Question: Our state government has directed that when a Medicaid mental health patient arrives at our Emergency Department, we are to immediately send that individual to a hospital with which the state has contracted for screening and care of this patient population.  Now I understand that following that state direction could get us in trouble under the Emergency Medical Treatment and Active Labor Act.  Is that true?  And if there’s a conflict between state law and the federal EMTALA law, which wins?

Answer:  Unfortunately, the answer is yes.  As described in CMS’s EMTALA Interpretive Guidelines:

Hospitals are not relieved of their EMTALA obligation to screen, provide stabilizing treatment and/or an appropriate transfer to individuals because of prearranged community or State plans that have designated specific hospitals to care for selected individuals (e.g., Medicaid patients, psychiatric patients, pregnant women).  Hospitals located in those States which have State/local laws that require particular individuals, such as psychiatric or indigent individuals, to be evaluated and treated at designated facilities/hospitals may violate EMTALA if the hospital disregards the EMTALA requirements and does not conduct an MSE and provide stabilizing treatment or conduct an appropriate transfer prior to referring the individual to the State/local facility. If, after conducting the MSE and ruling out an EMC (or after stabilizing the EMC) the sending hospital needs to transfer an individual to another hospital for treatment, it may elect to transfer the individual to the hospital so designated by these State or local laws.  Hospitals are also prohibited from discharging individuals who have not been screened or who have an emergency medical condition to non-hospital facilities for imposes of compliance with State law.  The existence of a State law requiring transfer of certain individuals to certain facilities is not a defense to an EMTALA violation for failure to provide an MSE or failure to stabilize an EMC therefore hospitals must meet the federal EMTALA requirements or risk violating EMTALA.

This means that the hospital has to fulfill its own EMTALA obligations, even if the state has designated another facility to screen and treat the patient.  And as you likely suspect, EMTALA wins in a fight with state law.  Federal law – EMTALA – trumps state law and state contracts.

Question: Should our hospital adopt a policy on physician relationships with medical devices companies and, if so, what should it say?

Answer: While not required, it is a very good idea to adopt such a policy.  Physician-owned device companies, or PODs as they are sometimes called, have been in the crosshairs of the federal government for a number of years.  While not illegal, the concern is that physician financial relationships with medical device companies or other vendors can lead to unnecessary utilization and higher costs.  On the other hand, an outright ban on such arrangements could stifle innovation and possibly adversely impact patient care.  Still, the patient should know about the potential conflict. Therefore, any hospital policy should focus on disclosure of such relationships to the hospital and to patients.  Here are some of the basic things that should be in such a policy:

• Any physician on the hospital’s medical staff who has a financial relationship with a medical device company shall disclose that financial relationship to the hospital.

• Physicians who have a financial relationship with any medical device company must disclose the relationship to the patient when they are ordering a medical device sold by the company for the patient.

• The hospital should pay only fair market value for medical devices obtained from companies with which physicians on its medical staff have a financial relationship pursuant to its normal purchasing policies.

• Cost, quality and clinical effectiveness should determine hospital purchases of medical devices.

Question: A JC surveyor told us that it is inappropriate for our Chief of Surgery, who is an anesthesiologist, to perform the initial FPPE to confirm competence for a general surgeon.  The surveyor indicated that FPPE should be performed by a physician in the same specialty.  He also stated that initial FPPE must be performed at our hospital and cannot be accepted from another facility.   How are smaller hospitals addressing FPPE when they have a limited number of physicians in a specialty that can perform the evaluation?

Answer: Taking the latter issue first  –  the Joint Commission has been very clear from the inception of the OPPE and FPPE Standards in 2008 that the purpose of FPPE for initially-granted privileges (new applicants or existing members requesting new privileges) is to confirm the competence of the practitioner to exercise those privileges.  No matter how sophisticated a hospital’s initial credentialing and privileging may be, initial determinations to grant privileges are based on the applicant’s paper credentials.  The objective of initial FPPE is to confirm the competence suggested by those paper credentials.  Therefore, we agree with the surveyor that obtaining additional paper credentials from other facilities where the applicant practices does not meet that objective or the Joint Commission Standards.

