Critical Access Hospital Program

1. Critical Access Hospital Program Myron E Bloom MD MMM Medical Director, Rural Healthcare Quality Network

2. Critical Access Hospital Program • Created by Congress in 1997 as part of the Balanced Budget Act to support “limited-service hospitals” located in rural areas. • Reimbursed on Medicare-allowable costs or “cost-based reimbursement” for inpatient and outpatient services

3. Critical Access Hospital Program Enhancements made in the: • Balanced Budget Refinement Act of 1999 • Medicare Medicaid and SCHIP Benefits Improvement and Protection Act of 2000 • Medicare Prescription Drug, Improvement and Modernization Act of 2003

4. Balanced Budget Act of 1997 (BBA) • To qualify the CAH had to: • Offer 24-hour emergency care services, • Have a maximum 15 acute patients, • Outpatient/Observation patients were not counted • (counting only inpatients, not beds occupied) • Facilities with Swing-beds were allowed to have up to 25 acute or SNF-level beds, provided that no more than 15 beds were used at any one time for acute care patients. • Keep each patient no more than 96 hours.

5. Balanced Budget Act of 1997 (BBA) To qualify the CAH had to be a: • Distance of 35 miles (or 15 in the case of mountainous terrain or with only secondary roads) from another hospital or • Necessary Provider of health care services certified by the State. • Certification will sunset January 1, 2006

6. The Balance Budget Refinement Act of 1999 Changed length of stay to an annual average of 96 hour patient stay, and Increased the opportunity for small hospitals to join the CAH program.

7. The Medicare, Medicaid, and SCHIP Benefits Improvementand Protection Act of 2000 (BIPA) • CAH Swing Beds became exempted from PPSand paid on a cost basis, • CAH provided ambulance services would be paid on a reasonable cost basis, if it is the only ambulance within a 35 mile drive of the CAH.

8. The Medicare, Medicaid, and SCHIP Benefits Improvementand Protection Act of 2000 (BIPA) • Emergency Room On-Call Physicians payment were now considered an allowable cost of outpatient CAH services after October 1, 2001. • So far just the cost of Doctors to be on call

9. Medicare Modernization Act of 2003 §405 (a) After January 1, 2004 for Method I • Reimbursement for services increased to 80% of 101% of reasonable costs (up from 100 %) or • 101% less Part B deductible and coinsurance amounts;

10. Medicare Modernization Act of 2003 §405 (d) • Increased Flexibility in Method II with • 115 % of the Fee Schedule Payment For Professional Physician Services, • 115 % of the 85 % of the Medicare Physician Fee for non-physician practitioner professional services. • Each practitioner has the option to participate in bundled Part B billing.

11. Medicare Modernization Act of 2003 §405 (b) And after January 1, 2005, • Cost-based reimbursement for other on-call emergency room providers: physician assistants, nurse practitioners, and certified nurse specialists. • But on call practitioners can not be simultaneously on call at any other facility.

12. Medicare Modernization Act of 2003 §405 (e) And after January 1, 2004, • A CAH could operate a maximum 25 beds for acute hospital level of care or swing bed services, • Notice “beds” not “patients” • Previously a CAH could operate 15 acute inpatient beds and up to 10 swing beds.

13. Observation Patient Servicesafter MMA • Any “beds” that are hospital-type beds are counted in the maximum bed count, • including those used by patients on observation status. • May NOT Co-mingle Inpatients and Outpatients. • Distinct Part Outpatient Areas and beds not interchangeable with inpatient beds.

14. “Excluded from the Bed Count” after MMA • Stretchers and Examination tables in Emergency Departments, • Obstetric labor and delivery beds, • postpartum and birthing room beds in which the mother remains after giving birth are counted! • Newborn bassinets and isolettes, • Operating and Procedure tables or recovery beds (which must be used exclusively for recovery).

