Disclaimer
This publication is designed to provide general information on pertinent legal topics. The statements made are provided for educational purposes only. They do not constitute legal or financial advice nor do they necessarily reflect the views of Holland & Hart LLP or any of its attorneys other than the author. This publication is not intended to create an attorney-client relationship between you and Holland & Hart LLP. Substantive changes in the law subsequent to the date of this publication might affect the analysis or commentary. Similarly, the analysis may differ depending on the jurisdiction or circumstances. If you have specific questions as to the application of the law to your activities, you should seek the advice of your legal counsel.
Privacy Policy
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Offering Free Screening Tests to Patients
/in Fraud and AbuseBy Kim Stanger
Healthcare providers often offer free screening tests or services as a way to generate business for their facility or practice; however, doing so may violate federal and state laws unless structured properly. The federal Anti-Kickback Statute (“AKS”)1 and Civil Monetary Penalties Law (“CMPL”)2 generally prohibit offering free or discounted items or services to patients as a way to generate business payable by Medicare, Medicaid or other federal healthcare programs unless the arrangement fits within a regulatory exception.3 Violations of the AKS or CMPL may result in criminal, civil, and/or administrative penalties. Read more
Consent Forms v. Informed Consent
/in ConsentBy Kim Stanger
Except in emergencies, healthcare practitioners must generally obtain the patient’s informed consent before providing treatment.1 If the patient lacks capacity due to age or incompetence, consent must be obtained from a personal representative authorized by law to provide consent.2 Failure to obtain or properly document informed consent may subject practitioners to civil, administrative, and/or criminal liability. It is therefore important to periodically review consent processes and forms to ensure that they adequately establish and document valid informed consent. Read more
The On-Call Physician’s Liability for Failing to Respond to Emergency Room Call
/in EMTALAby Kim Stanger
On-call physicians may not realize their potential exposure if they fail or decline to respond to a call from the hospital’s emergency department. Failure to respond is a violation of the Emergency Treatment and Active Labor Act (“EMTALA”) that may expose the physician to a $50,000 fine and exclusion from Medicare or Medicaid as well as contract liability. It may also expose the hospital to a fine of $50,000 and a lawsuit by the relevant patient or a hospital that receives an improper transfer.
EMTALA generally requires hospitals to provide an emergency screening examination and stabilizing treatment to a patient who comes to the hospital seeking emergency care. See 42 USC § 1395dd; 42 CFR § 489.24. EMTALA establishes the following penalties:
(A) A participating hospital that negligently violates a requirement of this section is subject to a civil money penalty of … not more than $25,000 … for each such violation.
(B) Subject to subparagraph (C) [below], any physician who is responsible for the examination, treatment, or transfer of an individual in a participating hospital, including a physician on-call for the care of such an individual, … is subject to a civil money penalty of not more than $50,000 for each such violation and, if the violation is gross and flagrant or is repeated, to exclusion from participation in [Medicare or Medicaid]….
Id. at § 1395dd(d)(1), emphasis added; see also 42 CFR §§ 1003.500(a)-(c) and 1003.510. EMTALA expressly states that the foregoing penalties apply when an on-call physician fails to respond to a call for assistance: Read more
HIPAA and Disclosure to Media
/in HIPAAby Kim Stanger
Last week, a Texas health system agreed to a $2,400,000 HIPAA settlement arising out of a hospital’s disclosure of a patient’s name in a press release. (See here). Last year, a New York hospital agreed to pay $2,200,000 for allowing media to film in its facilities. (See here ). Given these cases, it is a good time to review the HIPAA rules on disclosures to the media.
Protected Health Information. HIPAA applies to a patient’s protected health information (“PHI”), which includes any individually identifiable information concerning a patient’s health, healthcare or payment for their care. (45 CFR § 160.103). It includes the patient’s name or any other identifiable information even if additional details of treatment are not included. A provider may not avoid HIPAA by simply omitting the name; PHI includes any information “[w]ith respect to which there is a reasonable basis to believe the information can be used to identify the individual”. (Id.). Accordingly, details about an individual that would allow others to identify the individual are considered PHI even if the usual identifiers are omitted. PHI remains protected by HIPAA even if the information is widely known in the community or the patient has disclosed the information himself or herself.
Disclosures to Media. HIPAA generally prohibits healthcare providers from disclosing a patient’s protected health information to media unless either (i) the patient or their personal representative authorizes the disclosure, or (ii) the disclosure fits within a HIPAA exception. (45 CFR § 164.502).
1. Authorization. When seeking to disclose information to the media, the safest course is to obtain the patient’s or their personal representative’s written authorization to make the disclosure. Providers should ensure that the authorization clearly covers the information that will be disclosed, describes the purpose of the disclosure, and identifies the persons or entity permitted to make and receive the disclosure. (45 CFR § 164.508). For more information about valid authorizations, see https://www.hollandhart.com/valid-hipaa-authorizations-a-checklist. In addition to obtaining a HIPAA authorization, the provider may want to obtain a separate media release.
2. Response to Media Inquiries. HIPAA’s “facility directory” exception is often used to justify disclosures to news media, but it is very limited in scope. Under this exception, a provider may disclose certain limited information “for directory purposes”, i.e., to notify persons who inquire about the patient of the patient’s general condition and location in the facility. (45 CFR § 164.510(a)). To make the disclosure, the following standards must be met:
(OCR FAQ here). If the patient objects, the provider may not make the disclosure. If the patient is incompetent, the provider will have to establish both (i) that the disclosure is consistent with the patient’s prior expressed preferences and (ii) that the disclosure is in the patient’s best interests. That may be difficult to do in the case of media disclosures, and virtually impossible if the provider has never treated the patient before.
