Conditions of Participation and Coverage June 16, 2011 EHR Pharmacy Outpatient Informatics Neill Dial, BS RPh

Conditions of Participation (CoPs) & Coverage (CfCs) Foundation for improving quality and protecting the health and safety of beneficiaries Minimum health and safety standards for Health Care Organizations Health care organizations must meet the COPs/CfCs to begin and continue participating in the CMS programs. CMS also ensures that the standards of accrediting organizations recognized by CMS (through a process called "deeming") meet or exceed the Medicare standards set forth in the CoPs / CfCs.

CMS CoPs & CfCs Hospitals Federally Qualified Health Centers (FQHC) Home Health Agencies Rural Health Clinics Nursing Facilities End Stage Renal Disease Facilities Community Mental Health Centers

“Deeming” CMS allows Private, national accreditation organizations to "deem" that a Medicare Advantage organization is compliant with certain Medicare requirements. Six areas are deemable: quality assurance, antidiscrimination, access to services, confidentiality and accuracy of enrollee records, information on advance directives, and provider participation rules.

Accrediting Organizations National Committee for Quality Assurance (NCQA) Three levels of accreditation based upon NCQA's rigorous requirements and performance on HEDIS® and CAHPS® Excellent Commendable Accredited

Accrediting Organizations Accrediting Association for Ambulatory Health Care (AAAHC) Five types of accreditation decision based on: Initial accreditation One Year or Three Years Re-accreditation survey One Year or Three Years Six Month Provisional Not eligible for a 3-year term Re-survey Follows a One Year or Six month provisional, or Six month deferral

Accrediting Organizations Joint Commission (JCO) Levels of accreditation Accreditation with Requirements for Improvement Provisional Accreditation Conditional Accreditation Preliminary Accreditation

Joint Commission 10/24/08 CMS placed the JCO CAH Program on a 180 day probation period. Significant gaps remain between The Joint Commission standards and the Medicare hospital CoPs Commission-critical-access-hospital-program- on-probation.html Commission-critical-access-hospital-program- on-probation.html

Accrediting Organizations Additional Hospital Accrediting Organizations American Osteopathic Association Det Norske Veritas (DNV) Healthcare Inc.’s Annual Review NIAHO (National Integrated Accreditation for Healthcare Organizations) accreditation program

Hospitals Joint Commission, AOA or DNV accredited hospitals are deemed to meet all Medicare requirements State survey agency is notified when a hospital has been accredited and verified accreditation Removes the hospital from future resurvey schedules, and discontinues any follow-up on deficiencies. If Condition-level deficiencies still exist, the State refers the matter to the CMS Regional Office.

CMS Hospital Surveys All hospital surveys are UNANNOUNCED. Assess Medicare Conditions of Participation (CoP) Usually occur during daytime working hours (M-F) May include weekends and times outside of normal hours. Refusal to allow State Agency or CMS surveyor access can result in the Office of the Inspector General (OIG) exclusion from participation in all Federal healthcare programs. The CMS State Operations Manual (SOM) provides CMS policy for Survey and Certification activities

Conditions of Participation (CoPs) Hospital Pharmaceutical Services Must meet patient needs Pharmacy directed by a registered pharmacist or a drug storage area under competent supervision. Medical staff is responsible for developing policies and procedures that minimize drug errors but can delegate to the pharmaceutical service.

(a) Pharmacy Management and Administration The pharmacy or drug storage area must be administered in accordance with accepted professional principles. 1. FTE, PTE or Consultant pharmacist must be responsible for developing, supervising, and coordinating all pharmacy service activities 2. An adequate number of personnel to ensure quality pharmaceutical services, including emergency services

(a) Pharmacy Management and Administration 3. Current and accurate records of the receipt and disposition of all scheduled drugs. RPMS/EHR Upgrade: Accurate real time CS inventory with identification of remote stock in ADMs and their separate inventory breakout from total inventory

(b) Delivery of Services Drugs and biologicals must be controlled and distributed in accordance with applicable standards of practice, consistent with Federal and State law. 1. Compounding, packaging, and dispensing of drugs and biologicals must be under the supervision of a pharmacist and performed consistent with State/Federal law

(b) Delivery of Services (continued) 2.Drugs and biologicals must be kept in a locked storage area. 3.Outdated, mislabeled, or otherwise unusable drugs and biologicals must not be available for patient use. 4.When a pharmacist is not available, drugs and biologicals must be removed from the pharmacy or storage area only by personnel designated in the policies of the medical staff and pharmaceutical service, in accordance with Federal and State law.

(b) Delivery of Services (continued) 5. Drugs and biologicals not specifically prescribed as to time or number of doses must automatically be stopped after a reasonable time that is predetermined by the medical staff. RPMS Upgrade: Require Stop Dates for all inpatient meds

(b) Delivery of Services (continued) 6. Drug administration errors, adverse drug reactions, and incompatibilities must be immediately reported to the attending physician and, if appropriate, to the hospital- wide quality assurance program. RPMS Upgrade: Webcident RPMS/EHR link

(b) Delivery of Services (continued) 7. Abuses and losses of controlled substances must be reported, in accordance with applicable Federal and State laws, to the individual responsible for the pharmaceutical service, and to the chief executive officer, as appropriate. RPMS Upgrade: DEA 106 Form Link

(b) Delivery of Services (continued) 8. Information relating to drug interactions and information of drug therapy, side effects, toxicology, dosage, indications for use, and routes of administration must be available to the professional staff. RPMS/EHR Upgrade: Links to Up to Date and other references utilized by facility

(b) Delivery of Services (continued) 9. A formulary system must be established by the medical staff to assure quality pharmaceuticals at reasonable costs.

Questions?