Rural Health Clinic Compliance 2013

Rural Health Clinic Compliance 2013 Charles A. James, Jr. President and CEO North American Healthcare Management Services www.northamericanhms.com 888.968.0076

Presentation Topics Components of RHC Regulations and Inspections Annual Requirements RHC regulatory resources www.northamericanhms.com 888.968.0076

Presentation Objectives Determine Annual Requirements of the RHC program Determine annual physical facility requirements Determine compliance/staff education requirements Review what to do for re-inspection www.northamericanhms.com 888.968.0076

Is it the State or the Feds? Short Answer – Both The State Department of Health typically perform inspections. They are an agent of CMS for the purpose of an RHC survey. CMS interprets and enforces the federal RHC regulations. CMS approves or denies the state’s recommendations. www.northamericanhms.com 888.968.0076

AAAASF and Office Team These are outside accreditation agencies approved by CMS to perform RHC survey and re-survey. Think: The Joint Commission for RHCs. There is an additional expense. www.northamericanhms.com 888.968.0076

The Rules - 42 CFR 491 This is the Code of Federal Regulations (CFR) which stipulates rural health clinics’ conditions for certification. http://www.cms.gov/Regulations-and-Guidance/Legislation/CFCsAndCoPs/RHC_FQHC.html www.northamericanhms.com 888.968.0076

Rural Health Clinic Requirements • Compliance with Federal, State, and Local laws • Location of Clinic • Physical Plant and Environment • Organizational Structure • Staffing and Staff Responsibilities • Provision of Services • Policy and Procedure Manual • Medical Records • Annual Evaluation (vs. Quality Assurance) www.northamericanhms.com 888.968.0076

State Operations Manual The SOM is the surveyor’s guide to an RHC inspection. It contains detailed explanation of requirements for each compliance component. This document can be found at: http://www.cms.gov/manuals/Downloads/som107ap_g_rhc.pdf www.northamericanhms.com 888.968.0076

HRSA Sample Policy Manual Part of HRSA – Starting an RHC/ A how-to manual Excellent resource for sample language Contains samples of each section of policy manual Health Resource and Services Administration A link to the manual: ftp://ftp.hrsa.gov/ruralhealth/RHCmanual1.pdf www.northamericanhms.com 888.968.0076

RHC Inspections • Rural Health Clinic Regulations and Survey Report (CMS – 30) • State Operations Manual – Appendix G • Inspector Interpretation www.northamericanhms.com 888.968.0076

Compliance with Federal, State, Local Laws The clinic must be in compliance with federal RHC regulations and Medicare law. (J3) The clinic and staff are licensed pursuant to applicable State and local law. (J3 and J4) The clinic building meets applicable building and fire codes. (J5) www.northamericanhms.com 888.968.0076

Location of Clinic (J6 thru J18) Must be in HPSA or MUA For new certification – HPSA has to have been updated within the last four years Must be rural – Use this search tool: http://ims2.missouri.edu/rac/amirural/ www.northamericanhms.com 888.968.0076

Physical Plant and Environment The clinic is constructed, arranged, and maintained to ensure access to and safety of patients, and provides adequate space for the provision of direct services. (J20) www.northamericanhms.com 888.968.0076

Physical Plant: Patient Care Equipment and Drugs The clinic has a preventive maintenance program to ensure that: • All essential mechanical, electrical and patient care equipment is maintained in safe operating condition; • Drugs and biologicals are appropriately stored; • The premises are clean and orderly. www.northamericanhms.com 888.968.0076

Bio-medical Equipment Inspection Ensure that the clinic has policies and documentation for equipment maintenance and inspection. (J22) An annual bio-medical equipment inspection by is the gold standard. www.northamericanhms.com 888.968.0076

Drugs and Biologicals Drugs and biologicals are appropriately stored (J23) www.northamericanhms.com 888.968.0076

Drug and Biological Storage To Do LOCK all drug storage locations! Make sure all expired drugs are removed. Document/schedule this activity monthly. Documentation of review/removal activity should be available for review. Multi-use vials marked w/ date of opening and disposed 30 days after opening. www.northamericanhms.com 888.968.0076

Clean and Tidy The premises are clean and tidy. (J24) www.northamericanhms.com 888.968.0076

Facility Appearance The term “a clean and orderly environment” is explicit in the regulation. A neat, well-kept appearance makes a dramatic difference in the success of any type of inspection. www.northamericanhms.com 888.968.0076