15. Observation Patient Servicesafter MMA • Observation services defined as “to evaluate an outpatient’s condition to determine the need for possible admission as an inpatient”. • 48 hours maximum observation stay, after which the patient should be admitted, discharged, or transferred, and, • Must always be medically necessary. • Following an ER visit or outpatient medical procedures • Chest pain workup, asthma, or congestive heart failure treatments………………...InterQual criteria

16. Observation Patient Servicesafter MMA • Observation falls under Part B and the beneficiary may not understand the complex fee structure, • The CAH must give written notice of non-covered services prior to the stay. • Observation days do not count in the 3 day qualification for transfer to ECF. • Provider and patient/family consternation!

17. Medicare Modernization Act of 2003 §405 (g) And after October 1, 2004 • CAHs may establish distinct part (DP) Psychiatric and Rehabilitation units, • Maximum of ten beds in each “DP” which will not count against the CAH inpatient bed limit. • Same Medicare payments as made to general hospitals for these services.

18. Summary of MMA 2003 • Increased the beds that could be used for acute inpatient care from 15 to 25, • Any hospital-type bed located where the bed could be used for acute inpatient care counts toward the 25 bed limit! • Hospice beds count as part of the maximum bed count while not contributing to the 96 hour annual average length of stay. • Distinct part Psychiatric and Rehabilitation units now allowed and do not count in either bed capacity or length of stay.

19. Proposed Rulesfor CoPFederal Register,March 25, 2005 • H&P examination.   expand permissible practitioners and the time frame for the H&P; • Authentication of orders.   allow orders to be authenticated by any practitioner responsible for the care of the patient for five year transition period; • Post anesthesia evaluation.  permit any individual qualified to administer anesthesia to do post anesthesia evaluation for inpatients.  • http://a257.g.akamaitech.net/7/257/2422/01jan20051800/edocket.access.gpo.gov/2005/pdf/05-5916.pdf The PPS CoP catch up to CAH CoP

20. Conditions of ParticipationRev. 05-21-04Critical Access Hospitals Regulations and Interpretive Guidelines for Critical Access Hospitals (CAHs)

21. What is different for CAH’s? • Network agreements for Credentialing Privileging, and Quality Assurance • Required Emergency Services • Governing Body Responsibilities • Practitioner Responsibilities • Patient Care Policies • Quality Assurance Program • Periodic Evaluation

22. 485.616(b) Agreements for Credentialing and Quality Assurance Each CAH shall have an agreement with respect to credentialing and quality assurance with: (1) A hospital member of the network; (2) QIO or equivalent entity; or (3) Another appropriate qualified entity identified in the State rural health plan.

23. Condition of Participation §485.618 Emergency Services • Emergency services 24-hours a day, • Equipment, supplies, and medication used in treating emergency cases are readily available, and • Blood and Blood Products on a 24-hours a day basis.

24. §485.618 Emergency Services A doctor of medicine or osteopathy, a physician assistant, or a nurse practitioner on call and immediately available on site 24-hour a day within: 20 minutes for trauma 30 minutes non-trauma or 60 minutes if the CAH is a frontier area (less than 6 residents per square mile), the State has determined that longer than 30 minutes is the only feasible method of providing emergency care to residents, and maintains that 60 minutes is justified because other alternatives would increase the time needed to stabilize a patient in an emergency.

25. §485.627(a) Governing Body • The governing body is responsible for the quality of care provided to patients. • The governing body • must determine categories of practitioners eligible for appointment / reappointment, • must approve the medical staff bylaws and ensure that bylaws comply with State and Federal law, • must ensure that the medical staff is accountable to the governing body for the quality of care provided to patients.

26. §485.631 Staff Responsibilities All CAH patients • Must be under the care of a MD/DO member of the medical staff or • Under the care of a practitioner who is under the supervision of a member of the medical staff.

27. §485.631(b) (i)Responsibilities of the Doctor of Medicine or Osteopathy • Provides medical direction for the CAH’S health care activities and • Consultation for, and medical supervision of, the health care staff.

