February 25, 2021

Posted on February 25, 2021February 25, 2021 by jwilbert

QUESTION: A physician called requesting a patient transfer to our Hospital. We would like to start recording these types of calls for patient safety and quality purposes. Does the hospital have to obtain the callers’ consent prior to recording these communications?

ANSWER: The hospital’s obligation to get a caller’s consent prior to recording the communication depends on whether the hospital is located in a “one-party consent” or an “all-party consent” state.

One-party consent states allow a person to record so long as they are a party to the communication and consent to the recording. In this case, the physician making the call does not have to be informed that the call is being recorded since the physician receiving the call has already provided the necessary consent. The hospital may, as a courtesy, include an automated message at the top of the call that informs the physician making the transfer request that the conversation will be recorded.

On the other hand, states that have adopted “all-party consent” recording laws prohibit the use of devices to record absent the consent of all parties involved in the communication. Therefore, if you find yourself in an “all-party consent” state, then the hospital will be required to disclose that it is recording the call prior to the start of the conversation.

When deciding whether and how to record patient transfer calls, keep in mind that the hospital is obligated under the HIPAA Privacy Rule to protect patient health information shared during these communications. Therefore, it is important that the hospital determine how it will record and how it will store these communications. If, for instance, the hospital decides to contract with another entity to record and store these communications, then the entity will likely be furnishing business associate services. In this case, it would necessary for the hospital and the entity to enter into a business associate contract to ensure that the entity is safeguarding these communications in a manner appropriate under HIPAA.

February 18, 2021

Posted on February 18, 2021 by jwilbert

QUESTION: We entered into an exclusive contract with an anesthesia group, and were wondering whether we can require the anesthesiologists and other group personnel to submit to drug and alcohol testing?

ANSWER: Yes – as long as testing is addressed in the contract. Since exclusive contracts are usually between the hospital and the group – and not with the individual physicians of the group – only the group itself is actually bound by any requirements set forth in the contract. Therefore, it’s important that the contract language state that each of the group’s physicians, as a condition of providing services at the hospital under the contract, shall be free from the influence or presence of alcohol or drugs and that this shall be enforced by the group, which shall conduct testing of its physicians at the time of conditional offer of employment, following a reasonable suspicion of use or abuse, and upon return to work after a leave of absence for drug or alcohol treatment. This approach can be reinforced by requiring every physician of the group to sign an agreement to be bound by all the terms of the hospital’s contract with the group (and the contract should state that the group will require each physician to sign such a statement as a condition of employment). Also, a hospital and its medical staff can achieve a similar result by having drug and alcohol testing requirements in the bylaws or another medical staff policy. Since a group’s physicians would have to be appointed to the medical staff and granted clinical privileges in order to practice at the hospital, the group’s physicians would have to comply with any requirements in the bylaws or other policies, including those for drug and alcohol testing.

February 11, 2021

Posted on February 11, 2021February 11, 2021 by jwilbert

QUESTION: I hear that the new Stark regulations have a way that Stark violations can be corrected without penalty. Is that so?

ANSWER: Yes, within limits. CMS has now given hospitals and doctors a new way to correct noncompliance with the Stark law without having to make a self-disclosure. The regulations, which became effective on January 19, 2021, contain a new regulation at 42 CFR §411.357(h) that allows parties to a compensation arrangement to reconcile all discrepancies while a contract is in effect or up to 90 days after it terminates so long as after the reconciliation the arrangement fully complies with all elements of the applicable exception.

For example: say a hospital contract with a medical director calls for payment at $140 per hour but the doctor is paid $150 per hour. If $150 still is within FMV range, all that is necessary is to reflect that in amendment going forward. If the amount actually paid exceeds fair market value, the contract can be amended to recoup payments in excess of FMV via an offset against amounts due in the future (e.g., a payroll deduction) while the relationship is in effect, but the entire amount of the excess must be recouped within 90 days after the contract ends.

CMS also said that not every error will cause a financial relationship to be out of compliance with Stark nor must every mistake or error be corrected in order to maintain compliance. Administrative and operational errors that are identified and rectified in a timely manner will not cause a relationship to be out of compliance. In addition, CMS said that not all transfers of remuneration create compensation arrangements. Examples include mistaken payments that are never identified, theft, use of office space not in lease, use of equipment beyond the expiration of the lease term or slight deviation from written agreement such as a one-time incorrect rental payment.

