This chapter has been accepted for publication in Health Law Handbook 2014 (A. Gosfield, ed.) and is used by permission of the publisher.

EVOLVING MEDICARE POLICY ON PHYSICIAN ORDERS: FUNDAMENTAL CONCEPTS BUT HIGHER STAKES 1 Timothy P. Blanchard and Margaret M. Manning BLANCHARD MANNING LLP Introduction The traditional American health care system has, for more than a century, relied heavily upon physician orders. Medical care (items and services 2 for the treatment of illness) provided by licensed facilities and practitioners is generally furnished only on order of a physician or appropriate nonphysician practitioner (NPP)). 3 Thus, for example, nursing and therapy staff rely on attending physician orders for hospital or skilled nursing patient care; pharmacists rely on orders (prescriptions) in compounding and dispensing medication; and home health agencies look to physician- approved plans of care to determine what services are furnished to a patient. In addition, regulators and payors regularly look to orders to support claims for payment for services and to evaluate the quality of services provided by physicians and those carrying out their patient care instructions. Despite the importance of physician orders in our healthcare system in general, and in the Medicare program in particular, the fact is that the term is not clearly defined by the Medicare statute or regulations, 4 and many different and sometimes inconsistent interpretations exist. In this chapter, we identify the sources of certain Medicare requirements 5 regarding the role of 1 This chapter has been accepted for publication in Health Law Handbook 2014 (A. Gosfield, ed.) and is used by permission of the publisher. 2 In the interest of readability, we refer to medical items and services, the key phrases used in the Medicare statute, see, e.g., 42 U.S.C. 1395x(b), collectively as services in this chapter, unless the context requires otherwise. 3 We refer to physicians and NPPs collectively as physicians, unless the context requires otherwise. 4 Obviously, each state jurisdiction has its own statutory and regulatory definitions, and the Medicare program defers to some extent to that body of law to determine what actions are authorized within that jurisdiction. For example, the California Health and Safety Code, 11150, delineates who may write a prescription; the California Business and Professions Code, 4019, discusses "orders" entered on the chart or medical record of a patient; and the Business and Professionals Code, 4040, defines prescription. 5 We have limited the discussion in this chapter to certain specific issues and analysis

2 physician s orders in medical review, payment policy ( conditions of payment ), and certification or approval of providers and suppliers ( conditions of participation ) 6 and discuss the issues that arise in their application, primarily in relation to acute services. 7 What is a Physician s Order? The Medicare statute, regulation and interpretations repeatedly use the term physician order or, simply, order, to refer to orders of the treating physician or other authorized practitioners, but there is no general statutory or regulatory definition of the term. The Centers for Medicare and Medicaid Services (CMS) has instead chosen to define the term in policy manuals; 8 it has also referred to the manual definitions in several Federal Register preambles. 9 Fundamentally, the Medicare program considers an "order" to be a communication from a physician 10 directing that a service be provided to a Medicare patient (known in the system as a beneficiary ). 11 Depending upon the patient s status (e.g., facility inpatient), the order can be communicated in writing, by telephone, or by electronic mail; depending on context, the order may be relayed from the physician by the physician s staff. 12 CMS also recognizes orders entered into electronic medical records, physician order entry (POE), and electronic prescribing regarding Medicare program policies, but believe that many of the concepts we discuss are applicable generally to the analysis of other payers policies regarding physician s orders. 6 Professional liability issues whether something should or should not have been ordered are beyond the scope of this chapter. 7 Special rules regarding requirements for timing, content and authentication of physician orders exist for services of nursing facilities, home health agencies, hospice, therapy providers and durable medical equipment suppliers. The space available for this chapter does not allow us to address the issues that arise in those contacts, including the interaction between physician orders and required plans of care. 8 Interpretations of statute and regulations found in CMS Policy Manuals do not have the force of law and are not binding. Christensen v. Harris County, 529 U.S. 576, 587 (2000), that [i]nterpretations such as those in opinion letters like interpretations contained in policy statements, agency manuals, and enforcement guidelines... lack the force of law [and] do not warrant Chevron- style deference. 9 See, e.g., 75 Fed. Reg. 73170, 73483 (Nov. 29, 2010). 10 Generally, the treating or attending physician. 11 Medicare Benefit Policy Manual, CMS Pub. 100-02 ( BPM ), Ch. 15, 80.6.1 (regarding orders for diagnostic tests). Specific aspects of the definition related to diagnostic tests are discussed below. 12 Id.

