INSTITUTE ON MEDICARE/MEDICAID PAYMENT ISSUES MEDICARE CONDITIONS OF PARTICIPATION: WHAT IS YOUR GRADE?

INSTITUTE ON MEDICARE/MEDICAID PAYMENT ISSUES MEDICARE CONDITIONS OF PARTICIPATION: WHAT IS YOUR GRADE? Cindy Wisner, Esq. Teresa A. Williams, Esq. Trinity Health INTEGRIS Health, Inc. 20555 Victor Parkway 3030 N.W. Expressway Livonia, MI 48152 Oklahoma City, Ok 73112 (734) 343-1139 (405) 951-4777 wisnerc@trinity-health.com teresa.williams@integrisok.com CoPs WHAT ARE THEY? Conditions of Participation (CoPs) define specific requirements that providers must meet in order to participate in the Medicare Program The CoPs set forth the minimum standard that will ensure the provision of safe quality care to beneficiaries of services Purpose is to protect patient s health and safety and to ensure quality care provided to all patients 1

CONDITIONS OF PARTICIPATION Required: Federal, state and local laws Governing Body Patient s Rights QAPI Medical Staff Nursing Services Medical Record Services Pharmaceutical Services Radiological Services Laboratory Services Food and Dietetic Services Utilization Review Physical Environment Infection Control Discharge Planning Organ, Tissue and Eye Procurement CONDITIONS OF PARTICIPATION Optional Surgical Services Anesthesia Services Nuclear Medicine Services Outpatient Services Emergency Services Rehabilitation Services Respiratory Care Services 2

2013 PROPOSED AMENDMENTS TO CoPs On February 7, 2013, CMS released a Proposed Rule Deadline to submit comments April 8, 2013 at 5:00 p.m. EST Comment reference code CMS-3267-P Major changes for hospitals, long-term care facilities, transplant centers and rural health centers Based on comments provided by hospitals, healthcare providers and other organizations AHA, AMA and TJC Latest in series of rulemaking initiatives implementing Executive Order 13563 to reduce burdensome regulations on these providers 2012 AMENDMENTS TO CoPs On May 16, 2012, CMS published two Final Rules Effective July 16, 2012 Major changes to Hospital Governing Body Medical Staff and Leadership Standing and Verbal Orders Some of these CoPs are proposed to be modified by the 2013 Proposed Rule Per CMS, amendments will save $1 Billion Reduce time on processes and policies Fewer resources to implement 3

SINGLE GOVERNING BODY In 2012 Final Rule, CMS amended CoP to allow one governing body to oversee multiple hospitals in a system Not viewed favorably by AMA CMS added requirement that a medical staff member from at least one hospital be included on the governing body 2013 Proposed Rule doesn t alter ability to have single governing body, but does remove requirement concerning medical staff member on board SINGLE GOVERNING BODY Now there may be a single governing board to oversee a multi-hospital system Allows a healthcare system to have one governing body for all hospitals Each separate hospital must continue to comply with CoPs Designed to promote efficiency and integration Corporate bylaws may need revision to implement a single governing body in a multi-hospital system Single governing body is an option, not a requirement 4

MEDICAL STAFF ON GOVERNING BODY When released in 2012, this requirement generated significant concern in healthcare industry AHA wanted it rescinded AMA urged that it be retained Director of Survey/Certification delayed enforcement of this CoP in June 2012 Surveyors instructed not to assess a hospital s compliance with this requirement or cite deficiencies when conducting surveys MEDICAL STAFF ON GOVERNING BODY Under Proposed Rule, hospitals may, but are not required to, include one or more members of the medical staff on the hospital s governing body CMS proposing new requirement that hospitals must engage in consultations with medical staff leadership at least twice a year to discuss matters related to the quality of medical care provided to patients of the hospital to be responsive to urgent or periodic requests by medical staff leadership for consultations 5

MEDICAL STAFF ON GOVERNING BODY CMS expects the governing body to determine the number of consultations needed based on various factors: the scope and complexity of hospital services offered specific patient populations served by the hospital any issues of patient safety and quality of care identified by hospital s QAPI Hospitals should consider how to implement this revised CoP if it is finalized by CMS in the future MEDICAL STAFF ON GOVERNING BODY Hospitals have flexibility in determining how to structure the medical staff consultations Some hospitals may opt to invite medical staff leadership to two governing board meetings per year to discuss these matters Creation of sub-boards or advisory board committees that contain medical staff leadership Hospitals should consider how to implement this revised CoP if it is finalized by CMS in the future 6

