Question: We just put a new peer review process in place and want to be sure that we have adequate clinical staff (R.N.s) to support the process.  There are approximately 350 physicians on our Medical Staff.  Do you have any benchmarks that you could share?

Answer: As we work with hospitals and Medical Staffs around the country to revamp their peer review processes to make them more effective and efficient, questions like yours come  up over and over.  For a long time, we didn’t have good answers.

So, we began to survey registrants at our Peer Review Clinic to try to get data on that, and other, peer review questions.  While our sample size is still relatively small, our survey results reveal the following regarding your question:

Medical   Staff Size	FTE   Clinical Support Staff	Cases   Reviewed/Month
100-499	80%       1-3 Support Staff 17%       4-6 Support Staff	47.1%                  1-10 29.4%                  11-25 17.6%                  26-50 5.9%                    Over 50

We invite you to complete our peer review survey online by going to:  http://www.surveymonkey.com/s/PeerReviewClinicSurvey

Obviously, the larger our sample size, the more reliable the data will be.
We will share the results in future Questions of the Week.

And, plan to join us for The Peer Review Clinic this fall. It will be offered in October in Chicago and in November in New York.

Question: Our CEO is hesitating to authorize travel for me (Medical Staff Professional) to attend one of your seminars along with our new Medical Staff leaders.  How can I convince her that it is a good idea?

Answer: More experienced physician leaders (and the CMO, if your hospital has one) can be your best allies to explain the wisdom of having you participate side by side with new leaders.  You serve as a point of continuity.  Your guidance is essential for the transition from one leadership term to the next.  Medical Staff Professionals are able, during the time spent at seminars, to “bond” with the team and pave the way for them to be more productive, efficient and confident in their readiness to perform their ever more important tasks.  New physician leaders will have questions as they learn, and if you are there, you can help them increase their understanding on the spot.  You can also identify issues that need follow-up, such as policies and bylaws that should be updated, and thus help the organization get the most value out of the seminar and the materials.  It will be time and resources well invested!  You are the physician leaders’ best resource and the more you are with them, the better able you will be to assist them.

Question: Medicare requires hospitals to include in their discharge plan a list of Home Health Agencies (“HHAs”) or SNFs that participate in the Medicare program and serve the geographic area in which the patient resides.  Currently, we simply provide a list of all providers within a particular category.  However, we have an ever-increasing need to be more aware of the quality outcomes of such providers, since readmission rates ultimately reflect poorly on us (at least in CMS’s eyes).  Would we satisfy Medicare’s requirements if we continue to list all providers, but identify some of them as “preferred providers” based on their quality outcomes?

Answer: It appears that hospitals are not permitted to endorse certain post-hospital providers based on their quality of care.  The relevant regulation states:

The hospital must include in the discharge plan a list of HHAs or SNFs that are available to the patient, that are participating in the Medicare program, and that serve the geographic area (as defined by the HHA) in which the patient resides, or in the case of a SNF, in the geographic area requested by the patient. HHAs must request to be listed by the hospital as available….

The hospital, as part of the discharge planning process, must inform the patient or the patient’s family of their freedom to choose among participating Medicare providers of posthospital care services and must, when possible, respect patient and family preferences when they are expressed. The hospital must not specify or otherwise limit the qualified providers that are available to the patient.

42 C.F.R. §482.43(c)(6) – (c)(7) (emphasis added).

In preamble comments in the Federal Register, CMS explained further:

[I]if a hospital chooses to develop its own list of HHAs or SNFs, the hospital would have the flexibility of designing the format of the list. However, the list should be utilized neither as a recommendation nor endorsement by the hospital of the quality of care of any particular HHA or SNF.

69 Fed. Reg. 48916, 49224 (August 11, 2004).  Given recent developments with Medicare, it’s possible CMS will change its interpretation of this regulation.  However, for the time being, it seems lists of post-hospital providers may not identify “preferred providers.”

Question: Of every six Medicare patients admitted to the hospital for nonsurgical reasons, one will return within 30 days.  Beginning October 2012, CMS started reducing pay to hospitals for such readmissions.  About 80 times a week, U.S. patients undergoing surgery experience mistakes that safety advocates say should never happen.  Whose job is it to address these concerns:  the Medical Staff, Hospital Administration or the Board?