28. §485.631(b)(1)(ii)Responsibilities of the Doctor of Medicine orOsteopathy • In conjunction with the physician assistant and/or nurse practitioner, • Participates in developing, executing, and periodically reviewing the CAH’S written policies governing the services it furnishes.

29. §485.631(b)(1)(iii)Responsibilities of the Doctor of Medicine orOsteopathy • In conjunction with the physician assistant and/or nurse practitioner, • Periodically reviews the CAH’S patient records, providesmedical orders, and provides medical care services to the CAH patients.

30. §485.631(b)(1)(iv)Responsibilities of the Doctor of Medicine orOsteopathy • Periodically reviews and signs the records of patients cared for by nurse practitioners, clinical nurse specialists, or physician assistants, • MD/DO must review and sign ALL medical records for patients cared for by mid-level practitioners at the CAH.

31. Survey Procedures §485.631(b)(1)(iv) • Select a sample of inpatient and outpatient records, including both open and closed records, and verify that a MD/DO has reviewed and signed all records for patients cared for by mid-level practitioners. • “Prior to the May 21, 2004 revision, the interpretive guidelinescited a 25% review of outpatient records of by physicians. The current guidelines specify 100% because that is what the regulation states.”    • ‘CMS Central Office is now considering changing the regulation. In the near future Central Office Survey & Certification staff expect to send out a letter indicating that, until the regulation should be modified, a 25% sample for outpatient records will suffice IF the State law supports independent practice for the mid-level practitioner .”  Alma Hardy, Medicare Provider Services Branch CMS - Region 10

32. §485.631(b)(2)Responsibilities of the Doctor of Medicine orOsteopathy . • Is available through direct radio or telephone communication for consultation, assistance with medical emergencies, or patient referral. • Is present for sufficient periods of time to provide the medical direction, medical care services, consultation, and supervision. • Frontier facilities, at least once in every 2 week period, but a site visit is not required if no patients have been treated since the latest site visit.

33. 485.631(c)(1)Physician Assistant, Nurse Practitioner, and Clinical Nurse Specialist Responsibilities • Participates in the development, execution and periodic review of the written policies governing the services the CAH furnishes, • Participates with MD/DO in a periodic review of the patients' health records.

34. 485.631(c)(2)Physician Assistant, Nurse Practitioner, and Clinical Nurse Specialist Responsibilities • performs the following functions to the extent they are not being performed by a doctor of medicine or osteopathy: • Provides services in accordance with the CAH’S policies, • Refers patients for needed services that cannot be furnished at the CAH, and assures that adequate records are maintained and transferred when patients are referred.

35. 485.631(c)(3)Physician Assistant, Nurse Practitioner, and Clinical Nurse Specialist Responsibilities Whenever a patient is admitted by a nurse practitioner, physician assistant, or clinical nurse specialist, an MD/DO on the staff of the CAH is notified of the admission.

36. The CAH regulations do permit mid-level practitioners to admit patients as allowed by the State. CMS regulations require that Medicare and Medicaid patients admitted by a mid-level practitioner be under the care of an MD/DO if any medical or psychiatric problem during hospitalization is outside the scope of practice of the admitting practitioner.

37. Interpretive Guidelines §485.631(c)(3) • Evidence of “being under the care” of an MD/DO must be in the patient’s medical record, • As applicable, the patient’s medical record must demonstrate MD/DO responsibility/care. • Therefore If the CAH allows a mid-level practitioner to admit and care for patients, the governing body and medical staff must establish policies and bylaws to ensure patient safety.

38. Interpretive Guidelines §485.631(c)(3) • Surveyors verify that: • Admitting is only done by practitioners currently licensed and granted privileges as allowed by State law, • An MD/DO is monitoring and is responsible for the care of each Medicare or Medicaid patient for all medical problems during the hospitalization outside the scope of practice of the admitting mid-level practitioners.