This new option is a great alternative to resorting to the Stark self-disclosure protocol. To learn more about it, stay tuned for an upcoming Health Law Expressions podcast, where Horty Springer attorneys Josh Hodges and Dan Mulholland will discuss this new rule, or e-mail them at jhodges@hortyspringer.com or dmulholland@hortyspringer.com.

September 17, 2020

Posted on September 17, 2020 by jwilbert

QUESTION: Some big drug companies sent letters to our hospital saying that they would stop selling us 340B drugs unless we participate in the 340B “ESP” program and give them specific claims information. Is this legal?

ANSWER: There is some question as to whether drug companies can condition the sale of 340B to submitting this kind of information. The letters we have seen cite concerns about duplicate discounts between the Medicaid and the 340B program. These requests also raise serious questions about whether the disclosure of claims information would comply with HIPAA unless the protected health information is de-identified – which is easier said than done – or the drug companies sign business associate agreements – which is unlikely. The American Hospital Association recently sent a letter to the Secretary of HHS in opposition to these requests. Some of the requests set a deadline of October 1 for compliance, but it is doubtful that the matter will be resolved by then. Stay tuned for further developments. For more information, contact Henry Casale at hcasale@hortyspringer.com or 412-687-7677.

August 22, 2019

Posted on August 22, 2019 by jwilbert

QUESTION: Should we use a separate form to obtain informed consent for the administration of anesthesia?

ANSWER: The answer may vary depending on state law. As a general rule, most states will give you discretion on how to structure your informed consent forms. If you wanted, you potentially could place all relevant information onto a single form. However, our research shows that the trend nationwide is to utilize a separate form for this purpose. It tends to be more convenient and efficient. Similarly, most organizations will also employ a separate form for blood transfusions.

Be aware that it is crucial to document informed consent appropriately. If you have any questions about the design of your informed consent forms, or about the process outlined in your policies, we strongly encourage you to reach out to your hospital counsel. It is vital to have up-to-date documents that comply with all applicable laws and that meet the needs of your institution.

August 1, 2019

Posted on August 1, 2019August 1, 2019 by jwilbert

QUESTION: As a Medical Staff leader, what steps do I take if someone reports to me that a physician who is rounding on patients smells of alcohol or appears to be confused? While this doesn’t happen often, I want to be prepared.

ANSWER: We couldn’t agree more. These are the situations you have to plan for in advance so you can react quickly when action is needed.

The first step is adopt a good Practitioner Health Policy that outlines the authority of Medical Staff leaders to address such situations. Among other things, the Policy should:

Identify who has the authority to assess the situation and take needed action. This should include a broad list of individuals so someone is always available. Also, the Policy should permit designees to act if needed;
State that the physician can be required to submit to a blood, hair, or urine test, or other appropriate physical or cognitive evaluation, to determine his or her ability to safely practice;
State that a physician’s failure to agree to such testing will result in the “automatic relinquishment” of the physician’s clinical privileges pending further review of the matter. (An “automatic relinquishment” occurs by operation of the Policy and is not a professional review action that raises hearing rights or reports to government agencies);
Offer guidance on the use of voluntary agreements to refrain from practicing while a matter is reviewed. Particularly with health issues, it’s best to avoid (if possible) the use of “suspensions;”
Define a process for identifying someone to take care of the physician’s patients while the review continues.

The next step is to be sure Medical Staff leaders and hospital staff are aware of their duties and authority under the Policy. Staff should know they are required to report health issues, and shouldn’t “enable” the physician’s continued health problem by covering up for the physician. Medical Staff leaders should rehearse the steps they will take when these situations arise so they are comfortable acting when needed to protect patients and the physician in question.

To learn more about dealing with physician health issues, please join us for Strategies for Managing Physician Health and Disruptive Conduct in Las Vegas, Nevada this coming fall.

December 13, 2018

Posted on December 14, 2018 by jwilbert

QUESTION: We recently asked a physician to meet with our Leadership Council (a small group of Medical Staff leaders) to provide input regarding a concern about his behavior. He says he’ll be happy to attend the meeting, but only if accompanied by his attorney. Our policies do not address this issue – do we have to let the attorney attend the meeting?

ANSWER: No. The meeting is not a hearing. It’s simply an opportunity for physicians to talk with one another in a collegial manner. There’s no legal obligation to permit an attorney to attend, and the presence of an attorney would likely make the process less effective by making it seem more confrontational than it needs to be.

