Chapter 5

QUALITY ASSURANCE INHOME DRUG INFUSION THERAPY

ContentsPage

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87

Summary of Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87Quality Issues in HDIT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88

Patient Screening and Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88’Patient and Family Caregiver Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88Patient Rights and Responsibilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89Clinical Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90Staff Qualifcations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90The Role of the Physician ● . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91Service Coordination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92

Existing Standards for HDIT Providers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92Standards Issued by National Organizations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92Standards Issued by Health Insurers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93Developing Quality Indicators for HDIT Providers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93State Regulation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95

The Federal Role in HDIT Quality Assurance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96Current Medicare Quality Assurance Efforts Relevant to HDIT . . . . . . . . . . . . . . . . . . . 96Proposed Requirements Under the MCCA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97Determining Provider Compliance With Conditions of Participation . . . . . . . . . . . . . . . 101Case Review: Role of Medicare Peer Review Organizations and Fiscal

Intermediaries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103Quality Assurance for Beneficiaries Who Receive Care Through Risk-Based

Contracts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107

BoxesBox Page5-A. Blue Cross and Blue Shield of the National Capital Area Standards

for Participating Home Care Providers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 945-B. Quality Assurance in Home Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 955-C. The Medicare Peer Review Organization (PRO) Review Process . . . . . . . . . . . . . . . . 1045-D. Proposed Scope of PRO Review for Home IV Drug Therapy Services Under

the Medicare Catastrophic Coverage Act of 1988 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106

TablesTable Page5-1. Factors Affecting Compliance in Home Intravenous (IV) Antibiotic Therapy

Patients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 895-2. Examples of Home Infusion Nurse and Pharmacist Skills . . . . . . . . . . . . . . . . . . . . . . . 91

Chapter 5

QUALITY ASSURANCE IN HOME DRUG INFUSION THERAPY

OverviewIntroduction

As described in previous chapters, home druginfusion therapy (HDIT) is a high-technology,invasive service that can pose considerable risk topatients. Complications of therapy are potentiallymore serious in the home than in the hospital,because health personnel are not be immediatelyavailable to recognize and treat them. HDIT isfurther complicated in that it requires the coordina-tion of multiple services (medical, pharmacy, nurs-ing, laboratory, and supply) that are often providedby separate entities. If Medicare were to providecoverage for HDIT services, it would want toimplement some measures to protect beneficiariesfrom inappropriate and substandard care. This chap-ter examines what measures might be possible.

The chapter first discusses key issues in HDITquality assurance at the provider level and reviewsexisting standards for HDIT Next, it reviews pastand present Federal quality assurance efforts inhome care generally and in home infusion therapyspecifically. Finally, the chapter examines the po-tential Federal role in assuring the quality of HDITservices provided to Medicare beneficiaries.1 In thislast task, the chapter reviews and critiques some ofthe requirements that might have been imposed uponproviders in the wake of the Medicare CatastrophicCoverage Act of 1988 (MCCA)2 (which was re-pealed before proposed regulations could be madefinal). It also examines potential roles for Medicinepeer

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review organizations (PROS).

Summary of Conclusions

The complicated and invasive nature of HDIT,the limited knowledge about the safety andeffectiveness of some therapies in the homesetting, and the comparatively frail healthstatus of some Medicare beneficiaries warrantrigorous Federal oversight of HDIT quality

assurance at least at the outset of a Medicarebenefit, if not on a continuing basis.

The degree to which Medicare can rely on Statelicensure and certification as a means ofassuring HDIT quality is extremely limited.State regulation of HDIT providers is stillabsent in most States and inconsistent amongStates where it does exist. Federal policy couldhelp to focus and standardize State HDITregulatory efforts.

The most consistent measures of HDIT pro-vider quality currently available are standardspublished by the Joint Commission on theAccreditation of Healthcare Organizations(JCAHO) and the National League for Nurs-ing’s Community Health Accreditation Pro-gram (NLN/CHAP). However, accreditationthrough these channels can be costly to obtain,and many existing providers have not sought it.Thus, Medicare should rely on State agencies,acting under explicit and consistent guidelines,to determine initial and continuing compliancewith any conditions of participation (COPS)that Medicare develops. This will undoubtedlymean that some providers will need to seekmultiple certification (e.g., compliance withJCAHO standards for private insurer reim-bursement, State licensure requirements forfacility operation, and an additional set ofCOPS for Medicare reimbursement), whichmany will find burdensome. Eventually, JCAHO-and NLN/CHAP-accredited HDIT providerscould be granted “deemed status” if accredita-tion standards were commensurate with Medi-care’s COPS.

Individual case review at some level is criticalto assuring safety, appropriateness, and consis-tency in HDIT PROS could conduct at leastretrospective review of a random sample ofHDIT cases. Prior authorization by PROS for100 percent of HDIT claims would be administ-ratively costly and may not be necessary. As an

10TA defines “quality of health care” as the evaluation of the performancee of health care providers according to the degree to which the processof care increases the probability of outcomes desired by patients and reduces the probability of undesired outcomes, given the state of medical knowledge.Which elements of patient outcomes predominate depends on the patient condition (363).

2 fib~c ~w l(_)&360.

-87-

88. Home Drug Infusion Therapy Under Medicare

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alternative, prior authorization, performed byeither PROS or fiscal intermediaries (FIs),3

could be reserved for certain therapies orcertain patients who are determined to be atincreased risk.

Physician involvement is key to safe andeffective delivery of HDIT services. To ensureappropriate physician oversight in the event ofa Medicare benefit, HCFA could developspecific requirements or incentives and couldcharge PROS with reviewing compliance at thecase level.Although many patient care services may beperformed under contract rather than directlyby an HDIT provider, certain functions shouldremain the primary responsibility of the pro-vider. These functions include: initial patientassessment; quality assurance; maintaining clin-

ical records; periodic drug regimen review;coordinating all HDIT services; guaranteeing24-hour a day, 7-day a week availability ofemergency services; and serving as the initialpoint of contact for patients in the event ofquestions, concerns, requests for supplies, andany emergencies.Because many of these functions require theexpertise of a professional nurse well-versed inHDIT practice, an HDIT provider should em-ploy directly at least one registered nurse (RN)whose training and prior experience qualifyhim or her to assume these responsibilities. Inaddition, an HDIT provider should have aqualified pharmacist either on staff or hired ona consulting basis.In the event of an HDIT benefit, Federalpolicies could help both patients and providersprotect themselves from adverse outcomes andpotential legal consequences of those out-comes. For example, providers could be re-quired to ensure that patients understood theirresponsibilities for HDIT and consented tothem in writing. Providers could also berequired to give patients a single telephonenumber they can call in the event of anycomplication or emergency and be assured animmediate personal response.

Quality Issues in HDITOnly the provider can ensure that good quality

HDIT is provided on a day-to-day basis for eachindividual patient. As discussed later, many externalstandards are aimed at ensuring that providers haveinternal procedures for addressing quality-of-careissues. This section discusses some of the areaswhere provider procedures for quality assurance areespecially critical.

Patient Screening and AssessmentAppropriate patient screening is the first and most

important step in HDIT quality assurance theprovider takes. For Medicare beneficiaries, who aremore likely than other individuals to have fragilehealth conditions and limited functional capacity,careful assessment is crucial. As discussed inchapter 3, screening requires a thorough assessmentof medical and nonmedical characteristics thatrender a patient appropriate or inappropriate forHDIT. These characteristics include stability of thepatient’s medical condition, willingness of thepatient to undergo home therapy, knowledge andability of patient (or caregiver) to perform self-care,equipment used, type and toxicity of drug, andenvironmental characteristics of the home setting(25).

But a thorough initial assessment also requiresthat the provider consider what types of services it iscapable of delivering in a safe and efficient manner.If a patient requires services that a provider cannotdeliver directly, the provider must either refer thepatient elsewhere or make contractual arrangementsto provide those services. The complicated nature ofHDIT and the variety of factors that can influenceultimate patient outcome demand that patient screen-ing be a multidisciplinary effort involving physi-cians, nurses, pharmacists, and other health profes-sionals as necessary (e.g., a social worker) (131,270).

Patient and Family Caregiver4 TrainingHome care in general poses challenges for quality

assurance because many patient care factors are notunder the direct control of the provider. Proceduresas critical as catheter flushing and intravenous (IV)

3 M~c~e fiw~ h~mfi= include FM B carriers and Part A intermediaries who contract with the Health tie FtiCiIIS ~“ - tration toprocess claims and perform other administrative tasks associated with the Medicare program.

4 “Family caregiver” refers hereto a family memba or friend who assists the patient in self-care responsibilities on an unpaid basis. It does notinclude paid caregivers such as home health aides, for whose actions the employing agency is legally responsible.

Chapter 5-Quality Assurance in Home Drug Infusion Therapy .89

drug administration are often performed by thepatient without any supervision. A broad range offactors can affect the degree to which a patient is ableor willing to comply with self-care instructions(table 5-l).

Providers exercise control over the quality ofself-care techniques through comprehensive trainingof the patient and family caregiver. These techniquesare not trivial to learn. In a recent survey, 92 percentof primary care physicians felt that patients andfamily members could be taught general self-care,but only 47 percent felt their patients could be taughtthe complex level of self-care required for HDIT(342). Medicare beneficiaries with fictional orcognitive limitations may find it especially difficultto perform certain procedures safely (134). In thesecases, additional skilled nursing services may benecessary to ensure good-quality care (134) (see ch.3).