Physical Plant: Emergency Preparedness Emergency procedures. The clinic assures the safety of patients in case of nonmedical emergencies by: • Training staff in handling emergencies • Placing exit signs in appropriate locations • Taking other appropriate measures that are consistent with the particular conditions of the area in which the clinic is located. (J25-J28) www.northamericanhms.com 888.968.0076

Emergency Preparedness – (J25) Arrange an Annual Fire Inspection Document Fire/Natural Disaster In-services (J26) Post facility layout diagrams and exit routes (J27) Assess emergencies other than just fire – i.e. earthquake, tornado, etc.(J28) CPR certification for clinical (and administrative?) should be completed www.northamericanhms.com 888.968.0076

Organizational Structure Define the organizational structure of the clinic. Develop an organizational chart that reflects the clinic. If the clinic is owned/managed by a hospital – that should be part of the chart. www.northamericanhms.com 888.968.0076

RHC Staffing Requirements (J29) The clinic is under the direction of a physician. (J31) The clinic must employ one or more nurse practitioners, physician assistants, or nurse- midwife. (J31) The NP/PA must be available 50% of the time the clinic is open. (J41) www.northamericanhms.com 888.968.0076

RHC Staffing Requirements (Cont’d) A provider must be available to furnish services at all times during clinic hours. (J41) One clinic physician must function as the Medical Director. (J46) www.northamericanhms.com 888.968.0076

Physician Responsibilities The physician provides medical direction for the clinic’s health care activities and consultation for, and medical supervision of the health care staff. (J46) www.northamericanhms.com 888.968.0076

Physician Responsibilities In conjunction with the physician’s assistant and/or nurse practitioner member(s), the physician participates in developing, executing and periodically reviewing the clinic’s written policies and the services provided to Federal program patients; (J47) www.northamericanhms.com 888.968.0076

Physician Responsibilities The physician periodically reviews the clinic’s patient records, provides medical orders, and provides medical care services to the patients of the clinic. (J48) www.northamericanhms.com 888.968.0076

Medical Director Responsibilities A physician is present for sufficient periods of time, at least once in every 2 week period (except in extraordinary circumstances), to provide the medical direction, medical care services, consultation and supervision described in paragraph(b)(1) of this section, and, is available through direct telecommunication for consultation, assistance with medical emergencies, or patient referral. (J49) www.northamericanhms.com 888.968.0076

NP/PA Responsibilities (J50-J51) participate in the development, execution and periodic review of the written policies governing the services the clinic furnishes; (provide services in accordance with those policies; provide services in accordance with those policies; www.northamericanhms.com 888.968.0076

NP/PA Responsibilities (J50-J51) arrange for, or refer patients to, needed services that cannot be provided at the clinic; assure that adequate patient health records are maintained and transferred as required when patients are referred; (v) participate with a physician in a periodic review of the patients’ health records. www.northamericanhms.com 888.968.0076

CMS Proposed Rule 491.8(a)(iii) “ The physician assistant, nurse practitioner, nurse-midwife, clinical social worker or clinical psychologist member of the staff may be the owner or an employee of the clinic or center, or may furnish services under contract to the clinic or center. In the case of a clinic, at least one physician assistants or nurse practitioner must be an employee of the clinic.” CMS Proposed Rule www.northamericanhms.com 888.968.0076

RHC Staffing Recommendations Do not open the clinic if no provider is present. Post Clinic hours. Make sure a provider (Doctor/APN/PA) is present during those hours. Make sure the NP/PA staffing is 50% of posted PATIENT hours. If NP/PA clinic, make sure the Medical Director is on-site every two weeks, provides some patient care, and signs charts. www.northamericanhms.com 888.968.0076

Collaborative Physician Requirements The responsibilities of the clinic Medical Director are different than the requirements for collaboration with Nurse Practitioners and Physician Assistants. Reviewing and counter-signing charts for the NP/PA is a requirement collaborative agreement. www.northamericanhms.com 888.968.0076

RHC Policy Manual Requirement Written policies should consist of both administrative and patient care policies. In addition to including lines of authority and responsibilities, administrative policies may cover topics such as personnel, fiscal, purchasing, and maintenance of building and equipment. www.northamericanhms.com 888.968.0076

Patient Care Policies The clinic is primarily engaged in providing outpatient health services as described in §481.9 (c). (J53) The clinic’s health care services are furnished in accordance with appropriate written policies which are consistent with applicable State law. (J55) The policies are developed with the advice of a group of professional personnel that includes one or more physicians and one or more physician’s assistants or nurse practitioners. At least one member of the group is not a member of the clinic’s staff. (J56) www.northamericanhms.com 888.968.0076