It’s much easier to address this situation when the applicable policy includes language such as the following:

To promote the collegial and educational objectives of this Policy, all discussions and meetings with a Practitioner shall generally involve only the Practitioner and the appropriate Medical Staff Leaders and Hospital personnel. No counsel representing the Practitioner, Medical Staff or Hospital shall attend any of these meetings.

Of course, the physician may consult an attorney prior to the meeting (and the physician shouldn’t be discouraged from doing so). The attorney can even accompany the physician to the hospital and wait in an appropriate location, if the physician insists. But there’s no obligation to allow the attorney to accompany the physician during the meeting.

For more ideas on handling difficult peer review issues, check out our Peer Review Clinic.

July 12, 2018

Posted on July 12, 2018July 12, 2018 by jwilbert

QUESTION: In light of Oklahoma’s recent legalization of the use of medical marijuana, we are reminded that they join a majority of states that have already done so, begging the question of how does this affect the workplace and what requirements are placed on employers to accommodate the use of medical marijuana?

ANSWER: The answer to this question is unfortunately not simple, but rather varies state to state. As the laws pertaining to use of medical marijuana are unique to each state, so too are the laws governing the workplace and an employer’s duty to accommodate for such use. Although Oklahoma has yet to address the effect its legalization may have on the workplace, states that have been faced with these issues may lend some guidance. Some states, such as Georgia and Washington, have legalized use of medical marijuana but still permit employers to have a written zero tolerance policy prohibiting the on-duty and off-duty use of marijuana. Other states, such as Arizona and Pennsylvania, prohibit employers from taking any adverse action against an employee for use of medical marijuana. Importantly, those states that may prohibit adverse actions for an employee’s use of medical marijuana tend not to impose any affirmative duty on the employer to accommodate that employee’s usage. Further, there are some states that disallow such adverse actions, yet do not prohibit employers from banning the use of such substances during work hours or on the work premises. Not to be forgotten are the states that either have not yet legalized medical marijuana use or that have not addressed its effect on the workplace, namely Oklahoma.

As exhibited, these laws are not so cut and dry; making it important to take a deeper look into what exactly is and is not required of the employer. With the ever-growing popularity and shift toward legalization of medical marijuana use in the country, it is important to remain aware of your state’s stance on usage as well as any prohibitions or requirements placed on the employer when legalized.

July 5, 2018

Posted on July 5, 2018July 5, 2018 by jwilbert

QUESTION: Our On-Call Policy requires physicians to have 30 admissions or operating cases at the hospital per year to participate in the on-call schedule. The Policy also gives discretion to the department chairs, who develop the call schedules, to limit the ability of a particular physician to participate in the schedule for a number of reasons, some of which have nothing to do with the quality of care being provided. Do these provisions in our Policy pose any legal concerns?

ANSWER: Yes. First, conditioning participation in the call schedule on admissions at, or procedures done in, the hospital could be interpreted as conditioning participation on referrals to the hospital. Such a requirement could present compliance issues with the federal Anti-Kickback Statute. In Supplemental Compliance Program Guidance for Hospitals, the Department of Health and Human Services Office of Inspector General (“OIG”) cautioned that “conditioning privileges on a particular number of referrals or requiring the performance of a particular number of procedures, beyond volumes necessary to ensure clinical proficiency, potentially raise substantial risks under the [Anti-Kickback] statute.” Some state courts have found that participation on the call-coverage roster constitutes a “privilege.”

May 3, 2018

Posted on May 3, 2018 by jwilbert

QUESTION: We’re revisiting our on-call policy and we’re debating whether to set specific rules on physician response times. Has CMS issued any guidance on this?

ANSWER: Yes. CMS advises hospitals to establish detailed, specific guidelines on physician response times. In particular, CMS has said that a hospital would be “well?advised to establish in its on-call policies and procedures specific guidelines – e.g., the maximum number of minutes that may elapse between receipt of a request and the physician’s appearance for what constitutes a reasonable response time, and to make sure that its on-call physicians and other staff are aware of these time-sensitive requirements.”

This kind of agency guidance is not mandatory, but from a best practice perspective, we would encourage you to craft an on-call policy that follows this advice. We recommend that you set a bright-line rule for acceptable physician response times. The rule should be expressed in minutes.

You can carve out well-defined and carefully considered exceptions to the rule (so long as they are otherwise compliant with the law) if you want to allow for more flexibility. The key is to have clear, detailed, specific guidelines in your policy.

Author: jwilbert