Providers can undertake some specific measuresto assure the quality of patient education. Theseinclude:

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The use of standardized teaching and referencematerials (210,296). Patient instruction manu-als should be written on a level that patients canunderstand (90,240,296).Continuity in training with equipment andsupplies. If a patient is trained on one infusionpump and sent home with another, for example,he or she might not know how to start or stopthe pump (390).Continuity among instructors in patient in-struction (e.g., dressing changes and aseptictechnique). Teaching different ways of under-taking self-care techniques can cause confu-sion, leading to poor performance of self-caretasks (210).Beginning patient training before hospitaldischarge (for patients whose therapy is initi-ated in the hospital) (240,296,364). Ideally, toensure that the patient can transfer what he orshe has learned to the home setting, a nurse orpharmacist would visit the home to observe thatpatient or family caregiver administer the frosthome dose (240,364).

Patient Rights and ResponsibilitiesExisting standards for HDIT providers all require

that the primary provider assume legal responsibilityfor the quality of any services provided to its patients

297-913 0 - 92 - 7

Table 5-l-Factors Affecting Compliance in HomeIntravenous (IV) Antibiotic Therapy Patients

Physiologlcal factorsAgePhysical disabilities

ArthritisParalysisAmputationDecreased or poor visionCast requiring crutches, walker, or wheelchairNeuromuscular dysfunction, multiple sclerosis, Parkinson’s

diseaseNeuropathy secondary to diabetes mellitusDiagnosis: duration and severity of diseaseDosing frequency and length of therapyPainLack of fine motor skillsDecreased strength and dexteritySide effects of medicationsPoor venous access requiring central line placement

Psychosocial factorsEducationLack of care partnerDesire to go homeExternal locus of controlSocioeconomic statusHome environmentCommunity resourcesStorage/refrigeration spaceFear/isolationDecreased socialization (especially with multiple IV antibiotics

and frequent dosing)Cost/Insurance coverageSleep deprivation from frequent dosingOther family responsibilities (e.g., mother with small children, ill

spouse or parent, work, school)Altered body image due to heparin Iock/central lineDenial of diagnosis requiring IV antibiotic therapyInaccessible floor plan in home

Nursing/rnaditxl supportLack of adequate patient education programUnclear understanding of rationale of therapyInaccessibility to nursing personnel on a 24-hour basisPoor home followup by home care agency

SOURCE: Adapted from M.S. Neiderpruem, “Factors Affecting Compli-ance in the Home IV Antibiotic Therapy Client,” Journal of/intravenous Nursing 12(3):136-142, May/June 1989.

on a contractual basis. They also require that theprovider have written policies describing whatspecific services it is capable of providing and underwhat types of arrangements it provides them (178,230,237). Most standards require nurses or otherhealth personnel to document that patient training inself-care techniques has been completed satisfacto-rily (42,178,237).

The nurse’s documentation does not itself consti-tute a patient’s assertion of shared risk-i.e., that thepatient understands his or her responsibility forself-care to reduce the risk of adverse health events.To effect such an assertion, the HDITprovider could

90 ● Home Drug Infusion Therapy Under Medicare

be required to detail in writing those aspects of carefor which the patient is responsible and have thepatient acknowledge that responsibility by readingand signing an agreement.

Cost to the patient has been cited as a factor thatcan affect patient compliance in HDIT (240) (seetable 5-l). To minimize patient concern aboutunexpected costs associated with therapy, providerscould be required to inform patients before therapystarts about which specific items and services arecovered, which are not, and what the patient’s costshare will be.

Clinical ConsiderationsOne of the greatest risks of infusion therapy is risk

of secondary infection. Strategies for minimizingthis risk in the home include:

careful aseptic preparation of drugs and fluidsto be infused;using the aseptic technique (see ch. 3, box 3-A)each time the line is accessed or the catheterexit site is exposed (e.g., during drug adminis-tration, dressing changes, catheter care);minimizing the number of times the patient’scatheter, the administration set, or the containerof infusate are exposed or changed (since eachexposure increases the potential for contamina-tion);periodically replacing devices or parts of theequipment that are subject to contamination(e.g., peripheral catheters, administration sets,falters, injection caps); andutilizing in-line antimicrobial filters (unlesstheir use is contraindicated-see ch. 3) toeliminate possible contaminants from the in-fusate before it enters the vascular system.

To ensure that all these steps are followed, allpatients, family caregivers, and patient care staffmust be instructed in and be able to demonstrate therequisite techniques and precautionary measures.

Although patients may be expected to performroutine tasks associated with their therapy, theymust have access to emergency assistance shouldany complications arise. The invasive nature andpotential risks of HDIT demand that emergencyservices be available on a 24-hour a day, 7-day aweek basis (174,178,230,240,248). This means thatinfusion provider staff (e.g., nurses and pharmacists)and the patient’s physician must always be within

reach by phone and able, if necessary, to see thepatient personally or deliver emergency suppliesimmediately. To avoid patient confusion, providersmay give the patient a single number to call in orderto report any kind of emergency or problem. Thestaff person who answers that call can then immedi-ately contact the appropriate staff, contract employ-ees, or, if necessary, the physician, to respond to thesituation.

Staff QualificationsRegardless of how well organized and coordi-

nated the services of an HDIT provider are, thequality of patient care will suffer if the individualstaff members who provide those services are notadequately qualified to do so. HDIT involves avariety of skilled techniques with which the averagenurse and pharmacist are not likely to be familiar(see table 5-2).

As discussed in chapter 3, formal training andcertification in certain areas of specialty practicemay be reasonably good indicators of staff capabil-ity and experience, but they do not guaranteeproficiency in any given skill area. For example, acertified advanced practice RN may have difficultyinserting traditional peripheral catheters, while abasic RN who has pursued special training may beproficient in a technique as advanced as PICC(peripherally inserted central catheter) line place-ment. State pharmacy regulations in some cases actas indirect controls over general pharmacist qualifi-cations, but they rarely offer a direct mechanism forassessing specific proficiencies (63). The burdentherefore falls upon the employer to determine staffproficiency through employment screens, educa-tional requirements, and on-the-job training inspecific techniques.

In addition to knowing certain requisite tech-niques, skilled staff must be receptive and adaptiveto the constant stream of new technologies thatquickly become state-of-the-art in HDIT Recenttechnological advancements in home care have ledhome health agencies HHAs) and other home careproviders to seek more highly skilled staff and tooffer more in-service training in the use of newtechniques and equipment (12,182). A 1987 study of287 HHAs, for example, found that venipuncture,physical assessment, patient teaching, and IV ther-apy management skills were among the most highlyranked qualifications sought in agency nursing staff

Chapter 5-Quality Assurance in Home Drug Infusion Therapy .91

Table 5-2—Examples of Home Infusion Nurseand Pharmacist Skillsa

Nurse skills●

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Traditional peripheral catheter insertionPeripherally inserted central catheter (“PICC line”)placementCatheter maintenance and repairFamiliarity with equipment and supplies used in drugadministrationAwareness of potential side effects of specific therapeuticregimensAbility to recognize and treat infusion therapy-relatedcomplicationsAbility to practice autonomouslyPatient trainingAbility to communicate effectively with the patient,pharmacist, and other staffAbility to assess infusion-associated emergencies andundertake appropriate steps

Pharmacist skills● Compounding drugs for infusion. Thorough knowledge of infusion drug stability and

compatibility● Thorough knowledge of potential infusion drug side effects. Knowledge of therapeutic alternatives in the event of

complications. Familiarity with equipment and supplies used in drug

administration● Ability to communicate effectively with physicians, nurses,

and other staff. Ability to communicate effectively with patients directly. Ability to assess infusion-associated emergencies and

undertake appropriate stepsaSki119 ty@=l& bated with home infusion therapy provision. Not all

home infusion nurses and pharmacists need to be profident in all skillslisted. Larger home infusion providers maydivideresponsibilities betweenstaff who specialize in one or more skill.

SOURCE: Office of Technology Assessment, 1992.

(182). Similarly, pharmacists must be up to date onnewly emerging home therapies in order to advisephysicians, nurses, and patients of therapeutic risksand alternatives.

The HDIT provider can help to maintain theproficiency of its staff by encouraging, mandating,and even providing ongoing education in newtherapies, technologies, and techniques. The FederalGovernment can help ensure staff quality by requir-ing providers to offeror facilitate staff access to suchtraining and by requiring that providers evaluate anddocument staff proficiency on a regular basis. Aprecedent under Medicare is the requirement thatcertified HHAs provide in-service education andcompetency evaluations for home health aides (SSAsec. 1891(a)(3)). Regulations issued by HCFAspecify requirements for the curricular content ofhome health aide training programs (54 F.R. 155).

The Role of the PhysicianThe referring physician is the critical gatekeeper

in HDIT. It is the physician who is responsible forprescribing the therapy, ordering all services pro-vided to a patient, and consulting with HDIT staff inthe event of any complications (121,178,237). Thepatient’s physician must also be readily available forboth emergency and routine consultation (e.g., todiscuss lab results or changes to the therapy).

Because the physician bears responsibility for theplan of care, safe and effective delivery of HDITservices by the provider depends on the physician’sunderstanding of the services and willingness toparticipate in care. However, the Office of Technol-ogy Assessment’s (OTA’s) discussions with physi-cians and HDIT providers suggest that physiciansvary in their understanding of HDIT services andtheir willingness to play an active role in patientmonitoring. Ideally, physician abilities should in-clude home health care patient assessment skills;knowledge of home care therapies and technologies;knowledge of when to recommend specific non-physician home health services; ability to play anactive and effective role in home health care; andability to evaluate the efficacy of home health careservices and contribute to home health care qualityassurance efforts (12).

