Department of Health and Human Semites 

OFFICE OF 

INSPECTOR GENERAL 

NAPPROPRIATE PAYMENTS FOR TOTAL 

PARENTERAL NUTRITION (TPN) 
OFFICE OF INSPECI’OR GENERAL 

The mission of the Office of Inspector General (OIG), as mandated by Public Law 95-452, as 

amended, is to protect the integrity of the Department of Health and Human Services’ (HHS) 

programs as well as the health and welfare of beneficiaries served by those programs. This 

statutory mission is carried out through a nationwide network of audits, investigations, and 

inspections conducted by three OIG operating components: the Office of Audit Services, the 

Office of Investigations, and the Office of Evaluation and Inspections. The OIG also informs 

the Secretary of HHS of program and management problems and recommends courses to 

correct them. 

OFFICE OF AUDIT SERVICES 

The OIG’S Office of Audit Services (OAS) provides all auditing services for HHS, either by 

conducting audits with its own audit resources or by overseeing audit work done by others. 

Audits examine the performance of HHS programs and/or its grantees and contractors in 

carrying out their respective responsibilities and are intended to provide independent 

assessments of HHS programs and operations in order to reduce waste, abuse, and 

mismanagement and to promote economy and efficiency throughout the Department. 

OFFICE OF INVESTIGATIONS 

The OIG’S Office of Investigations (01) conducts criminal, civil, and administrative 

investigations of allegations of wrongdoing in HHS programs or to HHS beneficiaries and of 

unjust enrichment by providers. The investigative efforts of 01 lead to criminal convictions, 

administrative sanctions, or civil money penalties. The 01 also oversees State Medicaid fraud 

control units which investigate and prosecute fraud and patient abuse in the Medicaid program. 

OFFICE OF EVALUATION AND INSPEC’HONS 

The OIG’S Office of Evaluation and Inspections (OEI) conducts short-term management and 

program evaluations (called inspections) that focus on issues of concern to the Department, 

the Congress, and the public. The findings and recommendations contained in these inspection 

reports generate rapid, accurate, and up-to-date information on the efficiency, vulnerability, 

and effectiveness of departmental programs. This report was prepared in the Health Care 

Branch under the direction of Penny R. Thompson, Chief. 

Cathaleen A. Ahern, Project Leader 

Computer and statistical assistance provided by Wm. Mark Krushat, Sc. D., Linda M. Moscoe, 

and Brian P. Ritchie, of the Technical Support Staff, OEI. 

For additional copies of this report, please contact the Health Care Branch at (410) 966-3148. 
Department of Health and Human Services 

OFFICE OF 

INSPECTOR GENERAL 

INAPPROPRIATE PAYMENTS FOR TOTA . 

PARENTERAL NUTRITION (TPN) 

MAY 1993 OEI-12-92-O0460 
EXECUTIVE SUMMARY


PURPOSE


Thepurpose of this report istoexamine Medicare coverage of total parenteral


nutrition, a “high tech” means of feeding patients who do not have a functioning


intestinal tract.


BACKGROUND


Total parenteral nutrition is lifesaving for the small number of patients who lack a


functioning intestinal tract, usually because of severe bowel disease or a surgical


shortening of the bowel, so that insufficient length remains to absorb nutrients.


Medicare covers this very expensive therapy as long as strict coverage guidelines are


met. Prior to the advent of the common working file, inconsistent carrier reporting of


payments hampered analysis of payment data. Claims paid in 1991 represent the first


reliable source of data for analysis and are available at a time when the infusion


therapies, of which parenteral nutrition is one, are undergoing rapid expansion. This


is the first in a series of reports examining infusion therapy.


METHODS


We based this inspection on three data sources: a l-percent sample of paid claims for


parenteral setwices; a telephone survey of 93 randomly-selected dialysis facilities; and


intewiews with experts in the field. We examined the claims data to determine for


whom and for what conditions parenteral nutrition is being used, and the survey


information supplements the claims data for a subset of patients, those with end-stage


renal disease (ESRD).


FINDINGS


�	 Medicare overpaid $69 million for total parenteral nutrition in 1991, 43 percent 

of the total of $162 million paid for this service. 

�	 More than half the patients in the sample (53 percent) had ESRD, and 

received parenteral nutrition as a supplement, three times a week. The benefit 

of supplemental parenteral nutrition for these patients is unproven, and the 

charges are disproportionately high for the nutrients supplied. 

�	 Review of total parenteral nutrition use in the non-ESRD population reveals 

inappropriate patient selection and over- and under-feeding. 

i 
RECOMMENDATIONS 

The Health Care Financing Administration (HCFA) should: 

�	 instruct carriers to adhere to a strict interpretation of the coverage guidelines. 

We estimate this will result in savings of $69 million a year. 

�	 require the carriers to intensifY review of certificates of medical necessity, 

discuss therapeutic options with physicians, and monitor the use of nutrients 

over time. One approach might be the use of “case managers,” to interact with 

suppliers and physicians. 