But that is where our agreement with the surveyor ends.  The surveyor’s other statement – that FPPE must be performed by a physician in the same specialty – is surprising.  While proceeding in that manner is obviously optimal when it is possible to do so, we do not believe it is required.

We reviewed the FPPE Standard (MS.08.01.01) and the Elements of Performance under it, as well as FAQs about FPPE published by the Joint Commission on October 13, 2008.  None of those sources state that FPPE must be conducted by a physician in the same specialty as the physician whose competence is being evaluated.

In addition, both the glossary and the Elements of Performance under MS.07.01.03 (which pertain to peer recommendations that must be considered in the credentialing process) define a peer recommendation as “information submitted by a practitioner(s) in the same professional discipline as an applicant.”  Professional discipline is not defined in the glossary but is commonly understood to mean physician, dentist, advanced practice nurse, etc., not specialty.

Indeed, “peer” recommendations have traditionally been sought from department chairs at other hospitals where an applicant has practiced and department chairs play a primary role in the reappraisal of a physician’s competence to exercise clinical privileges at reappointment.   Department chairs may or may not practice the same specialty as the applicant for initial appointment or reappointment.  We are unaware of the Joint Commission ever taking the position that such peer recommendations are inadequate if the department chair does not practice in the same specialty as the applicant.

In fact, The Standards BoosterPak for Focused Professional Practice Evaluation/Ongoing Professional Practice Evaluation (FPPE/OPPE) published by the Joint Commission in 2011 states, in its implementation suggestions regarding FPPE, “Department chair (or whoever is evaluating the data) makes the determination to assign a period of focused evaluation.”  That certainly does not require (or even suggest) that the person who evaluates the data collected through FPPE must be in the same specialty as the person being reviewed.

So the bottom line is that there does not appear to be anything in the Standards or other materials published by the Joint Commission that supports the surveyor’s statement that FPPE must be performed by a physician in the same specialty as the physician being evaluated.

A detailed process for FPPE for initial privileges is just one of many topics presented at The Peer Review Clinic.  Join Paul Verardi and Phil Zarone for this intense, interactive program.

 

Question: We had a question raised about whether CMS requires our hospital to allow patients to self-administer their drugs when they are in our facility.  Is this a CMS requirement?

Answer:  No.  The CMS rules on self-administration are permissive, meaning each hospital has a policy decision to make in regards to this practice.

The revised Medicare Conditions of Participation (“CoPs”) that went into effect on July 16, 2012, added self-administration language into the regulations and allows hospitals to have policies and procedures which will permit patients, and their caregivers, to self-administer medications, so long as certain conditions are met.  (Prior to these revisions, the only reference to the self-administration of drugs was in the Interpretive Guidelines to the CoPs addressing the storage and security of meds.)  CMS endorsed the practice of allowing self-administration of medications based on data that indicates that self-administration programs have been shown to lead to great patient satisfaction, shorten lengths of stay, fewer medication errors and ultimately fewer readmissions related to medication problems.  However, to be clear, even under the revised CoPs, there is still no requirement for hospitals to allow self-medication.

If self-medication is allowed at the hospital, keep in mind that accreditation bodies may have their own standards to ensure that medications are safely and accurately administered.  For example, if your facility is accredited by the Joint Commission, we recommend that your hospital incorporate the general requirements found in Standard MM.06.01.01 (e.g., visual inspection), as well as the factors discussed in the revised CoPs (e.g., a determination by a practitioner caring for the patient that the patient, or patient’s caregiver, is capable of safely and accurately administering the meds) into your policy and procedures.

Question: We are revisiting our Anesthesia Policy and wanted to know whether there has to be a requirement in the Policy for a pre-anesthesia evaluation, intraoperative report, and postanesthesia evaluation for moderate and minimal sedation?

Answer:

The Medicare Conditions of Participation (“CoPs”), at 42 C.F.R. §482.52(b)(1), require a “pre-anesthesia evaluation completed and documented by an individual qualified to administer anesthesia…[to be] performed within 48 hours prior to surgery or a procedure requiring anesthesia services” (emphasis added).  There are similar requirements for an intraoperative anesthesia record and post-anesthesia evaluation at, respectively, 42 C.F.R. §§482.52(b)(2) & (3).