3 systems. 13 A prescription is an order that is written direction for the preparation, compounding, and administration of a medicine or device. 14 Not all orders are for separately billable or reimbursable services, but this does not mean that physician s orders need not be followed. For example, in the inpatient setting, the Medicare program does not pay on a fee- for service basis, but it is still necessary for hospitals and skilled nursing facilities to follow physician orders. Some orders have significant safety and quality implications (e.g., NPO after midnight, bed- rails up ); others can have an impact on Medicare reimbursement for outlier cases. We discuss additional requirements for seclusion and restraint orders below, and note that patients have the right to participate in decisions regarding their health care including decisions not to comply with physician orders and recommendations, or not to receive certain types of services at all. 15 While a patient has the right not to follow orders, health care providers fail to follow physician orders at their peril. 16 Why Do Orders Matter? Orders, and the authenticated documentation of orders, in particular, serve three related but distinct functions in the context of Medicare regulations: (1) communicating directives regarding the medical care of the patient; (2) demonstrating that the patient was under the care of a physician/practitioner and that the physician/ practitioner was actively involved in the care of the patient; and (3) providing evidence regarding the medical necessity of the items and services claimed for Medicare reimbursement. 13 See, e.g., http://www.cms.gov/regulations- and Guidance/Legislation/ EHRIncentivePrograms/downloads/1_CPOE_for_Medication_orders.pdf. 14 The U.S. Drug Enforcement Authority defines prescription as an order for medication which is dispensed to or for an ultimate user. Pharmacists Manual, U.S. Department of Justice, Drug Enforcement Authority, http://www.deadiversion.usdoj.gov/pubs/manuals/ pharm2/ pharm_content.htm#9. 15 See 42 C.F.R. 489.102 (COP regarding advance directives). Refer to applicable state laws and interpretations regarding DNR (do not resuscitate) orders. 16 See, e.g., St. Joseph Villa Nursing Center v. CMS, HHS Departmental Appeals Board, Civil Remedies Div., Doc. C- 09-127, Dec. No. CR2288 (Nov. 29, 2010) (facility failed to follow specific physician orders and plan of care); Crestview Parke Care Center v. Thompson, 373 F.3d 743, 752 (6 th Cir. 2004) (the nursing facility failed to follow physician- ordered treatment, which it categorized as incorrect and misguided. ) The court in Crestview Parke Care Center made quite clear that a challenge to the propriety of a physician- ordered plan of care must occur in communication with the physician when the issue arises, not in an appeal from the civil penalty for failure to follow it.

4 Securing proper documentation of orders is necessary to demonstrate that a provider/supplier meets the requirements for participation in the Medicare program (i.e., satisfies Conditions of Participation) and that particular services are covered and properly reimbursable by Medicare (i.e., satisfy Conditions of Payment). While some of the requirements for documented orders are conditions of participation regulated through the survey and certification process, and allow for corrective action with regard to identified deficiencies, other specific regulatory requirements for orders and establishing that services claims were reasonable and necessary are conditions of payment that must be satisfied in relation to each service for which Medicare payment is claimed. Failure to satisfy conditions of participation can result in termination from participation in the Medicare program and failure to satisfy conditions of payment exposes providers to overpayment recoveries, enhanced medical review procedures, potential adverse provider enrollment implications, and potential false claims liability. Failure to satisfy either or both of these types of conditions can also lead to exclusion federal health care programs. Accordingly, understanding and satisfying applicable requirements for orders is essential for all providers and suppliers furnishing services to Medicare patients. Proper documentation of physician orders for items and services is a prerequisite ( condition for ) Medicare payment. 42 C.F.R. 424.5. Such documentation provides evidence of coverage (reasonableness and medical necessity) of the items and services, 42 C.F.R. 424.5 (a)(1), generally. In addition, particular forms of physician orders (certification and recertification of the need for the services) are required for certain categories of items and services. 42 C.F.R. 424.5(a)(4); see 42 C.F.R. Part 424, Subpart B. When Are Orders Effective? An order is defined as a communication; 17 the earliest that a communication can be acted upon is when it is received. With one exception, an order will be considered effective as soon as it is entered in the medical record. Providers need to be sure that their systems and procedures enable clinical personnel to receive new or changed orders timely. 17 Although communication is susceptible of several definitions and might be interpreted to mean the message as opposed its successful transmission, an order is likely to be held effective against a provider as soon as it is properly entered in the medical record system, or for more urgent orders- - as soon as the fax, e- mail, courier message or telephone call is received.