�	 review research into the clinical appropriateness of and payment methodologies 

for intra-dialytic parenteral nutrition. 

AGENCY COMMENTS 

We received comments on the draft report from HCFA and the Assistant Secretary of


Management and Budget (ASMB), both of whom concurred with these


recommendations; HCFA has taken steps to implement them. The HCFA will defer


responding to the question of appropriate payment methods for intra-dialytic


parenteral nutrition until a coverage decision has been made. The HCFA’S comments


are appended in full.


ii 
TABLE OF CONTENTS


INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1


FINDINGS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6


� Overpayments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6


� ESRD Patients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7


� Non-ESRD Patients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9


RECOMMENDATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11


APPENDICES


A 1991 payments for Total Parenteral Nutrition . . . . . . . . . . . . . . . . . . . . . . . . A-1


B: Distribution of claims by carrier . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1


C:	 Survey of dialysis facilities. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . c-1


D: Agency comments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-1

INTRODUCTION


PURPOSE


The purpose of this inspection was to examine Medicare coverage of total parenteral


nutrition (TPN), a “high tech” means of feeding patients who do not have a


functioning intestinal tract.


BACKGROUND


Clinical: Total parenteral nutrition (TPN) is a therapy designed to maintain adequate


nutrition in those patients who cannot eat normally. Early attempts at enriched, easy-


to-digest formulas included carbohydrate-rich “joy juice,” taken by mouth, and vitamin-


enriched intravenous (IV) feedings. Generically called “hyperalimentation,” both


enteral and parenteral nutrition have become treatments of choice for nutritionally-


impaired patients.


Oral or tube feedings meet the needs of those patients with a functioning


gastrointestinal tract. Enteral formulas, which can be milk-based or milk-free, are


available in drugstores. The formulas can be merely protein or calorie supplements,


or nutritionally complete. These are administered by mouth for debilitated patients;


through naso-gastric tubes for patients who cannot swallow or who have a damaged


alimentary tract; and directly into the stomach or intestines via surgically-implanted


tubes for patients requiring long-term maintenance. A simple pump can be used to


maintain a steady flow, although gravity will suffice for all but those patients fed into


the jejunum. These are comparatively “low tech” therapies, easily managed in terms of


the patient’s nutritional status, cleanliness and patency of the tubes, and ease of


administration. Many patients on tube feedings are residents of nursing homes,


although the technique can be used in the patient’s own home, managed by the


patient or a family member, with the help of a visiting nurse.


An intermediate nutritional supplement, used mainly in conjunction with surgery, is


enriched IV feedings. Normally, IVS hydrate patients who should not take liquids


orally, for fear of vomiting and aspirating the tluid into the lungs during or following


surgery. They can be glucose solutions, to provide some calories, or other chemical


solutions to maintain the patient’s electrolyte balance. If a patient cannot tolerate


solid food, he or she can be maintained on IVS with additives, such as vitamins,


purified fats, and amino acids, for about 10 days. These solutions cannot be used for


longer than that since the patient’s peripheral veins cannot tolerate the enriched


solutions, and because these solutions may not be not sufficient to meet a patient’s


nutritional needs over time,


When a patient lacks a functioning gastrointestinal tract, nutrition must be supplied


directly into the blood stream, from which it can be absorbed by the tissues. This is


known as TPN. A catheter is advanced into a large vein, usually the superior vena


1

cava, through the chest wall. The catheter can be tunnelled through the fatty tissue of


the chest, both to anchor it and to prevent air from entering during dressing changes.


All stages of this therapy require the use of sterile technique - during surgery to insert


the tube, during dressing changes, during the preparation of the nutritional tluid, and


during the attachment of the fluid containers to the catheter.


Manufacturers sell standard nutrient solutions in quantity; these solutions are then


modified by prescription, depending on the patient’s condition, blood counts, organ


function, weight, etc. In the hospital, a pharmacist would add trace minerals,


additional amino acids, vitamins, etc., based on the physician’s order. The solution’s


composition might change daily, depending on the results of frequent blood tests,


urinalyses, and monitoring of fluid balance. A nurse attending the patient would add


medications such as insulin just before administering the solution. A pump maintains


a steady rate of flow, and a filter inserted in the line filters out bacteria or any other


particulate matter.


Although the TPN technique is more complex than other feeding regimens, patients


can learn to administer their own feedings. Teaching begins in the hospital, and can


be reinforced at home by visiting nurses. By the time the patient goes home, he or


she would not require such frequent adjustments of the formula, and would add


medication, vitamins, etc., by injecting them through the sterile rubber diaphragm over


the neck of the bottle or bag before hanging it. To successfully administer their own


TPN, patients (or family members) must be able to understand and maintain sterile


technique, monitor their weight and physical condition, and be alert for complications.


Patients who are otherwise healthy can infuse overnight, and go to work during the


day, plugging the catheter when not in use. Other patients are too debilitated by their


underlying disorder to lead a normal life.