The Interpretive Guidelines for the CoPs on Anesthesia offer a lengthy definition, consistent with the American Society of Anesthesiologists’ Guidelines, of what constitutes “anesthesia.”  The Interpretive Guidelines for the CoPs instruct:  “CMS, consistent with ASA guidelines, does not define moderate or conscious sedation as anesthesia” and minimal sedation “is also not anesthesia.”

The Interpretive Guidelines later state:

[w]hile current practice dictates that the patient receiving moderate sedation be monitored and evaluated before, during, and after the procedure by trained practitioners, a pre-anesthesia evaluation performed by someone qualified to administer anesthesia…is not required because moderate sedation is not considered to be ‘anesthesia’ (emphasis in original).

There are similar statements in the Interpretive Guidelines for intraoperative reports and post?anesthesia evaluations.  Since minimal sedation is also not considered “anesthesia” under the CoPs, these statements apply to minimal sedation as well.

Consequently, even though patients receiving minimal, moderate or conscious sedation are required to be monitored and evaluated before, during, and after the procedure by a trained practitioner, there is no requirement under the CoPs that a pre?anesthesia evaluation, intraoperative anesthesia report or post-anesthesia evaluation, as those terms are defined by the Interpretive Guidelines, be performed.  However, you may want to check your particular state’s law or regulations or accreditation entity’s standards on the subject to ensure that those sources do not impose a higher standard than the ones required by the CoPs.

Question: We are in the process of rewriting our Medical Staff Bylaws and other documents and were considering including a section on waiver of claims by the individual medical staff applicants.

Answer:  We recommend including release and immunity language in the Bylaws or associated policies to protect the hospital and those individuals participating in the evaluation of applications and associated peer review activities to ensure that rigorous and thorough examination not only occurs, but is encouraged.  The release and immunity language should be broad and begin by stating “to the fullest extent permitted by law, the applicant releases from any and all liability, extends immunity to, and agrees not to sue the Hospital….”  Courts have looked favorably on these protections written into Bylaws and found such releases binding on medical staff applicants and appointees who have sued hospitals and others for issues arising out of the examination of an application or a practitioner’s clinical practice.

For example, in a recent case, Brintley v. St. Mary Mercy Hospital, cited above, the court observed:

The language of the release in the Waiver of Claims provision in the Medical Staff Bylaws is clear and unambiguous.  Numerous courts have found such releases in medical staff bylaws binding on plaintiffs who…upon applying for clinical staff privileges, signed an acknowledgment agreeing to be bound by the terms and provisions of the Bylaws.

***

Here, there is a clear, unambiguous waiver of ‘any claim, present or future’.  Plaintiff…is an educated woman and an experienced healthcare professional.  She acknowledged receipt of a copy of the Bylaws and admitted in writing when she applied for clinical privileges at [the Hospital] that she ‘studied the contents carefully and agree[d] to be bound by them’ upon becoming a member of the medical staff.

If you do plan to include release and immunity provisions, ensure that they are clearly and broadly written so that the protections are available to the fullest extent permitted by the law.  Also require that medical staff applicants sign an acknowledgment form, or the Bylaws themselves, stating that they received the document, read it, and agree to be bound by it.

Question: Off-campus, hospital-based urgent care clinics are popping up like mushrooms all over the place.  Does the Emergency Medical Treatment and Active Labor Act (“EMTALA”) apply to them?

Answer: The first question is whether the off-campus urgent care center (“UCC”) is considered to be a part of the hospital under either the designation “provider-based” or “department of the hospital.”  The key determinant for this:  whether the UCC bills under the hospital’s CCN, previously known as a “provider number.”  If no, EMTALA does not apply to the UCC.  If yes, the key question is whether the UCC is considered to be a “dedicated emergency department” (“DED”) under EMTALA.  If the UCC is a DED, then all of EMTALA’s responsibilities that apply to any DED, like a hospital’s Emergency Department, apply to the UCC.  If the UCC is not a DED, EMTALA does not apply.

There are three ways in which the UCC can be determined to be a DED:  (1) it is licensed by the state as an emergency room or emergency department; (2) it is held out to the public as a place that provides care for emergency medical conditions through unscheduled appointments; or (3) a sampling of cases during the previous calendar year shows that at least one-third of all the UCC’s patient visits were for the treatment of emergency medical conditions without requiring a previously scheduled appointment.