SINGLE MEDICAL STAFF 2013 Proposed Rule clarifies that each hospital must have its own organized and individual medical staff If a multi-hospital system has several hospitals, each with its own provider number, each hospital must have its own medical staff Multi-hospital systems with an integrated medical staff will be required to undo their organizational structures and create independent medical staffs for each of the hospitals in the system MEDICAL STAFF COMPOSITION 2012 Final Rule revised definition of medical staff to include nonphysician practitioners who are granted privileges at the hospital Physician Assistants, Nurse Practitioners, Registered Dietitians and PharmDs Hospitals are not required to use new, broader medical staff definition If they do, hospitals must amend their medical staff bylaws, rules and regulations to reflect such changes These changes cannot be made unilaterally by the hospital, but must have the input and approval of the medical staff Any changes to the medical staff bylaws will require close coordination with the medical staff 7

MEDICAL STAFF LEADERSHIP 2012 Final Rule revised CoP to allow podiatrist to serve in medical staff leadership AMA strongly opposed this CoP Not changed by 2013 Proposed Rule If not prohibited by state law, podiatrists may now be responsible for the organization and conduct of the medical staff Physicians, dentists and podiatrists may be medical staff presidents Hospitals may choose to modify their medical staff bylaws to permit podiatrists to serve in leadership roles, but are not required to do so At discretion of governing body Must comply with state law and medical board rules and regulations STANDING ORDERS Standing orders have long troubled CMS because of risk that medically unnecessary services would be provided and/or patients would not receive personalized care 2012 Final Rule permits hospitals to use standing orders, order sets and protocols Including pre-printed and electronic standing orders 8

STANDING ORDERS It is acceptable to use standing orders The medical staff, nursing staff and pharmacy should approve written and electronic standing orders, order sets and protocols All standing orders must be based on nationally recognized and evidence-based guidelines and recommendations Hospitals must ensure policies are current and reflect the CoP requirements for standing orders, order sets and protocols STANDING ORDERS 2012 Final Rule finalized a temporary provision that permits authentication of orders by The physician/practitioner placing the order or Another physician/practitioner who is caring for the patient, so long as nonphysician practitioner satisfies hospital policy and state law requirements for writing orders These sections were not modified by the 2013 Proposed Rule 9

VERBAL ORDERS Verbal orders must be authenticated, dated, timed and signed by the ordering physician/another practitioner caring for the patient AND state law and hospital policy for authentication applies Previously verbal orders were required to be authenticated within 48 hours 2012 Final Rule eliminated this requirement Hospitals are not required to use a 48 hour time frame for physician signatures to authenticate verbal orders Hospitals now must look to state law for guidance in this area. If state law is silent, hospitals have flexibility in setting this deadline Hospitals should ensure that the relevant time frame is stated in their policies and procedures NURSING CARE PLANS 2012 Final Rules implemented several changes relating to nursing services Nursing care plans may now be maintained as stand-alone plans for each patient or as part of a single multidisciplinary plan that address nursing services and other disciplines Previously required to keep a separate nursing care plan The revised CoPs remove the requirement for separate nursing care plan if there is an interdisciplinary care plan Policies and procedures that refer to the nursing care plans should be revised to reflect changes in the nursing plan process 2013 Proposed Rule did not modify this CoP 10

PATIENT SELF-ADMINISTRATION 2012 Final Rules permitted hospitals to develop patient self-administration programs for certain medications Allows family members or patients to self-administer Can include medications, vitamins, over-the-counter drugs brought from home Does not include controlled substances If adopting a self-medication program There must be a documented order to self-administer a specific medication Hospital must assess patient or caregiver s capability to administer specific medication PATIENT SELF-ADMINISTRATION If adopting a self-medication program (cont d) Hospital must ensure appropriate documentation of medication administration in the medical record Implement a program that addresses safety and accuracy of medications Not changed by 2013 Proposed Rule 11

ORDERS BY OTHER PRACTITIONERS 2012 Final Rules allowed orders for drugs and biologicals to be prepared and administered on the order of nonphysician practitioners Nurses can take order from certain nonphysician practitioners Nonphysician practitioner may document/sign orders in accordance with state law and scope of practice Some states may limit scope of practice, but this change will allow hospitals to reduce some regulatory burdens and allow more efficient care practice Compliance with hospital policies and medical staff bylaws Not changed by 2013 Proposed Rule RESTRAINTS Previously hospitals were required to report to CMS patients who died under restraint or seclusion or following a period of restraint or seclusion 2012 Final Rule removed requirement for hospitals to notify CMS of a patient s death that occurred while a patient was in two-point soft wrist restraints without seclusion However, CMS implemented requirement that hospitals maintain log of all such deaths Includes patient s name, date of birth, attending physician, primary diagnosis and medical record number May include name of nonphysician practitioner rather than attending physician if patient under care of nonphysician practitioner Must be made immediately available to CMS upon request 12