Complications of TPN can be life-threatening. Among the metabolic complications of


the therapy are electrolyte imbalances, which can lead to irregularities of the


heartbeat, diabetic coma, fainting, etc., and fluid imbalances. Other complications of


long-term TPN are bone pain and liver dysfunction. Among other risks are


pneumothorax [lung collapse) caused by the catheter, and thrombosis or air embolism,


caused by a clot’s breaking loose or air entering the superior vena cava, usually


associated with a dressing or tube change. Another serious complication is septicemia


(“blood poisoning”) associated with use of the indwelling catheter. Some patients


cannot be maintained on TPN because of recurrent infection, intolerable diarrhea, or


an inability to manage their own care.


Among the conditions for which TPN is indicated are short-bowel syndromes, in which


the intestines have been removed due to cancer or necrosis of the tissues. In other


conditions such as Crohn’s disease, TPN may be used during acute phases of the


disease, and normal food may be tolerated during remissions. (Patients with Crohn’s


disease can use enteral nutrients during some stages of their disease.) Hospitalized


patients who have extensive burns can be given TPN, as can patients with multiple


organ failure. Surgeons will sometimes want to prepare poorly-nourished patients for


2

the demands of extensive surgery by putting them on TPN pre-operatively. Healing


can be delayed when nutrition needs are unmet, so TPN is sometimes used on a short-


term basis for patients who have functioning gastrointestinal tracts, but fail to take in


enough food to nourish themselves.


Other patients for whom TPN may be ordered are those who are cachectic, i.e., in a


disease-related state of profound ill health and malnutrition. Two conditions in which


cachexia is common are terminal cancer and renal failure. Acquired


immunodeficiency syndrome (AIDS) is associated with a wasting syndrome, in which


weight loss, fever, night sweats, oral thrush, and diarrhea are common.


Medicare coverage: Medicare covers TPN both at home and in the hospital. When


TPN is administered in the hospital, payment for it is included in the diagnosis-related


group (DRG) payment. No justification for using it is needed. In the home setting,


however, Medicare covers TPN as a prosthetic device, which replaces an inoperative


body organ or function. Most prostheses replace a missing body part, so they are by


definition permanent conditions. As discussed above, however, some patients use


TPN only intermittently. The Coverage Issues Manual addresses this, by providing for


a presumption of permanence if the impairment, in the judgment of the attending


physician, will be of long and indefinite duration.


A physician must certify the medical necessity of the therapy, the pump, and pre-


mixed (as opposed to patient-mixed) compounds. Only a one-month supply of


nutrients will be paid for at one time.


Medicare requires that the certifying physician describe the “functional impairment”


which necessitates the use of TPN. A diagnosis of “colon cancer” or “colostomy,” for


example, does not describe a functional impairment, since most patients with either or


both conditions could ingest and digest food normally. Generalized debility and weight


loss, as in cachexia, would similarly not meet the coverage guidelines, since no


functional impairment is identified. Thus, for example, a patient terminally ill with


cancer of the throat would be eligible for treatment with enteral therapy, most likely


through a tube into the stomach or intestines; while another very ill cancer patient,


with severe weight loss but no functional impairment, would not qualify at all; and yet


another patient, whose treatment included radiation treatment which scarred the


intestines so that they no longer function, would be eligible for parenteral therapy.


While such coverage guidelines may appear to restrict access for patients who would


benefit from nutritional therapy, such restriction can be justified by the invasive nature


of the treatment, the risk of complications, and the lack of proven benefit. A review


of the limited medical literature discussing parenteral therapy (in The New England


Journal of Medicine, Vol. 325, No. 8, August 22, 1991, pp 573-5) refers to the few,


largely inadequate clinical trials, mixed results of therapy, and the need to balance the


theoretical benefit with the risk of serious complications.


3

Both the Covera~e Issues Manual andthe Carriers Manual specifically exclude 

coverage of nutritional supplements. While the manual pages do not address the 

question of oral food intake (except in excluding nutritional supplements), the 

certification form does ask if TPN is the patient’s only form of intake. 

Beginning in 1985, the Health Care Financing Administration (HCFA) established two 

carriers for all hyperalimentation claims. Transamerica Occidental Life Insurance 

Company, Los Angeles, handles claims west of the Mississippi, and Blue Cross/Blue 

Shield of South Carolina processes those in the East, with the geographic determinant 

the location of the supplier’s head office. The Eastern carrier, South Carolina Blue 

Shield, processes the majority of all parenteral claims. The carriers have established 

special units to certify and process claims for enteral and parenteral patients. (Claims 

for Railroad Retirement beneficiaries are processed by the Travelers Insurance 

Company.) A Final Rule with comment period published in June 1992 outlined a 

change in the way durable medical equipment claims, including those for prosthetic 

devices and thus TPN, will be processed. Four specialty carriers with responsibility for 

segments of the nation will process these claims based on the beneficiary’s residence. 

