February 29, 2024

Since the COVID-19 waiver that paused certified registered nurse anesthetist (“CRNA”) supervision requirements expired in May 2023, our facility has been scrambling to find anesthesiologists to supervise our CRNAs.  Is there anything we can do?

Historically, CMS has required CRNAs to be under the supervision of a practitioner when administering anesthesia.  Given the nature of their work, most facilities required CRNAs to be under the supervision of an anesthesiologist.  As recruiting providers is becoming increasingly difficult, many facilities are running into the same problem that they do not have enough anesthesiologists to adequately supervise their CRNAs.

If your state has not yet joined the 24 states that have elected to opt out of CMS’s CRNA supervision requirements, Medicare has long had flexibility built into the Medicare Conditions of Participation (“COPs”) that may help ease your burden.  The COPs allow CRNAs to provide anesthesia, if they practice in an opt‑out state or in any other state, so long as the CRNA is under the supervision of the “operating practitioner or an anesthesiologist” who is immediately available.  According to CMS Interpretive Guidelines, in the case of procedures, an operating practitioner may include the surgeon performing the procedure.

While surgeons may be an alternative to help fill your need for supervising physicians, we would not consider this an open and shut problem.  Using surgeons as supervising physicians opens the door to several key conversations that still need to take place, both with legal counsel and internally.  For instance, does state law also allow surgeons to supervise CRNAs; is there any additional liability incurred by the surgeons for supervising the CRNAs; and will the surgeons agree to act as supervising physicians?

If you have a quick question about this, e-mail Hala Mouzaffar at hmouzaffar@hortyspringer.com.

February 8, 2024

This question was raised by a registrant at our Complete Course for Medical Staff Leaders last week – should we notify Medical Staff members immediately, as soon as a case “falls out” in our peer review process?

No!  There are so many different indicators that hospitals track – some required by Medicare, some by accreditation standards, some based upon specialty-specific evidence-based medicine – and the mere fact that a case “tripped” one of these many indicators does not mean that there are specific concerns that need to be addressed.  We hear that Medical Staff members already tend to view the peer review process as something that can feel more punitive than performance improvement based, and if we start sending letters out to individuals the minute that a case has met a specific indicator, we risk making that perception even worse.  Professional practice evaluation/peer review policies should clearly state that cases that make their way into the process can be closed at the earliest, most initial stage of review, and that practitioners need to be notified of cases only once questions or concerns about the care provided by the practitioner have been identified.

If you have a quick question about this, e-mail LeeAnne Mitchell at LMitchell@hortyspringer.com.

November 2, 2023

What’s this I hear about having to post a notice in all of our provider-based clinics that patients will be receiving a bill for facility fees?

It’s technically not required by law – yet.  But a lot of the Medicare Administrative Contractors are recommending it.  Here’s an example from Noridian. The provider-based billing rules, at 42 C.F.R. § 413.65, require that provider-based facilities hold themselves out to the public as part of the main provider.  When patients enter the provider-based facility or organization, they need to be aware that they are entering the main provider and are billed accordingly.  A poster like this is a good way to assure compliance with this requirement.

If you have a quick question about this or the provider-based rules in general, e-mail Dan Mulholland at dmulholland@hortyspringer.com.

June 15, 2023

What are the laws/regulations around listing providers on a hospital directory? We’re revamping our provider directory, and have heard there are certain requirements for listing a provider in a directory.  Can we limit the providers listed to just those who are employed by us?

The OIG has long had a safe harbor for “referral services.”  The regulation, at 42 CFR §1001.952(f), reads as follows:

Referral services.  As used in section 1128B of the Act, “remuneration” does not include any payment or exchange of anything of value between an individual or entity (“participant”) and another entity serving as a referral service (“referral service”), as long as all of the following four standards are met –

(1)        The referral service does not exclude as a participant in the referral service any individual or entity who meets the qualifications for participation.

(2)        Any payment the participant makes to the referral service is assessed equally against and collected equally from all participants and is based only on the cost of operating the referral service, and not on the volume or value of any referrals to or business otherwise generated by either party for the other party for which payment may be made in whole or in part under Medicare, Medicaid, or other Federal health care programs.

(3)        The referral service imposes no requirements on the manner in which the participant provides services to a referred person, except that the referral service may require that the participant charge the person referred at the same rate as it charges other persons not referred by the referral service, or that these services be furnished free of charge or at reduced charge.

(4)        The referral service makes the following five disclosures to each person seeking a referral, with each such disclosure maintained by the referral service in a written record certifying such disclosure and signed by either such person seeking a referral or by the individual making the disclosure on behalf of the referral service –

(i)         The manner in which it selects the group of participants in the referral service to which it could make a referral;

(ii)        Whether the participant has paid a fee to the referral service;

(iii)       The manner in which it selects a particular participant from this group for that person;

(iv)       The nature of the relationship between the referral service and the group of participants to whom it could make the referral; and

(v)        The nature of any restrictions that would exclude such an individual or entity from continuing as a participant.