Answer: The easy – and correct – answer is that it’s the job of the Medical Staff, Hospital Administration and the Board.  And, most importantly, that these three groups work together, not individually.

But, the strongest legal answer is the Board.  That’s because the Board is legally responsible for the conduct of the hospital as an institution.  That’s from federal law, state law, and accreditation standards.  And, emerging research shows that Boards can make an enormous difference in improving quality and patient safety.

How to do this?  By working with the Medical Staff and Administration in developing good policies, procedures and criteria for credentialing, privileging, peer review and ongoing performance improvement.  By spending 25% of Board time on quality and patient safety.  By creating a Board Quality committee.  And these are but three actions; there are many more.

These are all important improvements that are a necessary part of a hospital’s mission.  But there is also the hard reality that unless a hospital can shape (or reshape) itself to be paid on its quality outcomes, and not just its procedures, that hospital could find itself in a poor fiscal position to care for its community.  And, that is definitely on the Board.

To learn about the Board’s role in quality, and how critical this role is, join HortySpringer attorneys Linda Haddad and Alan Steinberg for an audio conference on July 2, The Board’s Role in Quality and Safety.

Question: We just discovered that we have been providing a service to certain medical staff members pursuant to a written agreement that has expired.  What can we do?

Answer: First and foremost, DO NOT PANIC!  While all agreements with any person who is in a position must be at fair market value, due to the potential financial penalties that can arise from noncompliance, a hospital’s primary concern is compliance with the Stark Law.  However, the first thing that you have to determine is whether the Stark Law applies.  Is the other party to the agreement a “physician” as this term is defined in the Stark Law?  In most instances, the answer will be yes.  However, if, for example, the other party is a physician assistant or CRNP, then those mid-level providers are not “physicians” and the Stark Law will not apply.

If a physician is involved, what is the physician’s specialty?  Is the physician a pathologist, radiologist or radiation oncologist?  If so, then, according to the Stark Bill, those physicians do not make “referrals,” so Stark does not apply.  Was there a previous agreement?  If so, then 42 C.F.R. §411.357(d)(1)(vii) provides that as long as a new agreement is executed within 180 days of the date of the expiration of the previous agreement, then the agreement will continue to comply with the personal services exception.  Then consider the law in your state regarding expired agreements.  In many states, the agreement will renew as an operation of law.

Also remember that while the personal services exception is the exception that usually applies, the hospital must only satisfy one exception to the Stark Law.  If the physician is making a payment to a hospital for any item or service, see if the “payment by physicians” exception applies (42 C.F.R. §411.357(i)).  This often overlooked exception may prove to be invaluable in these types of situations since the exception does not define “item or services,” and does not require a written agreement.  A written agreement is also not required if an employment relationship is involved, or if the service can be considered to be a medical staff incidental benefit (42 C.F.R. §411.357(m)).

If all else fails and your legal counsel advises you that a voluntary disclosure is legally required, make sure that your legal counsel advises you to consider the foregoing when determining the amount that may be due to the government pursuant to that disclosure.

Want more information on this and many other issues related to hospital-physician financial relationships?  Then join Dan Mulholland and Henry Casale in New York City on November 21-23 for our Hospital-Physician Contracts:  Survival Strategies seminar.

Question:  Has the Internal Revenue Service (“IRS”) issued proposed regulations on the requirement that charitable hospitals perform a community health needs assessment?

Answer:  Yes.  Internal Revenue Code Section 501(r)(3) requires that charitable hospitals perform a community health needs assessment (“CHNA”) every three years or risk losing tax-exempt status.  The IRS has issued proposed regulations on the CHNA requirements and set forth the consequences of failing to meet the requirements.

The proposed regulations state that a hospital meets the CHNA requirements if it has conducted a CHNA within the current tax year or in either of the two immediately preceding tax years and the board has adopted an implementation strategy to meet the community health needs identified through the CHNA by the end of the tax year in which the hospital conducts the CHNA.