Legal, financial, and professional concerns canimpede physician involvement in home care (12).Physicians cite fear of malpractice, lack of compen-sation, and lack of faith in the quality and supervi-sion of home care personnel as deterrents to referringtheir patients to home care (203,342). To date, legalconcerns of physicians regarding home care havebeen largely theoretical, since few if any legalactions have been taken by home patients (12).Because HDIT services are generally delivered bylicensed nonphysician health professionals who,along with their employers, assume legal liability forthe care they provide, a physician’s legal risks fromreferring a patient to HDIT may be no greater thanthose associated with referral to an acute-carehospital (248). However, the potential for physicianliability-particularly where high-technology homecare is involved-continues to be of concern,particularly where the physician feels he or she haslittle control over the conduct of the patient carereceived in the home (12,108,248). In a recentnational survey of 1,100 primary care physicians,

92. Home Drug Infusion Therapy Under Medicare

over 60 percent felt there were significant differ-ences in quality of care offered by different HDITproviders (342). Sixty-four percent of the physicianssurveyed preferred providers who could offer bothHDIT and general, comprehensive home health careservices (342).

In the event of an HDIT benefit under Medicare,several strategies would be available to encourageadequate physician involvement in HDIT. For ex-ample:

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Regulations could require a minimum fre-quency of physician-patient and physician-provider contact. The appropriate frequencywould probably vary depending on the type oftherapy and the patient’s overall medical condi-tion.Medicare could provide financial reimburse-ment for the time physicians spend monitoringtheir HDIT patients (see ch. 7).Physicians could be involved in the develop-ment and periodic review of providers’ intro-dquality assurance programs. This activity mightincrease physicians’ sense of control over thequality of home services they prescribe for theirpatients.

Service CoordinationThe decentralized nature of HDIT services poses

an additional challenge for quality assurance. OTA’sdiscussions with HDIT providers and patients stronglysuggest that communication between the patient,referring physician, all HDIT staff, and any otherparties either directly or indirectly involved in thepatient’s care are key to goodquality care andfavorable outcome of therapy. Communication andcoordination may be of particular concern to provid-ers who subcontract pharmacy or nursing services.

Furthermore, some elderly patients require homecare services beyond those generally required byyounger, healthier patients on HDIT (e.g., homehealth aide services) (see ch. 3). Coordinating HDITwith general home health services (e.g., making surehome health aide staff are aware of the patient’sHDIT regimen) can improve quality of care, reduceconfusion for the patient, and cut overall costs ofcare by eliminating unnecessary duplication ofservices.

Many existing specialized HDIT providers havelimited experience with elderly patients who requireadditional home services (see ch. 4). Of the varioustypes of HDIT providers, Medicare-certified HHAsare probably the most likely to have had experiencein coordinating these services because they providethe full range of Medicare-covered home care.Under anew Medicare benefit, Federal policy couldaddress these issues by establishing explicit require-ments for coordination of services between allagencies or individuals involved in patient care.

Existing Standards for HDIT Providers

Standards Issued by National OrganizationsStandards developed by national organizations

often serve as models for Medicare provider require-ments. Existing published standards for HDIT pro-viders or services, which vary in scope and detail,address areas such as:

● protocols and procedures for patient assess-ment and care,

● equipment and facility standards,. staffing requirements and qualifications,. the physician’s role, and. internal quality assurance program require-

ments.

Some of these standards are issued as guidelinesfor voluntary accreditation; others, for purposes ofgeneral reference and guidance. The two organiza-tions currently offering accreditation for HDITproviders are JCAHO and NLN/CHAP (237). Otherorganizations that have issued advisory or modelstandards applicable to HDIT include the NationalAlliance for Infusion Therapy (NAIT)5 (230), theIntravenous Nurses Society (INS) (174), and theNational Association of Boards of Pharmacy (231).Most of these standards have been developed duringthe past few years and have undergone frequentrevisions.

Although an increasing number of HDIT provid-ers are obtaining accreditation, others have notpursued it. As of September 1991, JCAHO hadaccredited approximately 920 home infusion provid-ers, including freestanding infusion companies,hospital-based providers, and visiting nurses associ-ations that provide HDIT under contract (33).NLN/CHAP, which began offering accreditation for

5 Fo~erly he i+lj.i~~ for Medical Nutrition.

Chapter 5-Quaility Assurance in Home Drug Infusion Therapy .93

HDIT in late 1989, had accredited a total of 38providers as of November 1991 (95).

It is impossible to determine the actual proportionof existing home infusion providers that are accred-ited because of differences in the way providers arecounted. Depending on the organization of a multi-site provider and the way in which it seeks accredita-tion, JCAHO and NLN may accredit the parentorganization as a whole or each individual branch orfranchise separately (95). Furthermore, because bothNLN and JCAHO have a 3-year accreditation cycle,some providers accredited only for noninfusion-related home health care may have begun to offerinfusion therapy services in the interim. Theseproviders, although accredited, are not accreditedspecifically for HDIT.

Standards Issued by Health Insurers

Some private third-party payers that cover HDITservices have developed specific standards or guide-lines for providers that wish to obtain reimburse-ment. The purpose of these guidelines is both toassure quality and to contain costs.

Blue Cross and Blue Shield of the NationalCapital Area (BCBS/NCA), for example, has issuedparticipation guidelines for home health care provid-ers that specifically address HDIT services delivery(see box 5-A). Although the BCBS/NCA guidelinesdo not specify core staffing requirements, they dorequire that a single provider assume responsibilityfor the provision of all services. They also requirethat the primary provider hire, on at least a consult-ing basis, a licensed pharmacist proficient in infu-sion therapy practice. Under the guidelines, HDITproviders must have written policies and proceduresregarding frequency of physician and staff contact,patient selection criteria, and monitoring require-ments for each type of therapy they provide.Providers who deliver infusion antineoplastic ther-apy and total parenteral nutrition services must meetsome additional requirements (42).

While many standard-both national standardsand those issued by health insurers-require provid-ers to implement an ongoing internal quality assur-ance program (178,230,237), few offer specificguidelines for structuring such a program. BCBS/NCA is an exception (see box 5-A) (42).

Developing Quality Indicatorsfor HDIT Providers

Most HDIT providers operating today have someform of internal quality assurance program, althoughthe degree of effort varies considerably (364). Mostproviders focus on structural and process measuresof quality (see box 5-B). These include suchmeasures as reading and recording of patient vitalsigns during each nursing visit, completion ofrequired continuing education by provider staff, anddocumentation of patient training activities.

Although structure and process measures canprovide a strong quality assurance framework for theoperations of an HDIT provider, specific quality ofcare problems may go unnoticed if patient outcome

regularly (96). Poten-criteria are not also examinedtial criteria that can be examined in an ongoinginternal quality assurance program are as numerousas the provider’s list of written protocols for patientcare. If performance of every protocol is docu-mented in the patient records, then those records canbe examined for compliance in every aspect ofpatient care. Depending on the number of patientsserved by a provider, review can be performed on allor on a sample of patient records. Specific outcomecriteria that might be helpful to monitor include:

rate of equipment malfunction (103);rate of nonroutine infusion restarts and reasonsfor these restarts (81);level of patient satisfaction with HDIT servicesand specific reasons for dissatisfaction (thiscould be accomplished through periodic retro-spective patient satisfaction questionnaires)(219);specific patient complaints (e.g., request for adifferent professional caregiver) (219);rate of infusion therapy-related complications(e.g., phlebitis, infection, catheter occlusion, airembolism, infiltration) (96);rate of early detection and treatment of drugside effects (e.g., laboratory testing performedand results reported according to protocols,appropriate followup by physicians and nurses)(96); andeffectiveness of HDIT (therapeutic goals achieved;no recurrence of condition noted 6 months afterlast treatment) (96).

Studying outcomes of HDIT is useful not only forthe identification of noncompliance with specific

94. Home Drug Infusion Therapy Under Medicare

Box 5-A—Blue Cross and Blue Shield of the National Capital Area Standardsfor Participating Home Care Providers

Blue Cross and Blue Shield of the National Capital Area has published standards for home infusion providerswho wish to obtain reimbursement from the plan. These standards address areas such as:

. licensure, organization, governance, and management; development of written policies and procedures for all treatment modalities;● monitoring frequency of physician contact;. professional training and continuing education for nurses and pharmacists; coordination of services;● 24-hour availability of services;. testing and maintenance of equipment;* patient assessment and training;● arrangements for collection, analysis, and reporting of laboratory test results; and. availability of social work services to patients as needed.

In addition, the standards set the following specifications for an ongoing internal quality assurance program:1. There is evidence of an ongoing quality assurance program supported by the provider to monitor the quality

and appropriateness of patient care and services provided. The program includes, but is not limited to: assessment of the competency of personnel providing services, including the appropriateness of

responsibilities assigned to each individual;. appropriate execution of physician orders;* effective emergency response to patient or caregiver problems;● evaluation of services including review of provider policies and procedures;* ongoing, concurrent review of any infections, complications, adverse reactions, and therapeutic failures;* review of the records of maintenance, repairs, and faulty supplies for all equipment;* evaluation of the effectiveness of the patient and caregiver training and education program; and● hiring a fully licensed pharmacist as a consultant to the staff of the infusion therapy program to participate

in the development of educational programs, policies and procedures, and ongoing quality assuranceactivities.

2. Assessment of documentation within the medical record includes, but is not limited to: designation of the attending physician primarily responsible for the patient’s therapy at home;* initial and ongoing physical and psychosocial assessments;● evidence that the patient and/or caregiver has completed training; presence of a plan of treatment; signed and dated progress notes for each home visit and telephone contact noting: treatment administration,

response to therapy, complications or adverse reactions, modification in prescription, patient/caregivercompliance, condition of infusion site, and catheter site changes.

appropriate and complete diagnostic and therapeutic orders signed by the attending physician;● relevant laboratory test determinations and procedure findings;* pharmacy dispensing record including date and time; solution type, volume, and lot number, medication

additives; and dose and infusion rate; documentation of ongoing contact with the attending physician and other agencies/vendors providing

patient services;● supplies and equipment used; and a summary statement at termination of therapy which includes results of therapy, complications, outcomes,

and disposition or status of the patient upon discharge from care.SOURCE: Blue Cross and Blue Shield of the National Capital ~‘ ‘Guidelines for Participation of Home Care Providers,” Washingtotq DC,

Fdxuary 1989.

protocols, but also for gaining a general base of rational coverage and delivery policies. Some pro-knowledge about the problems associated with viders have already begun to incorporate specificHDIT and how to resolve them. As HDIT evolves, outcome measures into their quality assurancecareful documentation of patient problems and programs. NLN/CHAP accreditation surveys foroutcomes will be crucial to the development of home infusion providers also incorporate outcome

Chapter 5—Quality Assurance in Home Drug Infusion Therapy .95

Box 5-B-Quality Assurance in Home Care

Quality assessment is the measurement and evaluation of the quality of health care provided to individuals orto groups of patients. Quality assurance is the conduct of activities that safeguard or improve the quality of healthcare by correcting deficiencies found through quality assessment (363).

