December 21, 2011 SUBMITTED ELECTRONICALLY Marilyn Tavenner Acting Administrator Centers for Medicare & Medicaid Services Hubert H. Humphrey Building 200 Independence Ave, SW Room 445-G Washington, DC 20201 27870 Cabot Drive Novi, MI 48377-2920 ph 248.489.6000 34605 Twelve Mile Road Farmington Hills, MI 48331-3221 ph 248.489.6000 www.trinity-health.org Re: CMS 3244 P (42 CFR Parts 482 and 485: Medicare and Medicaid Programs; Reform of Hospital and Critical Access Hospital Conditions of Participation) Dear Ms. Tavenner, welcomes the opportunity to comment on the Centers for Medicare & Medicaid Services (CMS) proposed rule, Reform of Hospital and Critical Access Hospital Conditions of Participation, as published October 24, 2011 in the Federal Register. In this letter, we offer our reactions and recommendations to the proposed rule. is one of the largest Catholic health care systems in the country. Headquartered in Novi, Michigan, operates 47 acute-care hospitals, 401 outpatient facilities, 31 long-term care and senior living facilities, and numerous home health offices and hospice programs in ten states California, Idaho, Illinois, Indiana, Iowa, Maryland, Michigan, Nebraska, Ohio and Oregon. Our hospitals and clinics employ nearly 1,000 physicians, and we work with another 7,000 physicians through our open medical staff model. hospitals are appreciative of the opportunity to comment on this proposed rule. Overall, firmly supports the proposed as outlined by CMS, as simplifies Medicare and Medicaid conditions of participation requirements for hospitals and critical-access hospitals (CAHs) to focus more on quality and patient safety. Below we offer comments on portions of the notice. Governing Body ( 482.12) Under the current Conditions of Participation, each hospital must have its own governing body or identify people that are legally responsible for it. This requires that all hospitals have a unique governing body or have appointed legal representatives, regardless of whether the hospital is part of a larger system that already has a governing body. As noted in the proposed rule, this requirement can result in duplicative efforts. As such, supports the proposed changes that would permit multi-hospital systems to have a single governing body, rather than requiring one for each hospital facility. By allowing hospital systems with multiple CMS Certification Numbers (formerly known as Medicare Provider Numbers) to have a single governing body, hospitals would be able to streamline governance and administrative processes.
Page 2 Medical Staff ( 482.22) Practitioner Privileges In addition, CMS proposed clarifying the rule allowing a hospital to grant privileges to physicians and non-physicians to practice within their state s scope of law, whether or not they are members of the hospital s medical staff. strongly supports this clarification as it would allow practitioners to be granted privileges regardless of whether they are members of the medical staff. This proposal would allow for increased flexibility and allow for more practitioners to operate at the highest levels of their expertise and training. Organization Oversight and Responsibility Likewise, supports the CMS proposal to expand the list of practitioners who may be granted responsibility to oversee the organization and its medical staff. Under the current regulations, only doctors of medicine and osteopathy and, state law permitting, doctors of dental surgery or medicine may be granted such responsibilities. CMS proposal to augment the list to include doctors of podiatric medicine will reduce barriers for such doctors and also allows for practitioners to take on new leadership roles, enabling them to use their experience to improve the organization as a whole. Nursing Services ( 482.23) Nursing Care Plan The Conditions of Participation currently require hospitals to develop a unique nursing care plan for each patient. However, many hospitals, including, use an integrated care plan for patients. The requirement that an additional nursing-specific plan be developed is unnecessarily burdensome. Consequently, agrees with CMS proposal to allow hospitals to integrate the nursing care plan into the interdisciplinary care plan for patients, as it reduces clinical burdens and duplicative efforts. Drug and Biologic Orders Currently, the Conditions of Participation limit the types of practitioners who may order the preparation and administration of drugs and biologics, and who may document and sign for them. These limitations apply regardless of whether the state allows for greater flexibility, such as allowing nurse practitioners and physician assistants to order them in certain instances. By allowing for more flexibility, the proposed revisions to the Conditions of Participation will allow states especially those with physician shortages to simplify processes and allow other practitioners to take on additional roles. We serve together in, in the spirit of the Gospel, to heal body, mind and spirit