Please note that these are proposed regulations, and that the final regulations may differ.  However, a hospital can rely on the proposed regulations for any CHNA performed or implementation strategy adopted up to six months after the proposed regulations are published as final or temporary regulations in the Federal Register.

Also, please note that the IRS is accepting comments on the proposed regulations that are received by July 5, 2013.

Question: We’ve had concerns raised about a member of our medical staff writing scripts for themselves and family members.  There was also a question raised about another member who performed a test on a family member without going through the formal mechanisms for patient registration.  What can we do to educate our medical staff about the risks involved with these kinds of practices?

Answer: Medical staff members need to be reminded of the significant concerns that arise when a physician treats himself or herself, a family member, or someone with whom the physician has a close relationship (such as a domestic partner, fiancé, etc.) Such activities also present serious risks for the hospital, including the legal risk of malpractice liability and the risk of citation for violation of regulatory and accreditation requirements for proper documentation of care provided to patients, all of whom should be registered in the usual manner.

The American Medical Association has spoken specifically to this issue, in its Code of Ethics (see Standard E-8.19), as have various state medical boards.  We recommend reviewing the guidance provided by these bodies and adopting policy language in the Medical Staff Rules and Regulations that reinforces that the standards of acceptable medical practice do not allow physicians to treat themselves or members of their own families.  Of course, there is an exception to every good rule, so the provision should recognize specific exceptions, like where the patient’s disease is rare or exceptional and the physician is considered an expert in the field or in an emergency where no other medical staff member is readily available to care for the family member.

 

Question: Our hospital is in a state with a very weak peer review privilege.  We are looking for ways to better protect our peer review information and thought that the federal Patient Safety and Quality Improvement Act (“Patient Safety Act”) could assist us in achieving this goal.  Is this possible?

Answer: Yes.  The Patient Safety Act can be used to protect peer review information.  The confidentiality and privilege protections under the Patient Safety Act are extremely strong and in most cases exceed those available under traditional state peer review privileges.  The preamble to the proposed regulations for the Patient Safety Act instructs that the protection of peer review information is one of the specific purposes of the Patient Safety Act.  The preamble provides as follows:

Traditional state-based legal protections for such health care quality improvement activities, collectively known as peer review protections, are limited in scope:  They do not exist in all States; typically they only apply to peer review in hospitals and do not cover other health care settings, and seldom enable health care systems to pool data or share experiences between facilities.  If peer review protected information is transmitted outside an individual hospital, the peer review privilege for that information is generally considered to be waived….  [T]he Patient Safety Act specifically addresses a number of these long-recognized impediments to improving the quality, safety, and outcome of health care services.

Thus, the Patient Safety Act not only considers peer review information to be within the scope of its protections, it also seeks to broaden the protections available under state laws by allowing for the sharing of peer review information between hospitals and affiliated entities (e.g., physician group practices) and eliminating the ability of a provider to “waive” the privilege and confidentiality protections under the law.

However, once a hospital reports peer review information to a Patient Safety Organization under the Patient Safety Act, it is difficult to retrieve in identifiable form the information and then use the information for other purposes.  Consequently, if a hospital needs peer review information to conduct a medical staff hearing, appeal, or investigation and has already reported the information to a Patient Safety Organization, it will be hard to access.

But, the regulations for the Patient Safety Act anticipated this situation and allow providers to maintain information in a Patient Safety Evaluation System before reporting the peer review information to the Patient Safety Organization.  Information maintained in a Patient Safety Evaluation System is subject to the same strong privilege and confidentiality protections that apply to information reported to Patient Safety Organizations.  The only difference is that information held in a Patient Safety Evaluation System can be removed easily to be used for other purposes, such as to satisfy external reporting requirements or for conducting medical staff hearings and appeals (once the information is removed from the Patient Safety Evaluation System, it is no longer subject to the protections under the Patient Safety Act).  The key is to have a well-defined Patient Safety Evaluation System that provides guidelines for when the hospital will report peer review information from its Patient Safety Evaluation System to the Patient Safety Organization.