5 The exception is the situation in which the physician is either present or in contact with staff by telephone and giving oral direction for immediate action. These so- called verbal orders 18 may be effective even before it is entered in the medical record. Medicare policy recognizes that there will be circumstances in which patient care demands implementation of physician instructions more quickly than normal order entry procedures allow, warning: 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. 19 Accordingly, CMS survey guidelines for the nursing service Condition of Participation (COP) explain that: Hospitals are expected to develop appropriate policies and procedures that govern the use of verbal orders and minimize their use; that nationally accepted read- back verification practice is expected for all verbal orders; 20 and that verbal orders are to be promptly documented in the patient s medical record by the individual receiving the order. 21 A verbal order for drugs and biologicals may only be accepted by an individual who is permitted by Federal and State law and hospital policy to accept verbal orders. 22 18 Verbal means things that are put into words, whether written or spoken, while oral pertains to the mouth, to medications taken by mouth, and to things that are spoken. http://www.merriam- webster.com/dictionary/verbal. English traditionalists have objected, without success, to the erroneous use of verbal in reference to spoken things for example, verbal (oral) communications, verbal (oral) reports, and verbal (oral) warnings but verbal is increasingly used in these phrases. http://public.wsu.edu/~brians/errors/oral.html. CMS has led the way in the regulatory arena and verbal should be interpreted as oral in CMS publications. 19 CMS State Operations Manual, CMS Pub. 100-07 ( SOM ), Addendum A (Survey Protocol) at A- 0407 (Rev. 95, 12-12- 2013) (emphasis added); quoting 71 Fed. Reg. 68672, 68679 (Nov. 27, 2006); see 77 Fed. Reg. 29034, 29052-53 (May 16, 2012). These Conditions of Participation provisions relate specifically to nursing service preparation and administration of drugs, see 42 C.F.R. 482.23(c)(3), but should be considered sound guidance regarding the use of oral orders in health care facilities, where similar concerns and risks of miscommunication errors exist. 20 21 22 SOM, Addendum A (Survey Protocol) at A- 0407, citing 71 Fed. Reg. at 68680. SOM, Addendum A at A- 0407. SOM, Addendum A at A- 0408.

6 Authentication of Orders All orders must be authenticated to be proper medical record entries and to be used for related purposes, such as medical review of claims for the services provided. 23 Medicare regulations provide, in the medical records service Conditions of Participation for Hospitals, that: 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. 24 Note that the authority of a practitioner other than the ordering practitioner is subject not only to applicable state scope of practice rules, but also to hospital rules and policies. CMS advised in response to a comment in the Federal Register that a hospital is free to adopt a more stringent policy than that required under the regulations, should it believe it is prudent to do so. 25 Although CMS eliminated the requirement that verbal orders be authenticated within 48 hours unless state law or the hospital policy provided otherwise, 26 the prompt authentication of orders- - like all medical record entries- - is nevertheless important to establish that the medical record is accurate and correctly reflects the physician s instructions for the care of the patient. Prompt authentication allows necessary corrections to be made based while the physician s recollection is fresh. CMS now recognizes that properly- entered amendments, corrections and delayed medical record entries should be given full credit in medical review, 27 but CMS does not accept late or 23 Medicare Program Integrity Manual, CMS Pub. 100-08 (PIM), 3.3.2.4. 24 42 C.F.R. 482.42(c)(2); see 77 Fed. Reg. at 29053-54. The term practitioner in this regulation refers to physicians as well as other practitioners authorized by the hospital and their scope of practice under state law to give orders. 25 77 Fed. Reg. at 29054. 26 77 Fed. Reg. at 29054-55. 27 PIM, Ch. 3, 3.3.2.5 (Rev. 422, effective 01-08- 13) (revising prior policy that provided, problematically: The MACs, CERT, Recovery Auditors, and ZPICs shall give less weight when making review determinations to documentation, including a provider s internal query responses, created more than 30 calendar days following the date of service. ) Under the current policy, to be considered in medical review, the amendments, corrections or addenda must: 1. Clearly and permanently identify any amendment, correction or delayed entry as such, and

