May 2, 2024

QUESTION:
May a physician be on call for more than one hospital at the same time (take “simultaneous call”) or perform elective surgeries while on call?  If so, is that physician required to identify a specific back-up physician who will take calls at our hospital if the original physician is called to another hospital or is in the middle of an elective surgery when called by our hospital?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY MARY PATERNI:
CMS doesn’t specifically require that another physician be identified to take back-up call if the original on-call physician is performing elective surgery or is taking call at another hospital when the ED needs assistance.  Instead, CMS says that a “back-up plan” must be in place.  Per CMS, “some hospitals may employ the use of ‘jeopardy’ or back-up call schedules,” indicating that other hospitals may choose to not use back-up call schedules.  Here’s the full quote from the EMTALA Interpretive Guidelines (found in Appendix V of the Medicare State Operations Manual):

The [hospital’s] policies and procedures must also ensure that the hospital provides emergency services that meet the needs of an individual with an EMC if the hospital chooses to employ any of the on-call options permitted under the regulations, i.e., community call, simultaneous call, or elective procedures while on-call. In other words, there must be a back-up plan to these optional arrangements. For instance, some hospitals may employ the use of “jeopardy” or back-up call schedules to be used only under extreme circumstances. The hospital must be able to demonstrate that hospital staff is aware of and able to execute the back-up procedures. https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_v_emerg.pdf

Of course, a hospital may decide that its On-Call Policy will not permit simultaneous call or elective surgeries while on call.  Or, a hospital’s policy may require on-call physicians to identify a specific individual to provide back-up coverage in such cases.  The key is to clearly identify the requirements in the hospital’s On-Call Policy.

If you have a quick question about this, e-mail Mary Paterni at MPaterni@hortyspringer.com.

February 29, 2024

QUESTION:
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?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY HALA MOUZAFFAR:
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.

October 12, 2023

QUESTION:
As of last week, we no longer maintain a contract with a particular insurer, resulting in a change of network status.  How do we handle patients who are now considered “out-of-network”?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY MARY PATERNI:
The No Surprises Act has anticipated this issue.  Moving forward, if a contract terminates between a plan and provider or facility, the NSA applies continuity of care protections to individuals who are considered a “continuing care patient” and who are in the process of receiving items or services from the facility for which their insurance would cover.

In the event a plan’s contract is terminated with a provider or facility, the plan will notify its enrollees who are continuing care patients.  These patients will have the right to elect continued transitional care from the provider and can choose to have the same benefits as they would have had under the plan had the contract not terminated.  This election would only apply to the course of treatment currently being furnished by the provider or facility that qualifies the individual as a continuing care patient.

If the patient elects to continue treatment with their provider or facility, then the provider or facility must (1) accept payment from the plan for items or services furnished to the continuing care patient as payment in full and (2) continue to adhere to the policies, procedures and standards imposed by the plan for the individual as if the termination has not occurred.

According to CMS, this election may continue for the earlier of 90 days from the time the patient is notified of the plan’s termination or until the date on which the patient no longer qualifies as a continuing care patient with the provider or facility.

As an example, if a pregnant woman learns at her next obstetrician appointment that her physician no longer maintains a contract with her insurance, she would be eligible for continuity of care protections because she is receiving ongoing treatment for her pregnancy.

If you have a quick question about this, e-mail Mary Paterni at mpaterni@hortyspringer.com.

March 2, 2023

QUESTION:
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?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY HENRY CASALE:
You have asked several questions and so I will take them one at a time.

WHAT IS A RURAL EMERGENCY HOSPITAL?
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).

AN REH IS NOT A HOSPITAL
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 DOES NOT PROVIDE INPATIENT SERVICES (EXCEPT SNF SWING BEDS)
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 PAID AT A SPECIAL RATE
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.

STARK APPLIES, BUT…
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.

DON’T FORGET ABOUT STATE LAW
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.

January 26, 2023

QUESTION:
From time to time, patients in our emergency department will leave without being seen (“LWBS”). Can we get in trouble under the EMTALA law when that happens?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY JOHN WIECZOREK:
Generally no, as long as you document the event correctly. Here is what the CMS Interpretive Guidelines for EMTALA say about LWBS:

If a screening examination reveals an emergency medical condition (EMC) and the individual is told to wait for treatment, but the individual leaves the hospital, the hospital did not “dump” the individual unless:

  • The individual left the emergency department based on a “suggestion” by the hospital;
  • The individual’s condition was an emergency, but the hospital was operating beyond its capacity and did not attempt to transfer the individual to another facility; or
  • If an individual leaves a hospital Against Medical Advice (AMA) or LWBS, on his or her own free will (no coercion or suggestion), the hospital is not in violation of EMTALA.

