QUESTION:       I read that President Obama signed into law something called the “21st Century Cures Act” – what is it?

ANSWER:           The 21^st Century Cures Act includes provisions to expand medical research, invest in mental health resources, and combat the prescription and opioid drug epidemic.  However, there are several parts to it that deal with things such as electronic health records interoperability (expedites interoperability among Electronic Health Records by developing or supporting a voluntary model framework and common agreement for the secure exchange of health information between networks), the Health Insurance Portability and Accountability Act (directs clarification of the circumstances when a health care provider or covered entity may use or disclose protected health information related to the treatment of an adult with a mental or substance use disorder), and Medicare reimbursement rules.  Watch this space for potential audio conferences on the Act.

QUESTION:        Does the recently released final rule for MACRA (or the law itself) require hospitals and other entities to revise contracts they have with physicians?

ANSWER:           MACRA does not require hospitals and other entities to revise contracts they have with physicians.  However, we recommend conducting a MACRA audit of the physician contracts in your organization to determine if revision is necessary and permitted and, if so, how to go about working with physicians to restructure their contracts so that they are aligned with the focus of MACRA.

MACRA repealed the Medicare Sustainable Growth Rate methodology for updates to the Physician Fee Schedule and replaced it with an approach to physician payment which is heavily dependent on rewarding the delivery of high-quality patient care through two methods:  Advanced Alternative Payment Models and the Merit-based Incentive System.  Both of these models incorporate various quality, cost, and use of certified Electronic Health Record criteria into determining the amount of reimbursement.  These reimbursement models may conflict with the compensation plan used for your current physician contracts.

A MACRA audit seeks to address any such conflicts by reviewing physician contracts to answer the following questions: (1) Will MACRA affect the agreement? (2) If so, how? (3) Where MACRA will affect the agreement, what can the entity do to revise its agreements to be more consistent with MACRA?

With respect to this last question, it is important to remember that physician contracts are legal documents and the terms of those contracts are binding on the contracting entity and the physician.  Any revisions have to be consistent with those terms.  Often, contracts will have provisions on amendments, which specify how and for what reasons the contract can be revised.  An amendment provision may allow the contract to be revised for legal or regulatory changes affecting reimbursement.  Under such circumstances, an amendment may be permitted due to MACRA.  Some contracts only permit amendments by consent of the parties to the agreement.  Regardless of the content of the amendment provisions in your physician contracts, engaging physicians in any amendment process is vital to ensure buy-in and transparency.

QUESTION:       We are a small, rural hospital and do not have the capabilities (e.g., lifts, reinforced toilets, etc.) to accommodate morbidly obese patients.  Are we permitted to implement a policy on transferring these patients to another hospital that can?

ANSWER:           The answer to this question isn’t entirely clear but a couple of laws which you should consider in implementing this type of policy include the Americans with Disabilities Act (“ADA”) and EMTALA.

Even though there is not widespread consensus on whether morbid obesity is a disability under the ADA, there appears to be a recent trend concluding that it is, following the amendment of the ADA which gave a broader definition to the term “disability.”  In fact, the Equal Employment Opportunity Commission (“EEOC”) has been involved in at least one suit alleging that an individual was discriminated against in violation of the ADA because of his morbid obesity.

Under Title III of the ADA, hospitals are places of public accommodation.  Thus, the mandates of Title III apply.  Title III requires places of public accommodation to make reasonable modifications unless such modifications would fundamentally alter the nature of the services.  The regulations permit hospitals and other medical service providers to refer an individual with a disability to another medical service provider for specialized services that the referring medical service does not provide.

If one of the concerns a hospital has with respect to treating morbidly obese patients is that these patients do not fit into some of the hospital’s imaging equipment, this would seemingly permit the hospital to transfer the patient without violating the ADA since it does not provide certain specialized services (here, imaging equipment that accommodates morbidly obese patients).

Title III of the ADA also requires hospitals to remove architectural barriers when the removal is readily achievable.  Readily achievable means that it is easily accomplishable and able to be carried out without much difficulty or expense.  In determining whether a removal is readily achievable, several factors must be considered, including the nature and cost of the removal and the overall financial resources of the hospital.

If a hospital does wish to move forward with a policy on transferring morbidly obese patients, it would be wise to do an assessment of exactly how much it would cost to accommodate these patients through architectural/equipment modifications and balance this cost against the finances of the hospital.

