Proposed rule could eliminate many Conditions of Participation (CoPs) and Conditions for Coverage (CfCs)

On September 17, 2018, the Centers for Medicare and Medicaid Services (CMS) released an advance copy of a proposed regulation which aims to eliminate some of the Medicare Program’s Conditions of Participation (CoPs) and Conditions for Coverage (CfCs) for certain Medicare providers.  As a reminder, CoPs and CfCs are specific minimum standards that health care providers must meet to participate in, and be reimbursed by, the Medicare Program.  CoPs and CfCs are intended to improve health care quality and ensure the health and safety of Medicare beneficiaries who receive services from Medicare providers.  Further, CoPs and CfCs are used to inform CMS’s recognition of accrediting body standards, also known as the “deeming” process, which permits accrediting organizations to survey Medicare providers’ compliance with CoPs and CfCs.

CMS’s proposed rule is its latest action in response to Executive Order 13771 which directs federal agencies to repeal two existing regulations for each new regulation the agency enacts.  In this context, the proposed rule aims to simplify and streamline current Medicare CoPs and CfCs and could impact health care providers and service arrangements in the following ways: 

Hospitals:

• Authorizing multi-hospital systems to use unified and integrated infection control programs and Quality Assessment and Performance Improvement (QAPI) programs for member hospitals;
• Allowing hospitals discretion to adhere solely to state requirements when an autopsy is indicated;
• Allowing medical staff policies to describe circumstances under which outpatient pre-surgery/pre-procedure assessments may be used instead of comprehensive medical histories and physical examinations; and
• Permitting non-physician practitioners or doctors of medicine and osteopathy (MDs/DOs) to document inpatient progress notes for patients in psychiatric hospitals.

Swing-Bed Arrangements:

• Eliminating long-term care cross-reference requirements in swing-bed agreements due to the short amount of time patients use these beds.

Critical Access Hospitals (CAH):

• Extending the time period for CAH policy and procedure reviews from annual to biennial; and
• Eliminating the requirement that a CAH disclose the names of persons with financial interests in the CAH.

Rural Health Clinics (RHC) and Federally Qualified Health Centers (FQHCs):

• Extending the time period for RHC and FQHC patient policy and procedure reviews from annual to biennial.

Ambulatory Surgery Centers (ASC):

• Eliminating the requirement that ASCs have either written transfer agreements with Medicare-accepted hospitals or ensure that all ASC surgery providers have admitting privileges in a Medicare-accepted hospital; and
• Requiring ASCs to establish and implement a policy that identifies patients who need a complete comprehensive medical history and physical assessment (H&P), but also for eliminating the requirement that ASC physicians conduct H&P on each patient within thirty (30) days of a scheduled surgery.

Transplant Centers:

• Updating regulatory language to include terminology that is widely used and commonly understood within the transplant community; and
• Eliminating the requirement that transplant centers re-submit clinical experience, outcomes, and other data to obtain Medicare approval.

Hospices:

• Allowing hospices to defer solely to state training and competency requirements when hiring hospice aides;
• Eliminating the requirement that a hospice’s core interdisciplinary group confer with an individual with education and training in drug management to ensure medications meet patient needs, provided the hospice can secure such information and expertise, if needed;
• Allowing hospices to explain to patients and patient’s family members information about the proper use, storage, and disposal of controlled substances instead of requiring the hospice to provide paper copies of policies and procedures regarding such information; and
• Eliminating the requirement that hospices solely ensure skilled nursing facility (SNF) and intermediate care facility (ICF) staff undergo hospice orientation training when caring for hospice patients, and instead allowing the hospice and SNF or ICF to address this requirement in their contracts.

Comprehensive Outpatient Rehabilitation Facilities:

• Permitting CORFs to conduct and implement utilization review plans once per year instead of four times per year.

Community Mental Health Centers (CMHC):

• Eliminating the requirement that CMHCs update comprehensive client assessments for each patient every thirty (30) days and instead allowing CMHCs to make updates only if the patient receives partial hospitalization services.

Portable X-ray services:

• Replacing the four training and education requirements focused on Joint Review Committee on Education in Radiologic Technology (JRCERT), American College of Radiology, and American Medical Association training requirements with a single qualification focusing only on the skills and abilities of a radiology technologist; and
• Allowing portable x-ray services to be ordered in writing, by telephone, or by electronic methods.

Religious Nonmedical Health Care Institutions (RNHCI):

• Allowing RNHCIs to develop a discharge plan only if the patient is discharged to the home-setting and not to an acute or post-acute care medical provider; and
• Allowing RNHCIs to provide only discharge instructions to a patient or the patient’s caregiver instead of a complete discharge evaluation and plan as previously required by regulation.

Additionally, CMS’s proposed rule aims to reduce the complexity of requirements concerning emergency preparedness programming.  Historically, emergency preparedness programming has been a daunting exercise for health care providers, sometimes including semi-annual full-scale testing and frequent staff training, as well as annual overhauls of emergency policies and procedures and documentation of efforts to contact local community emergency resources.  Given the complexity and magnitude of emergency preparedness programming, CMS’s proposed rule will greatly simplify providers’ emergency preparedness obligations as follows:

• Providing facilities flexibility to review emergency preparedness programming at least once every two (2) years instead of annually;
• Removing the requirement that emergency preparedness plans include documentation of efforts to contact local, tribal, regional, state and federal emergency preparedness officials, as well as the facility’s participation in collaborative and cooperative planning efforts;
• Allowing facilities to conduct emergency preparedness trainings once annually or more often in their own discretion;
• Allowing one (1) of two (2) annually required emergency preparedness tests to be performed using innovative methods such as simulations, desk top exercises, workshops or other methods that best meet the needs of the facility; and
• Authorizing facilities to conduct one (1) emergency preparedness testing exercise annually, instead of two (2) times per year.

Should CMS’s proposed rule be finalized, impacted Medicare providers may realize a reduction in Medicare CoPs and CfCs burdens, but could also see changes in their accreditation requirements as accrediting organizations will also likely revise accreditation standards to accommodate for changes to Medicare CoPs and CfCs.  As such, Medicare providers must be fully aware of any changes that are finalized as a result of CMS’s proposed rule as it could impact the provider’s participation and reimbursement through Medicare, as well as the provider’s policies and procedures used to achieve accredited status.

Furthermore, CMS estimates that if the proposed rule is finalized, Medicare providers, insurers and patients will save $699 million annually, with the majority of the savings accruing to providers.  CMS notes, however, that providers’ savings could be passed on to insurers and patients depending on how payment and reimbursement mechanisms adjust to accommodate for CoPs and CfCs changes.  In other words, CMS supposes that insurers may tighten reimbursement mechanisms to account for provider savings created by CoPs and CfCs changes. 

Should you or your organization need more information about CMS’s proposal to reduce CoPs and CfCs requirements, or how CMS’s proposal could affect your organization’s reimbursement, accreditation, operations or compliance obligations, please contact your Dinsmore attorney.  Further, if you wish to provide comments or feedback to CMS about its proposed rule, please note Dinsmore can assist you in making comments no later than 60 days after publication of the proposed rule.