734491
research-article2017
NCPXXX10.1177/0884533617734491Nutrition in Clinical PracticeBonnes et al
Invited Review
Parenteral and Enteral Nutrition—From Hospital to Home: Will It Be Covered?
Nutrition in Clinical Practice Volume XX Number X Month 201X 1–9 © 2017 American Society for Parenteral and Enteral Nutrition https://doi.org/10.1177/0884533617734491 DOI: 10.1177/0884533617734491 journals.sagepub.com/home/ncp
Sara L. Bonnes, MD1; Bradley R. Salonen, MD1; Ryan T. Hurt, MD, PhD1,2,3; Megan T. McMahon, PA-C1; and Manpreet S. Mundi, MD2
Abstract With scientific advances allowing for the safe delivery of parenteral and enteral nutrition in the home setting, challenges have risen with determining how this will be financially feasible for patients. In the United States, the government is one of the major payers for home parenteral and enteral nutrition (HPEN). Thus, it is important for nutrition providers to have an understanding of the Medicare criteria that must be met in order for these services to be covered. It can be difficult for clinicians to sift through these requirements and decipher for whom and when HPEN is covered. As our nutrition science knowledge and delivery continue to grow and evolve, potential barriers to this coverage may arise. This article provides background on those currently on HPEN in the United States, the current Medicare HPEN coverage criteria, and challenges we may face in the future. (Nutr Clin Pract. XXXX;xx:xx-xx)
Keywords Medicare; nutritional support; parenteral nutrition; enteral nutrition; home care services; reimbursement
It has long been realized that nutrition plays an important role in health and healing. However, as a medical discipline, nutrition support is relatively young with many discoveries of micronutrients made in the past century.1 For hundreds of years, attempts had been made to feed patients either enterally or parenterally with varying degrees of success.2 It was not until the 1960s that an intravenous (IV) mixture of fat, protein, and carbohydrate was successfully used to deliver complete nutrition, which quickly proved to be a lifesaving and life-changing therapy.2–4 As advances were being made in the development of parenteral and enteral nutrition (PEN), the federal government of the United States was also working on improving healthcare coverage by creating Medicare and Medicaid in 1965.5,6 Over time, improvements were made in compounding formulations, development of novel fat emulsions, and administration of PEN, allowing more and more patients to safely use these therapies in their home environment.7 Unfortunately, over the same time, Medicare, which tends to have the most stringent criteria for coverage of home PEN (HPEN), has not modified its coverage criteria. This often leads to significant challenges in obtaining coverage for HPEN therapies, despite there being significant economic benefit to allowing patients to receive nutrition at home instead of a hospital setting.8 This article reviews current demographics of the HPEN population, the benefits that current Medicare guidelines provide, the challenges of meeting nutrition needs of patients who would benefit from these therapies but are not covered by these guidelines, and considerations that may be beneficial for future review and development of new Medicare coverage guidelines.