The first criterion is pretty straightforward; the other two require a more sophisticated analysis.  All things considered, you probably don’t want your UCC to be a DED.  EMTALA doesn’t allow for copays with registration, for example.  (But no, you don’t need an on-call list or schedule for a UCC.)

Question:  We understand that CMS and the Joint Commission are now requiring the inclusion of information on Histories and Physicals (“H&Ps”) in the Medical Staff Bylaws.  Does this mean we have to include all information on H&Ps in the Bylaws or can we put some of the details in the Medical Staff Rules and Regulation and other policies?

Answer:  We recommend moving all provisions regarding H&Ps from the Rules and Regulations to the Bylaws.  We make this recommendation to avoid duplication and the possibility of inconsistencies between the Bylaws and Rules and Regulations that could arise over time because one document is revised and the other is not.

However, the Medicare Conditions of Participation (“CoPs”) and Joint Commission Accreditation Standards do not require inclusion of information for short stays and reassessments and consults, etc. in the Bylaws if this information is included in Rules and Regulations.

The CoPs, at 42 C.F.R. §482.22(c)(5),  state that the Bylaws must include a requirement that:

(i)         A medical history and physical examination be completed and documented for each patient no more than 30 days before or 24 hours after admission or registration, but prior to surgery or a procedure requiring anesthesia services. The medical history and physical examination must be completed and documented by a physician…, an oromaxillofacial surgeon, or other qualified licensed individual in accordance with State law and hospital policy.

(ii)        An updated examination of the patient, including any changes in the patient’s condition, be completed and documented within 24 hours after admission or registration, but prior to surgery or a procedure requiring anesthesia services, when the medical history and physical examination are completed within 30 days before admission or registration. The updated examination of the patient, including any changes in the patient’s condition, must be completed and documented by a physician…, an oromaxillofacial surgeon, or other qualified licensed individual in accordance with State law and hospital policy.

Thus, the implication is that only the details required in the quoted language are required to be included in the Bylaws.

The Joint Commission, in MS.01.01.01, E.P. 16 and PC.01.02.03, E.P.s 4 and 5, mirrors the requirements in the CoPs, but states that the requirements for H&Ps in the Bylaws should be included in accordance with MS.01.01.01, E.P. 3, which permits “associated details, some of which may be extensive” to reside in the Rules and Regulations or other policies.  An FAQ published in March 2011 by the Joint Commission is consistent with this and provided as follows:

Question: EP 16 provides that the ‘requirements’ for performing histories and physicals (H&P) must be in the bylaws.  Does that mean that the bylaws must now contain all the details regarding the required contents of an H&P, which are commonly found in medical staff rules or a medical record policy?

Answer:  CMS CoPs (Section 482.22(c)(5)) require that the medical staff bylaws contain the requirements for completing and documenting an H&P that must be completed for each patient.  EP 16 was included to align Joint Commission requirements with CMS requirements which include information on who can perform an H&P and the time frame (e.g., not more than 30 days prior to and within 24 hours after admission; requirements for H&P updates; requirements for H&P outpatient procedures; and any countersignature requirements).  Requirements for other information or details, such as the medical history, psychological history, body systems review, etc., can be placed in other documents (rules, regulations, or policies) if desired.

Therefore, while we recommend that all provisions relating to H&Ps be included in the Bylaws to avoid duplication and possible inconsistencies, the CoPs and Joint Commission Accreditation Standards do not require this, as long as the requirements outlined in 42 C.F.R. §482.22(c)(5) are included in the Bylaws.

Question:

Can our hospital’s Institutional Review Board (“IRB”) be structured like and function as a medical staff committee?

Answer:

No.  The federal Food and Drug Administration regulations pertaining to IRBs, 21 C.F.R. §56.101 et seq., define an IRB as “any board, committee, or other group formally designated by an institution to review, to approve the initiation of and to conduct periodic review of biomedical research involving human subjects.”  The Department of Health and Human Services’ regulations echo the “institutional” aspect of the formal designation of IRBs (45 C.F.R. Part 46).  Federal regulations require the IRB to be a committee formally designated by a hospital’s Governing Board to review biomedical research involving human subjects at the hospital.

