January 21, 2016

QUESTION:        We have an e-mail exchange with a referring physician that clearly describes the services that the physician is to perform and the amount that the hospital is to pay the physician for those services. However, we cannot locate a written agreement. Do we have a Stark problem?

ANSWER:           No, thanks to the new Stark Regulations that went into effect on January 1, 2016. These regulations were promulgated as part of Medicare’s 2016 Physicians’ Fee Schedule. In these regulations, CMS stated that, based in large part on what CMS has learned from voluntary self-disclosures, CMS wanted to clarify the terms that are required in order to satisfy the Stark writing requirement that is included in many of the compensation arrangement exceptions.

CMS first stated that “in most instances, a single written document memorializing the key facts of an arrangement provides the surest and most straightforward means of establishing compliance with the applicable exception.” However, CMS then made it clear that this is not the only means of complying with the Stark writing requirement, stating: “CMS’ existing policy is that a collection of documents, including contemporaneous documents evidencing the course of conduct between the parties, may satisfy the writing requirement of the exceptions for compensation arrangements that require a writing.”

CMS then listed a number of examples that will comply with the writing requirement that included, but are not limited to: board minutes or other documents authorizing payment for specified services; written communications between the parties “including hard copy and electronic communication”; time sheets; fee schedules for specified services; check requests or invoices identifying items or services provided and the rate of compensation; or accounts payable or receivable records documenting the date and rate of payment and the reason for the payment.

Therefore, your e-mail exchange will satisfy the Stark writing requirement and the electronic signatures in the e-mail will satisfy that the arrangement must be signed by both parties (see the Federal Electronic Records and Signatures in Commerce Act).

The new rules are not intended to undo hospital compliance efforts and an effective compliance process remains an essential component of any health care organization. However, the new Stark rules will allow the parties to place substance over form when determining compliance with an applicable Stark exception.

January 14, 2016

QUESTION:        We have an applicant who has been sued for medical malpractice ten times during the past ten 10 years and seven of those cases have resulted in medical malpractice payments being made on behalf of the applicant. The payments range from pretty significant ($850,000) to nominal ($12,000). What should we do?

ANSWER:            A single malpractice claim, standing alone, does not necessarily indicate a quality problem or even a lapse in the standard of care. However, frequent malpractice actions, even without any accompanying liability, often reflect an underlying issue with behavior, communication, or clinical practice.

Hopefully your Credentials Policy (or Medical Staff Bylaws) clearly states that the applicant has the burden of producing information deemed adequate by the hospital for the proper evaluation of current competence, character, ethics, and other qualifications and that the applicant must also resolve any and all doubts about his or her suitability as a candidate.

With reference to this language, the applicant should be informed that in order for the hospital to move forward with the application, the applicant must resolve the concerns raised by his or her malpractice history and that this will be accomplished by some (or all) of the malpractice claims being evaluated through the peer review process.

Given the large number of claims at issue, the hospital could decide to retain an external expert to assist in the review of the cases. And, since the burden is on the applicant to resolve all questions and concerns, the hospital could decide that the applicant will be responsible for the costs associated with the review by the external expert. The report of the expert could then be considered in reviewing the application.

January 7, 2016

QUESTION:        Our hospital is interested in using an electronic application that allows individuals to schedule a time to come to our Emergency Department by picking a time slot through our website. Is that going to get us in trouble under the Emergency Medical Treatment and Active Labor Act (“EMTALA”)?

ANSWER:            It’s a good question. The CMS EMTALA Central Office says that simply using such an electronic application is not in and of itself an EMTALA violation. The key point is how patients are treated when they arrive at the ED.

Per the Central Office, the use is not an EMTALA violation because the potential for an EMTALA violation is interpreted as beginning when the patient presents to the ED or is on the hospital’s property. Once a person arrives at the ED or is on the hospital’s property, EMTALA obligations begin equally for everyone, regardless of any prior contact or communication made. So long as the hospital maintains the obligation to perform an appropriate medical screening examination and stabilizing treatment to everyone equally once a person presents for ED care, any other arrangement is irrelevant to EMTALA compliance.

This means that how the electronic application is used is a key to EMTALA compliance. If it’s used so potential patients can see how crowded the ED might be at any given time and plan an arrival time, and if patients are then triaged and screened according to standard procedure, there should not be an EMTALA problem. If, however, the application is used to allow a patient to move to the front of the line when he or she arrives at the ED or on hospital property regardless of what the hospital’s triage and screening processes say, then there would be an EMTALA concern, and so the potential for a violation.

The bottom line, all must be treated equally when they arrive at the ED.

December 17, 2015

QUESTION:        One of our surgeons has been preparing operative reports over the weekend for his upcoming surgeries on Monday or Tuesday. He explained that he has more time over the weekend, so he copies and pastes op reports from prior, similar surgeries into the record for the upcoming surgery, then revises them after the surgery as needed. Should we be concerned with this practice?

ANSWER:          Medicare and other payors recognize the efficiencies that can result from the copy and paste feature of EMR technology. At the same time, those payors are also concerned that such technology will be used improperly in a way that is bad for patient care and leads to inflated payments.