7 corrected entries to support orders for inpatient admission or outpatient observation services. 28 Accordingly, it is critical for providers to work together to assure timely and accurate documentation of orders. The requirement of authentication is not just a Condition of Participation; it is also necessary to satisfy Conditions for Payment because medical record entries that have not been authenticated are not considered in the determination of whether services were reasonable and necessary during medical review, 29 thereby jeopardizing a Condition of Payment for almost all Medicare services. 30 According to the PIM: For medical review purposes, Medicare requires that services provided/ordered be authenticated by the author. The method used shall be a handwritten or electronic signature. Stamped signatures are not acceptable. 31 The PIM also provides instructions for evaluating illegible signatures, specific signature circumstances in medical records, and when attestation statements can be used to support claims when signatures are found to be missing from the medical record. According to the PIM, 2. Clearly indicate the date and author of any amendment, correction or delayed entry, and 3. Not delete but instead clearly identify all original content. PIM, 3.3.2.5.B. 28 The final rule adopting the revised inpatient admission order and physician certification requirements includes several statements to support this position, including citation of a manual provision regarding Condition Code 44 for the proposition that Medicare does not permit retroactive orders or the inference of physician orders. CPM, Ch. 1, 50.3.2. The final rule also states: The physician order cannot be effective retroactively.... [W]e are not changing our definition of a hospital inpatient. Inpatient status only applies prospectively, starting from the time the patient is formally admitted pursuant to a physician order for inpatient admission, in accordance with our current policy. 78 Fed. Reg. 50495, 50942 (Aug. 19, 2014). Finally, the rule concludes: We reiterate that the physician order, the remaining elements of the physician certification, and formal inpatient admission remain the mandated means of inpatient admission. While outpatient time may be accounted for in application of the 2- midnight benchmark, it may not be retroactively included as inpatient care for skilled nursing care eligibility or other benefit purposes. Inpatient status begins with the admission based on a physician order. 78 Fed. Reg. at 50950. 29 PIM, 3.3.2.4. 30 42 U.S.C. 1395y(a)(1); 42 C.F.R. 411.15(k)(1). 31 PIM, 3.3.2.4 (emphasis added). There is an exception allowing the use of a rubber stamp for signature in accordance with the Rehabilitation Act of 1973 in the case of an author with a physical disability that can provide proof to a CMS contractor of his/her inability to sign their signature due to their disability. Id.

8 however: 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). 32 For services not subject to specific signature requirements, the issue would become whether medical necessity is substantiated by medical record entries other than the unsigned order. For certain services, Medicare requires orders to be documented and authenticated at earlier times (e.g., prior to discharge or prior delivery of the items or services). See, for example, rules applicable to certain categories of durable medical equipment, discussed below. Standing Orders What Are Standing Orders and When Are They Allowed? Unfortunately, the term standing orders means different things to different people within the health care industry and its regulators. CMS recently concluded that there is no standard definition for standing orders in the hospital community at large, much less in the broader healthcare industry, finding that agreement on what is meant by the term standing orders does not exist. 33 This is unfortunate because this general ambiguity and lack of unified Medicare policy on the subject creates a situation in which some types of standing orders are permitted for some purposes, but not for others, resulting in confusion. Current Medicare Condition of Participation regulations for hospitals allow the use of standing orders and protocol orders as follows: Hospitals may use pre- printed and electronic standing orders, order sets, and protocols for patient orders only if the hospital: (i) Establishes that such orders and protocols have been reviewed and approved by the medical staff and the hospital's nursing and pharmacy leadership; (ii) Demonstrates that such orders and protocols are consistent with nationally recognized and evidence- based guidelines; (iii) Ensures that the periodic and regular review of such orders and protocols is conducted by the medical staff and 32 33 Id. 77 Fed. Reg. at 29055.

9 the hospital's nursing and pharmacy leadership to determine the continuing usefulness and safety of the orders and protocols; and (iv) Ensures that 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 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. 34 The regulation uses the terms pre- printed standing orders, electronic standing orders, order sets, and protocols for patient orders, but these terms are themselves ambiguous. According to CMS, these terms are all ways in which the term standing orders has been applied. 35 In its survey and certification guidance, CMS generally use[s] the term standing order(s) to refer interchangeably to pre- printed and electronic standing orders, order sets, and protocols. This approach is overly simplistic. CMS recognizes that [n]ot all pre- printed and electronic order sets are considered a type of standing order covered by this regulation. 36 Indeed, many standardized order sets are not standing orders in any sense. Rather, they are menus of options to be selected by the physician as necessary for the specific individual patient. Such an order set might be used to create one or more types of standing orders, or might in some cases yield only a group of one- time orders, not a standing order. Types of Standing Orders What makes a standing order standing? We believe that it is useful to consider five situations reflecting the intent of the ordering physician and/or the hospital regarding the implementation or initiation of specified action by nonphysician personnel in response to specified clinical circumstances. 34 42 C.F.R. 482.24(c)(3) (emphasis added). Standing orders may not be used in certain clinical situations where they are specifically prohibited under Federal or State law. For example, 42 C.F.R. 482.13(e)(6) expressly prohibits the use of standing orders for restraint or seclusion of hospital patients. 35 SOM, Addendum A (Rev. 95, eff. 06-07- 2013) at A- 0457. CMS recognizes that 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 the requirements of 482.24(c)(3).... 36 Id.