Quality assessment involves the application of structural, process, and outcome measures (98). Structuralmeasures assess whether the availability and organization of resources (e.g., quality of personnel, equipment,facilities, and coordination of services) are adequate to assure a certain standard of quality. Process measuresexamine the amount of careprovided and the performance of health professionals who deliver it by comparing actualcare delivered with accepted standards. Outcome measures assess the relative effectiveness of structure and processin determining quality of care by looking at specific patient outcomes (e.g., health status, incidence ofcomplications, satisfaction with care). While structural and process standards can measure the capacity to deliverquality care, only outcome measures can determine whether providers are in fact meeting that capacity (292,293).

Quality assessment and assurance methods for ambulatory and home care are less developed than those forinpatient care (48,192,252,253,292,395). Quality assurance efforts in home care to date have focused on structuraland process measures rather than patient outcomes, which are less well-researched and designed. State licensure,accreditation, and Medicare certification are the three primary quality assurance mechanisms used in home healthcare today (292).

However, sophisticated and more narrowly defined home services such as infusion therapy may be conduciveto outcomes assessment in a way that other home health services are not. For example, IV antibiotic therapy outcomecan be measured by resolution of the infection within a given time period and by nonrecurrence of that infectionfor a specific time period following completion of therapy. In contrast, “outcomes” of ongoing home healthservices for a chronic arthritis patient are less tangible.

Even the most sophisticated and comprehensive quality assurance program cannot guarantee successful patientoutcomes, because factors other than quality of care can affect these outcomes (25,47,293). This maybe particularlytrue in the home setting where many of the factors that can affect patient outcomes are beyond the provider’ control(25). Thus, screening patients for some of these potentially problematic factors (e.g., ability to perform self-caretasks adequately) becomes key in HDIT quality assurance.

and consumer-oriented measures of quality (237), settings, however, is limited (352). The require-and JCAHO has put together a task force to examine ments set forth by States vary considerably in depthoutcome-oriented quality indicators for HDIT (229). and scope, and some States have no regulations at all

State Regulationfor certain types of providers (e.g., HHAs andhospices) (352). As of March 1991, for example, 11

Medicare sometimes looks to State regulatory States still had no licensure requirements for Medi-mechanisms as one means of assuring the level and care-certified HHAs, and 20 States had no licen-quality of services offered by participating provid- sure requirements for non-Medicare-certified HHAsers. Generally, if a State has applicable licensure or (233). 7

certification laws, Medicare requires that a provider— To the extent that HHAs are involved in anywhether it be a physician, a hospital, or an HHA-belicensed or certified according to those laws in order aspect of HDIT, Medicare regulation and existing

State regulation of HHAs could serve as an indirectto qualify for reimbursement from the program(74). 6 means of assuring the quality of those HDIT

services. At present, however, Federal regulation ofThe extent to which State licensure and certifica- Medicare-certified HHAs does not directly address

tion laws can serve as reliable and consistent quality assurance issues unique to HDIT or othermeasures of quality for nonhospital health care high-technology home services (352). The extent to

G The same rule was to apply under the proposed regulations for home IV drug therapy providers issued pursuant to the MCCA (54 F.R. 172—seeappendix C).

7 Medicare began covering services provided by HHAs that met its conditions of participation in 1966. Initially, private HHAs were allowed toparticipate inthe Medicare program only if they were licensed pursuant to State law (74). In 1981, requirements were relaxed to allow for the participationof private agencies in States with no licensing mechanism (74).

96. Home Drug Infusion Therapy Under Medicare

which State HHA regulations specifically addressHDIT services is unknown, but since many Stateshave used Medicare COPS as a model for their ownHHA regulations (232,233,292,352), it may bepresumed that it is very limited. For new servicessuch as HDIT, it may be years before States developspecific licensure or certification mechanisms, ifthey develop them at all.

Most of the existing State regulations for HDITproviders have been developed and implemented byState boards of pharmacy. A May 1989 survey of all50 State boards of pharmacy found that 15 States hadpublished some relevant regulations and an addi-tional 18 States were planning to do so (210). Thescope of these regulations varies considerably fromState to State, however. Some apply only to prepara-tion of parenteral drugs, while other States defineand regulate a broader role for pharmacies in HDITprovision:

● At least two States require separate licensurefor home infusion therapy pharmacy providers(366). Regulations in Washington State addressthe full scope of home infusion therapy serv-ices, including nursing, pharmacy, delivery,coordination, and physician involvement. Wash-ington has even designed and implementedspecial training programs for inspectors ofhome infusion pharmacies/providers (210). Reg-ulations in New Jersey are more limited inscope (295).

. An additional 20 States claim to have someform of home infusion therapy regulations inplace, but OTA found that most of theseregulations address only the preparation andlabeling of parenteral solutions rather than thebroader range of home infusion therapy serv-ices (366). Regulations typically address areassuch as physical plant, staffing, procedures,internal quality assurance, and recordkeeping(63,366). Most States have specific regulationsfor the handling and preparation of cytotoxicdrugs (e.g., antineoplalstic drugs) (63,366).Regulations vary, however, in their descriptionof the scope of pharmacist responsibilities forpatient care (63).

● AS many as 28 States claim they do notcurrently regulate home infusion pharmacies.Of these, eight claim that such regulations are

currently under development (210,366). How-ever, some of these States may actually regulateparenteral drug preparation at a level commen-surate with that of States that claimed they doregulate home infusion pharmacy (366).

The Federal Role in HDITQuality Assurance

The high level of coordination and skill involvedin the provision of HDIT services raises concernsthat, under Medicare, all providers might not offer aconsistent acceptable level of quality services.Under a separate HDIT benefit, Medicare couldexercise control over the quality of HDIT servicesby:

1.

2.

3.

4.

establishing COPS for providers, implement-ing survey and certification procedures toensure compliance with those COPS, andapplying penalties for noncompliance;conducting case-by-case review (both priorand retrospective), either through FIs or PROS;developing a list of covered drugs that aregenerally safe and appropriate for home deliv-ery; andcreating a system of payment that providesappropriate incentives for the referral of pa-tients to HDIT and for the participation ofqualified health professionals (nurses, phar-macists, and physicians) in the conduct of thatcare.

The following section focuses on the first twomechanisms. Coverage and payment considerationsare discussed in chapters 6 and 7 of this report,respectively.

Current Medicare Quality Assurance EffortsRelevant to HDIT

Under Medicare, all qualifying providers8 mustcomply with certain conditions set forth by theSecretary of the Department of Health and HumanServices in order to obtain reimbursement for theirservices (42 CFR 417). These conditions are Medi-care’s most systematic method of assuring quality ofcare at the provider level.

Existing Medicare coverage for HDIT is limitedand fragmented. The key sources of coverage are the

a ~~hovidms~~ ~der M~~ me defm~ to include the following: hospi~, skilled nursing f-ties, comprehensive Outpatient rehabfitationfacilities, home health agencies, hospices, and providers of outpatient physical therapy or speech pathology services (42 CFR 417,416).

Chapter 5-Quality Assurance Home Drug Infusion Therapy ● 97

Part A home health care benefit and the Part Bdurable medical equipment (DME) benefit (see ch.6). Existing COPS for HHAs are broad and do notaddress many of the quality assurance concernsspecific to HDIT. DME suppliers, because they aresuppliers of equipment rather than providers ofservices, are not subject to any direct Medicarequality control measures in spite of the fact that theyare another major source of Medicare-coveredHDIT.9

Under Part A, certified HHAs are required tocomply with specific COPS that include staff qualifi-cations and annual program evaluation by a groupcomposed of HHA staff and consumers (42 CFR484). These COPS, discussed in more detail later inthis chapter, are for home health services generallyand do not specifically address HDIT quality con-cerns. Medicare PRO oversight of home healthservices, also discussed later in the chapter, has beenlimited and indirect.

Drugs and other fluids administered via aninfusion pump are occasionally covered under thePart B DME benefit along with the pump (see ch. 6)(365). Direct Medicare quality assurance efforts are.virtually nonexistent, however, because DME sup-pliers who bill Medicare are not subject to anyspecific COPS or conditions of coverage (74). Theyare required by law to provide instruction in theoperation of DME, but the degree to which they doso is currently not documented or regulated, and insome cases it may consist merely of includingwritten manufacturers’ instructions in an equipmentdelivery (156).

The Safe Medical Devices Act of 1990 requiresthat device user facilities10 report medical devicemalfunction events that contributed to the death orserious illness or injury of a patient to either themanufacturer or the Secretary of the Department ofHealth and Human Services within 10 days of theiroccurrence (Public Law 101-629).11 Such reportscould be useful for identifying and monitoring the

use of potentially harmful HDIT devices (e.g., aninfusion pump prone to malfunction).