Based on this, it would be OK to only list your employed providers in the directory. Just make sure that the list clearly discloses that only employed physicians are listed.

If you have a quick question about this, e-mail Dan Mulholland at DMulholland@hortyspringer.com.

May 18, 2023

What is a Medicare NCD and why would an NCD be relevant to the delineation of hospital clinical privileges for certain procedures?

A National Coverage Determination (“NCD”) is a general outline of coverage which is applicable regardless of which Medicare Administrative Contractor (“MAC”) is administering Medicare claims for a particular region.  According to CMS, NCDs are made through an evidence-based process and in some cases are supplemented by outside assistance in order to establish nationwide Medicare payment conditions for the treatment or procedure subject to the NCD.

Medicare does not have the authority to dictate the practice of medicine.  However, the Medicare program does have the authority to define what it will pay for, and under what conditions.  That is where the NCDs (as well as LCDs which are Local Coverage Determinations and are specific to a particular MAC) become relevant to clinical privilege delineations.

For example, the NCD for Percutaneous Left Atrial Appendage Closure (“LAAC”) describes the conditions under which Medicare will pay for LAAC technical and professional services.  Among the requirements of the current NCD, the LAAC must be performed by an interventional cardiologist, electrophysiologist, or cardiovascular surgeon who satisfies the following criteria:

(1)        Has received training prescribed by the manufacturer on the safe and effective use of the device prior to performing LAAC; and

(2)        Has performed ≥ 25 interventional cardiac procedures that involve transeptal puncture through an intact septum; and

(3)        Continues to perform ≥ 25 interventional cardiac procedures that involve transeptal puncture through an intact septum, of which at least 12 are LAAC, over a 2-year period.

What happens if you do not use the NCD in your delineation of clinical privileges for an LAAC?  That is not unlawful.  But neither the Hospital’s nor the physician’s claim will be reimbursed by Medicare if the physician who performs the LAAC does not at least satisfy the requirements in the NCD (or any other procedure where an NCD or LCD specifies certain training and/or experience).

If a claim has been submitted for such a procedure by a physician who did not satisfy the NCD or LCD’s criteria, then both the technical and the professional fees paid by the Medicare program for that procedure must be refunded.  Submitting a claim to Medicare in reckless disregard or in deliberate ignorance of Medicare’s conditions of payment constitutes a False Claim.  Keeping the reimbursement for a claim that should not have been submitted to Medicare because it did not satisfy the requirements of an NCD or LCD constitutes a “reverse false claim.”   The penalty for a violation of the False Claims Act is three times the amount of the claim plus a possible per claim penalty of between $13,508-$27,018.

Therefore, a prudent hospital will be aware of Medicare’s conditions of payment, where they exist, and will make their delineation of clinical privileges for an LAAC, or any other procedure where physician qualifications are defined in an NCD or LCD, so that at a minimum, the clinical privileges needed to perform that procedure in the hospital meet or exceed the requirements in any relevant NCD or LCD.

If you have a quick question about this, e-mail Henry Casale at hcasale@hortyspringer.com.

If you want to learn more about the False Claims Act, Anti-Kickback Statute, the Stark law, amendments to the regulations of those laws, and much more, consider joining Dan Mulholland and Henry Casale in Phoenix November 16-18, 2023, for our next seminar.  

In the interim, be sure to check out “The Kickback Chronicles” on the Health Law Expressions Podcast featuring Hala Mouzaffar and Henry Casale, so you can learn from the misfortune of others.

March 2, 2023

I heard that CMS added a new kind of provider – A Rural Emergency Hospital (“REH”).  Is this a new category of hospital? Does the Stark Law treat it like a hospital for purposes of physician investment?

You have asked several questions and so I will take them one at a time.

A Rural Emergency Hospital or REH is a new provider type that became effective on January 1, 2023.  In order to qualify to become an REH, a provider must have been either a Critical Access Hospital (“CAH”), or a rural hospital with not more than 50 beds, and must have been participating in Medicare as of the date of the December 27, 2020 enactment of the Consolidated Appropriations Act, and satisfy the new REH Conditions of Participation (which closely align with the current CAH Conditions of Participation).

Please do not be confused by the name of this new provider. An REH is not a “Hospital” for purposes of the Medicare Program or the Stark Law.  Rather, an REH is a new kind of provider.  The REH payment rules are unique as is the manner in which the Stark Law applies to an REH. 

An REH is defined as an entity that operates for the purpose of providing emergency department services, observation care, and other outpatient medical and health services specified by the Secretary in which the annual per patient average length of stay does not exceed 24 hours.

