October 10, 2024

QUESTION:
We are amending our medical staff governance documents and considering giving Advanced Practice Professionals (“APPs”) a larger role in medical staff affairs.  Do you have any recommendations based on your experience working with other hospitals?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY CHARLES CHULACK:
With the ever-increasing role that APPs, such as physician assistants and nurse practitioners, play in the delivery of health care in hospitals, we are seeing many hospitals across the country wrestle with this question.  Unfortunately, there is not a “one-size-fits-all” answer and the appropriate solution needs to take into consideration federal and state regulations and the culture of your medical staff and hospital, among other things.

Let’s start with the regulations.  The Centers for Medicare & Medicaid Services Conditions of Participation (“CoPs”) defer to state law when it comes to appointing APPs to the medical staff:  “The medical staff must be composed of doctors of medicine or osteopathy.  In accordance with State law, including scope-of-practice laws, the medical staff may also include…non-physician practitioners who are determined to be eligible for appointment by the governing body.”  42 C.F.R. §482.22(a) (emphasis added).  However, you want to be sure to check your state’s laws and regulations to determine if those sources are more restrictive.  By way of example, Pennsylvania limits medical staff membership to physicians and dentists.  28 Pa. Code § 107.2.  Even though Pennsylvania has a “structured exception” allowing hospitals to admit podiatrists to the medical staff, there is no corresponding exception for APPs.  Compare Pennsylvania’s restrictive approach with the approach taken by Colorado, which allows both physicians and non-physician practitioners to be on the medical staff.

Even in the states that permit APPs to be on the medical staff, we are seeing a variety of approaches.  Some hospitals make APPs eligible for medical staff membership, including appointment to the Active Staff.  That being said, these hospitals impose appropriate limitations on their prerogatives when compared to physician members of the Active Staff such as not being able to serve as the President of the Medical Staff (the Interpretive Guidelines to the CoPs say that the President of the Medical Staff “must be a doctor of medicine or osteopathy, or, if permitted by state law where the hospital is located, a doctor of dental surgery, dental medicine, or podiatric medicine”).  While we don’t see this approach taken frequently, it is more common with Critical Access Hospitals or smaller hospitals where the majority of clinical services are provided by APPs.

A more common approach is gradual integration of APPs into medical staff functions.  For example, the medical staff may begin by creating an APP Credentials Committee which reviews applications of APPs and reports to the regular Credentials Committee, or appoint APPs to the Credentials Committee to tap into their expertise when it comes to state scope of practice laws for APPs, how they practice, and what they are permitted to do in similarly-situated hospitals.  Some hospitals are also appointing an APP to the Medical Executive Committee and Multi-Specialty Peer Review Committee.  It varies with respect to whether they are given voting rights since we have seen some physician members of the medical staff express discomfort with an APP, who may have a supervising agreement while practicing in the hospital, evaluating the care they provide as a part of one of these committees.

In conclusion, APPs are increasing in number and have a growing role in providing clinical services in hospitals.  If your medical staff has not yet addressed this issue, the odds are that it will need to in the future.  Nevertheless, these are interesting and exciting issues whose solutions can result in a more vibrant and robust medical staff and hospital.

If you have a quick question about this, e-mail Charles Chulack at CChulack@hortyspringer.com.

June 27, 2024

QUESTION:
Is there any evidence that offering free trips or other freebies to a physician induces that physician to order the product sold by the person or entity that offered the freebie?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY HENRY CASALE:
The federal government thinks so and so did the jury in a recent case.

In a qui tam case that was brought against the Cameron-Ehlen Group, Inc., d/b/a Precision Lens (“Precision Lens”), and its owner Paul Ehlen, the qui tam relator, and ultimately the federal government, alleged that Precision Lens and Mr. Ehlen provided kickbacks to ophthalmologists in various forms, including travel and entertainment, to induce those physicians to order Precision Lens’ Intraocular Lens (“IOLs”).

The unlawful “remuneration” in this case was alleged to consist of Precision Lens and Mr. Ehlen transporting certain physicians who had a history of using Precision Lens’ IOLs to luxury vacation destinations on a private jet – which was typically flown by Mr. Ehlen. The alleged remuneration included multiple trips, high-end skiing, fishing, golfing, hunting, sporting, and entertainment vacations, often to exclusive destinations such as New York City to see a Broadway musical, the College Football National Championship Game in Miami, and the Masters golf tournament in Augusta, Georgia.

Mr. Ehlen claimed that he was personal friends with these physicians and that the trips were gifts from one friend to another.  Mr. Ehlen and Precision Lens argued that the Antikickback Statute (AKS) does not prohibit a friend from providing a gift to another friend, even if the friends happen to do business with each other. Armed with this “friends” defense, Mr. Ehlen and Precision Lens rolled the dice, and risked a jury trial.

