AHLA. GG. Physician Orders. Timothy P. Blanchard Blanchard Manning LLP Orcas, WA

Transcription

1 AHLA GG. Physician Orders Timothy P. Blanchard Blanchard Manning LLP Orcas, WA Institute on Medicare and Medicaid Payment Issues March 26-28, 2014

2 Physician Orders Timothy P. Blanchard, MHA, JD Medicare and Medicaid Institute American Health Lawyers Association March 26-28, Blanchard Manning LLP. Plan for Discussion What are physician s orders and why they matter? Verbal orders Authentication of orders Standing orders Orders for diagnostic services Hospital inpatient admission orders Note some services with special rules 1

3 What Are Physicians Orders? No general statutory or regulatory definition Communication from a physician directing that a service be provided in writing, by telephone, by electronic mail electronic medical record entries physician order entry (POE) may be relayed by the physician s staff a prescription for medicine or device 3 Why Do Physician Orders Matter? Three functions for Medicare purposes Communicating directives regarding the medical care of the patient Demonstrating under the care of a physician and active involvement of physician in the care of the patient Evidence of medical necessity Conditions of Participation and/or Payment Medical practice rules, scope of practice 4 2

4 When Are Orders Effective? As a communication Is it the message or its successful transmission? When it is received When it is entered in the medical record When the fax, , courier message or telephone call is received? When given orally i.e., verbal orders 5 Verbal Orders Erroneous Term of Art Meaning spoken or oral orders Hospitals are expected to develop appropriate policies and procedures that govern minimize their use, including: Read-back verification practice Promptly documented in the patient s medical record by the individual receiving the order -- legal qualification to accept Not always allowed, e.g., IDTFs, seclusion, restraints 6 3

5 COP Instructions (Hospitals) Verbal orders, if used, must be used infrequently. This means that the use of verbal orders must not be a common practice. Verbal orders pose an increased risk of miscommunication that could contribute to a medication or other error, resulting in a patient adverse event. Verbal orders should be used only to meet the care needs of the patient when it is impossible or impractical for the ordering practitioner to write the order or enter it into an electronic prescribing system without delaying treatment. Verbal orders are not to be used for the convenience of the ordering practitioner. (Emphasis added.) 7 Authentication of Physician s Orders (Medical Records) COP for Hospitals All orders, including verbal orders, must be dated, timed, and authenticated promptly by the ordering practitioner or by another practitioner who is responsible for the care of the patient only if such a practitioner is acting in accordance with State law, including scope-of-practice laws, hospital policies, and medical staff bylaws, rules, and regulations. 8 4

6 Authentication: Condition of Payment For medical review purposes, Medicare requires that services provided/ordered be authenticated by the author.... Stamped signatures are not acceptable. Program Integrity Manual If specific signature is required If the signature is missing from an order, MACs and CERT shall disregard the order during the review of the claim (e.g., the reviewer will proceed as if the order was not received). If no specific signature is required Unsubstantiated medical necessity 9 Authentication of Orders Authentication within 48 hours (unless state law/hospital policy provided otherwise) no longer required by Medicare, BUT Prompt authentication of medical record entries important to establish accuracy. Allows necessary corrections to be made based on fresh recollection. Special rules may require earlier times (e.g., prior to discharge or prior delivery). 10 5

7 Standing Orders What, when, why, how, when not? CMS recognizes that there is no standard definition for standing orders the lack of a standard definition for these terms and their interchangeable and indistinct use by hospitals and health care professionals may result in confusion regarding what is or is not subject to [Medicare COPs]. (SOM at A- 0457) 11 Medicare COP Regulations: (c)(3) Hospitals may use pre-printed and electronic standing orders, order sets, and protocols for patient orders only if: (i) such orders and protocols have been reviewed and approved by the medical staff and the hospital's nursing and pharmacy leadership; (ii) such orders and protocols are consistent with nationally recognized and evidence-based guidelines; 12 6

8 482.24(c)(3) (continued) (iii) periodic and regular review is conducted by the medical staff and nursing and pharmacy leadership to determine the continuing usefulness and safety ; and (iv) such orders and protocols are dated, timed, and authenticated promptly in the patient's medical record by the ordering practitioner or by another practitioner responsible for the care of the patient Not all pre-printed and electronic order sets are a type of standing order covered by the regulation 13 Types of Standing Orders Individual Physician s Established Patient, PRN Orders Hospital-Wide PRN/Emergency Orders Individual Physician s Established Patient, Treatment Protocol Orders Individual Physician s Standard Procedure/Admission Orders Hospital Triage Patient Orders 14 7

