orally or in writing. There is no requirement for formal documentation of the declination. However, a notation in the patient’s medical record of the offering of the test and the patient’s declination may help keep track of those patients that have already been offered the test.