Another law which should be taken into consideration is EMTALA.  Even though there is nothing in EMTALA, the EMTALA regulations, interpretive guidelines, or case law directly on point, EMTALA does not appear to restrict the transferring of morbidly obese patients that a hospital cannot accommodate.  EMTALA only requires hospitals with dedicated emergency rooms to provide medical screening examinations and stabilizing treatment for those who come to the hospital’s emergency room within the hospital’s capabilities and capacity.  The Interpretive Guidelines for the EMTALA regulations state that a hospital “must provide screening and stabilizing treatment within the scope of its abilities.”  Thus, as long as a hospital complies with the EMTALA requirements for transferring patients and provides a screening and stabilizing treatment within the scope of its abilities, it should not run afoul of EMTALA.

QUESTION:        We have a group of surgeons on our staff who are interested in employing a physician assistant.  Wasn’t there a new Stark regulation that will allow our hospital to provide recruitment assistance to the group to assist it with the costs of employing this PA?

ANSWER:           The good news is that, as of January 1, 2016, there is a new Stark exception that will permit a hospital to provide recruitment assistance to a physician group to recruit a nonphysician practitioner.  The bad news is that the exception is limited to groups who provide primary care services or mental health services.  So a surgical group would not qualify for this exception.

Even if the exception did apply, an income guaranty is not permitted.  Rather, the recruitment subsidy cannot exceed 50% of the actual compensation paid to the nonphysician practitioner (including signing bonus and benefits) during the first two years the nonphysician practitioner is employed by the group.

Since the Stark Law only applies to compensation arrangements involving a physician or a physician group, the Stark Law would not apply if the hospital decided to provide assistance, such as educational loan assistance, directly to the nonphysician practitioner.  However, remember the Anti-kickback Statute still applies even if the Stark Law does not.  So, you cannot provide that recruitment assistance if it is intended to induce the nonphysician practitioner (or his/her employer) to refer or otherwise generate business for the hospital.

So while the new Stark nonphysician practitioner recruitment assistance exception is helpful, it is limited both in the types of medical specialists who may receive this recruitment assistance and the type of the recruitment assistance that may be provided.

QUESTION:         We’re trying to re-design our peer review process.  One of the biggest obstacles is the perception that any review will be subjective, and depend on the characteristics of the reviewer rather than the quality of care provided.  Is there any way to address this problem?

ANSWER:           Here are a few ways to make the peer review process more objective:

1. Adopt Evidence-Based Protocols to Define Excellent Care Ahead of Time. Evidence-based protocols should be used to define excellent care.  Once a protocol has been adopted, physicians should still be free to not use it as long as they document their rationale for doing so.  If a physician fails to follow a protocol that has been properly adopted and fails to document a valid reason for doing so, the physician could be sent an “Informational Letter” or given some other form of feedback to encourage compliance.  Physicians who habitually fail to comply with adopted protocols could be evaluated through the peer review process, because the physician’s noncompliance could be a sign that the individual is using outdated or ineffective methods.  The peer review policy should define the threshold number of Informational Letters that will lead to a more focused review.

   A deliberate and transparent process should be used to adopt protocols, with input being sought from all relevant specialties.  The Medical Staff, acting through its designated committees, should begin by identifying a limited number of clinical situations in which there is little doubt about the efficacy of an evidence-based protocol.  Ideally, these would be commonly occurring situations, so that adopted protocols will have the greatest possible impact.  The use of protocols in the peer review process could be expanded over time based on experience.

2. Build Checks and Balances into the Process.  There should be a committee that engages in active oversight of the peer review process.  This role can be filled by a multi-specialty “Professional Practice Evaluation Committee,” or PPEC.  If the PPEC questions a decision made during the review process or identifies a problematic pattern of decisions made elsewhere in the process, it can seek (or provide) a “second opinion” about the matter.  This additional layer of review will promote consistency between specialties as to how clinical concerns are being addressed.

3. Manage Conflicts of Interest. Often, peers with the clinical expertise needed to review a case will have a conflict of interest, such as being a competitor or partner of the physician under review.  Such individuals are not necessarily precluded from participating in the review of a case.  For example, a conflict that would disqualify an individual from performing certain roles in the process (e.g., sitting on a hearing panel) would not necessarily prevent the individual from conducting the initial review of a case early in the process.  Peer review policies should explicitly address such issues and outline clear rules as to when individuals with conflicts are precluded from participating in various levels of the review process.  Peer review policies should also make clear that individuals may be recused from the review process if their participation would lead to an undue perception of bias.

4. Develop Standard Review Forms.  Forms used to document reviews should be detailed enough to prompt reviewers to consider the same, fundamental issues for each case.  However, they should not be so detailed that they overwhelm reviewers or waste their time.  Care should be taken to ask questions in a manner that elicits relevant, candid responses.  For example, a review form might ask if any complications were avoidable, if proper steps were taken to avoid the complication, and if the complication was recognized and managed appropriately.