The time calculation for determining the length of stay of a patient receiving REH services begins with the registration, check-in or triage of the patient (whichever occurs first) and ends with the discharge of the patient from the REH. The discharge occurs when the physician or other appropriate clinician has signed the discharge order, or at the time the outpatient service is completed and documented in the medical record.

The REH must not provide inpatient services, except those furnished in a unit that is a distinct part licensed as a skilled nursing facility to furnish post-hospital extended care services.  This prohibition on providing inpatient services to a rural population is thought to be the major factor discouraging many eligible CAHs and rural hospitals with not more than 50 beds, from converting to an REH.

An REH is not a hospital and is not reimbursed in the same manner as a hospital.  Rather an REH is reimbursed at the then-current Medicare Hospital Outpatient Prospective Payment System (“OPPS”) rate PLUS 5%.  The REH is also entitled to a beneficiary copayment (which is not to take the additional 5% reimbursement into account).  In addition, an REH will be paid a monthly facility fee.

An REH is required to provide radiology and other outpatient services which fall within the Stark definition of a Designated Health Service (“DHS”).  Therefore, the Stark Law applies, and a physician may not have a compensation arrangement with, or an investment interest in, an REH unless an exception to the Stark Law can be satisfied.

Initially, CMS proposed a special exception for physician investment in an REH which was based on the whole hospital exception.  However, those regulations were never finalized.  Rather, CMS will require an REH to comply with the same compensation arrangement exceptions as any other entity that provides a DHS.

When it comes to whether a physician may have an investment interest in an REH, remember, an REH had to have been a critical access hospital or rural hospital with not more than 50 beds, and there is currently a broad exception to the Stark Law for physician investment in an entity that is located in a rural area.  Therefore, the rural provider exception should be available to most, if not all, REHs.   See 42 C.F.R. § 411.356(c)(1). 

However, an REH does not automatically qualify for this rural provider exception   Rather, this exception requires that in addition to the REH being located in a “rural” area, at least 75% of the REH’s services must be furnished to individuals who reside in a “rural” area.

Effective January 1, 2023, CMS also revised the definition of “Rural” for purposes of the Stark Law to state that a “Rural” area is any area that is not defined as “urban” under 42 C.F.R. § 412.64(b)

42 C.F.R. § 412.64(b) then states that a rural area is essentially any area located outside of a Metropolitan Statistical Area or a Metropolitan Division (in the case where a Metropolitan Statistical Area is divided into Metropolitan Divisions), as defined by the Executive Office of Management and Budget.  However, there are exceptions so you need to check the regulations.

Adding to the confusion is that CMS has stated in the preamble to the Stark regulations that the rural provider test “differs from the rural/urban test that a hospital uses for wage index purposes.”

CMS has also amended each compensation arrangement exception that applies to a Federally Qualified Health Center (“FQHC”) and Rural Health Clinic (“RHC”), to state that as of January 1, 2023, that exception will also apply to an REH.

Please keep in mind that your analysis of whether you should organize an REH should not rely solely on the new REH Medicare rule.   Some states (Pennsylvania for example) do not permit free-standing Emergency Departments.  Unfortunately, regardless of whether Medicare will recognize an REH as a provider, an REH cannot operate in a state unless it is licensed, and in order to be licensed, the state must either permit a free-standing Emergency Department, or adopt new rules licensing an REH.

Therefore, there are some states where REHs cannot lawfully operate under state law and as a result do not have the opportunity to achieve the enhanced reimbursement available to an REH.  If you are in such a state you must wait for your state to create a license category that will recognize either a free-standing Emergency Department or an REH.  But do not lose hope, even where currently prohibited, state licensure bodies are under pressure from rural providers to create a license category for an REH – but until they do, an REH will not be permitted to operate in some states.

If you want to learn more about the Stark Law, the False Claims Act, the Anti-Kickback Statute, recent developments like REHs, and other current issues in Hospital-Physician compliance, consider joining Dan Mulholland and Henry Casale at our next Hospital‑Physician Contracts and Compliance Clinic that will be held in Phoenix on November 16-18, 2023.

If you cannot wait until November for more information on these and many other health law related topics, check out HortySpringer’s Health Law Expressions “Kickback Chronicles” podcast episodes with Henry Casale and Hala Mouzaffar.

November 10, 2022

I hear the new Medicare Hospital Outpatient Payment Rules that were just published by CMS last week created a new breed of cat called a “Rural Emergency Hospital.”  What’s that?