On September 24, 2012, the federal Department of Justice (“DOJ”) and Department of Health and Human Services (“HHS”) issued a letter regarding the fraud and abuse concerns about certain EMR documentation practices. DOJ and HHS stated “[a] patient’s care information must be verified individually to ensure accuracy; it cannot be cut and pasted from a different record of the patient, which risks medical errors as well as overpayments.” The letter spoke generally about the willingness of DOJ and HHS to prosecute health care fraud based on improper EMR documentation practices. A copy of the letter is available at: http://www.modernhealthcare.com/Assets/pdf/CH82990924.PDF.

In December 2013, the HHS Office of Inspector General followed up with a report titled “Not All Recommended Fraud Safeguards Have Been Implemented in Hospital EHR Technology.” http://oig.hhs.gov/oei/reports/oei-01-11-00570.pdf. The report discusses risks and benefits of the copy and paste feature in EMR technology.

Following the lead of DOJ and HHS, National Government Services (a Medicare Administrative Contractor) discussed the overpayment risks of “cloned” documentation as follows:

Documentation is considered cloned when it is worded exactly like or similar to previous entries. It can also occur when the documentation is exactly the same from patient to patient. Individualized patient notes for each patient encounter are required.

* * *

Whether the documentation was the result of an Electronic Health Record, or the use of a pre-printed template, or handwritten documentation, cloned documentation will be considered misrepresentation of the medical necessity requirement for coverage of services due to the lack of specific individual information for each unique patient. Identification of this type of documentation will lead to denial of services for lack of medical necessity and the recoupment of all overpayments made.

EMR technology can improve the content and consistency of documentation, and make it less burdensome to produce. However, using a template to prepare documentation in the EMR before the procedure is actually performed increases the risk of allegations of “cloned documentation” and “fraud and abuse” by the government or third-party payors.

 

 

December 10, 2015

QUESTION:        We employ physicians through a corporation affiliated with the hospital. One of our employed physicians recently submitted a request to the Chief of Staff, his friend, requesting that he be excepted from taking nighttime and weekend call due to “seniority” and years of service. The request was approved at the last MEC meeting. The physician now claims that he is exempt from covering the medical practice too, since an exception was granted. Is he right?

ANSWER:            The question you raise is not uncommon. The answer is that the physician is not right, but it is best to be clear in your employment contracts about the difference between ED call and practice call so there is no confusion or dispute.

The obligation to serve on the Emergency Department’s on-call roster arises from the Medical Staff Bylaws, Credentials Policy, and related documents (for example, the hospital’s on-call policy or EMTALA policy). Accordingly, any physician who wishes to be a member of the medical staff or exercise clinical privileges must agree to serve on the ED call roster that is developed in accordance with hospital policy (often by the department chairs, subject to approval of the MEC and Board). In your case, the physician in question has made arrangements through the medical staff leadership to obtain an exemption from the requirement in the Bylaws.

The obligation to “take call” for the practice is separate and aside from any obligations that a physician may have to the hospital or its ED. All physicians have to cover their practice, whether they are affiliated with the hospital or not. It is through this coverage that the practice’s patients are able to obtain after-hours consultation and advice regarding emergencies. The obligation to be on call for the practice does not arise through the hospital’s Medical Staff Bylaws or related documents. Rather, it is an obligation associated with employment. In turn, the medical staff leadership has no authority over whether your employed physician takes call for the practice and cannot grant the physician an exemption from such duties.

So there is no confusion or dispute, we recommend that your employment contract language state that the physician will be required to be on call for the practice, along with other practice physicians, according to the schedules established by the employer. The language should go on to state that, in addition, the physician must fulfill any obligations of medical staff membership or clinical privileges at all hospitals with which he or she is affiliated, including service on the hospitals’ ED call rosters.

December 3, 2015

QUESTION:         The new, final, Stark regulations permit a hospital to provide financial assistance to a physician or physician group to employ or contract with certain non-physician practitioners. What types of non-physician practitioners are covered under the new regulations?

ANSWER:            Hospitals may provide financial assistance to help physicians or a physician group hire or contract with physician assistants, nurse practitioners, clinical nurse specialists, certified nurse-midwives, clinical social workers, or clinical psychologists. Financial assistance for other types of non-physician practitioners, such as nurse anesthetists, physical therapists, and dietitians, is not covered by the new exception.

November 19, 2015

QUESTION:        We are currently in the process of adopting new Medical Staff Bylaws. A member of the Medical Staff questioned whether language that was included in the draft Credentials Policy indicating that the appropriateness of utilization patterns would be considered when granting privileges would constitute “economic credentialing.” Does it?

ANSWER:           Not in our experience. This type of language is often included in medical staff documents to allow for consideration of patterns related to comparative lengths of stay, medical necessity issues, and similar matters. The purpose is not to exclude someone from the medical staff; rather, it is intended to allow for performance improvement. For example, if someone was an outlier in length of stay, as compared to his or her peers, that variance would be something that could be addressed as a part of the Ongoing Professional Practice Evaluation (“OPPE”) process. Such a scenario would only result in “economic credentialing” if the data was used to serve as the basis for revoking that physician’s clinical privileges.