Demographics of HPEN Currently, there is not a complete database of HPEN patients in the United States. Shortly after the first patients were sent home on parenteral nutrition (HPN), a registry of these patients was started.1 Since then, multiple databases have been initiated by major organizations such as the Oley Foundation, American Society for Parenteral and Enteral Nutrition (ASPEN), and independent institutions and infusion companies.1,8–12 Unfortunately, these registries have met with challenges to not only capture all HPEN patients but to also remain current while depending on volunteers to upload/provide data.8,10–16 One such attempt was the North American Parenteral and Enteral Nutrition Registry, which collected yearly outcome information on >12,000 patients treated with HPEN from 1985 to 1992 from 217 volunteer home nutrition support programs.12 By comparing registry data to information available from Medicare, they were able to estimate that the prevalence of HPN From the 1Division of General Internal Medicine, Mayo Clinic, Rochester, Minnesota, USA; 2Division of Endocrinology, Diabetes, Metabolism and Nutrition, Mayo Clinic, Rochester, Minnesota, USA; and the 3Division of Gastroenterology, Mayo Clinic, Rochester, Minnesota, USA. Financial disclosure: None declared. Conflicts of interest: R. T. H. is a consultant for Nestlé Nutrition. Corresponding Author: Sara L. Bonnes, MD, Division of General Internal Medicine, Mayo Clinic, 200 First St SW, Rochester, MN 55905, USA. Email: [email protected]
2 and home enteral nutrition (HEN) was 40,000 and 152,000, respectively, in 1992.12 Our group recently performed a similar analysis using data from 3 large durable medical equipment providers and Medicare to report an estimated prevalence of 25,011 patients on HPN and 437,882 patients on HEN in 2013.17 This reflected a decrease in HPN use from 157 per million Americans in 1992 to 79 per million Americans in 2013.17 HEN use, on the other hand, has increased significantly, going from 597 per million in 1992 to 1382 per million in 2013.17 Although there may be a number of reasons for this change, the decline in HPN use could partly be explained by changing indications for HPN. In 1992, cancer was the most common diagnosis resulting in HPEN.12 Swallowing disorder was the second most common indication for HEN while Crohn’s disease followed by ischemic bowel and motility disorders were common indications for HPN.12 The Sustain registry provided more recent indication data and enrolled 1251 patients from 2011 to 2014 at 29 participating sites.10 The most common indication for HPN had changed to short bowel syndrome (SBS) (24%), with gastrointestinal (GI) obstruction a close second (23%). Fistula, motility disorders, and diarrhea/malabsorption not related to SBS were each >10% of the diagnoses represented in adults.10 Certainly, from 1992 to 2014, treatment for both cancer and Crohn’s disease has continued to evolve, leading to improved outcomes that may have decreased the need for HPN. Clinical trials favoring early EN initiation have also led to change in clinical practice and guideline recommendations.18 Given changes in medical practice, we anticipate that the indications for HPEN will continue to evolve over time. As an example, one of the largest changes in healthcare over the past few decades has been the rise in obesity. This has resulted in an increase in the number of bariatric surgery procedures performed, which can be associated with complications requiring HPN support.19 In an effort to prevent weight loss and malnutrition complications, many institutions now routinely place access for enteral feeds prior to treatment for head and neck cancer.20 Other conditions that were generally fatal such as massive ischemic bowel may now be survivable with HPEN support. With advances in neonatal and pediatric care, HPEN is being used to meet the nutrition needs of many patients who would not have survived in the past.
Cost of HPEN While it is difficult to accurately assess the true expense of HPEN, several studies have evaluated these costs.8,21,22 In 1992, it was estimated that the annual cost of HPN may be up to $150,000, and this was the basis for reimbursement for Medicare expenses.8 However, over time, the reimbursement has declined, with allowable charges being up to $122,000 per year and patients increasingly being responsible for the remainder.8 The expense of HEN, on the other hand, has been calculated to be much lower, closer to $20,000 per year, but there is wide variation in cost of both therapies.22 In addition to estimates of the cost of administration of HPEN, time lost from work, medical visits, hospital stays from