To learn more about protecting peer review information under the Patient Safety and Quality Improvement Act, join Horty, Springer & Mattern attorneys Henry Casale, Rachel Remaley, and Charlie Chulack for the Institute on Employed Physicians and Their Impact on the Medical Staff in Chicago from October 3 through October 5, 2013.

Question:

I’ve never quite understood hospital accreditation.  Is it the same as a regulation?  What do TJC, HFAP, and DNV stand for anyhow?  And why are they important?

Answer:

Accreditation is different from regulation.  Regulation comes from governmental entities.  On the federal level, the Centers for Medicare & Medicaid Services (“CMS”) set the regulations to which hospitals need to comply in order to be a Medicare participating hospital.  CMS issues the Medicare Conditions of Participation (“CoPs”) that must be met.  On the state level, usually the state’s department of health issues hospital licensing regulations that the hospital must meet in order to stay licensed.

In contrast, accreditation is a process and outcome by which a hospital voluntarily undergoes a review by an accreditation organization.

The Joint Commission is the oldest of the three accrediting bodies.  Its roots run back to the early 1900s when the American College of Surgeons created its Hospital Standardization Program.  The Joint Commission on Accreditation of Hospitals (“JCAH”) began in 1951, created by the merging of the Hospital Standardization Program with similar programs run by the American College of Physicians, the American Hospital Association, and the American Medical Association.  The JCAH changed its name in 1987 to The Joint Commission on Accreditation of Healthcare Organizations (“JCAHO”), and then slimmed down, name-wise, in 2007 to “The Joint Commission.”

The Healthcare Facilities Accreditation Program (“HFAP”) was originally created in 1945 to conduct an objective review of services provided by osteopathic hospitals.  The HFAP is an accreditation program of the American Osteopathic Association.

DNV Healthcare, Inc. (“DNV Healthcare”) is the third provider of hospital accreditation.  DNV Healthcare is a subsidiary corporation of Det Norske Veritas (the original “DNV”), an independent Norwegian foundation that has as its primary purpose the safeguarding of life, property and the environment.  The Original DNV goes back to 1864 and is quite global.  DNV Healthcare is the most recent of the accrediting bodies in terms of accrediting U.S. hospitals.

Why would any hospital voluntarily agree to be accredited by any of these organizations?  Because accreditation by The Joint Commission, HFAP, or DNV Healthcare provides “deemed status” – automatic recognition that the hospital has complied with the Medicare CoPs and so remains or becomes a Medicare participating hospital.

But, while “deemed status” comes with any of these accrediting bodies, each of these organizations have different approaches and standards by which they review and accredit hospitals.  The differences among these organizations run from large conceptual differences to differences in the details.  Which accrediting body to use, if any, is an important decision for any hospital.

To learn more about accreditation, its benefits, its costs, and many other important issues, please join us on June 4, 2013 from 1:00 to 2:00 p.m. (Eastern Time) for Grand Rounds – Accreditation:  What Physicians Need to Know!

Question:

As Chief of Staff, I appointed a new Vice Chief of Staff a month ago to serve out the term of an ill elected Vice Chief.  The new Vice Chief made negative comments about another physician (who is in a competing group) in an elevator where he was overheard by a family member of a patient. After learning of these remarks from the family member, the physician about whom the remarks were made asked for an investigation into what he sees as defamation. We had a hard time finding anyone willing to serve; this Vice Chief has not yet had any leadership training.  What can I do as Chief of Staff?

Answer:

You, along with one or more other Medical Staff leaders and perhaps the CMO, could try counseling the new Vice Chief and follow up with a written statement of expectations.  Disparaging comments in a public area are never acceptable.  Leaders have a responsibility to set a good example for others.  If this new Vice Chief (or any physician) has information relevant to clinical performance or professional conduct of any other physician, he should direct that information into the peer review process.  Discussing such issues publicly might be grounds for removal from office, but if he is cooperative, leaders might be willing to give him a chance to learn and improve.  If leaders are convinced that he is sincerely committed to appropriate conduct in the future and wishes to continue to serve, it would be a good idea for this physician to obtain some leadership training. The physician who asked for the investigation cannot be told the outcome of the counseling, but leaders can advise him that the process is confidential and that leaders take the concerns seriously.