10 1. Individual Physician- Established Patient PRN Orders. A physician can provide instructions to be implemented based on an order (or set of orders) entered by the physician for a specific patient in the event specified circumstances arise during a course of treatment. This type of standing order allows a physician to expedite certain interventions based on standard orders, and would be subject to the standing order conditions: [I]f an order set includes a protocol for nurse- initiated potassium replacement, that protocol must be reviewed under the requirements of this regulation before it may become part of a menu of treatment options from which a physician or other qualified practitioner would select treatments for a particular patient. 37 In this example, the trigger for initiation of the standing order for potassium replacement could be a lab result showing a potassium level below a specified value. If the patient s potassium level falls below the specified value, the nurse is instructed to implement a specified clinical protocol and need not contact the physician for additional orders before doing so. Additional orders are not necessary because the physician has already given specific instructions for handling that clinical situation. This is not a situation in which the nurse is called to exercise discretion outside the nursing scope of practice; the trigger for the standing order is an objective laboratory test result and does not require an exercise of medical judgment on the part of the nurse. It would, of course, be within the nurse s scope of practice to contact the physician before implementing the standing order if, based on a nursing evaluation, the nurse believes implementing the order would endanger the patient. 2. Hospital Wide PRN/Emergency Orders. While similar to the established patient PRN order, this order differs in that the authority of the nonphysician to implement specified instructions for the patient is based on hospital policies, rather than physician orders for an individual patient. CMS permits this type of standing order as follows: [W]here hospital policy permits treatment to be initiated, by a nurse, for example, without a prior specific order from the treating physician /practitioner, this policy and practice must meet the requirements of this regulation for review of standing orders, regardless of whether it is called a standing order, a protocol, an order set, or 37 Id.

11 something else. Such treatment is typically initiated when a patient s condition meets certain pre- defined clinical criteria. For example, standing orders may be initiated as part of an emergency response or as part of an evidence- based treatment regimen where it is not practical for a nurse to obtain either a written, authenticated order or a verbal order from a physician or other qualified practitioner prior to the provision of care. 38 According to CMS, most of the evidence supporting the effectiveness of standing orders has been in use by hospital rapid response teams addressing inpatient emergency situations. Other areas in which CMS believes such standing orders may be appropriate include post- operative recovery areas, 39 appropriate immunizations 40 and emergency room triage. 3. Individual Physician- Established Patient Treatment Protocol Orders. Protocol orders are physician s instructions to implement a specific documented treatment regimen for a specific patient. Such protocols might include initiating drug treatment and making specified dosage adjustments based on a protocol or algorithm driven by the results of laboratory tests performed periodically as part of the standing order set. Such protocol orders enable a physician to implement standardized adjustments to the drug treatment in response to the physiological responses of the patient based on evidence- based guidelines and the medical judgment of the physician in designing or adapting the protocol ordered for the patient. In this situation, the nursing actions that make this a standing order are dosage adjustments based on the protocol specified by the physician, rather than discrete additional orders from the physician specifying each dosage adjustment. Nurses occasionally express concern that these types of orders require them to change the physician s orders, because the nurse would be implementing changes in the dosage of the medication without seeking a new order from the physician. 41 38 Id. (emphasis added). 39 Note, however, that CMS has stated: General standing orders for observation services following all outpatient surgery are not recognized. CPM, Ch. 4, 290.2.2; see 66 Fed. Reg. 59856, 59881 (Nov. 20, 2001). 40 Note that standing orders for influenza and pneumococcal vaccines administered do not require physician authentication. See 42 C.F.R. 482.23(c)(3). 41 In our experience working with health care providers, the term protocol seems to have acquired four different meanings, ranging from a standard operating procedure, a practice guideline for physicians, the documentation of a delegation of authority to an NPP, to a specific algorithm or calculation for determining changes in treatment (e.g., the dosage of a medication in response to particular laboratory values). Standard operating procedures do not