This issue has been gaining momentum lately in research audits performed by both the Office of Human Research Protections and the Food and Drug Administration.  It is becoming commonplace for the auditing agency to take issue with the fact that the institutions included their IRBs as one of several “medical staff committees” that lived in a medical staff governance document.  The auditors pointed generally to the language cited above, that it is an institutional responsibility to maintain an appropriate IRB not a medical staff responsibility.  As a practical matter, the concern is that (however unlikely), if the IRB procedures need to be revised because of a regulatory change, the medical staff may refuse to do so as is contemplated by the amendment process to these rules.  By comparison, if the IRB is a hospital committee, hospital administration and/or the Board could implement a change on its own action.  Again, while the likelihood of a Medical Executive Committee or a Medical Staff as a whole acting in such an obstructionist manner is very slim, it is a valid concern.

Therefore, we recommend that the IRB be created by a Board resolution and thereafter function as a committee of the hospital, rather than the medical staff, with its independent authority derived from the Board.  For this reason, a medical staff committee should not act as the IRB.  There may be substantial overlap of the IRB membership with those of a medical staff committee.  However, the IRB should be constituted as a separate committee of the Board in accordance with the membership requirements set forth in the federal regulations.

Question:

We want to enter into a medical director agreement with a medical staff member as an independent contractor, but don’t know which Stark exception applies.  Could you shed some light on this for us?

Answer:

The Stark Law provides that a physician cannot (1) refer patients to an entity (2) for the furnishing of “designated health services” (“DHS”) specified in the law and regulations thereunder (3) if there is a financial relationship between the physician (or an immediate family member) and the entity (4) unless the financial relationship fits within a specific exception in the Stark Law or regulations.  Entities are prohibited from billing Medicare or Medicaid for any services furnished under a prohibited referral.  This is a strict liability statute and billing for prohibited referrals can form the basis of a recoupment action by CMS and/or an action under the False Claims Act against the hospital and the physicians.

Inpatient and outpatient hospital services are included within the definition of DHS for the purposes of the Stark Law.  Thus, any transaction between the hospital and a physician on its Medical Staff or physician group would prohibit referrals to the hospital of any Medicare and fee-for-service Medicaid beneficiaries for any inpatient or outpatient service by those physicians unless the relationship fits within one of the statutory or regulatory exceptions.

The Stark Law and regulations thereunder contain an exception for personal services arrangements, which would include medical director agreements.  The relevant requirements of this exception are set forth at 42 C.F.R. §411.357(d) as follows:

(i)         Each arrangement is set out in writing, is signed by the parties, and specifies the services covered by the arrangement.

(ii)        The arrangement(s) covers all of the services to be furnished by the physician (or an immediate family member of the physician) to the entity.  This requirement is met if all separate arrangements between the entity and the physician and the entity and any family members incorporate each other by reference or if they cross-reference a master list of contracts that is maintained and updated centrally and is available for review by the Secretary upon request.  The master list must be maintained in a manner that preserves the historical record of contracts….

(iii)       The aggregate services contracted for do not exceed those that are reasonable and necessary for the legitimate business purposes of the arrangement(s).

(iv)       The term of each arrangement is for at least 1 year….

(v)        The compensation to be paid over the term of each arrangement is set in advance, does not exceed fair market value, and, except in the case of a physician incentive plan (as defined at §411.351), is not determined in a manner that takes into account the volume or value of any referrals or other business generated between the parties.

(vi)       The services to be furnished under each arrangement do not involve the counseling or promotion of a business arrangement or other activity that violates any Federal or state law.

(vii)      A holdover personal service arrangement for up to 6 months following the expiration of an agreement of at least 1 year that met the conditions of paragraph (d) of this section satisfies the requirements of paragraph (d) of this section, provided that the holdover personal service arrangement is on the same terms and conditions as the immediately preceding agreement.

All of these requirements must be met in order for the personal services exception to apply.

To help you understand financial arrangements between hospitals and physicians, on November 6 HortySpringer attorneys Dan Mulholland and Nick Calabrese will explain what options you have and what is at stake. Join them for the audio conference Money Talks: Financial Arrangements between Doctors and Hospitals.