RESTRAINTS Hospitals should have current policies that differentiate between patients who die in restraints that are used to prevent removal of IVs and those whose death is attributable to restraints or seclusion Restraint/seclusion incidents should be routinely reviewed Ensure staff is knowledgeable of the requirements Face-to-face evaluations Orders Not changed by 2013 Proposed Rule TRANSPLANT CENTERS 2013 Proposed Rule proposes that organ transplant centers would no longer have to be resurveyed every three years Transplant centers would no longer have to report to CMS when they are out of compliance with the 3- year average of 10 transplants per year CMS believes it obtains enough information from other sources and can conduct a survey if necessary 13

SURVEY AND COMPLIANCE Providers must comply with all regulations listed in these sources: Medicare regulations Conditions of Participation, Conditions for Coverage, and Conditions of Certification Medicare statute 42 U.S.C. 1320c-5(a)(6) ACA Condition of Enrollment State law licensing and reimbursement requirements Medicaid statute and regulations The Joint Commission and other accrediting agencies SURVEY AND COMPLIANCE State survey agencies carry out Medicare certification process CMS publishes State Operations Manual (SOM) for state survey agency use SOM contains the regulatory language of the CoPs as well as interpretive guidelines and survey procedures that provide guidance on how to assess provider compliance 14

CoPs AND CfCs CoPs and CfCs differ depending on the type of entity Common criteria: a governing body responsible for effectively governing affairs of the institution a quality assurance program to evaluate entity-wide patient care medical record service responsible for medical records utilization review that reviews the services furnished a facility constructed, arranged and maintained according to a life safety code that ensures patient safety and the deliverance of services appropriate for the needs of the community ACCREDITATION Approved accreditation programs: The Joint Commission American Osteopathic Association/Healthcare Facilities Accreditation Program Det Norske Veritas Healthcare, Inc. (DNV) Accredited institutions are deemed to meet most of the Medicare CoPs 15

WHAT IF CoPs ARE NOT MET? Sanctions may be imposed upon the provider, including a corrective action plan, monetary sanctions and increased reporting requirements Exclusion is relatively rare and only occurs if the provider fails to become substantially compliant during the corrective period For that reason, a number of courts have recognized that it would be both inappropriate and premature for the government to refuse to pay otherwise appropriate claims on the basis that the provider failed to fulfill all CoPs CASE LAW Several courts have concluded that Medicare CoPs are not conditions of payment and therefore, a violation cannot serve as the basis for a False Claims Act claim U.S. ex rel. Landers v. Baptist Memorial Health Care Corp. Hospital failed to meet standards of care and CoPs Certifications were not material to government decision to make payment CoP noncompliance could lead to corrective action, but in this case, it was not shown that Hospital was ineligible to receive payments from Medicare 16

CASE LAW U.S. ex rel. Conner v. Salina Regional Health Center Hospital had unqualified staff, poor facilities and failed to investigate quality of care issues in violation of the CoPs Tenth Circuit Court found no basis for theory that Medicare CoPs violations subject defendant to FCA liability Government payment was not conditioned on compliance with Medicare CoPs First federal appellate court to find that violations of Medicare CoPs did not subject defendants to FCA liability CASE LAW Hospitals should be aware that frequent and blatant patient neglect and abuse may create FCA liability for substandard care U.S. ex rel. Amanda v. Community Psychiatric Centers, Inc. Court permitted FCA prosecution based on the hospital s alleged failure to provide children and adolescents with the reasonably safe environment required by the Medicare regulations 17

TEACHER EVALUATION COMPONENT Deference to State Law and Medical Staffs for qualifications of licensed/registered health care providers - GRADE A Reduction in requirements for direct supervision - GRADE A Reduction of burdensome survey requirements - GRADE B Estimate of cost savings from 2012 Final Rules and Proposed Rules - GRADE C CONCLUSION Educate staff about the changes Involve hospital and medical staff in changing policies, including medical staff bylaws and hospital operating procedures To keep up to date on the CoPs check out the CMS website weekly and join CMS email lists CMS is happy to offer a free email subscription service, which allows CMS.HHS.gov users to receive notifications by e-mail when new information is available. http://www.cms.gov/regulations-and- Guidance/Legislation/CFCsAndCoPs/Hospitals.html 18