12 Even when the standing order in question establishes this type of treatment protocol order, authorizing changes in dosage or other treatment parameter based on specified diagnostic test results, providers must be aware that Medicare interpretations regarding coverage for diagnostic tests may limit the practice efficacy of these approaches. For example, when physicians managing frail diabetic patients in nursing facilities developed protocol orders for managing glucose levels and insulin treatments, the Medicare program routinely denied claims for the glucose testing incorporated in the protocols and implemented by the facility nursing staff. CMS argued that the glucose testing was not reasonable and necessary for the diagnosis and treatment of the patient because, CMS asserted, the treating physician was not actually using the tests results in the care of the patients. Based on these interpretations, reviewers asserted that, unless the ordering physician reviewed each glucose level between dose adjustments, the physician was not using the test results in the treatment of the patient as required for coverage of the diagnostic test under 42 C.F.R. 410.32. In several cases, however, Medicare administrative law judges rejected these unreasonable interpretations, finding instead, for example, that: [I]t makes every sense for the doctor to be able to monitor blood sugar after a series of blood tests over a period of a week or so, in order to assess any fluctuations.... Expecting a physician to check every day on the results and make changes based on each report in isolation is neither cost- effective nor warranted for good health. 42 Notwithstanding the logic of these administrative decisions, or perhaps because of it, CMS formalized the policy of denying Medicare coverage of glucose monitoring under standing orders in skilled nursing facilities (SNFs) 43 by National Coverage Determination, 44 manual provision 45 and, ultimately, by regulation. 46 fall within the category of standing orders. Nor should expecting a nurse to make changes in the dosage of a medication based on a practice guideline, which is not appropriate because practice guidelines are generally not sufficiently specific; they are written to guide medical decision- making by physicians and clinical judgment in the practice of medicine. Similarly, standard procedures adopted to guide the practice of NPPs carrying out authority delegated by a physician would normally still allow for the exercise of discretion outside the scope of nursing practice. The fourth meaning of protocol could, however, properly be incorporated into a standing order ( protocol for patient orders in the language of the COP regulations), provided it is premised on evidence- based guidelines, is sufficiently specific regarding the instruction to the nursing personnel (i.e., if x then y, with no discretion except to call the physician or implement the indicated treatment/dosage changes), and satisfies the required procedures for development adoption, monitoring and revision. 42 E.g., In the Case of Extendicare Health Services, Inc., Docket No. 999-30- 0088 (Aug. 12, 2004), decision of Kenneth E. Stewart, Administrative Law Judge. 43 See Willowood of Great Barrington v. Sebelius, 638 F. Supp. 2d 98 (D. Mass. 2009) for a summary. 44 See National Coverage Determination Manual, CMS Pub. 100-03, 190.20, Trans. No. 28 (Feb. 11, 2005).

13 We believe that the experience of SNF providers with glucose monitoring standing orders is very likely distinguishable from other standing order situations, but providers should consider this cautionary tale while continuing to develop appropriate protocol orders and monitoring procedures to improve the efficiency and effectiveness of patient care where possible. 4. Individual Physician s Procedure/Admission Standard Orders. This is a standard set of orders entered by a physician for every patient scheduled to receive a particular procedure/treatment or admitted for a particular condition. These orders are only standing in the sense that they are standardized and always used by the physician when furnishing particular types of services. These are not really standing orders in that they are ordered specifically for each patient even though they are the same from patient to patient. These orders would not be subject to the standing orders conditions, unless they included other elements of standing orders triggering applicability. 5. Hospital Triage Patient Orders. These are instructions to triage personnel adopted in hospital policies authorizing nonphysician personnel to initiate specified testing and/or initial treatment for any patient who presents with specified symptoms or clinical circumstances, without awaiting a patient- specific order from a physician. CMS contemplates that these could be appropriate in well- defined clinical scenarios such as inpatient rapid response teams, [p]rotocols 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. 47 45 See Claims Processing Manual, Ch. 7, 90.1 ( Routine glucose monitoring of diabetics is never covered in a SNF, whether the beneficiary is in a covered Part A stay or not. Glucose monitoring may only be covered when it meets all the conditions of a covered laboratory service, including use by the physician in modifying the patient's treatment ). 46 See 42 C.F.R. 424.24(f) ( For each blood glucose test, the physician must certify that the test is medically necessary. A physician's standing order is not sufficient to order a series of blood glucose tests payable under the clinical laboratory fee schedule. ) 47 SOM, Addendum A (Rev. 95, eff. 06-07- 2013) at A- 0457 (noting parenthetically: This does not relieve a hospital of its obligations under the Emergency Medical Treatment and Labor Act (EMTALA) to have qualified medical personnel complete required screening and, when applicable, stabilizing treatment in a timely manner); see also CMS Survey and Certification Memorandum, S&C 09 10 (October 24, 2008); http://www.cms.gov/ SurveyCertificationGenInfo/downloads/SCLetter09-10.pdf.

14 Requirements for the Use of Standing Orders in Hospitals In accordance with the regulations quoted above, hospitals that wish to use, or allow medical staff physicians to use, standing orders must recognize that these guidelines represent an exception from the general disdain of CMS for standing orders, 48 even when used to address well- defined clinical scenarios where there is an opportunity to improve the quality and efficiency of health care. Hospitals must take care to develop, adopt, monitor, and revise applicable policies and assure proper documentation of such orders in patient medical records. CMS survey guidelines 49 require the following steps to satisfy Medicare conditions of participation regarding standing orders: 50 48 The Medicare program has long discouraged the use of standing orders, as the OIG explains: 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. Accordingly, the insurer may reject standing orders as evidence that a test is reasonable and necessary. Medicare contractors can and may require additional documentation to support the medical necessity of the test. As a result of the potential problems standing orders may cause, the use of standing orders is discouraged. Thus, while laboratory compliance programs may permit the use of standing orders executed in connection with an extended course of treatment, the compliance program should require the laboratory to periodically monitor standing orders. Standing orders should have a fixed term of validity and must be renewed at their expiration. 63 Fed. Reg. 45076, 45081 (August 24, 1998). The OIG further suggests that all standing orders be verified at least annually. 49 SOM, Addendum A (Rev. 95, eff. 06-07- 2013) at A- 0457; see also 76 Fed. Reg. 65891, 65896 (October 24, 2011)(proposed rule); 77 Fed. Reg. 29056. 50 CMS further advises providers that: [W]hile standing orders may be used as prescribed under the provisions finalized here, hospitals should be aware that some insurers, including Medicare, might not pay for the services provided because of these orders. Id.; 77 Fed. Reg. at 29056 (emphasis added).