Unfortunately for Precision Lens and Mr. Ehlen, the government was able to convince a jury that the various “gifts” that Precision Lens, and its owner, Mr. Ehlen provided to the ophthalmic surgeons constituted unlawful remuneration that was intended to induce the physicians to order Precision Lens’ IOLs in cataract surgeries that were reimbursed by Medicare. It didn’t help that the government was also able to prove that Precision Lens maintained a fund, referred to internally at Precision Lens as a secret fund or slush fund, that was used to finance many of these multiple physician trips.

Another interesting aspect of this case that helps to explain the jury’s verdict was the government’s expert witness.  In order to convince the jury that the intent of the free trips was to induce the physicians to order Precisions Lens’ IOLs rather than IOLs manufactured by another company, the government presented a medical device marketing expert who provided testimony on how companies use gifts and incentives to influence physicians to use their products.  The expert witness provided research that showed that gifts and other incentives trigger the impulse to reciprocate, even if it was just subconsciously, and even at levels disproportionate to the gift.

This expert also testified that although doctors generally claim that their medical decisions are not influenced by the financial benefits they receive from product manufacturers, these benefits do in fact have a strong influence on medical decision making.

Apparently, the jury believed this expert witness along with the other evidence presented by the government because the jury concluded that the free trips were unlawful kickbacks provided to the ophthalmic surgeons with the intent to induce their use of the Precision Lens’ IOLs in cataract surgeries reimbursed by Medicare.  The jury then entered a judgment against Precision Lens and Mr. Ehlen in the amount of $487,048,705.13, which in early 2024 was reduced to a mere $216.7 million.

The OIG and DOJ believe that the fraud and abuse laws level the playing field for all competitors. They argue that a company such as Precision Lens should be competing with the manufacturers of similar products, on price and quality, not by giving the physicians who order their products lavish gifts.  The expert testimony in this case supported this argument.  That expert testimony should be kept in mind any time a referral source considers providing something of value to a referring physician.

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

If you want to learn more about the OIG, the Anti-Kickback Statute, the Stark Law, the False Claims Act, exclusive agreements, the recent FTC regulations on noncompete agreements, and much more, check out our latest episode of The Kickback Chronicles podcast and also join us at the Hospital-Physician Contracts and Compliance Clinic Seminar in Las Vegas from November 14-16, 2024!

May 30, 2024

QUESTION:
Are provider-based services performed in a mobile unit in an off-campus location covered by the site neutrality rules passed in 2016?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY DAN MULHOLLAND:
No.  Just like “grandfathered” services and off‑campus dedicated emergency departments, hospital services provided in an off-campus location through a mobile facility or portable unit are excepted from that rule and are reimbursed at the full hospital outpatient rate.

Section 603 of the Bipartisan Budget Act of 2015 generally eliminated reimbursement under the Medicare outpatient prospective payment system for items and services furnished in off-campus hospital outpatient provider‑based departments established on or after November 2, 2015. Instead, hospitals would be reimbursed at the lower Medicare physician fee schedule rate.  CMS promulgated rules implementing this law in 2016, and since then the site neutrality rules have been expanded from time to time.

The key exceptions to this rule are services performed in on-campus facilities (within 200 yards of the main hospital building), dedicated emergency departments, off-campus facilities that were in operation or “mid-build” on the date the law was enacted, or a “remote location of the hospital” (a facility furnishing inpatient hospital services under the name, ownership, and financial and administrative control of the main provider hospital). But services performed through a mobile facility and/or portable unit are excepted as well and paid at the full OPPS rate. See CMS Transmittal 2394 (November 15, 2019).

Mobile facilities and portable units are services that require medical equipment which is provided in a vehicle or the equipment for the service is transported to multiple locations within a geographic area. The most common types of mobile facilities/portable units are mobile diagnostic testing facilities, portable X‑ray units, portable mammography units and mobile clinics. But the equipment must travel around.  A hospital can’t just park a mobile facility or leave a portable unit permanently in a off-site provider-based location and then get paid at the full OPPS rate.

Also, physical therapists and other practitioners (e.g., physicians, nurse practitioners, physician assistants) who perform services at multiple locations (e.g., house calls, assisted living facilities) are not considered to be mobile facilities/portable units.  They’re people.

On the other hand, physician services performed on mobile units are reimbursed by Medicare Part B as if they were performed in a freestanding office rather that in a hospital as they normally would be in a provider-based facility.  That is, they are reimbursed at the full physician fee schedule rate. See Medicare Claims Processing Manual 20.4.2 – Use Place of Service Code 15.

If you are still awake after that spiel and have a quick question about this topic, e‑mail Dan Mulholland at dmulholland@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.

February 8, 2024

QUESTION:
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?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY LEEANNE MITCHELL:
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

QUESTION:
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?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY DAN MULHOLLAND:
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

QUESTION:
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?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY DAN MULHOLLAND:
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

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

OUR ANSWER FROM HORTYSPRINGER ATTORNEY HENRY CASALE:
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

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.

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.