The Guidelines tell the surveyors to look for this:

In cases where an individual (or person acting on the individual’s behalf) withdrew the initial request for a medical screening examination (MSE) and/or treatment for an EMC and demanded his or her transfer, or demanded to leave the hospital, look for a signed informed refusal of examination and treatment form by either the individual or a person acting on the individual’s behalf. Hospital personnel must inform the individual (or person acting on his or her behalf) of the risks and benefits associated with the transfer or the patient’s refusal to seek further care. If the individual (or person acting on the individual’s behalf) refused to sign the consent form, look for documentation by the hospital personnel that states that the individual refused to sign the form. The fact that an individual has not signed the form is not, however, automatically a violation of the screening requirement. Hospitals must, under the regulations, use their best efforts to obtain a signature from an individual refusing further care.

So as long as you follow these guidelines, you should be OK.  But make sure your ED staff understand these rules.

November 10, 2022

QUESTION:
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?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY DAN MULHOLLAND:
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.

September 8, 2022

QUESTION:
Can the medical staff of a critical access hospital be part of a unified medical staff within a multi-hospital system?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY DAN MULHOLLAND:
As of the date of this e-mail (September 8, 2022), the answer is no, but a change could be in the works soon.  In 2014, the Centers for Medicare & Medicaid Services (“CMS”) revised the Medicare Conditions of Participation to allow a “unified and integrated” medical staff in hospitals that are part of a health system.  Previously, CMS had required that each hospital have its own separate medical staff.  In the past, even if medical staffs in a system had overlapping membership, CMS required that the medical staffs be “separate.”  However, the CMS Interpretive Guidelines provide as follows:

[A] hospital system that includes certain types of hospitals, i.e., Hospitals-within-Hospitals or Hospital Satellites, that are being paid under a Medicare payment system other than the Hospital Inpatient Prospective Payment System (IPPS) might jeopardize the Medicare payment status of those excluded hospitals if it owns both the tenant and host hospitals and uses a unified medical staff for both.  (Emphasis added.)

42 CFR §482.22(b)(4).  This effectively prevented CAHs from being part of a unified medical staff within a system.  CMS reiterated this rule in 2017 when it approved an application from The Joint Commission to have deemed status for surveys of CAHs. 82 Fed. Reg. 49,817, 49,818 (Oct. 27, 2017).

However, on July 6, 2022, CMS proposed that this prohibition be lifted and that medical staffs of CAHs be permitted to be part of a unified medical staff within a multi-hospital system subject to essentially the same rules (e.g., opt-in and opt-out rights, consideration of local circumstances, etc.) that apply to unified medical staffs within PPS hospitals. 87 Fed. Reg. 40350, 40376.  Comments closed on August 29, 2022, so the proposal may be final at any time now.  Stay tuned for further developments in the Health Law Express.

August 11, 2022

QUESTION:
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?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY HALA MOUZAFFAR:
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.

February 3, 2022

QUESTION:
What’s all this I hear about “appropriate use criteria” that Medicare will use to determine payment for outpatient imaging?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY DAN MULHOLLAND:
The Protecting Access to Medicare Act of 2014 (a/k/a “PAMA”) established a new program to increase the rate of appropriate advanced diagnostic imaging services provided to Medicare beneficiaries.  Examples of such advanced imaging services include:  CT, PET and MRI scans.  Under this program, at the time a practitioner orders an advanced diagnostic imaging service for a Medicare beneficiary, he/she, or clinical staff acting under his/her direction, will be required to consult a qualified Clinical Decision Support Mechanism.  CDSMs are electronic portals through which appropriate use criteria can be accessed.

The program won’t go into effect until January 1, 2023 or the January 1 after the current public health emergency ends, whichever is later.  And it only applies to services in a physician’s office, hospital outpatient department (including the emergency department), an ambulatory surgical center or an independent diagnostic testing facility and whose claims are paid under the physician fee schedule, hospital outpatient prospective payment system or ambulatory surgical center payment system.  So (at least for now) it does NOT apply in critical access hospitals.