METHODS 

We relied on three data sources developed for this inspection. The first involved a 

l-percent, random sample of al] patients who had claims paid on their behalf by 

Medicare for a parenteral pump or parenteral nutrients in 1991. A total of 58 

patients were identified in June 1992. We selected this sample from the common 

working file (CWF), and it is the source of the summary payment data presented in 

this report. Patients whose first claims were submitted later than May 1992, even if 

the semices were rendered in 1991, may not be represented in this sample. These 

data represent patients with claims paid as of December, 1991, updated for the final 

report with claims paid through March 1993. We further identified the patients 

appearing in the sample in the enrollment data base, for information on their age, 

date of death (when applicable), and basis of eligibility. 

We also asked the three carriers for copies of a certification of need for TPN for each 

sample patient. We did not examine medical records, but rather obtained diagnostic 

information from the Part A payment records and from the certification of the need 

for TPN. 

The second data set was information received from a randomly-selected sample of 93 

outpatient dialysis facilities. We sumeyed the facilities by telephone, asking for the 

number of patients currently receiving intra-dialytic parenteral nutrition (IDPN) (that 

is, parenteral nutrition given to a patient who is being dialyzed), whether any of these 

patients were on TPN at home, whether they received the nutrients through a central 

line, and how many days a week they were given IDPN, among other questions. 

We also interviewed a number of experts in the field. Among those to whom we 

spoke were a physician who prescribes TPN, a home health agency nurse, a hospital 

4

pharmacist, hospital discharge planners, a hospital nurse specializing in infusion 

therapy, a dietitian, supplier representatives, infusion therapy and nutritional therapy 

association staff members, dialysis facility staff, and HCFA and carrier staff. 

We conducted this review in accordance with the Qua&y Standards for Inspections 

issued by the President’s Council on Integrity and Efficiency. 

5

FINDINGS


Medicare overpaid $69 million for TPN in 1991 

�	 Qf $162 mllwn paid in claims for ZPN in 1991, 43 pe~ent or $69 million was 

impropedy paid for patients who did not meet Medicare’s coverage guidelines. 

Most of thae were end-stage renal dkease (ESRD) patients 

Based on our sample results, we estimate that $68,862,240 (90 percent confidence 

interval: $53,910,825 to $83,813,654) could be saved. Appendix A provides 

information about the classes of patients for whom Medicare made payments. The 

following discussion centers around their status as ESRD enrollees or not ESRDeligible, since the two groups are very different in their use of parenteral nutrition. 

.	 i%e ESRD pahents in the sample (53 percent) do not meet coverage guidelinm. 

Zlze entire $545,000 spent for parentera[ num”tion on their behalf is an 

oveqnynen~ projected to $54.5 million nationally in 1991. 

As discussed earlier, coverage guidelines prohibit payment for supplemental feedings,


and require that patients have a functional impairment of the gastrointestinal tract.


None of the 31 ESRD patients in the sample was totally dependent on parenteral


feedings. Generally, documentation of functional impairments of the gastrointestinal


tract was not found in our review of certificates of medical necessity (CMNS) and


hospital admission data. Only one patient in the sample had a diagnosis code


associated with a hospital admission that indicated any failure of the gastrointestinal


tract.


The CMNS for these patients were incomplete, non-specific, and misleading. Ten of


the 31 certificates did not indicate how many days a week the patient received


nutrients. This was not merely a failure to document the number of times the patients


were fed, since payment amounts and the sumey of dialysis facilities discussed in


appendix C indicate that these patients are given nutrients three times a week, as are


the ESRD patients whose CMNS were completed. The average number of grams of


protein ordered per day was 42, which is suboptimal for most patients. The average


@ equivalent (i.e., the grams given per day times the three days given, divided by


the 7 days a week most TPN patients are fed) is less than 17 grams of protein a day,


which is clearly supplemental, since it is not enough protein to sustain life in infants,


much less in adults. Non-ESRD patients were given an average daily equivalent of 74


grams of protein per day, every day in most cases.


The diagnoses entered on the CMNS were non-specific, referring to, for example,


“malnutrition syndrome with weight loss and visceral protein depletion.”


“Malabsorption” is mentioned for many patients. However, the medical literature uses


the term malabsorption to describe the impaired absorption of nutrients due to


specific disorders of the digestive tract, not to episodes of nausea, vomiting and


6

diarrhea in the absence of digestive disease. The most specific term used in the


CMNS was “diabetic gastroparesis,” or paralysis of the stomach. This evidently refers


to delayed gastric emptying seen in some patients with diabetes. Regardless of the


presence or absence of a functional impairment of the gastrointestinal tract, these


patients used parenteral nutrition to supplement their oral intake. Thus it is not a


covered service.


We also saw misrepresentations in the Ch4NS. For example, 6 CMNS indicated


incorrectly that parenteral nutrition was the patient’s only form of intake; and all


indicated the reason pre-mixed formula was required was “sterility” or “patient unable


to learn,” when in fact the patient need not touch the nutrients or equipment, since


nurses in the dialysis facility administer the nutrients. The “Beneficiary is in . . . “ field


was shown as “home” or “SNF” in al] instances in which it was filled in, although in fact


the nutrients were administered in a dialysis facility. Additional information


concerning carriers and the number of ESRD beneficiaries they cover is in appendix


B.