Because current Medicare coverage for the com-ponents of HDIT is very fragmented, a compre-hensive HDIT quality assurance program is notpossible at present. The responsibility for qualityassurance is therefore implicitly relegated to theprescribing physician, who often has little controlover the services provided to HDIT patients. Somecarriers (the Part B FIs) have been reluctant to coverdrugs under the DME benefit because they perceivethe lack of a defined ‘infusion provider’ ‘—and thequalifications that such a designation might require-as a quality problem (365). Some carriers go so faras to require preauthorization of all claims involvingpayment for drugs under the DME benefit (365).

Proposed Requirements Under the MCCAIf a Medicare HDIT benefit were created, COPS

would probably need to be established specificallyfor providers of this service. Fortunately, HCFA hasalready given considerable thought to developingCOPS for HDIT providers, because the now-repealed MCCA was to have included home IV drugtherapy .12 Proposed regulations issued pursuant tothe MCCA specified detailed COPS for qualifiedproviders (see app. C). The proposed COPS ad-dressed:

●

●

●

●

●

●

●

●

●

●

●

●

compliance with Federal, State, and local laws,governing body and administration,patient selection,plan of care and physician review,maintenance and handling of central clinicalrecords,core staff and services,nursing services,pharmacy services,patient and family caregiver evaluation andinstructions,written protocols and policies,provider quality assurance activities, andinfection control (54 F.R. 172).

g Medicare also covers total parenteral nutritio~ another form of home infusion therapy, under the Part B prosthetic devices benefit (see ch. 6).Coverage is limited to nutrients, equipmen~ and supplies. Medicare has no structural quality assuran ce requirements for total parented nutrition (TPN)providers.

10 Devi~userf~ilities ~clude hospi~, ~b~atory ,su@calfacilities, nursing homes, or outpatient treatmentfacilities that arenotphysicians offices(e.g., HHAs, DME suppliers) (Public Law 101-629).

11 Repo~ ~ovisiom of tie Stie Mdicd Devices Act of 1990 were eff~tive as of NOV. 2% 191.12 ~ dwelop tie cops, Ha’ sought gui~ce ~m in&@y represen~tives, h~~ pmfessio~s, pmfessio~ ~soc~tions, orgtitions tit

currently aamxlit or publish standards for home IV drug therapy providers, and other knowledgeable parties (54 F.R. 172).

98. Home Drug Infusion Therapy Under Medicare

Although the proposed rules were never madefinal, they generated mostly positive comments fromresponding organizations (167). The remainder ofthis section focuses on specific areas of the proposedCOPS that deserve additional attention if a newbenefit were to be implemented.

Routes of Drug Administration

The MCCA benefit was to cover IV therapy alone.If Congress were to develop an HDIT benefit thatalso covered other routes of administration (e.g.,subcutaneous, intraspinal), relevant COPS and otherregulations would need to address the attendantdifferences in intensity of services, required equip-ment and supplies, and specific techniques used. Forexample, the proposed conditions issued pursuant tothe MCCA required that peripheral catheters bechanged at least every 3 days (54 F.R. 172).Although existing standards support the 3-dayrotation of peripheral venous catheters, peripheralarterial catheters are generally changed less fre-quently, and subcutaneous infusion needles arechanged every 48 hours (see ch. 3) (174).

Patient Care Policies and Physician Review

The proposed regulations specified that it wouldbe the referring physician’s responsibility to initiallydetermine whether home IV therapy is appropriatefor the patient and to prescribe the drug regimen forthat patient. In addition, they required the referringphysician to review the plan of care at least every 30days (54 F.R. 172).

The proposed rules made no specific requirementsfor frequency of contact between patient and physi-cian during the course of therapy, however. For asubstantial proportion of HDIT patients, a 30-dayminimum review requirement might mean that theirplan of care would undergo only initial review,leaving the possibility that some complications orside effects of therapy would go unnoticed. Morefrequent physician contact during therapy may beespecially appropriate for elderly patients withmultiple health problems. Specific requirements forpatient-physician or provider-physician contact couldeven be established by type of therapy or type ofcondition. For example, some programs recommendweekly physician visits for patients on antibiotictherapy (91). In addition, HCFA could require morefrequent comprehensive review of the plan of careby the referring physician.

Patient Selection

The proposed rule required that a provider screeneach patient before acceptance, and that this screen-ing be performed by a multidisciplinary team ofexperts in home IV therapy. Both medical criteria(e.g., the patient’s clinical status) and nonmedicalcriteria (e.g., patient’s ability to undertake self-care)were to be considered in patient selection (54 F.R.172).

The proposed conditions did not provide specificscreening criteria to use in determiningg that patients“have a clinical status that allows IV drugs to besafely administered at home. ” Although it is ulti-mately the physician’s responsibility to determinewhether a patient’s medical condition is sufficientlystable for HDIT, additional requirements might aidproviders or other parties involved in initial determi-nation of appropriateness of HDIT (e.g., PROS orFIs). As discussed below, the MCCA mandatedPROS to perform prior authorization on all home IVtherapy claims. Presumably, each PRO would de-velop its own screening criteria to determine safetyand appropriateness. Separate criteria in each PROjurisdiction, however, could lead to inconsistency incoverage and quality of care.

In addition, if a new Medicare benefit were tocover HDIT for patients not capable of self-care,more explicit patient selection and provider servicesrequirements would need to be developed.

Staffing and Services

The Health Care Financing Adminis tration(HCFA)proposed that home IV therapy providers meetcertain staffing and service requirements. Specifi-cally, the proposed regulations stated that:

. Home IV providers must directly employ atleast one full-time-equivalent (FTE) nurse orpharmacist.

. The home IV provider must perform the follow-ing services directly:-developing, supervising, and coordinating

all nursing and pharmacy services;—assuring that only qualified personnel pro-

vide home IV services;-consulting with pharmacists involved in

patient care to coordinate the plan of carewith the physician; and

—performing quality assessment activities in-cluding drug regimen review.

Chapter 5-Quality Assurance in Home Drug Infusion Therapy ● 99

There was extensive debate both before and afterpublication of the proposed rule regarding corestaffing requirements (167) (52 F.R. 172). Therationale behind the proposed requirement for eithera full-time nurse or a full-time pharmacist was thatHDIT involves both nursing and pharmacy services,and that a provider should therefore have at least oneof either of these professionals within its directemploy. A nurse or a pharmacist alone, however,would not have been able to provide all of theproposed core services. For example, a nurse wouldnot be capable of drug regimen review, and apharmacist would not be capable of developing andsupervising nursing services. HCFA had initiallyconsidered requiring that both a nurse and a pharma-cist be employed directly, but professional providerorganizations objected on the grounds that thiswould disenfranchise many existing providers (e.g.,HHAs with no in-house pharmacy) (54 F.R. 172)(167).

A possible solution to this problem would be torequire that providers who have only an RN underdirect employ maintain a consulting contract with apharmacist who is experienced in HDIT. Thispharmacist would assist the HDIT provider on anongoing basis with development, coordination, andevaluation of pharmacy services and with periodicdrug regimen review. (This model is similar to thatused by BCBS/NCA (42)).

Nursing Service-The proposed rule requiredthat all nurses providing home IV services be RNswho had at least 2 years’ experience in patientassessment and infusion therapy. Nurses were re-quired to be proficient in all procedures directlyrelated to IV therapy and the insertion of all types ofneedles and catheters commercially available (52F.R. 172).

The comprehensiveness of these proposed skillrequirements may be unrealistic in the existingspecialized HDIT market. HDIT providers—especially those with numerous staff-tend to dividepatient care responsibilities among nursing staffaccording to individual nurses’ skill levels (see ch.3, box 3-C). For example, one nurse may specializein PICC line placement, performing it on all of theproviders’ patients, while another may be responsi-ble for placement, maintenance, and repair of

standard peripheral catheters. Still other nurses mayspecialize in the care of patients with central accessdevices.

In addition, although some HDIT-related proce-dures are skilled procedures that mu@ be performedby an RN (e.g., venipuncture), other tasks (e.g.,dressing changes and central catheter care) may beperformed by other staff who have been trainedproperly and who work under the supervision of anRN. Some providers use licensed practical nurses toperform noninvasive catheter care and drug adminis-tration procedures (3).13 Greater flexibility in staffskill requirements could improve the ability ofproviders to recruit qualified staff. For example,most home infusion provider nursing staff today arenot proficient in inserting PICC lines, a type of“commercially available” catheter (see ch. 3).Although the level of proficiency and experiencedescribed in the proposed conditions is not reasona-ble to require of each individual nurse involved inHDIT, it is reasonable to require it of at least onenurse who is employed directly by the provider.

Pharmacy Services-HCFA did not address thequalifications pharmacists, despite the fact thathome infusion pharmacy requires expertise andknowledge as specific as that in infusion nursing. Inthe future, specific experience in relevant aspects ofHDIT phamacy (e.g., drug compounding, patienteducation, drug therapy monitoring, drug regimenreview) could be required of pharmacists whoseresponsibilities included such activities.

HCFA’s proposed standards for drug preparationwere also inconsistent in some areas with existingprivate standards for home infusion pharmacies. Forexample, the proposed regulations would haveallowed either clean work benches or laminar flowhoods for the preparation of IV drugs (54 F.R. 172).In contrast, JCAHO, NLN/CHAP, NAIT, and Amer-ican Society of Hospital Pharmacists (ASHP) stand-ards all require the use of laminar flow hoods toprotect against microbial and particulate contaminat-ion (178,199,230,237).

Patient and Family CaregiverAssessment and Training

Proposed COPs required that an RN performpatient and family caregiver evaluation and educa-

13 HCFA*S exp~ence that “none of the entities [it] contict~ allowed anyone but a registered nurse to furnish nursing services connattd with Ndrug therapy” (54 F.R. 172) may have been influenced by the fact tba~ at the time the proposed rule was published, it had contacted mostly proprietaryhome IV drug therapy providers (167).