For more information, check out the CMS website.

November 18, 2021

QUESTION:
Our hospital has more than 100 employees.  Do we have to comply with both the OSHA vaccine mandate and the one issued by CMS?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY DAN MULHOLLAND:
OSHA has issued two different Emergency Temporary Standards (“ETS”) that are the source of some confusion.  The first was issued on June 21, 2021.  It required that covered health care employers must develop and implement a COVID-19 plan to identify and control COVID-19 hazards in the workplace and implement requirements to reduce transmission of COVID-19 in their workplaces related to the following:  patient screening and management, standard and transmission-based precautions, personal protective equipment (facemasks, respirators), controls for aerosol-generating procedures, physical distancing of at least six feet when feasible, physical barriers, cleaning and disinfection, ventilation, health screening and medical management, training, anti-retaliation, recordkeeping, and reporting.  The June OSHA ETS encouraged but did not require vaccination by requiring employers to provide reasonable time and paid leave for employee vaccinations and any side effects.

In early November, OSHA issued a second emergency temporary standard requiring worker vaccinations for any employers (not just health care employers) with 100 or more employees or weekly testing for those who remain unvaccinated without an eligible exemption.  This ETS that was enjoined by the 5th Circuit Court of Appeals this past Friday, and the 5th Circuit  ordered that OSHA take no steps to implement or enforce the ETS until further court order.  CMS said it worked closely with OSHA to ensure that the November regulations of both agencies were complementary.

The FAQs issued with the CMS rule on November 5 contained the following guidance:

Q. Which rule is a given health care facility expected to follow – the CMS Omnibus Staff Vaccination Rule, the Executive Order on Ensuring Adequate COVID Safety Protocols for Federal Contractors, the OSHA COVID-19 Healthcare Emergency Temporary Standard, or the upcoming (or new) OSHA Emergency Temporary Standard?

A.  If a Medicare- or Medicaid-certified provider or supplier falls under the requirements of CMS’s Omnibus Staff Vaccination Rule, it should look to those requirements first. Health care facilities are generally subject to new federal vaccination requirements based on primacy.  If facilities participate in and are certified under the Medicare and Medicaid programs and are regulated by the CMS health and safety standards known as the Conditions of Participation 11 (CoPs), Conditions for Coverage (CfCs), and Requirements for Participation, then they are expected to abide by the requirements established in the CMS Omnibus Staff Vaccination Rule.  This rule takes priority above other federal vaccination requirements.  CMS’s oversight and enforcement will exclusively monitor and address compliance for the provisions outlined in the CMS Omnibus Staff Vaccination Rule, while also continuing to monitor for proper infection control procedures as established under previous regulations.  The OSHA COVID-19 Employer Emergency Temporary Standard (for facilities with greater than 100 employees) applies to employers that are not subject to the preceding two regulations.  Facilities should review the inclusion criterion for these regulations and comply with all applicable requirements.

Hospitals that participate in Medicare subject to the CMS’s Omnibus Staff Vaccination Rule which amended the Conditions of participation, so per this FAQ guidance hospitals are NOT subject to the November ETS which requires weekly testing for those who remain unvaccinated without an eligible exemption.  Therefore, testing is not an alternative for staff who have not been exempted from the CMS vax requirement to comply with the rule.

On the other hand, while testing is not a substitute for vaccinations under the CMS rule, hospitals are allowed to require testing of unvaccinated/exempt workforce members as a mitigation measure.  The CMS FAQs say:  “In granting such exemptions or accommodations, employers must ensure that they minimize the risk of transmission of COVID19 to at-risk individuals, in keeping with their obligation to protect the health and safety of patients” but this does not require testing.

CMS explained in the preamble to the regulation:  “we considered requiring daily or weekly testing of unvaccinated individuals.  We have reviewed scientific evidence on testing and found that vaccination is a more effective infection control measure.  As such, we chose not to require such testing for now but welcome comment.  Of course, nothing prevents a provider from exercising testing precautions voluntarily in addition to vaccination.”  86 Fed. Reg. 61614.

However, the September 2020 CMS emergency rule that established new requirements for Long Term Care facilities (nursing homes) to test facility residents and staff for COVID-19 is still in effect.  The new FAQs say:  “CMS expects continued compliance with this requirement.”

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

Also, listen to HortySpringer’s latest podcast on the CMS vaccine mandate here.