Rural Emergency Hospitals (“REHs”) are a new provider type established by the Consolidated Appropriations Act, 2021 to address the growing concern over closures of rural hospitals.  The REH designation provides an opportunity for Critical Access Hospitals (“CAHs”) and certain rural hospitals to avert potential closure and continue to provide essential services for the communities they serve.  Conversion to an REH allows the facility to continue providing emergency services, observation care, and, if elected by the REH, additional medical and health outpatient services, that do not exceed an annual per patient average of 24 hours.  The implementation of this new provider type, effective January 1, 2023, is designed to promote equity in health care for those living in rural communities by facilitating access to needed services.

For more information, see the CMS information page here.

October 20, 2022

We are currently updating our informed consent forms. Can you remind us of what information should be included on these forms

Informed consent is critical to providing quality care, so I commend your efforts to review your forms. In almost every state, the treating provider is responsible for explaining to the patient ˗ in such a way that the patient can understand ˗ (1) the item or service that will be provided, (2) the benefits and risks associated with that care, and (3) any alternatives. In some states, failure to obtain a patient’s informed consent may render the treating provider liable for any injury that results from the rendered care, so be sure to check your state law!

Under the Medicare Conditions of Participation, the medical record must contain documentation of the patient’s informed consent for certain treatments and procedures. The Medicare Conditions of Participation Guidelines offer a detailed explanation of what a properly executed informed consent form should look like. When revising your informed consent forms, be sure that they have at least the following elements:

  • The name of the facility where the care is going to take place;
  • The name of the procedure or treatment for which consent is being given;
  • A statement that the procedure or treatment, including the anticipated benefits and material risks, and alternative treatments, was explained to the patient or the patient’s legal representative;
  • The signature of the patient or their legal representative; and
  • The date and time the informed consent form is signed by the patient or their legal representative.

CMS also states that a well-designed informed consent form may also include:

  • The name of the provider who conducted the informed consent discussion;
  • Date, time, and signature of the person witnessing the patient or their legal representative signing the consent form;
  • An indication or listing of the benefits and material risks of the procedure or treatment discussed; and
  • A statement that physicians and providers who are not physicians, other than the treating provider, including residents, will be involved in the care of the patient and will perform important parts of the procedure or treatment, as allowed under state law and regulations, in accordance with the clinical privileges granted and/or scope of practice.

If in doubt, reach out to Mary Paterni to review whether your informed consent forms comply with state and federal law.

August 11, 2022

Our state Department of Health informed us that we are required to have cameras installed in our chemotherapy unit so that patients receiving treatment can be observed via a monitor at the nurses’ station. Since we will be recording patient care activity, do we need to post signs stating that cameras are in use?

CMS’s Interpretive Guidelines to the Medicare COPs regarding physical privacy indicate that “audio/video monitoring (does not include recording) of patients in medical surgical or intensive-care type units would not be considered violating the patient’s privacy, as long as there exists a clinical need, the patient/patient’s representative is aware of the monitoring,” and the monitors or speakers are not visible or audible to visitors or the public.  However, “video recording of patients undergoing medical treatment requires the consent of the patient or his/her representative.”

If the hospital is only monitoring the patients via video and not creating a recording, the patients and their representatives only need to be “aware of the monitoring.” In that case, signs would satisfy the requirement and be an appropriate way to inform them that monitoring is occurring.  On the other hand, if a true “recording” will be made, then a more formal consent would be required by CMS.

It is also important to check state law in these circumstances, as most states have their own laws that govern audio and video recordings that could be applicable.

May 19, 2022

Our hospital is negotiating with health insurers to perform delegated credentialing on their behalf.  The insurers are telling us that we cannot have a hearing officer option for conducting a hearing when providers are subject to certain adverse actions, such as termination of participation on a panel. Is this correct?

Yes. This is how health insurers interested in delegating credentialing functions to health care providers interpret the Medicare Advantage rules for provider participation.  According to those rules, a health insurer involved in the Medicare Advantage program has to give physicians certain rights when it suspends or terminates the physician’s participation agreement.  Among those rights are the right to receive notice of the reasons for the action and the right to appeal that action. The rules go on to talk about a hearing panel but only state that the insurer (or insurer’s delegate) must ensure that the majority of the hearing panel members are peers of the affected physician.

Now you could follow the constitutional principle of English law that instructs that “everything that is not forbidden is permitted” and go ahead and draft your delegated credentialing policies so that they allow for the hearing officer alternative to using a hearing panel.  However, this may create headaches down the road since health insurers have to perform a pre-delegation audit of your policies and procedures before delegating credentialing and will most likely require a revision to your policies if they permit the hearing officer option. Some providers, such as hospitals, use their existing medical staff credentialing policies and procedures to build off of to put delegated credentialing processes in place. To the extent that a hospital is interested in doing so and its existing Credentials Policy allows for the hearing officer option, it can simply revise its Credentials Policy to indicate that the option is not available when a hearing is offered for delegated credentialing purposes (as opposed to medical staff purposes).