100. Home Drug Infusion Therapy Under Medicare

tion. This requirement would have been problema-tic, for two reasons. First, patient and familycaregiver evaluation is often a multidisciplinaryeffort that involves not only the nurse but thereferring physician, pharmacist, and other healthprofessionals such as a nutritionist or social worker.Second, some aspects of patient/family caregiverinstruction (e.g., discussion of side effects of ther-apy, use of infusion devices, self-care techniques)may sometimes be appropriately given by pharma-cists or other types of health personnel, such asspecially trained pharmacy technicians (see box3-C) (15). Future COPS for HDIT providers couldreflect this practice by allowing a broader range ofhealth professionals to perform some of thesefunctions, perhaps under the supervision and coordi-nation of a qualified RN. Also, any future COPsmight want to specifically address patient responsi-bilities in HDIT.14

Protocols and Policies

First-Dose of Medication—Proposed COPS re-quired that the first dose of any IV therapy be givenunder the direct supervision of a physician or nursewho is equipped with resuscitation medication andequipment to treat anaphylaxis (54 F.R. 172).Alternatively, under a new benefit, HCFA mightrequire that the first dose of infused drugs with aknown potential for allergic reaction or other com-plications always be delivered under a physician’ssupervision.

The nature of the supervision could vary depend-ing on the setting in which the initial dose is given.For example, patients who are discharged to HDITfrom the hospital could be required to receive theirfirst dose in the hospital where physicians are readilyavailable. For outpatient-initiated therapy, patientscould be required to receive the first dose in aphysician’s office or hospital outpatient setting. Foroutpatients who are homebound, special exceptionscould be made or, alternatively, a physician homevisit could be required for the initial dose.

Catheter Care-Catheter care requirements inthe proposed rule were generally consistent withrecognized standards of infusion nursing practice(174,199,237). In light of the rapid pace of techno-logical innovation and change in HDIT, however,

rigid standards such as those proposed might haverequired frequent updating to stay abreast of currentpractice. For example:

●

●

The proposed rule required that the sites of allperipheral catheters be rotated by a nurse atleast every 3 days (54 F.R. 172). Some newercatheters can remain in place longer than 3 days(see ch. 3) (364). Alternatively, HCFA couldrequire that the catheter site be inspected by anurse at least every 3 days and changed asnecessary.The proposed rule required that IV administra-tion sets be changed at least every 24 hours (54F.R. 172). Although support for this require-ment may be found in existing standards orprofessional literature, the appropriate fre-quency of administration set change varies withthe particular therapy and dosing fiquency.For example, patients on continuous infusionmay only change their administration set every5 to 7 days, while patients using disposableinfusion devices may change their administra-tion sets up to 4 times a day by default, becausethe administration set is integral to the device.A less rigid requirement for administration setchange could thus be appropriate.

Air-Elimination Filter and Catheter Testing—As an additional measure of quality control, HCFAproposed that nurses routinely collect a randomsample of discarded catheters and air-eliminationfalters and send them to a laboratory for analysis ofparticulate and microbial contamination (54 F.R.172). Both ASHP and the Association for Practition-ers in Infection Control objected to this condition onthe grounds that the catheters and falters could easilybecome contaminated between the time they wereremoved from the patient and the time they wereexamined in the laboratory (1,199). Both thesegroups recommended culturing the catheter or filteronly when there were clinical signs of possibleinfection (1,199).

Drug Therapy Review—The proposed rule re-quired that the pharmacist review the prescribedcombination of IV drugs and equipment for appro-priateness before therapy began. In addition, thepharmacist was to be required to review the appro-priateness of drug therapy at least every 3 days and

M For emple, the patien~f~y c~egivm might be instructed and required to document on a chart each drug and 501Ution admiIIi5t@i0n Or d.bHDIT-related procedure (e.g., catheter flushing, administration set change, dressing change) and note any attendant difficulties they experienced. Thesecharts could be incorporated into the central clinical record to complement nurse and physician notes.

Chapter 5—Quality Assurance in Home Drug Infusion Therapy . 101

report significant findings to the physician (54 F.R.172).

Review every 3 days may not be necessary in allcases, and it may sometimes be logistically difficultif the pharmacist must meet with the patient’s nursein order to review appropriateness. Some providershave most staff on site and can hold regular meetings(e.g., routine drug regimen review once a week)attended by all members of the provider staff.Providers who send staff to patients’ homes and/orsubcontract for pharmacy services, however, mayhave to resort to other modes of communication(e.g., telephone, facsimile, extensive patient encoun-ter notes) to accomplish the conferencing necessaryfor ongoing drug regimen review. HCFA mightinstead require pharmacists to review appropriate-ness of therapy at least once a week and wheneverrequested to do so by patient care staff.

Patient Rights and Responsibilities-The pro-posed conditions specified that treatment shouldbegin only if the provider is capable of furnishingcare at the level of intensity required by the patient.In addition, providers were to inform patients oftheir responsibilities and rights in writing uponinitiation of therapy. The proposed rule also requiredproviders to establish procedures for patient com-plaints (54 F.R. 172).

Under anew benefit, HCFA might want to furtherrequire that written consent be obtained frompatients before therapy begins. For instance, provid-ers could be required to obtain signed statementsfrom patients documenting that they fully under-stand and are able and willing to perform all aspectsof required self-care, that they are aware of the risksassociated with their therapy, and that they under-stand what their share of costs for the services areexpected to be.

Provider Quality Assurance Activities

The proposed conditions required home IV pro-viders to maintain ongoing, systematic qualityassurance programs to evaluate the quality andappropriateness of patient care, correct deficiencies,and improve patient care (54 F.R. 172). A writtenevaluation plan was to include scope and objectivesof quality assurance activities, specific activities tobe monitored, methods for evaluation and reportingof results, mechanisms for corrective action, andstaff responsibilities for each activity. Home IVproviders were to be required to collect and analyze

data at least annuully on the length of therapy bydiagnosis and treatment; patient complications andrehospitalizations; and the nutritional status ofpatients. In addition, providers would have beenrequired to determine that activities had been carriedout appropriately (e.g., that delivery of drugs andequipment was timely, that any peripheral catheterpatient had their catheter rotated by a nurse every 3days, etc.) (54 F.R. 172).

The proposed quality assurance standards lackedspecificity in some areas. For example, they failed tospecify whether the quality assurance activities (e.g.,collecting data on negative outcomes) should beapplied to all cases or to a sample of cases. Also,although the proposed COPS required the provider tospecify “staff responsibilities for each activity in thequality assurance program,” they did not specifywhere activities should involve both nursing andpharmacy Staff.

Nor did the rule specify a role for the patient in theongoing quality assurance program. Providers couldhave been required to conduct an exit interview witha sample of patients (or with all patients), forexample, to verify that care documented in theclinical record was in fact performed.

Determining Provider Compliance WithConditions of Participation

Activities of State Survey Contractors

To determine compliance with its COPS, HCFAgenerally relies on a State agency (usually a depart-ment of health or department of aging) with whomit contracts to conduct periodic surveys of allfacilities in the State (351). State surveyors are givenguidelines and, in some cases, specific assessmenttools, to use in the survey process for each type offacility.

Because the proposed COPS for home IV therapyproviders were never implemented, mechanisms fordetermin ing provider compliance were never tested.However, past experiences with HHAs can shedlight on potential problems in determiningg compli-ance with any future Medicare COPS for HDITproviders.

In order to qualify for reimbursement through theMedicare program, HHAs must comply with COPSthat address the following two general areas:

102. Home Drug Infusion Therapy Under Medicare

administration (acceptance of patients, plan ofcare, patient rights, medical supervision, dis-closure of information, organization and ad-ministration of services, policy review), andfurnishing of services (staff qualifications andtraining, maintenance of clinical records, pro-gram evaluation, survey and certification proc-ess) (42 CFR 484).

Compliance for both initial and continuing certifi-cation is determined by surveyors15 from a Stateagency who make an unannounced visit to the HHAat least once every 15 months. On each visit, a‘‘standard survey’ is conducted that assesses com-pliance with a specified subset of the COPS. Thesurvey visit can include review of a random sampleof medical records,16 review of written patient careprotocols, verification of staff qualifications and training, site visits to patients’ homes t. witnessthe direct provision of care and interview patientsregarding their satisfaction with the HHA services.Based on the standard survey, the surveyor makes ajudgment as to whether the HHA seems to beproviding standard or substandard care. If it isjudged substandard, the State conducts an extendedsurvey that assesses compliance with the exhaustivelist of COPS. If the HHA fails the extended survey,sanctions can be applied.

The Omnibus Budget Reconciliation Act of 1987(OBRA-87) 17 mandated that quality of care meas-ures based on patient outcomes be incorporated intothe HHA survey procedure. Measures such as deathor readmission to a hospital or nursing home duringor shortly after termination of treatment are amongthose to be used to detect problems (42 CFR 484).OBRA-87 also mandated that visits to the homes ofHHA patients be included in the survey process toenable direct observation of care currently beingprovided, and to ensure that procedures documentedin the patient record were actually performed (351).Accordingly, HCFA has published revised COPS forHHAs (42 CFR 484) and has issued instructions toState survey agencies on how to conduct outcomes-oriented surveys (370).

Because the outcomes-oriented survey and certi-fication mandates did not go into effect until March

1991 (132), it is too early to know whether they arein fact improving the quality of HHA care. However,a 1989 study by the U.S. General Accounting Oftlce(GAO) found numerous problems with the conductof HHA surveys by State agencies prior to imple-mentation of the new provisions. These included:

inadequate guidance and oversight by HCFAon conduct of surveys;inconsistent interpretation by State surveyorsof requirements for compliance with MedicareCOPS;inconsistency in scope of surveys and methodsused to select samples of records for review;lack of coordination between State surveyagencies, FIs, and Medicare PROS;18 andlack of personnel training standards for high-technology services such as infusion therapy(351).