Nutrition in Clinical Practice XX(X) complications, and many other factors contribute to the true cost of HPEN.8,22 Thus, the actual monetary cost of these therapies is presumably much greater. As providers, we are also entrusted with caring not only for the physical but also the psychological well-being of our patients. Many factors contribute to psychosocial well-being, but concerns over payment for HPEN may certainly factor into the concerns of our patients and thus should be considered when these therapies are initiated.21
Who Pays for HPEN? In addition to the difficulty in determining who is on HPEN, it is challenging to determine who is actually paying for HPEN in the United States given our nonnationalized healthcare system. The North American Parenteral and Enteral Nutrition Registry reported that between 1986 and 1992, Medicare accounted for 27% of HPN and 46% of HEN patients in the registry.12,17 By 2013, the HPN Medicare coverage had remained at 27% while the HEN Medicare percentage had decreased to 26%.17 Our analysis further noted that for HPN, 13% of patients were covered by Medicaid and close to 60% of HPN patients were covered by commercial or other insurance plans. For HEN, 21% were covered by Medicaid and 53% were covered by commercial or other insurance plans. Despite these declines, it is clear that Medicare and Medicaid combined make up one of the largest insurers to cover HPEN.8,10
Government-Funded Healthcare The first president to voice the need for government-funded healthcare was President Truman in 1945.23 It was not until July 30, 1965, that President Lyndon Johnson signed the bill that funded Medicare and Medicaid.5,24 The initial plans were to help provide medical coverage to those older than 65 years or disabled, but coverage has broadened over time.5,6,25 Different components of Medicare cover different medical care costs: Part A covers inpatient expenses; Part B covers medical nutrition therapy, prosthetic devices (including HPEN), durable medical equipment, and outpatient hospital services; Part C (Medicare Advantage) provides coverage for additional services not covered in Part A or B; and Part D covers prescription drug costs.6,26,27 Enrollment in Parts B, C, and D is optional with a variety of plans available that vary in coverage of services and medications. Enrollment for some of these plans may have time restrictions, and delaying enrollment from when first eligible may result in a penalty fee if you choose to enroll later.28,29 HPEN is generally covered under Medicare Part B in the prosthetic device act as an “artificial intestine.” The duration of need is required to be “long term or indefinite,” further clarified as at least 3 months or greater, and patients must meet strict medical need criteria. If the patient does not have a Part B qualifying diagnosis, Part D may help defray some of the cost of prescription HPN therapy.6,30,31 Unfortunately, Part D coverage may not include infusion pumps or other supplies, making HPEN unaffordable for many patients. Certain
Bonnes et al Medicare Part C plans may provide coverage for HPEN, without needing to meet the strict criteria for Medicare Part B. However, given variation on plans, this benefit would need to be investigated within a patient’s specific plan.
Medicare HPEN Criteria Until 1984, Medicare coverage for HPEN was based on medical diagnosis.32 At that time, it was recognized that there was a significant rise in the medical indications being cited for HPN coverage, and this was leading to significant inflation of the cost to Medicare for HPN.32 In July 1984, guidelines for the coverage of HPN were clarified to help curb the rising costs of HPEN.32–34 These guidelines caused controversy at the time and continue to do so.30,33–35 Anecdotally, not much has changed regarding eligibility, but enforcement of the criteria has been recommended to be more strict given the high cost.36 Medicare provides guidance on multiple medical situations by which a patient can qualify for HPEN.37–40 These criteria have been developed into flowsheets and checklists created by the companies contracted by Medicare to provide HPEN and used by those working to determine a patient’s eligibility for coverage (Figures 1 and 2).41–44 While nutrition support providers have a responsibility to help ensure that patients have coverage for HPEN, since these providers are not reimbursed for the additional nonvisit care required for HPEN and the home infusion company is taking the risk of not getting reimbursed, their Medicare experts are generally crucial in determining if a patient meets coverage criteria. If it is expected that Medicare coverage for HPN will be denied, it is the responsibility of the home infusion company to provide the patients with an Advance Beneficiary Notice (ABN) to provide them with information about estimated cost of these services.45 We highly recommend working closely with the infusion company to verify benefits prior to initiating HPEN as the cost without coverage is often prohibitive.