Interestingly, the Final Rule related to the new Comprehensive Care for Joint Replacement (“CJR”) bundled payment model highlighted in this week’s Government at Work includes a question about the effect such programs might have on credentialing, being that they encourage hospitals to use only the most “efficient” or “cost-effective” physicians. While CMS indicates that existing antitrust laws may limit a hospital’s ability to keep privileges from a non-compliant or high-cost physician, it does not include any restrictions that would specifically prohibit a hospital from doing so.

Please join LeeAnne Mitchell and Ian Donaldson at an upcoming Credentialing Clinic to learn more about the new wave of credentialing matters facing Medical Staff leaders. You can join us for this interactive course by clicking here.

November 12, 2015

QUESTION:         Our hospital recently received a discovery request (a request for production of documents) in a malpractice suit brought against one of the physicians practicing at our hospital. The request seeks documents which contain protected health information (“PHI”), as that term is defined by the Health Insurance Portability and Accountability Act (“HIPAA”). Should we respond by producing the documents?

ANSWER:           This is a question that can best be answered by your attorneys and should be referred to them for an answer because the answer may depend on a number of variables, such as whether the information is protected by your state’s peer review privilege or some other evidentiary privilege. Nonetheless, assuming no privilege applies and that the information is otherwise discoverable, PHI under HIPAA may only be disclosed under certain circumstances. In litigation, disclosures of PHI are often made pursuant to a “qualified protective order.” A covered entity may disclose PHI if it “receives satisfactory assurance…from the party seeking the information that reasonable efforts have been made by such party to secure a qualified protective order….” At a minimum, the qualified protective order must prohibit the parties from using or disclosing the PHI for any purpose other than the litigation and require the return to the covered entity or destruction of the PHI, and any copies made, at the end of the litigation. If a qualified protective order that meets HIPAA requirements is in place and the documents are not otherwise privileged or protected, it may be appropriate to provide the documents.  Of course, your hospital may also provide PHI that is sought in discovery after it is de-identified according to the requirements of HIPAA. Disclosure of de-identified health information may be appropriate if the discovery request does not seek health information that is tied to a particular individual and does not cover a large number of documents.

November 5, 2015

QUESTION:        In response to a credentials verification inquiry about a former staff member, one of our newest department chiefs disclosed that this former staff member had been subject to a performance improvement plan. Now a lawyer for that former staff member has demanded a retraction and threatened to sue for defamation. What should we do?

 

ANSWER:           Refer the letter to counsel, who can send a response educating the lawyer about custom and practice in credentialing and about the immunity for provision of accurate information. There is nothing to retract if the response was true, nor would a defamation claim succeed. (More importantly, such a letter can help with other potential audiences, in case a suit is filed.) Credentialing would break down if no one responded truthfully to verification inquiries. The Health Care Quality Improvement Act provides for immunity in favor of those who provide information to other hospitals. 42 U.S.C. Section 11111(a)(2). However, even meritless suits are a drain on resources and may have a chilling effect on future leaders.

Immunity helps if there is a suit, but are there ways to minimize the likelihood of a suit? If there were issues with a former staff member, it may be prudent for all inquiries to be referred to a central place, such as a VPMA/CMO, who can guide a new Chief. Your Medical Staff Services Professional can also be a great help in fielding such inquiries and helping new leaders who have never faced such an issue. In the future, you might consider, as a policy matter, developing a standard communication for use when inquiries relate to a practitioner who experienced concerns, advising inquiring hospitals that no response to any credentialing inquiry will be provided without a signed specific release. That will send a message without revealing anything.

Be sure you have excellent and strong release and immunity language in your Bylaws or Credentials Policy. And – be sure your new Chiefs attend our Credentialing Clinic or Complete Course for Medical Staff Leaders! The first step to an excellent medical staff is careful credentialing!

October 29, 2015

QUESTION:        We had a nurse practitioner apply for privileges at our hospital, but the application didn’t identify a collaborating physician, which is required under our hospital policy. When we followed up with the applicant, he responded that he didn’t need a collaborating physician because our state now allows nurse practitioners to practice independently. Is this true?

ANSWER:           It depends, but probably not. A state’s decision (through modification of the professional licensing statutes and regulations) to expand the scope of practice for an advance practice nurse, and to allow such practitioners to practice independently in that state, does not generally supersede the policy decision of a hospital that such practitioners must still work in collaboration with a physician appointed to the medical staff in that hospital setting. The only exception would be if the statute “mandated” that such practitioners be permitted to practice independently – in all clinical settings – which most of the statutory changes have not done. While it may be a question that the medical staff and board wish to consider further, there is a significant difference between a statute that permits independent practice and one that mandates independent practice. If the hospital policy continues to require a collaborative relationship, the applicant should be informed that he or she is ineligible to apply unless he or she can supply evidence of a collaboration agreement with a physician.