.	 Non-ESRD patients who are not dependent upon TPN had $144,000 overpa@ 

which projects LO$14.4 million national& in 1991. 

Of the 27 non-ESRD patients in the sample, 11 received too few grams [~f protein to


sustain life; or received TPN for only a short while (less than 3 months) and did not


die; m- both. This indicates that the therapy was not necessary to sustain life and/or


not required as a result of a functional impairment, in violation of coverage guidelines.


We calculated the overpayment for non-ESRD patients as follows:


One patient who received too little protein to survive,


on TPN for a year $41,407.2(1


Eight patients who were on TPN for less than 3 months,


averaging 37 days $91,644.43


Two patients who received too little protein to sumive,


for an average of 42 clays $10,584.61


Total overpayment $143,636.24


The benefits of parenteral nutrition for ESRD patients are unproven, its use is


associated with a high rate of complication, and the cost of care is disproportionate to


the resources expended.


The basis for giving dialysis patients nutrients appears to rest on the perceived


connection between raising serum albumin levels and reducing mortality in ESRD


patients, rather than on gastrointestinal impairments. This connection does not


appear to have been rigorously tested, with few clinical trials and mixed results. The


7

current strict requirements for Medicare payment make it unlikely that such trials 

would be conducted within dialysis facilities largely supported by Medicare (since trials 

would include patients who do not meet the coverage guidelines), unless a separate 

grant were to support such research. 

The high rate of complications may be related to using dialysis patients’ access ports 

for both IDPN and the returning flow of dialyzed blood. (In contrast, indwelling 

central catheters used by TPN patients are not to be used for any other purpose.) 

The 31 ESRD patients had 30 readmission with mechanical complications of their 

shunts, and 12 readmission with other complications of treatment (many related to 

tluid overload). Eleven of these 42 readmission were also for septicemia. These 

admissions may have been for complications of their dialysis treatments, their IDPN 

treatments, or both. Only six patients had no readmission. We do not know how this 

compares to the rate of readmission for dialysis patients not receiving IDPN. 

The Medicare Carriers Manual, Part 3, Chapter III, section 3329, refers to 1 to 1.5 

grams of protein per day per kilogram of body weight as a guideline for adult TPN 

patients. Using a rough measure of ideal body weight (100 pounds plus or minus 5 

pounds for each inch over or under five feet in height), we calculated the range of 

grams of protein required and received by those patients whose CMNS contained 

adequate information to perform the analysis. We considered patients over- clr underweight if they deviated from their ideal weight by 10 percent or more. Note that for 

ESRD patients, the prescribed grams “per day” were actually administered only three 

days a week. We found that only six of 29 patients were underweight and two 

overweight. Taking the CMNS at face value, only 5 were fed within the range of 1 to 

1.5 grams of protein per day per kilogram of body weight, and none were overfed. 

,- —.. 

ESRD patients fed too little	 ~fed within correct I fed too much ~ 

i range 

~ Within 10 Yo of I 16 5 01 

~ ideal weight I 

I


1~Totals I 24 I 51 () II 

The costs associated with delivering nutrients to ESRD patients should be less per 

infusion than for non-ESRD patients for the following reasons: The nutrients can be 

stored in bulk in the facility, with less wastage than at home (particularly when 

patients are hospitalized); the facility’s nurses should be expert at handling the 

equipment, resulting in less contamination and thus waste; no catheter is involved, as 

the solution goes into the patient’s blood stream with the cleansed blood; pumps and 

IV poles could be shared between patients infused on different schedules. The daily 

cost per gram of protein delivered, however, for the 25 non-disabled ESRD patients 

8 

I 
($5.96) does not reflect such savings, since the equivalent cost per gram per day for 

the 9 disabled, non-ESRD patients is $3.72. A representative of one major supplier of 

both dialysis and nutritional therapy indicated that savings should not be expected, 

because suppliers cannot become simply “shippers;” rather, according to the 

representative, the demands on the clinical expertise of the supplier remain the same, 

including training of the facility’s nurses (rather than the patients and families). This 

does not, however, explain why the costs for ESRD patients are higher than for nonESRD patients. 

The payments for nutrients and supplies associated with the 328 days that ESRD 

patients spent in the hospital were $29,257. We cannot be sure of the days on which 

ESRD patients would have received dialysis and nutrients if they had not been 

hospitalized, or if they received nutrients in the hospital (in contrast to TPN patients, 

who are infused every day). 

The use of TPN in the non-ESRD population, while adhering more closely to the 

coverage requirements for a demonstrable functional impairment is not closely 

monitored by the carriers, resulting in inappropriate patient selection and over- and 

under-feeding. 

We saw patterns of stopping TPN - a life-saving therapy - which raise questions. 

