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.

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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:

Our emergency physician group has been recruiting to fill an open slot and they finally found someone.  They are eager to get her started ASAP, with temporary privileges.   While most of her references are stellar, one indicated that she was subject to a performance improvement plan related to medical recordkeeping three years ago.  She authorized us to inform the head of the ED group, and she explains that during a period of three months when she was caring for her ailing mother, she had some issues.  Since then there have been no problems, she says.    Should we wait for the full Credentials Committee to meet in three weeks?  The head of the ED group is very insistent.

Answer:

It would be prudent to wait, so that you can get full information to verify her explanation.  Temporary privileges can be granted when there is a complete, clean application.  This application is not complete unless and until all issues have been explained to the satisfaction of the Credentials Committee.  A Credentials Committee sometimes recommends conditional appointment to address issues in an applicant’s background.  If you don’t follow your process for this applicant, others who do not satisfy your qualifications may demand that they also be granted temporary privileges. Physicians who have not been involved in credentialing may not appreciate the legal and accreditation standards that define circumstances in which temporary privileges may, or may not, be granted.

Join Barbara Blackmond and Charlie Chulack for an audio conference on December 11, 2102  to explore the pressures that sometimes lead hospital recruiters and physician groups to push for quick action on an application when that simply can’t be done safely and wisely.  We’ll provide some practical guidance to help educate all of those involved in recruitment.

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.

Question:

A surveyor from The Joint Commission is at our hospital and has stated that Ongoing Professional Practice Evaluation (“OPPE”) must be completed every six months.  Our policies specify that OPPE must be completed every nine months.  Is the surveyor right?  Help!

Answer:

The Joint Commission requires OPPE to be conducted on an ongoing basis.  Although the written standards and elements of performance do not specify an exact time frame for gathering and evaluating OPPE data, a 2008 “FAQ” on The Joint Commission website states that it is expected that OPPE reviews will occur more frequently than annually, preferably at least once every six months.

This FAQ was updated in March 2010 and states in part as follows:

Q.  What is the intent of the requirement for Ongoing Professional Practice Evaluation?

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2.  A clearly defined process would include but not be limited to:

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• how often the data will be reviewed. The frequency of such evaluation can be defined by the organized medical staff, e.g., three months, six months, nine months, etc.  However, as noted in the teleconferences during 2007, twelve months would be periodic rather than ongoing.

So clearly, six months is not a hard and fast rule, and the FAQ even stretches out to nine months.

Question: We have several older surgeons on our medical staff.  We do not have any quality data to show that they are practicing in an unsafe way but we would like to be proactive since we have heard rumors at least about some of them.  Can we require that all physicians over the age of 70 be reappointed annually and/or get a physical and neurocognitive exam?

Answer:

Dealing with older physicians typically feels like the proverbial “rock and hard place.”  These physicians often have served in leadership positions on the medical staff and maybe even the board.  They are committed to their patients and to the practice of medicine.  And, given the physician shortage, we need them.

At the same time, we have an obligation to protect patients and to only allow physicians who are safe and competent to practice.

With respect to physicians, the conventional wisdom was that “practice makes perfect.”  Several studies have turned this wisdom on its head.  A 2005 article in the Annals of Internal Medicine showed that there was an inverse relationship between performance and years of practice.  In other words, performance declined as years of practice increased.  Even though another study, reported in the Annals of Surgery in 2006, had slightly different results and reached a different conclusion, older physicians still had a higher mortality rate in three out of eight procedures.

However, establishing a rule that “all physicians over age 70 must be reappointed annually” or “must be subject to a focused evaluation” or “must undergo a physical and neurocognitive examination” may not be consistent with state or federal antidiscrimination laws.  As the Oury case (discussed above) demonstrates, we are seeing a growing number of claims brought by physicians under the Age Discrimination in Employment Act (ADEA) and similar state laws.  Although the federal law allows age to be used as a factor in employment decisions if age is a “bona fide occupational qualification,” establishing this is no easy matter.

Therefore, we recommend that the best approach, to address concerns about patient care and safety, is to improve your peer review process and address concerns as they arise.  This improvement can start with education.  Physicians, advanced practice providers, and staff alike need to understand their obligation to report concerns through the peer review process.  Enabling an impaired physician, even if that physician is a beloved elder surgeon, is not good for patients and ultimately not good for the physician. (Who wants to end a stellar career with a horrible patient outcome and an ugly lawsuit to boot?)

Once a concern has been reported, an individualized and focused review of the physician’s practice can be initiated.  This review can include proctoring, monitoring, a competency assessment, and a physical or neurocognitive examination.  The record of concerns will support that the action was legitimate and non-discriminatory and will be useful to have if a claim for discrimination is brought.

While bright line rules are sometimes nice to have, in this area, we think a rule that singles out older physicians may be counterproductive and an invitation to be sued.

 

Learn effective ways to handle the aging physicians on your medical staff at The Complete Course for Medical Staff Leaders and The Advanced Roundtable for Physician Leaders. Both will be held in San Francisco, October 25-27, and New York, November 15-17.