Benefits of the Guidelines Many providers experienced with using the Medicare guidelines have dealt with the challenges that can be encountered. However, there are multiple benefits to having guidelines that are standard across the United States to help ensure appropriate use of HPEN. The field of nutrition is truly a multidisciplinary field with healthcare providers from many different backgrounds—nurses, pharmacists, dietitians, physicians, nurse practitioners, physician assistants, and others. It is generally recognized that nutrition education is lacking among the health professionals in our country, and this education varies by health profession.46–51 In addition, as opposed to Europe where nutrition support is centralized and managed by specialized centers, HPEN in the United States is typically prescribed by providers who may cover only 1 or 2 HPEN patients annually.17 This lack of experience limits the development of proficiency in HPEN support. Due to this, the strict criteria outlined in the Medicare guidelines help ensure that
3 all Medicare patients have equal access to HPEN, regardless of region of the United States, home infusion provider, or healthcare provider training, background, and proficiency. While lifesaving for many, HPEN does have risk of lifethreatening complications.7,8,52–59 Advances in nutrition care options have helped decrease risk of bloodstream infection, but patients can still experience bloodstream or skin and soft tissue infection with either enteral or parenteral access.53,56,60 Repeated loss of access can result in no further access options for artificial nutrition and is considered an indication to consider intestinal transplant.61 Use of standard guidelines can help ensure that the safest routes to meet nutrition needs are attempted prior to pursuing those with higher risk for serious complication. While patient preference and choice is important, patients sometimes request artificial nutrition because they view it as “easier” than alternative therapies. When surveyed, 1 study found that patients expressed a preference for PN as opposed to EN in the hospital setting.62 However, these patients had no previous experience with these forms of nutrition, thus possibly influencing these results.62 There are also situations where there is not clear evidence for use of HPEN, such as prolonged use in the perioperative setting, and use of strict guidelines may help prevent unnecessary use in these situations.63
Challenges of the Guidelines While providing guidance and limiting inappropriate use, these guidelines are not without challenges. Many patients do not easily fit into these algorithms, leading to difficulty in obtaining coverage for HPEN and frustration in trying to meet the nutrition needs of these patients.
Challenges in Obtaining Coverage for HPEN The first challenge in meeting coverage requirements for HPEN is the need for the intestinal dysfunction to be “permanent.” Many patients would benefit from HPEN for a shorter period of time but are not able to go home because of the shorter term need for nutrition support. Providers may also anticipate that patients will require HPEN for >3 months, but a change in clinical status or condition may change that plan. While we have not yet had coverage denied because of such a change in clinical status, there is real concern that coverage may be more closely scrutinized in the future and not reimbursed in these situations. Providers are also put in an ethically challenging situation when asked to estimate the length of need. The Medicare guidelines for HPEN are widely available, and the knowledge that length of need has to be >3 months for HPEN coverage may prompt providers to overestimate the length of need to help get patients covered, and if coverage is provided, it may prompt providers to keep patients on HPEN longer than needed so that coverage is not denied or scrutinized because the need for HPEN was actually 50% day IV of oral or enteral intake
Situation C Bowel rest
Situation D Complete mechanical small bowel obstruction
Surgery occurred in the last 3 months
Situation B Short bowel syndrome
Figure 1. Criteria for Medicare coverage for home parenteral nutrition. The following links present similar information in alternative formats: http://www.nhia.org/ac15/ handouts/documents/23-FSUPPLEMENTALHandout2aTPNDecisionTree.pdf and https://med.noridianmedicare.com/documents/2230703/6750839/Documentation+Checklist++Parenteral+Nutrition. GI, gastrointestinal; IV, intravenous; NOS, not otherwise specified; SIBO, small intestinal bacterial overgrowth.
Documentation: May include - operative reports - hospital summary - radiology reports - physician documentation of need
Medicare Situation
Situation A Small bowel resection
Bonnes et al
5
Figure 2. This is a decision tree to help determine if patients meet Medicare home enteral nutrition criteria. BUN, blood urea nitrogen; CKD, chronic kidney disease; Cr, creatinine; EN, enteral nutrition; GFR, glomerular filtration rate; MCR, Medicare. Reprinted with permission from Martin K, McGinnis C. Home nutrition support: ethics and reimbursement. Nutr Clin Pract. 2016;31(3):325-333.