9 Individual Physician's Est. Patient PRN Entered by an individual physician For a specific established patient Directing a specific intervention in the event specified circumstances arise Nursing is not called to exercise discretion outside scope of practice or to exercise medical judgment 15 Hospital-Wide PRN/Emergency Hospital policy permits treatment to be initiated, by a nurse, for example, without a prior specific order from the treating physician Typically initiated when a patient s condition meets certain pre-defined clinical criteria. Part of an emergency response or an evidence-based treatment regimen. Where it is not practical for a nurse to obtain either a written, authenticated order or a verbal order prior to the provision of care. 16 8

10 Established Patient Treatment Protocols Specific treatment regimen for a specific patient with specified dosage adjustments based on a protocol or algorithm. Nursing adjusts dosage administered based on laboratory test results and protocol without additional discrete orders. Nurses are implementing, not changing, physician's orders. Beware of medical necessity concerns. 17 OIG Concerns Regarding Standing Orders Although standing orders are not prohibited in connection with an extended course of treatment, too often they have led to abusive practices. Standing orders in and of themselves are not usually acceptable documentation that tests are reasonable and necessary... As a result of the potential problems standing orders may cause, the use of standing orders is discouraged. 63 Fed. Reg , (Aug. 24, 1998). 18 9

11 Coverage Policy Concerns Example: physician-ordered insulin treatment protocol for frail diabetics in SNFs Glucose testing claims denied physicians allegedly not using the results ALJs, however, thoughtfully disagreed e.g., Extendicare Health Services, Inc. (Aug. 12, 2004) CMS specific rule on SNF glucose testing See 42 CFR (f); Claims Proc. Manual, Ch. 7, 90.1; NCD Manual (2005) 19 Indiv. Physician s Std. Proc./Admission Standard set of orders entered by a physician for every patient scheduled to receive a particular procedure/treatment or to be admitted for a particular condition. Standardized--not standing --because they are ordered specifically for each patient. Not subject to the standing orders conditions, unless they include elements of standing orders triggering applicability

12 Hospital Triage Patient Orders Hospital policies authorizing specified testing/treatment w/o a specific order. Appropriate for well-defined clinical scenarios such as protocols for triaging and initiating required screening examinations and stabilizing treatment for emergency department patients presenting with symptoms suggestive of acute asthma, myocardial infarction, stroke, etc. 21 COP Conditions for Standing Orders Review and Approval of Standing Orders Consistent with Nationally Recognized Evidence-Based Guidelines Specific Clinical Criteria Under no circumstances may a hospital use standing orders in a manner that requires any staff not authorized to write patient orders to make clinical decisions outside of their scope of practice in order to initiate such orders

13 COP Conditions for Standing Orders Policies/Procedures for Standing Orders Initiation of Services under Standing Orders Not really orders, but linguistic confusion likely. Authentication Subsequent to Initiation Responsible practitioner must be able to modify, cancel, void or decline to authenticate orders that were not medically necessary in a particular situation. Acknowledgment of Initiation of Services Acknowledg[e] and authenticat[e] the initiation of each standing order after the fact. (?) 23 COP Conditions for Standing Orders Entry in the Medical Record The medical record is expected to include the standing order that was used for the patient, in order to fully and accurately document the care provided. Periodic Monitoring Latest standard of practice. Preventable adverse events. Has standing order has been initiated and executed in a manner consistent with the order s protocol, and if not, whether the protocol needs revision and/or staff need more training in the correct procedures. Training and Instruction of Personnel 24 12

14 Authentication Standardized Order Sets Standardized order sets include, but are not limited to, standing orders Ordering practitioners must: Sign, date, and time the last page of the orders, last page must identify the total number of pages in the order set, AND Sign or initial any internal pages where selections or changes have been made 25 Orders for Diagnostic Services All diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests must be ordered by the physician who is treating the beneficiary, that is, the physician who furnishes a consultation or treats a beneficiary for a specific medical problem and who uses the results in the management of the beneficiary's specific medical problem. Tests not ordered by the physician who is treating the beneficiary are not reasonable and necessary. 42 C.F.R (a)