Good: Vital signs are stable and within normal limits. Patient is conscious and comfortable. Indicators are excellent.
Fair: Vital signs are stable and within normal limits. Patient is conscious but may be uncomfortable. Indicators are favorable.
Serious: Vital signs may be unstable and not within normal limits. Patient is acutely ill. Indicators are questionable.
Critical: Vital signs are unstable and not within normal limits. Patient may be unconscious. Indicators are unfavorable.
Treated and Released: Patient received treatment but was not admitted.
Treated and Transferred: Received treatment. Transferred to a different facility. (Although a hospital may disclose that a patient was treated and released, it may not release information regarding the date of release or where the patient went upon release without patient authorization.)
(AHA, HIPAA Privacy Regulations: Frequently Asked Questions, available here). The OCR has stated, “[t]he fact that a patient has been “treated and released,” or that a patient has died, may be released as part of the directory information about the patient’s general condition and location in the facility, provided that the other requirements at 45 CFR § 164.510(a) also are followed.” (OCR FAQ here).
To summarize, the “facility directory” exception may allow limited disclosures to the media, but it is difficult to satisfy all the necessary prerequisites, including patient notice and consent. Moreover, I question whether such disclosures to the media are really for “facility directory purposes”—the reason the exception exists. Finally, the exception does not require disclosures to the media; it merely allows the disclosures if the conditions are satisfied. Out of respect for their patient’s privacy, the patient’s best interests, and regulatory intent, providers may appropriately decide it is safer not to disclose PHI to the media, or to limit the disclosure, unless the patient or the patient’s personal representative expressly consents to such disclosures.
Media Access to or Filming in Treatment Areas. The provider’s primary duty is to care for his or her patients. Media access, if not managed in an appropriate way, may impede care along with violating patient privacy, including the privacy of patients who may not be the subject of the media inquiry. Per the OCR’s FAQ:
There are very limited situations in which the HIPAA Privacy Rule permits a covered entity to disclose limited PHI to the media without obtaining a HIPAA authorization. For example, a covered entity may seek to have the media help identify or locate the family of an unidentified and incapacitated patient in its care. In that case, the covered entity may disclose limited PHI about the incapacitated patient to the media if, in the hospital’s professional judgment, doing so is in the patient’s best interest. See 45 C.F.R. 164.510(b)(1)(ii). In addition, a covered entity may disclose a patient’s location in the facility and condition in general terms that do not communicate specific medical information about the individual to any person, including the media, without obtaining a HIPAA authorization where the individual has not objected to his information being included in the facility directory, and the media representative or other person asks for the individual by name. See 45 C.F.R. 164.510(a).
The HIPAA Privacy Rule does not require health care providers to prevent members of the media from entering areas of their facilities that are otherwise generally accessible to the public, which may include public waiting areas or areas where the public enters or exits the facility.
(OCR FAQ at https://www.hhs.gov/hipaa/for-professionals/faq/2023/film-and-media/index.html).
Remember Other Laws. HIPAA preempts less restrictive laws, but providers must comply with more restrictive privacy laws. It may be that state or other federal laws prohibit media disclosures even if HIPAA might allow them. For example, 42 CFR part 2 places stringent privacy requirements on federally assisted drug and alcohol treatment programs. Providers should consider other potentially applicable laws or common law duties before making any disclosure.
In short, when it comes to dealing with the media, it is generally safer to simply explain that federal and state law prohibits your disclosure of health information. If a disclosure is to be made or media access allowed, providers must take extreme caution to comply with the HIPAA rules.
For questions regarding this update, please contact:
Kim C. Stanger
Holland & Hart, 800 W Main Street, Suite 1750, Boise, ID 83702
email: kcstanger@hollandhart.com, phone: 208-383-3913
This publication is designed to provide general information on pertinent legal topics. The statements made are provided for educational purposes only. They do not constitute legal or financial advice nor do they necessarily reflect the views of Holland & Hart LLP or any of its attorneys other than the author. This publication is not intended to create an attorney-client relationship between you and Holland & Hart LLP. Substantive changes in the law subsequent to the date of this publication might affect the analysis or commentary. Similarly, the analysis may differ depending on the jurisdiction or circumstances. If you have specific questions as to the application of the law to your activities, you should seek the advice of your legal counsel.
Admitting Privileges in Hospitals: New Idaho Law
/in Hospitals & Health Systemsby Kim Stanger
A new Idaho statute confirms that physician assistants and advanced practice nurses may admit patients to hospitals and other healthcare facilities if allowed by the facility’s bylaws.
Background. Historically, admitting privileges were usually reserved to physicians; however, such a limitation (whether real or imagined) seems to have become somewhat outdated given the expanding role of physician assistants and advanced practice nurses, whose licensure allows them to perform services traditionally performed by physicians. Many hospitals increasingly rely on midlevel practitioners to care for patients, especially in rural areas where physicians are in short supply or decline to participate in call coverage. The new statute resolves regulatory ambiguity concerning the authority of midlevels to admit patients. Read more