Although some of these problems have been ad-dressed in the new instructions issued by HCFA(132), it remains to be seen whether they will beresolved.

If future HDIT coverage under Medicare entails anew class of certified providers, similar problemscould arise. Problems might be avoided by improvi-ng the clarity of the conditions themselves, offeringmore thorough and consistent guidance to the Stateagencies that conduct the surveys, and mandatingand facilitating cooperation between all organiza-tions involved in HDIT quality of care review (e.g.,PROS, FIs, and relevant State licensing agencies)(351).

Reliance on Standards Issued by NationalAccrediting Bodies

Section 1865 [a] of the Social Security Act permitsHCFA to grant “deemed status’ ’-i.e., to considercertain health facilities as meeting any or all ofMedicare’s COPS for that type of facility-tofacilities accredited by a national accreditationprogram (SSA, sees. 1864, 1865[a]). Deemingauthority is monitored through a validation reviewprocess in which a small sample (5 percent) ofproviders are surveyed directly by HCFA to test how

15 ~ ~eyors are always registered n~es.

16 smle She dewnds on he s~e of tie agency ~ k defm~ u a f~ed n~ber of r~ords mtier - a percentage (132).

17 Public Law 100-203.16 pROs me r~~ by law to coordinate their efforts with other levix bodies.

Chapter 5—Quality Assurance in Home Drug Infusion Therapy . 103

well the accrediting organization’s standards con-tinue to reflect Medicare’s COPS (55 F.R. 51434).

Until last year, HCFA had extended deemedstatus only to hospitals accredited by JCAHO(127).19 In October 1991, HCFA granted deemedstatus to HHAs accredited by NLN/CHAP. JCAHOhas also applied to HCFA for recognition as adeeming authority for HHAs, but authority has notyet been granted.

It is unlikely that Medicare could initially rely on“deeming authority” as a mechanism for certifica-tion of HDIT providers due to inherent limitations ofthe standards themselves and the accreditationprocesses. First, accreditation surveys performed bynational organizations may not be as good a measureof compliance with COPS as surveys by Stateagencies, because they tend to be conducted lessfrequently and are generally scheduled in advance,giving providers the forewarning they need to get“Up to speed.” To date, JCAHO has conducted fullsurveys once every 3 years and has given providersa minimum of 4 weeks’ formal notice (179).20

NLN/CHAP also operates on a 3-year accreditationcycle, but it conducts abbreviated annual surveys ininterim years and all of its site visits are unan-nounced (237).

Also, the cost of obtaining accreditation throughJCAHO or NLN/CHAP may deter some smallerproviders from seeking it. JCAHO’s average fee fora single-site HDIT provider is approximately $4,800for the full three-year accreditation period (33). The1992 NLN/CHAP fee for a medium-sized single-siteprovider whose net revenue was under $1 millionwould be roughly $13,000 over a 3-year period(95).21

Case Review; Role Of Medicare Peer ReviewOrganizations and Fiscal Intermediaries

While Medicare relies on State and nationalsurvey and certification processes to determinecompliance with specific COPs, it generally relieson PROS to assess the quality and appropriateness of

care at the individual case level. Mandated under theTax Equity and Fiscal Responsibility Act of 1982(Public Law 97-248), PROS have the authority todeny Medicare payment for inappropriate or unnec-essary services and to discipline and/or sanctionproviders and practitioners to correct any unaccepta-ble medical practices (363).

Because HDIT is a complicated service to deliver,and an HDIT benefit might be prone to overutiliza-tion if Medicare did not cover other outpatientprescription drugs (see ch. 6), some level of PROreview of claims would be warranted. A minimallevel of PRO review would be retrospective reviewof a random sample of claims within each PROjurisdiction. (Even this form of review is currentlynot required for Medicare home health servicesclaims.) The most rigorous level of review, whichwas to be required under the MCCA benefit until1993, would be prior review and authorization of allHDIT claims.

Current PRO Activities

To date, PROS have been involved primarily inreview of claims for hospital and physician services.Due to the large volume of Medicare claims, reviewis usually conducted retrospectively on a randomsample of claims. However, prior review is currentlyrequired for a few select procedures. (See box 5-Cfor a description of PRO prior and retrospectivereview processes.) PROS also review cases wherequality of care has been brought into question, butthis mechanism is limited by the ability and willing-ness of beneficiaries, providers, and health profes-sionals to recognize and report suspected deficien-cies or problems.

Because the initial PRO claims review is usuallyperformed by individuals (usually nurses) who arenot experts in the particular type of care provided, akey element to the prior review process is explicitreview criteria for the service in question (183). Atpresent, Medicare instructs each PRO to develop itsown criteria for care, diagnosis, and treatment based

19 Unti 19s4, ~owmcefor “deemed status” was limited to hospitals, skilled nursing facilities, and HHAs. Legislation in 1984 @blic hw 98-369)expanded the allowance to include rural health clinics; psychiatric hospitals; ambulatory surgical ~ters; clinical laboratories; hospices; comprehensiveoutpatient rehabilitation facilities; and clinic, rehabilitation agency, or public health agency providers of occupational therapy, speech pathology, orphysical therapy services. This expanded authority has not been us~ in part due to lack of relevant national accrediting bodies (127).

m J~O has a&eed to perfOrXII -qunannounced surveys as required under OBRA-87 if granted deemingauthority by HCFA for HHAcertification (287).

21 ~1~ f= ~o~ ~cludes ~~ fees ~~~ on net revenue wording to a sfi~ fee s~e), cost of the initial visit (2 Stdf On-Site fOr 3days), plus the cost of two additional survey visits (appro ximately half the cost of the initial visit) (95).

104. Home Drug Infusion Therapy Under Medicare

Box 5-C-The Medicare Peer Review Organization (PRO) Review Process

Prior ReviewThe physician or provider contacts the appropriate PRO for preauthorization, furnishing the plan of care and

any additional documentation required for the review process (183). The first level of review, generally conductedby nurses, involves the application of explicit review criteria that have been developed by the PRO for the particularprocedure or service. If the request for authorization fails to meet the initial explicit review criteria, it is referredto a physician reviewer who subjects it to implicit criteria based on his or her own clinical judgment and onprofessionally recognized standards of care. During this second level of review, the physician reviewer may requestadditional information from the referring physician. If the request fails second level review (after affording thephysician and/or provider an opportunity to discuss the case), authorization is denied (183).Retrospective Review

Each record identified for retrospective review undergoes five different basic reviews: generic quality screen,admission, discharge, invasive procedure and items/services coverage, and DRG (diagnosis-related group)validation. First-1evel reviewers (usually nurses) use explicit criteria to determine potential quality-related orutilization problems, If initial review uncovers a potential problem the records are referred to a PRO physicianadviser for further review (105). Potential quality problems not detected by one of the five reviews (e.g.,mismanagement of the case) maybe discovered by the initial nurse reviewer based on his or her medical judgement.In this case, the medical record would also be refereed to a physician adviser. If the initial reviewer can determinethat a case failing one of the generic quality screens is not actually a quality problem, the case is not referred to aphysician adviser (357).

A physician reviewer conducts a more in-depth examination of the medical record, based on his or her clinicaljudgment, to determine whether there actually is a problem. The review process also allows the attending physicianand hospital an opportunity to discuss the specifics of the case in question. These discussions often reveal uniquecharacteristics of the case that explain why it may have failed the initial screens. Most cases of potential problemsare resolved this way (92).

If the physician reviewer determines after the discussions that the care provided was not medically necessaryor that it should have been provided in another setting, a payment denial notice is sent by the PRC) tn the beneficiary,physician, provider, and fiscal intermediary. If the physician reviewer identifies a quality of care problem that isnot cleared up after discussing the case with the patient’s physician, the PRO will initiate appropriate interventions.These interventions may include physician education through a continuing medical education program, a correctiveaction plan, intensified review of the physician and hospital, or the initiation of a sanction review (357).

on typical patterns of practice within its geographic denials, mortality, and confirmed quality problems.area or, where appropriate, on national criteria (374).

The retrospective review process uses separatequality screens that focus on potential problem areasand the overall appropriateness of care provided.The quality screens used to review the interveningHHA care received by readmitted hospital patients,for example, address such issues as the adequacy ofpatient screening and education, the provider’sresponse to any changes in the patient’s healthcondition, whether any deaths occurred within 48hours of transfer to the hospital, and documentationof the plan for appropriate followup care (375).

Based on the information collected in medicalrecord reviews, PROS produce physician and hospi-tal “profiles” containing information on claims

The profiles are used to identify patterns of care thatdeviate from the norm for particular types ofproviders or deviate from established criteria andstandards (350). The identification of an aberrantpattern of care may trigger a PRO’s evaluation of alarger sampling of records from the physician orhospital in question. If PROS were to be involved inreviewing HDIT claims, the development and use ofsuch profiles for HDIT providers might be anadditional mechanism for safeguarding the qualityand appropriateness of HDIT services.

At present, PROS’ only involvement in qualityassurance for home health is through hospitalreadmission review and beneficiary complaints(Public Law 99-509).22 The PRO takes a 25 percent

~ They do not review intervening care rendered inaphysician ofllce setting, emergency room, or any other sett@, alt.houghemergency mom set-sare proposed to be included as an intervening care review setting in the fourth contract cycle for PROS (53).

Chapter 5—Quality Assurance in Home Drug Infusion Therapy ● 105

sample of all hospital readmission for a given year.From that sample, it reviews 20 percent of thosereadmission that received intervening care in ahospital outpatient clinic, HHA, or skilled nursingfacility, obtaining relevant clinical records from theintervening care setting to determine whether thecare provided was adequate and appropriate (53).The sampling method and small sampling size,however, limit the usefulness of these data inassessing quality at the individual provider level.Even the Keystone PRO in Pennsylvania, which wasthe first to review intervening care claims and hashad the most experience with the process, hadreviewed an average of only one patient per HHAper year in the State as of 1990 (53).