Seven of the 27 patients stopped using TPN following an admissicm due to 

complications of the therapy (although one of those patients spent 212 days in the 

hospital, and may have been on TPN then). Only five patients who used TPN 

intensively did not cease its use even when serious complications ensued. 

Some of the high-intensity, longer-term patients who stopped therapy (and who are 

not included in the overpayment calculation) may have gone into remission, although 

this cannot be determined from the available data. We believe that the pattern of 

stopping what is supposed to be a life-saving therapy on which the patient is 

dependent may indicate poor patient selection by prescribing physicians, or 

exaggerated claims on CMNS, or both. In only two cases of the six who were on TPN 

for very short periods of time were the CMNS completed in such a way that the 

carrier reviewer could reasonably have thought the patient qualified for TPN. In one 

of the cases, the patient appeared to qualify for enteral rather than parenteral 

therapy, based on the diagnosis and functional impairment. 

Again using the Medicare Carriers Manual guidelines and a rough measure of ideal 

body weight, we calculated the grams of protein required and received by those 

patients whose CMNS contained adequate information to perform the analysis. We 

considered patients over- or under-weight if they deviated from their ideal weight by 

10 percent or more. The results are displayed on the next page. 

9

I Non-ESRD fed too little ~fed within correct ~fed too much I 

1 patients , range I 

1Totals I 4! 81 6! 

Patients who are on TPN for only short periods (less than a month) have higher-thanaverage monthly bills (in one instance $17,470 for a 30-day period). This is probably 

due to (1) high contamination rates when patients are not familiar with the therapy, 

(2) intense efforts to overcome nutritional deficits, and (3) the delivery of a month’s 

supply when the patient only uses the therapy for a short time. Conversely, some 

long-term, stable patients can (and should, according to a physician who sees many 

“overfed” TPN patients) reduce their intake, and thus achieve economies that shortterm patients do not. This is not true of all long-term patients, some of whom excrete 

large quantities of fluid through fistulae, for example. One such patient had payments 

for 12 months in 1991 of $122,130, for 145 grams of protein a day. The other longterm, relatively-stable patients in whom economies might be achieved do not appear to 

bear out this possibility. One who received 85 grams of protein a day for $73,781 (for 

12 months) was hospitalized 7 times for a total of 70 days, so the low total payment 

could reflect failure to bill while the patient was hospitalized (i.e., the $73,781 actually 

covered services for fewer than 10 months.) Another long-term patient had payments 

of $105,098 for 11 months, for 85 grams of protein a day, but was able to maintain a 

weight of only 100 pounds. 

Non-ESRD patients in the sample spent a total of 252 days in the hospital while TPN 

was being billed. Using average daily costs, we estimate Medicare paid $5S, 195 for 

TPN that was not used because the patient was hospitalized, although, as mentioned 

above, some suppliers may reduce charges when patients are hospitalized. Because 

suppliers ship a month’s supply at a time (unless the patient or a care giver asks for a 

smaller shipment because of a planned admission or likely prescription change), and 

because nutrients have a limited shelf life, this wastage is largely unavoidable as cases 

are currently managed. Patients cannot take their prescription nutrients into the 

hospital when they are admitted, because the hospital will not accept the liability for 

infusing solutions their pharmacy did not prepare and store. Neither nutrients nor 

sterile supplies can be returned to stock, because of the chance that they may have 

been stored at an improper temperature or have been contaminated. Close 

communication between the supplier and patient (directly or through an agent) can 

help to reduce the provision of unnecessary supplies, as can proper training and 

supervision of patients, particularly in the early stages of therapy. 

10


I
RECOMMENDATIONS


F	 The HCFA should instruct carriers to adhere to the coverage guidelines. 

Failure to do so puts patients at risk of developing severe complications, and 

wastes resources. We estimate that a strict application of coverage guidelines 

would result in $69 million in savings yearly. 

�	 Carriers should intensify their review of CMNs, discuss therapeutic options with 

physicians, and monitor the use of nutrients over time. One approach to 

carrying out these responsibilities would be the use of case managers to interact 

with physicians and suppliers, and to monitor patients on TPN. Case managers 

should have clinical backgrounds and extensive training in the use of TPN and 

Medicare’s requirements. They should have the authority to approve hydration 

therapy, brief home health agency coverage, and other benefits for TPN 

patients. They should give prior approval to TPN, and monitor “weaning” of 

patients with some functioning intestinal tract. They should monitor as well 

those patients who use excessive TPN (more than 100 grams of protein per day, 

for example) or who are not given enough protein to sustain life. Case 

managers should pay particular attention to ESRD patients for whom IDPN is 

proposed. 

b	 The HCF~ as the major payer, should review research concerning the use of 

IDPN. Among the questions to be answered are the relationship of low serum 

albumin levels to mortality, whether blood samples drawn within days of 

infusing amino acids can give an accurate reading of albumin levels, whether a 

history of complications with the venous shunt should be a contraindication t[~ 

the infusing of IDPN through the shunt, whether IDPN results in better 

nutritional status than enteral supplements, whether the low level of treatment 

(an average of 42 grams of protein three times a week) can be expected to 

improve nutritional status, whether the fluid used in lDPN is excessive for 

ESRD patients, whether albumin levels (or nutritional status) can be raised in 

some less-invasive way, whether it is necessary to use pumps to deliver the 

nutrients. Until these and related questions are answered, parenteral nutrition 

should be used only in those ESRD patients who would qualify for it based on 

a documented, life-threatening, functional impairment of the gastrointestinal 

tract, and in whom it is not a supplement to oral intake. 