15 - - Review and Approval of Proposed Standing Orders Proposed standing orders must be reviewed and approved by the hospital s medical staff and its nursing and pharmacy leadership before use. We also recommend review by the compliance department or legal counsel of proposed standing orders and related documentation regarding the review and adoption by the hospital. - - Consistent with Nationally Recognized And Evidence- Based Guidelines The hospital must be able to document that each standing order is consistent with nationally- recognized and evidence- based guidelines. CMS warns that the burden of proof is on the hospital. - - Specific Clinical Criteria Each standing order must include clear, specific criteria (e.g., specific clinical situations, presenting conditions, diagnoses, test results) triggering the initiation of services under the standing order (i.e., execution of the order) by nursing or other authorized personnel. The execution criteria must be clear and not require or permit the exercise of clinical judgment outside the scope of practice of the initiating personnel. 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. 51 Policies and Procedures for Standing Orders The hospital must have policies and procedures that address the process of standing order development; approval; monitoring; initiation of services under standing orders by authorized personnel; and authentication by physicians or other practitioners responsible for the care of the patient subsequent to the initiation of services. Several points warrant discussion here: - - Initiation of Services under Standing Orders Hospitals need procedures for medical record documentation by the personnel implementing services pursuant to a standing order. Since there is already an order for the services, the documentation would not technically be an order, although it may be necessary in some systems to enter a transaction similar to an order to initiate the service so that it can be 51 Id.

16 administered. This process can lead to concerns that the nurse is ordering a service or, in the case of protocol order treatment regimens, changing an order. This linguistic confusion is unfortunate, but can be addressed through careful communication with affected personnel. - - Authentication Subsequent to Initiation In cases involving hospital or departmental standing order policies, 52 the initiation of the standing order must itself be authenticated by a physician or other practitioner responsible for the care of the patient. This is essentially a review and counter signature to document that the physician has reviewed the case and agrees that standing order has been implemented appropriately (i.e., the clinical criteria triggering the services were satisfied and the correct action was taken under the standing order). Authentication by the ordering physician, or another physician who is responsible for the care of the patient, also demonstrates that the patient is under the care of a physician. If the physician concludes that the standing order was incorrectly or improperly initiated, the physician should prepare a progress note and enter appropriate new orders for the care of the patient as necessary. According to CMS the responsible practitioner must be able to modify, cancel, void or decline to authenticate orders that were not medically necessary in a particular situation. The medical record must reflect the physician s actions to modify, cancel, void or refusal to authenticate a standing order that the physician determined was not medically necessary. 53 Such circumstances should also be reported for review by nursing and/or other hospital departments responsible for the personnel who initiated the services, and potentially by risk management and compliance departments. - - Acknowledgment of Initiation of Services The hospital s policies and procedures must address how the responsible practitioner, or another authorized practitioner, will acknowledge[] and authenticate[] the initiation of each standing order after the fact. (This is not required for influenza and pneumococcal vaccines.) It is unclear whether a physician is required to sign off on every service furnished under a standing order protocol or whether acknowledgment of the initiation of services followed by on going monitoring and periodic progress notes would be sufficient. Based on the each standing 52 Although the CMS instructions do not note this distinction, in cases in which a patient- specific standing order has been entered, as in the case of treatment regimen protocol orders, it should not be necessary for the ordering physician or other practitioner responsible for the care of the patient need not re- authenticate an order itself because the standing order has presumably already been authenticated. As noted below, however, it will be necessary for the physician acknowledge and sign off on the initiation of services under the order. 53 Id.