PROS also review HHA claims involving bene-ficiary complaints, but the flow of complaints to datehas been highly inconsistent among States (53). Thismay be due to lack of beneficiary awareness of theavailability of the PRO to investigate such com-plaints (44). Confidentiality provisions that preventthe PRO from informing the beneficiary of theresults of such an investigation may also serve as adisincentive for beneficiaries to lodge formal com-plaints (53).

Proposed PRO Activities Under the MCCA Benefit

The MCCA called for extensive PRO involve-ment in oversight of home IV drug therapy servicesto ensure that care was being provided safely to anappropriate set of patients. Regulations and instruc-tions issued pursuant to the MCCA articulated sixareas of direct PRO involvement (54 F.R. 173).

Prior authorization:1.

2.

3.

Prior review of 100 percent of home IV therapyclaims until 1993.23 PROS were to completereview prior to initiation of services forinpatient starts, and within 1 working day ofservice initiation for outpatient starts.Review of all requests for continuation ofhome IV therapy beyond the date or number ofdays specifed in the original request. Thesereviews were to be completed within 3 work-ing days of the original termination date.Review of all requests for changes of home IVdrug therapy during the specified course oftreatment, to be completed within 1 workingday of the prescribed therapy change.

Retrospective review:4.

5.

6.

Postpayment review of a random 5 percentsample of all paid home IV therapy claims todetermine provider and physician compliancewith professionally recognized standards ofcare.Periodic validation reviews of a random sam-ple of claims in which initial approval wasgranted after the PRO had reviewed medicalinformation via telephone but had not re-viewed actual medical records, to validate theaccuracy of information given verbally.Prepayment review of any cases where PROinitial authorization was required but had notbeen completed.

Universal prior authorization for HDIT may notbe necessary. The rationale for this requirementunder the MCCA was to ensure safety and appropri-ateness of a relatively new and complicated mode ofservice delivery through a front-end mechanism.However, as the range of therapies that can be safelyand effectively provided in the home setting expandsand the volume of claims increases, it may no longerbe practical for PROS to perform prior authorizationon all claims. Furthermore, some therapies (e.g.,certain antibiotic therapies) pose relatively littleserious risk to patients. Claims for these might behandled through retrospective review unless HCFAfelt there were a potential for mis- or overutilizationof home IV antibiotic therapy (e.g., if oral drugswere usually sufficient for the condition but were notcovered by Medicare).

Requiring PROS to perform prior authorizationfor all drug changes during the course of HDIT.services also may be unnecessary. As one alterna-tive, Medicare could implement more limited safe-guards, such as requiring additional patient instruc-tion as to potential complications and mandatingprofessional supervision during administration ofthe first dose of a new drug. Targeted retrospectivereview of drug changes by either a PRO or an FIcould identify problems with particular drugs (orparticular providers).

In some circumstances, there may be a need forongoing review of a patient’s HDIT to ensure thatthe course of treatment continues to be safe andeffective for that patient. In the event of futureMedicare coverage for HDIT, an appropriate regula-

~ PRO Pfior revi~ of w home IV claims was mandated under the MCCA until 1993 and left at HCFA’S discretion thereafter (~).

297-913 0 - 92 - 8

106 ● Home Drug Infusion Therapy Under Medicare

Box S-D—Proposed Scope of PRO Review for Home IV Drug Therapy ServicesUnder the Medicare Catastrophic Coverage Act of 1988

From the time it received a request for review of home IV drug therapy services from either a physician or ahealth care facility, a PRO was to have 8 working hours to determine whether the services were reasonable,appropriate, and necessary for treatment of the patient’s condition. Before approving home IV drug therapy service,the PRO was to have determined or to have been assured that:

* the patient’s condition was such that inpatient hospitalization was not justified either:1) as a continuation of an existing hospitalization, or2) as a medically necessary and appropriate admission;

the patient met the selection criteria specified in the regulations (see appendix C);● the patient and/or caregiver had been or would be sufficiently trained to administer the drugs safely and

effectively in the home;. the patient or caregiver would independently administer at least one dose of the drug under supervision;* the plan of care developed by the referring physician had enough information to support coverage of home

IV drug therapy services;. the covered drug was being used for one of the indications approved by the Secretary of the U.S. Department

of Health and Human Services; the drug was medically indicated for treatment of the patient’s condition; the prescribed dosage of the drug was correct for the patient’s height, body weight, and other considerations;● appropriate periodic monitoring had been or would be performed;● the drug was not contraindicated;● the home IV drug therapy services prescribed met professionally recognized standards of care; and. the intavenous route of administration was the only safe and effective route for the patient.

SOtXtC!ES: 1%0 Review of Home IV Drug Thwapy !%rviees, guidelines issued to PROS by the Health Standards and Qwdity B- HealthCare Fkumcing Adm.inistratio& September 1989; 54F.R. 173, Sept. 8, 1989.

I

tory body might want to identify specific drugs or tively, prior review could be made the responsibilityconditions that warrant a more intense level ofongoing review and require that PROS or FIsperform such reviews.

Finallly, prior authorization of HDIT cases re-quires the ability for rapid response, since lack ofresponsiveness can delay hospital discharge or theinitiation of therapy. Prior authorization of all HDITclaims within 1 working day might present seriousadministrative challenges to PROS. FIs might be analternative body that could evaluate the appropriate-ness of HDIT on a prior, case-by-case basis. FIs havesome experience with current HDIT coverage underthe Part B DME benefit and the Part A home healthbenefit (365) (see ch. 6). Prior review might even bedivided between PROS and FIs depending on type oftherapy and the potential for its overuse. Forexample, prior review for therapies with which FIshave limited experience might be placed initiallywithin the domain of PROS until a sufficient base ofexperience has been obtained to develop explicitreview criteria. At that point, responsibility could betransferred to the FI, who could either continue priorreview or resort to retrospective review. Alterna-

of FIs from the start, with PROS reviewing only arandom sample of claims retrospectively. FIs mightalso be a more appropriate choice than PROS forconducting change-of-therapy review in cases whereHCFA deems this necessary.

Before the MCCA was repealed, HCFA hadproposed generic quality screens to be used by PROSin prior review of home IV therapy claims (see box5-D), as well as retrospective quality of care screens(53,167,376). HCFA had also developed diagnostictesting and other special criteria specific to the typeof therapy and diagnosis to be used by PROS forreview purposes (376).

If Congress were to create a new HDIT benefit,the work begun by HCFA in developing guidelinesand screening criteria for prior and retrospectivereview of home IV therapy could serve as a startingpoint for the development of final screening criteria.New criteria would be needed, however, if thebenefit were to cover alternative routes of parenteraladministration, additional drugs, and/or benefici-aries who were not capable of self-care procedures.

Chapter 5—Quality Assurance in Home Drug Infusion Therapy . 107

Quality Assurance for Beneficiaries WhoReceive Care Through Risk-Based ContractsUnder the proposed regulation, HCFA intended

not to extend PRO review (either prior or retrospec-tive) to home IV drug therapy services delivered tobeneficiaries in risk-based health maintenance or-ganizations (HMOs) or competitive medical plans(CMPs) (54 F.R. 173).24 HCFA reasoned that:

[B]ecause risk-based HMOs/CMPs already havethe clear incentive to prevent unnecessary utilizationof covered health care services, it would be largelyduplicative and, therefore, wasteful to have PROSuse their limited resources to make the samedeterminations (54 F.R. 173).

Although PRO utilization review activities mayhave been duplicative of existing HMO/CMP initia-tives, it is not clear that PRO quality review wouldhave been duplicative. Because HMOs and CMPsare paid on a per capita basis for the services theyrender to Medicare beneficiaries, they have incen-tives to control the utilization of potentially costly

services such as HDIT. They do not have as direct anincentive to control the quality of services delivered.

In 1985, Congress mandated PRO review ofquality of inpatient and outpatient services providedto these beneficiaries after January 1987 (PublicLaw 99-272).25 A recent study by GAO foundserious deficiencies in PRO external review ofquality of care provided in risk-based HMOs, citingdata collection and sampling problems as the majorbarriers to adequate oversight (355). The GAO studyalso found that HCFA does not adequately assess theeffectiveness of HMO internal quality assuranceprograms. Although PRO case-by-case review ofHMO quality of care is mandated, PRO review ofHMOs’ internal quality assurance programs is op-tional and most HMOs have chosen not to subjecttheir programs to PRO review (355). The increasingenrollment of Medicare beneficiaries in risk-basedHMOs in recent years (355) makes it all the moreimportant to extend any Medicare HDIT qualityassurance efforts (including PRO review) to theseplans.26

u ~enm~ of M~cme&neficfies ~11~ inrisk-wHM@ more than doubled between 1985 ~d 1990 (from 383,480 to 1,238,479) (355).See 42 CFR part 417 for a description of Medicare contmcts with risk-based HMOs/CMPs.

~ ~blic IAW 99-509 arnend~ this Provisioxq a.llowing HMOS to contract with organizations other than PROS for quality review and _ theeffective date of mandated PRO review to April 1,1987. As of Septemba 1990, despite the allowance of Public Law 99-509, all risk-based HMO qualityof care review was being conducted by 30 Me&are PROS (355).

~ H@A has r=nfly propo~ mjor c~es in the PRO review process for HMO/CMP enrollees. The changes, which would bC implementedsometime during 1992 or 1993 if approved, include a move away from inpatient hospital claims review toward a more comprehensive review of all caredelivered over a 12-month period for a random sample of enrollees (46). HCFA has also proposed tbat PROS conduct a more focused review of recordsof deceased beneficiaries (46).