�	 If IDPN is considered reasonable and necessa~ for the treatment of a subset of 

~RD patients, it should be paid for on a per-capita basis, with discounts 

negotiated by each facility or the networks, or by using some other method that 

takes into account the efficiencies associated with facility administration of the 

nutrients. 

11

AGENCY COMMENTS


We received comments on the draft report from HCFA and the Assistant Secretary of


Management and Budget (ASMB), both of whom concurred with these


recommendations; HCFA has taken steps to implement them. The HCFA will defer


responding to the question of appropriate payment methods for intra-dialytic


parenteral nutrition until a coverage decision has been made. The HCFA’S comments


are appended in full.


12

APPENDIX A


MEDICARE PAYMENTS FOR TPN 

Medicare made paymena of approxirnate~ $162 million in 1991 for TPN for 5,800 

patients, projecting jiom a random~-selected one-percent jile of patienfi who received 

TPN. 

These patients fell into four classes: 

Class (number) 1991 TPN average average age average 

from enrollment payments from daily TPN number of 

data one-percent payments days with 

samp]e, CWF A TPN bills 

disabled, not $653,255.83 $255.28 49.9 284# 

ESRD (9) — I 

not disabled, not $420,176.11 $232.27 ~ 74.9 101 

ESRD ( 18) 

disabled, ESRD 

(6) 

not disabled, 

ESRD (25) 

$122,910.58 $97.70” 49.8 210 

I 

$422,075.67 $99.29* ! 70.9 170# 

$1,618,418.19 

* f3SRD patientsdo not receive nutrientsdaily; they are given nutrients three times a week during their outpatient 

cfi~ilysistreatments. These “daily” payments are calculated from the tot~ll ~:lid for the patients and the number of days 

(inclusive)forwhichpaymentswere“made.Theyreceive so few grams o~ protein, however, that their costs per gram 

are twice that of patients fed more and daily. 

# These represent the number of days billed in 1991. Including the days billed in 1990, the first class of patients 

had an average time of use of 397 days, and the last class, 173 days. 

A See a discussion of the limitations of the data in the footnotes, appendix B. 

A-1

PATIENT CHARACIT3RISTICS 

These patients varied in intensity of therapy, and in the length of time they received 

TPN, as the table on the previous page shows. They also varied in their underlying 

conditions and in their outcomes: 

;——— [ I 

: Class Most frequent diagnoses admitted with I stopped ~died in ~ 

, (number) (from hospital claims) complication of‘ ,~TPN, did ~ 1991

‘1 

I

i disabled, not Crohn’s disease, short- 67 % admitted, 1 22 % 11%1 

~ ESRD (9) bowel syndrome, to 7 times 

septicemia 

~ not disabled, I 

i metastatic cancer, ~42 % admitted, 1 56 % 44%1 I 

therapy ~not die ! ;1

not ESRD ~septicemia, dehydration, ~to 3 times 

~ (18) ~intestinal obstruction ~: 

I 

‘ disabled, I chronic renal failure, ~50 $ZO admitted, 1 I 100 % ~ 17 % ~ I 

ESRD (6) ~ diabetes I to 3 times ——— .——— .~..... — 

: not disabled, chronic renal failure, 40 % admitted, 1 1 44%’ 52 % 

ESRD (25) , hYPertens~ renal to 4 times 

1 disease, diabetes, ““-] 

l! ~congestive heart failure, 

I fluid overload. semis I 11 

A -2

I

APPENDIX B


CARRIER DETERMINATIONS 

Cam-em varied widely in their coverage determinations 

I 1 

Carrier ~ Patients in ~Sample patients Number of I 

~ sample ~with ESRD: CMNS missing ‘1 

I ~ number (percent) critical data ‘1 

‘1 

~~South Carolina Blue Shield ~! 48 (83 %) ~ 27 (56 %) I 

~~Transamerica Occidental ,1 7 (12 %) I 2 (29 %) I 

~ Travelers for Railroad i 3(5%)~ 2 (66 %) ~ 1 I 

‘i Retirement Board (RRB) ~ 

I z;! 