15 Conditional or Reflex Testing Orders An order may conditionally request an additional diagnostic test if the result of the initial test yields to a certain value determined by the treating physician BPM, Ch. 15, OIG Compliance Guidance for Clinical Labs advises that: the condition under which the reflex test will be performed should be clearly indicated on the requisition form. 27 Laboratory Requisitions vs. Orders An order is a communication from the treating physician/practitioner requesting that a diagnostic test be performed. According to CMS, a requisition is: the actual paperwork, such as a form, which is provided to a clinical diagnostic laboratory that identifies the test or tests to be performed for a patient. We believe it is ministerial in nature, and serves as an administrative convenience to providers and patients

16 Confusing Flip-Flop on Signature Rule 2010 policy change required signatures on lab requisitions longstanding policy restored: Medicare does not require the signature of the ordering physician on a laboratory service requisition. While the signature of a physician on a requisition is one way of documenting that the treating physician ordered the service, it is not the only permissible way of documenting that the service has been ordered. 29 Further Lab Order Confusion Rationale for the 2010 policy change was: eliminating uncertainty over whether the documentation is a requisition or an order But BPM, Ch. 15, says: No signature is required on orders for clinical diagnostic tests, or for physician pathology Recommendation: Document orders (i.e., the communication) in properly authenticated medical record entries

17 Telephone Orders for Diagnostics (!) If the order is communicated via telephone, both the treating physician or his/her office, and the testing facility must document the telephone call in their respective medical records. BPM Ch. 15, See Nephropathology Associates PLC v. Sebelius, 2013 U.S. Dist. Lexis (E.D. Ark., June 27, 2013) (upholding denials) 31 Changing/Clarifying Diagnostic Orders Only when the interpreting physician documents the change in the report and one of the following conditions is satisfied: Test Design Unless specified in the order Clear Error Apparent to reasonable layperson Patient Condition Canceling an order because the beneficiary s physical condition will not permit performance of the test Special pathology services exception 32 16

18 Additional Testing Based on Results IF Can t contact ordering physician for orders Need is based on abnormal results Both factors must be documented as must be why the additional testing was medically necessary. Additional testing results communicated to the treating physician and used in treating the patient. An IDTF may not add any procedures based on internal protocols. 33 Hospital Inpatient Admitting Orders Physician orders are now a Condition of Payment for Inpatient hospital services. 42 C.F.R Physician Certification includes admitting orders and timing requirements requiring coordination with discharge orders 42 C.F.R (b) (must be authenticated prior to discharge) 34 17

19 412.3 Admitting Order Conditions (a) This physician order must be present in the medical record and be supported by the physician admission and progress notes, in order for the hospital to be paid for hospital inpatient services under Medicare Part A. (b) The order must be furnished by a qualified and licensed practitioner who has admitting privileges at the hospital as permitted by State law, and who is knowledgeable about the patient s hospital course, medical plan of care, and current condition Physician Order Conditions (c) Physician order also constitutes a required component of physician certification of the medical necessity of hospital inpatient services under subpart B of Part 424 (d) Physician order must be furnished at or before the time of the inpatient admission. (e) [2-midnights standards] 18

20 Orders for DMEPOS: PIM, 5.2. et seq. Suppliers must have treating physician orders before dispensing a DMEPOS item. May dispense some items on verbal order or prelim. written order w/ description of item, patient's name, physician's name, start date. Detailed written order required before billing. Other items require: Detailed written order before delivery Face-to-face encounter prior to completing order 37 Some Services with Additional Rules Home Health Hospice Skilled Nursing Facility Physical Therapy, Occupational Therapy, Speech Pathology Psychopharmacological drug administration Seclusion and Restraint Inpatient Psychiatric and Rehabilitation 38 19

21 Final Things To Remember/Consider Authentication policies for medical review Payment/coverage policies vs. COPs vs. medical practice, malpractice, ethics Establishing that ordered diagnostics are used in the treatment of the patient Testing/approving proposed standing orders (treatment protocols) Standardizing discharge order process 39 Questions Timothy P. Blanchard Blanchard Manning LLP