39. §485.635(a) Patient Care Policies • The CAH services are furnished in accordance with appropriate written policies that are consistent with applicable State law. • The policies are developed with the advice of a group of professional personnel • that includes doctors of medicine or osteopathy and physician assistants, nurse practitioners, or clinical nurse specialists, • AND at least one member who is NOT a member of the CAH staff.

40. §485.635(a) Patient Care Policies • (i) A description of the services the CAH furnishes directly and those furnished through agreement or arrangement; • (ii) Policies and procedures for emergency medical services; • (iii) Guidelines for the medical management of health problems.

41. Interpretive Guidelines §485.635(a)(3)(iii) • Policies should establish the agreement between the MD/DO providing the medical supervision and the mid-level practitioners for medical diagnosis and treatment. • Policies should describe the scope of service performed by the mid-level practitioners. • They should cover most health problems; • They should describe the authorized treatments and procedures available to the PA, NP and/or CNS.

42. Interpretive Guidelines §485.635(a)(3)(iii) • Policies should describe the regimens to follow and also stipulate when consultation or referral is required. • They should describe the medical conditions, signs, or developments that require consultation or referral.

43. Interpretive Guidelines §485.635(a)(4) • To ensure policies are reviewed at least annually by the professional personnel. • “Review the meeting notes and policy and procedure books to verify that the patient care policies are reviewed on an annual basis by the professional group,” which includes a member not on the CAH staff.

44. Administration of drugs and biologicals 485.635(d)(3) • All orders must be legible and include date, time, name of the ordering practitioner and for verbal orders the signature of the accepting individual. • The ordering practitioner must sign, date, and time a verbal order as soon as possible consistent with Federal & State law and CAH policy. • “The next time the prescribing practitioner provides care to the patient, assesses the patient, or documents in the patient’s medical record”

45. Interpretive Guidelines §485.635(d)(3) • “We recognize that in some instances…the ordering practitioner…is “off duty” for…a…period of time. In such cases, it is acceptable for a covering practitioner to co-sign the verbal order of the ordering practitioner. The signature indicates that the covering practitioner assumes responsibility for his/her colleague’s order as being complete, accurate and final. This practice must be addressed in the CAH’S policy. • However, a qualified practitioner such as a physician assistant or nurse practitioner may not “co-sign” a MD/DO’s verbal order or otherwise authenticate a medical record entry for the MD/DO who gave the verbal order.”

46. Interpretive Guidelines §485.638(a)(4)(ii) • All or part of the history and physical exam may be delegated to other practitioners in accordance with State law and CAH policy, but the MD/DO must sign and assume full responsibility for the H & P. • This means that a nurse practitioner or a physician assistant may perform the H & P. • All entries must be timed, dated, and authenticated and may be made only by individuals as specified in CAH and medical staff policies.

47. §485.639(c)(2) CRNA anesthetist must be under the supervision of the operating practitioner unless the Governor in the State in which the CAH is located requests exemption by submitting a letter to CMS. • Washington CRNAs have been exempted.

48. §485.641(a) Periodic Evaluation • The CAH carries out or arranges for a periodic evaluation of its total program to be performed at least once a year. • The utilization of CAH services, including number of patients served and the volume of services; • The purpose of the evaluation is to determine whether the utilization of services was appropriate, the established policies were followed, and if any changes are needed.

49. Interpretive Guidelines §485.641(a) • “A representative sample means not less than 10 percent of both active and closed patient records.” • Who is responsible for the review of both active and closed clinical records? • How are records selected and reviewed? • How does the process ensure that the sample of records is representative of services furnished? • What criteria are utilized in the review of both active and closed records?

50. §485.641(b) Quality Assurance • The CAH has an effective quality assurance program to evaluate the quality and appropriateness of the diagnosis and treatment and the outcomes. • All services affecting patient health and safety; • Nosocomial infections and medication therapy; • Diagnosis and treatment by the mid-level practitioners is evaluated by a MD/DO on the CAH staff or by another doctor under contract with the CAH.