Patient Care Policies (J57) The RHC Policy Manual must include: • a description of services furnished directly and those furnished by arrangement; • guidelines for the medical management of health problems, including conditions for referral and consultation; • guidelines for storage of drugs and biologicals. www.northamericanhms.com 888.968.0076

Description of Services “Such statements as the following sufficiently describe services: Taking complete medical histories, performing complete physical examinations, assessments of health status, routine lab tests…” “Statements such as ‘complete management of common acute and chronic health problems’ standing alone, do not sufficiently describe services.” (CMS State Operations Manual) www.northamericanhms.com 888.968.0076

Written Policies and Procedures The clinic must be able to provide written documentation of clinic policies. It ‘must be possible to ascertain who developed them’. If the personnel have changed since originally developed, then the doctor, APN, and/or PA must have in-depth knowledge of the policies… www.northamericanhms.com 888.968.0076

Provision of Services The clinic staff furnishes those diagnostic and therapeutic services and supplies that are commonly furnished in a physician’s office or at the entry point into the health care delivery system. These include medical history, physical examination, assessment of health status, and treatment for a variety of medical conditions. (J60) www.northamericanhms.com 888.968.0076

Guidelines for Medical Mgmt Scope of Services for APN/PA are critical. These represent an agreement between the APN/PA which stipulate medical direction, and designate their privileges and limits of medical diagnosis and treatment. Track APN/PA collaboration/supervision! Confirm/assess state collaborative requirements. www.northamericanhms.com 888.968.0076

Drugs and Biological Policies Policies must stipulate requirements for dealing with: • All drug storage locations are locked; • Storage of drug samples, • dealing with outdated medications, • Securing and accounting for Schedule II drugs. • Others…(See SOM) www.northamericanhms.com 888.968.0076

Policy Review It MUST be documented that the Medical Director and APN/PA review all policies annually. This is absolutely mission critical. This can be achieved by signing and dating the manual annually!! www.northamericanhms.com 888.968.0076

RHC Manual Recommendations Review all job descriptions and make sure they are accurate. Make sure that an annual policy review/update is documented. Include the physician/np/outside member! www.northamericanhms.com 888.968.0076

RHC Manual Recommendations Organize Manual according to RHC regulations. Document/demonstrate physician involvement. Keep business, personnel, and medical licenses current!! Make sure that patient care and administrative polices are included and current! Maintain the organizational chart. Assign one person and an alternate responsibility for the manual in case of inspection. www.northamericanhms.com 888.968.0076

Provision of Services – Lab (J61) • An RHC must have the ability to perform the following lab tests: • Blood Sugar • Hemoglobin or Hematocrit • Pregnancy • Urinalysis – Dipstick • Occult Blood www.northamericanhms.com 888.968.0076

Lab - PPM Provider-Performed Microscopy This means being licensed by CLIA to use a microscope in the office. Short answer – if you are using a microscope, be sure your CLIA license says this. www.northamericanhms.com 888.968.0076

Emergency Kit The clinic provides medical emergency procedures as a first response to common life-threatening injuries and acute illness, and has available the drugs and biologicals commonly used in life saving procedures, such as analgesics, anesthetics (local), antibiotics, anticonvulsants, antidotes and emetics, serums and toxoids. (J62) www.northamericanhms.com 888.968.0076

Sample Emergency Drugs Analgesics - ASA, Tylenol, Aleve Anesthetics - Xylocaine, Lidocaine Antibiotics - Rocephin Anticonvulsants - Valium, Cerebyx Antidotes - EpiPenR and EpiPenR Jr Auto-Injectors, Epinephrine Emetics - Activated Charcoal/911 Serums/toxoids - Vaccines, Tetanus www.northamericanhms.com 888.968.0076

Provision of Service Recommendations An emergency kit is required – a defibrillator is not (yet). Make sure the clinic can perform a Hemoglobin or Hematocrit and that your supplies are current. The RHC must be able to admit to a hospital - or have a written agreement with someone who can. www.northamericanhms.com 888.968.0076

In-Patient Services and Specialists (J62) The clinic has agreements or arrangements with one or more providers or suppliers participating under Medicare or Medicaid to furnish other services to its patients, including: (i) inpatient hospital care; (ii) physician(s) services (whether furnished in the hospital, the office, the patient’s home, a skilled nursing facility, or elsewhere); and (iii) additional and specialized diagnostic and laboratory services that are not available at the clinic. www.northamericanhms.com 888.968.0076

Rural Health Clinic Compliance 2013