Page 3 Medications CMS currently requires that all drugs and biologics be administered by, or under the supervision of the appropriate medical staff. However, the proposal to allow for patients and/or their caregivers to administer specific medications under the certain circumstances is supported by. By allowing for hospitals to develop policies enabling patients and/or caregivers to self-administer certain drugs, hospitals will be able to reduce costs and allow for patients to play a larger role in their own care management. Medical Record Services ( 482.24) Verbal Orders CMS has proposed permanently extending the current 5-year exception that allows for non-ordering practitioners who are responsible for the patient s care to authenticate orders. Under current regulations without the exemption the ordering practitioner must be the one to authenticate the order. In addition, CMS is proposing to remove the requirement that verbal orders be authenticated within 48 hours, instead deferring to hospital policy and state law. applauds both of these proposals. These changes would allow for greater flexibility in practices and also recognize the different practice and structural environments of community hospitals, teaching hospitals, and critical access hospitals. Further, expanding the roles of available practitioners becomes even more important in the face of physician and nurse shortages, limitations on the workweek of residents, and cuts to graduate medical education payment. Standing Orders Similarly, also supports CMS proposal to allow for the use of electronic and pre-printed standing orders, order sets, and protocols for patient s orders, as long as these orders comply with 482.24(c)(3) Medical Record Services requirements. This proposal will allow hospitals to improve administrative policies and make clinical care processes more efficient. Moreover, in conjunction with the proposed changes to verbal orders and drug and biologic orders, this proposal will allow physicians to spend more of their time on directly providing care to patients allowing other providers to take on additional tasks and simplifying administrative processes. History and Physical (H&P) Requirements Current regulations require that hospital update H&P during the last 30 days prior to admission. believes that this requirement is too vague, and is often interpreted too narrowly, resulting in unnecessary comprehensive examinations. recommends that CMS clarify the requirement to specify what constitutes an update of H&P to ensure that hospitals are complying appropriately with the requirement. We serve together in, in the spirit of the Gospel, to heal body, mind and spirit
Page 4 Outpatient Services ( 482.54) Under current regulations, hospitals must assign one person responsible for all outpatient services, but as more care is provided outside of the hospitals, many hospitals, including, believe that the responsibility for these services should divided among multiple staff members. As a result, supports CMS proposed change to allow hospitals to assign one or more individuals to oversee outpatient services. Definitions and Provisions of Services ( 482.602 and ( 482.635(b)) Under the proposed rule, critical access hospitals (CAHs) would no longer be required to provide diagnostic, therapeutic, laboratory, radiology, and emergency services directly. Instead, the proposed rule allows for CAHs to provide these services under service arrangements with third parties. Trinity Health supports this change as it would allow for more flexibility for CAHs, and encourage more efficient use of resources. Physical Environment ( 482.41) At present, the Conditions of Participation require hospitals to comply with the 2000 edition of the Life Safety Code, even though this is not the most recent edition. recommends that CMS update the Conditions of Participation to ensure that hospitals comply with the 2012 edition. Since many other accrediting bodies require hospitals to comply with more recent versions, updating the regulations to require that hospitals comply with the 2012 edition would reduce hospital burden and reduce the number of inconsistencies across accrediting bodies. Patient s Rights ( 482.13) CMS has also proposed lengthening the amount of time hospitals would have to report deaths involving the use of soft two-point wrist restraints, when such restraints are not used in combination with seclusion. supports this change, as well as CMS proposal to allow for additional reporting methods, such as fax and other electronic means, for deaths related to restraint and seclusion. Additional Items Lastly, CMS proposes to eliminate (1) the requirement that non-physicians undergo special training for administering blood transfusions and intravenous medicines, (2) the need for a separate infection control log, and (3) the need for blood type verification at the transplant center. supports all of these proposals, agreeing that such changes would better reflect current care processes and external reporting and training requirements. Closing Remarks strongly supports updating the Conditions of Participation to streamline clinical processes, eliminate duplicative efforts and roles, and allow for more flexibility in the roles of nonphysician clinicians. believes that, if finalized, CMS proposed changes will allow hospitals to improve patient care and enhance patient experience, while also reducing healthcare We serve together in, in the spirit of the Gospel, to heal body, mind and spirit
Page 5 costs. These changes are especially important as hospitals face reductions in payment and struggle with physician and nurse shortages. We urge CMS to issue final guidance soon after the end of the comment period, so that hospitals and other accrediting entities can begin to work under the final regulations. We appreciate the opportunity to comment on the Conditions of Participation proposed rule and look forward to working with CMS further to improve our healthcare system. If you have any questions about our comments, please feel free to contact me at 248-489-6068 or wellstk@trinity-health.org. Sincerely, Tonya K. Wells Vice President, Federal Public Policy & Advocacy We serve together in, in the spirit of the Gospel, to heal body, mind and spirit