QUESTION:        Some big drug companies sent letters to our hospital saying that they would stop selling us 340B drugs unless we participate in the 340B “ESP” program and give them specific claims information.  Is this legal?

 

ANSWER:          There is some question as to whether drug companies can condition the sale of 340B to submitting this kind of information.  The letters we have seen cite concerns about duplicate discounts between the Medicaid and the 340B program. These requests also raise serious questions about whether the disclosure of claims information would comply with HIPAA unless the protected health information is de-identified – which is easier said than done – or the drug companies sign business associate agreements – which is unlikely. The American Hospital Association recently sent a letter to the Secretary of HHS in opposition to these requests. Some of the requests set a deadline of October 1 for compliance, but it is doubtful that the matter will be resolved by then.  Stay tuned for further developments.  For more information, contact Henry Casale at hcasale@hortyspringer.com or 412-687-7677.

QUESTION:        Should we use a separate form to obtain informed consent for the administration of anesthesia?

ANSWER:           The answer may vary depending on state law.  As a general rule, most states will give you discretion on how to structure your informed consent forms.  If you wanted, you potentially could place all relevant information onto a single form.  However, our research shows that the trend nationwide is to utilize a separate form for this purpose.  It tends to be more convenient and efficient.  Similarly, most organizations will also employ a separate form for blood transfusions.

Be aware that it is crucial to document informed consent appropriately.  If you have any questions about the design of your informed consent forms, or about the process outlined in your policies, we strongly encourage you to reach out to your hospital counsel.  It is vital to have up-to-date documents that comply with all applicable laws and that meet the needs of your institution.

QUESTION:        As a Medical Staff leader, what steps do I take if someone reports to me that a physician who is rounding on patients smells of alcohol or appears to be confused?  While this doesn’t happen often, I want to be prepared.

ANSWER:          We couldn’t agree more.  These are the situations you have to plan for in advance so you can react quickly when action is needed.

The first step is adopt a good Practitioner Health Policy that outlines the authority of Medical Staff leaders to address such situations.  Among other things, the Policy should:

• Identify who has the authority to assess the situation and take needed action. This should include a broad list of individuals so someone is always available.  Also, the Policy should permit designees to act if needed;
• State that the physician can be required to submit to a blood, hair, or urine test, or other appropriate physical or cognitive evaluation, to determine his or her ability to safely practice;
• State that a physician’s failure to agree to such testing will result in the “automatic relinquishment” of the physician’s clinical privileges pending further review of the matter. (An “automatic relinquishment” occurs by operation of the Policy and is not a professional review action that raises hearing rights or reports to government agencies);
• Offer guidance on the use of voluntary agreements to refrain from practicing while a matter is reviewed. Particularly with health issues, it’s best to avoid (if possible) the use of “suspensions;”
• Define a process for identifying someone to take care of the physician’s patients while the review continues.

The next step is to be sure Medical Staff leaders and hospital staff are aware of their duties and authority under the Policy.  Staff should know they are required to report health issues, and shouldn’t “enable” the physician’s continued health problem by covering up for the physician.  Medical Staff leaders should rehearse the steps they will take when these situations arise so they are comfortable acting when needed to protect patients and the physician in question.

To learn more about dealing with physician health issues, please join us for Strategies for Managing Physician Health and Disruptive Conduct in Las Vegas, Nevada this coming fall.

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.