I Totals ,____ I 58 (100 %) 31 (53 %) I 

II 

South Carolina Blue Shiekl pays for (he majority OJ TPN/IDPN clairru; inconsklenl and 

incomplete reporting make it impossible to determine payment trends 

,[ I I

‘1 ~South Carolina ~Transamerica Travelers for ,i 

~1 I Blue Shield I Occidental RRB I 

,11991 ~ $125,535,876 ~ $32,061,953 I $4,243,990 I $161,841,8190 ~~ 

I 7896 20 % 2%1 100 Yo* ~ l— I 1 

1990 $122,911,719 I $32,285,943: $2,492,626 ~ $156,690,280 ~ 

‘, 1989 ~ $69,289,206A I $28,474.910 I $2.260,578 I $1 OO,024,695A 1~ 

!l__ I 69 % 28 % 2% 100 5ZO*~ 

� This amount is projected from the cases in the sample discussed in this report. The 1990 and 1989 figures tire 

from summary Part B files maintained by HCFA. 

* These totals understate total TPN payments slightly, since other carriers made minimal, spor~idic payments for 

TPN nutrients and supplies in all three years. 

A This probably underst:ites payments made by south Carolina Blue shield, which has a history of inconsistent and 

incomplete reporting of TPN payments. Thus, these figures should not be used to attempt to determine trends in 

TPN use and payment. 

B-1

APPENDIX C


ESRD PATIENTS RECEIVING NUTRIENTS IN DIALYSIS FACILITIES 

An average of 2.4 percent of patients in a’iaiyti facilities receive intra-dia~hc parenteral 

nutntion (IDPN), in all cases only 3 times a week through their shunt. 

Facility size*; Facilities Have used Currently have ~ Number of ~ 

number in which have IDPN in the 

sample never used past 

IDPN 

Small; 27 12 5 

Medium; 44 13 11 

Large; 22 4 3 

Total 29 19 

* Small = 1-9 stationy medium = 10-19; klrge = 20 or more. 

[ I , 

Status; number ~ Do not use ~ Past use Now use Patients on ~~ 

~ IDPN , IDPN IDPN ! 

For-profit; 53 I 12 ~ gi 32 I 109 I 

—+---–— .——..,,

Not for-profit; 40 17 i 10 ~ 13 51 II 

Total 29 191 45 160 !: 

All patients in the 45 sample facilities currently using IDPN are fed 3 times a week, in 

all cases through their access ports or venous shunts (rather than a central line). 

None of them are on TPN at home. 

We asked respondents (usually the nursing supervisor, but in some cases a staff nurse 

or staff dietitian) to discuss their facility’s use of IDPN. We did not speak to patients. 

These responses are all anecdotal, since few facilities had any historic information 

about patients’ use of IDPN and their outcomes. 

The changes in patients’ health and quality of life most often cited by the respondents 

(in descending order) were improved laborato~ values (particularly serum albumin); 

weight gain; the patients’ feeling better, more energetic, or stronger; or the patients’ 

having a better outlook. The responses ranged from saying that IDPN “maintains life” 

and “decreases mortality,” to saying that improvements are-’’not dramatic” or patients 

had negative reactions. Two patients were cited who improved enough to qualify for 

c-1 

11 
transplants, and indeed were transplanted. Another respondent noted that in her


experience, only 10 percent of patients improve, 50-60 percent maintain their status,


and the rest are too late in the course of their disease to be helped.


Fifty-one of the facilities outlined their criteria for putting patients on IDPN. The


criteria mentioned most frequently were low serum albumin levels and weight loss.


Five mentioned Medicare’s requirements, one cited guidance from their network, and


18 mentioned gastrointestinal disorders. Among the reasons for using IDPN were that


“enteral fills them up and they don’t want to eat” and that “enteral products don’t


work because of fluid retention and no reimbursement for them.” Other respondents


noted, however, that “oral supplements work if patients will take them” and that IDPN


is used infrequently in children, because “children can’t refuse NG (naso-gastric)


tubes.”


Among the reasons given for stopping IDPN were “dramatic improvements,” reaching


a “target goal,” elevated blood glucose levels, chest pain (from tluid retention),


diarrhea, the treatment’s not helping, and the patient’s death. When IDPN is stopped


because of improvements, respondents noted that some patients maintain their


improved status, but many do not. Those patients who use IDPN to recover from the


demands of surgery reportedly tend to maintain their status. Most respondents noted


that patients are reevaluated, usually every three months, with one respondent noting


“no patient has ever needed to go off treatment.”


c-2 
APPENDIX D 

COMMENTS OF THE HEALTH CARE FINANCING ADMINISTRATION 

D-1 
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Date 

F~om 

Acting Administrator 

Sublect	 Office of Inspector General (OIG) Draft Report: Inappropriate Payments for 

Total Parenteral Nutrition (TPN) (OEI-12-92-00460) 

To 

Bryan B. Mitchell


Principal Deputy Inspector General


We reviewed the above-referenced draft report which examined 

Medicare coverage of total parenteral nutrition (TPN), a “high tech” means of 

feeding patients who do not have a functioning intestinal tract. 

Our detailed comments on the report findings and recommendations are 

attached for your consideration. Thank you for the opportunity to review and 

comment on this draft report. Please advise us if you agree with our position 

at your earliest convenience. 

Attachment