17 order language of the guidelines and on the failure of CMS to recognize a clear distinction between the order and the services, potentially numerous services will require physician sign off. Under the current guidelines, we believe that hospitals should require physicians to sign off on all services furnished under a standing order, but we believe it should be sufficient to have physicians do so in connection with the preparation of progress notes regarding visits that would otherwise be clinically relevant and otherwise reasonable and necessary for the treatment of the patient. Entry in the Medical Record The CMS Survey Guidelines require that: An order that has been initiated for a specific patient must be added to the patient s medical record at the time of initiation, or as soon as possible thereafter. The hospital must ensure each standing order that has been executed is dated, timed, and authenticated promptly in the patient s medical record by the ordering practitioner or another practitioner responsible for the care of the patient. 54 As noted above, in some cases the standing order will already have been entered in the record by the ordering physician. In such cases, the implementing personnel would document the initiation of services under that existing order. In cases involving hospital or departmental standing order policies, rather than specific standing orders entered by a physician for a particular patient or patients under his or her care, it will be necessary for the person initiating the order to enter it into the record for authentication by a physician of other practitioner responsible for care of the patient. Periodic Monitoring Each standing order must be subject to periodic review by the medical staff and the hospital s nursing and pharmacy leadership, to determine the continuing usefulness and safety of the orders and protocols. 55 The hospital must have a process for the identifying the need for and timely updates, corrections, modifications, or revisions of an approved standing order based on 54 SOM, Addendum A (Rev. 95, eff. 06-07- 2013) at A- 0457. The guidelines further explain that : Another practitioner who is responsible for the care of the patient may date, time and authenticate the standing order instead of the ordering practitioner, but only if the other practitioner is acting in accordance with State law, including scope of practice laws, hospital policies, and medical staff bylaws, rules and regulations. 55 Id. CMS suggests that: At a minimum, an annual review of each standing order would satisfy this requirement. Id.

18 changes in nationally recognized, evidence- based guidelines. CMS expects these reviews to consider, at least, whether: The standing order s protocol continues to be consistent with the latest standards of practice reflected in nationally recognized, evidence- based guidelines; There have been any preventable 56 adverse patient events resulting from the use of the standing order, and if so, whether changes in the order would reduce the likelihood of future similar adverse events; and The 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 Policies and procedures should address instructions to the medical, nursing, and other applicable professional personnel regarding the conditions and criteria for using standing orders and individual responsibilities associated with the initiation and execution of standing orders. Authentication of Standardized Order Sets (Including Standing Orders) Providers sometimes permit physicians to identify a standard order set by name when ordering it; for example, to allow a physician to state: Start XYZ protocol for Patient Jones, or to simply check off XYZ Protocol on an admitting orders form. This is not sufficient, because the regulations further provide that the complete order set must be included in the medical record for each patient for whom it is ordered. 57 Once the order set has been put into the record, it is 56 The guidelines acknowledge that adverse events that are a likely outcome of the course of patient s disease or injury need not be considered unless there is concern that use of the standing order exacerbated the patient s condition. Id. 57 42 C.F.R. 482.24(c)(3)(iv). CMS explained this requirement as follows: 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. In the case of an electronic health record or a pre- printed order set, it should not prove unduly burdensome to incorporate the standing order into the patient s record.... Both the current requirements and standards of practice regarding medical records dictate that any patient order given by a practitioner authorized to do so automatically becomes a required part of the patient s medical record and must be

19 permissible to reference it in subsequent orders, but simply referring to documentation outside the medical record when ordering the initiation of a standing order or standard order set is not. Accordingly, a hospital would need to place a copy of the order set or protocol itself into the patient medical record for every patient for whom those orders have been given. It is not sufficient for the hospital to maintain a notebook of listed order sets and standing orders for reference when reviewing the medical records. Requiring a copy of the ordered protocol or order set to be included in each patient s record makes sense from compliance and clinical efficacy perspectives because (1) each patient s medical record should stand on its own in documenting the care provided to the patient 58 and (2) as a practical matter, order sets and protocols are not static overtime, but tend to be revised and updated based on new evidence and evolving medical consensus regarding appropriate practices. Version controls and naming conventions could prove ineffective in assuring the accuracy and reliability of a system of cross- references to documentation maintained outside the individual patient s record to establish exactly what (which order set) was ordered for a particular patient. Such an approach would potentially require numerous discrete versions of the order sets to accommodate any patient specific modifications or specifications in the orders. CMS Survey Guidelines require special authentication procedures when preprinted order sets or the equivalent in an electronic record, including but not limited to standing orders, are used. In these situations: [T]he ordering practitioner may be in compliance with the requirement at 482.24(c)(1) to date, time, and authenticate an order if the practitioner accomplishes the following: Last page: Sign, date, and time the last page of the orders, with the last page also identifying the total number of pages in the order set. Pages with Internal Selections: Sign or initial any other (internal) pages of the order set where selections or changes have been made. documented to reflect this, regardless of whether it is contained in pre- printed or electronic standing orders, order sets, or protocols, or whether it is a written or verbal order. 77 Fed. Reg. at 29056 (emphasis added). 58 Those using the medical record for treatment or medical review purposes should not have to refer to documentation outside the record to determine the patient s course of treatment and current orders. This is important to avoid errors and to provide prompt access to all information relevant to ongoing medical decision making in the care of the patient.