sarcopenia, obesity, and other conditions that affect caloric needs are not outlined in the Medicare criteria. If patients are being provided with an appropriate amount of calories to maintain or promote weight but not the amount of calories that Medicare requires for HPEN, there is risk that coverage will be denied or that patients may be overfed to meet the Medicare criteria. When working to gain coverage for HPEN, transition from EN to PN, or obtain a specialized EN formula, you may be required to document a failed enteral trial. However, there is lack of clarity as to what is a true “failure.” This may require an attempt to place a tube in a patient that is anatomically risky given recent surgery or other anatomic changes. Tube placement may require sedation, repeat radiographic imaging, or frequent adjustments. If the patient is having difficulty with diarrhea, bloating, vomiting, gas distension, and so on, attempts need to be made to decrease the rate, dilute the concentration, and optimize medications prior to changing formulas or considering it a failed trial.35 These attempts can lead to significant discomfort and frustration in patients, as well as creating a challenging patient-healthcare team relationship as patients may struggle to trust a team that continues to try to make these adjustments instead of more quickly progressing to an alternate route to meet nutrition needs. While these trials are occurring, patients, who are often already malnourished continue to fall further behind in their nutrition needs.
Determining the ability of the GI tract to meet nutrition needs may not be feasible. It may be difficult to determine radiographically that a patient has an obstruction of the GI tract that would require HPEN, as symptoms do not always correlate with clinical imaging. While some patients with partial obstructions can be fed with EN, many are not able to completely meet their nutrition needs in this way. In addition, in patients who have recently undergone surgery, it may not be safe to place an enteric tube or try to feed right away. While these situations may not be common, they may prevent coverage in some patients who would potentially benefit from HPEN. In addition, following the algorithm may require additional testing to be completed that is otherwise considered unnecessary to prove impaired digestion or absorption. Frequently, patient history when considered in addition to weight loss and micronutrient deficiencies indicates malabsorption. Some patients undergo further evaluation with a 48-hour fecal fat test to prove this diagnosis. However, this test leads to worsening discomfort for these patients with true malabsorption and does not meet the Medicare standard of a 72-hour fecal fat test to prove malabsorption for HPN coverage and may necessitate a second test for malabsorption being done if HEN cannot meet the patients’ nutrition needs.
6
HPN-Specific Challenges Situation A: Small bowel resection. It is difficult to provide documentation of the exact length of small bowel remaining. Surgeons vary significantly in practices to report bowel resections, and frequently the length removed is documented but not the length remaining. At times, surgeons will estimate the length of bowel remaining, but given the complexity of abdominal surgeries, it is not practical to expect surgeons to routinely measure the amount of small bowel remaining, and given bowel edema, the length removed is more frequently reported. Incorrect estimations or lack of documentation may result in lack of Medicare coverage for patients who need HPN. Situation B: SBS. Patients may meet length criteria for SBS, but if HPN was not started within the first 3 months, they are required to undergo further testing to meet criteria for HPN under situation B. Documentation of strict intake and output is quite challenging for patients to perform, not only to consume the volume required but accurately measure and report it. In addition, if patients do experience
research-article2017
NCPXXX10.1177/0884533617734491Nutrition in Clinical PracticeBonnes et al
Invited Review
Parenteral and Enteral Nutrition—From Hospital to Home: Will It Be Covered?
Nutrition in Clinical Practice Volume XX Number X Month 201X 1–9 © 2017 American Society for Parenteral and Enteral Nutrition https://doi.org/10.1177/0884533617734491 DOI: 10.1177/0884533617734491 journals.sagepub.com/home/ncp
Sara L. Bonnes, MD1; Bradley R. Salonen, MD1; Ryan T. Hurt, MD, PhD1,2,3; Megan T. McMahon, PA-C1; and Manpreet S. Mundi, MD2
Abstract With scientific advances allowing for the safe delivery of parenteral and enteral nutrition in the home setting, challenges have risen with determining how this will be financially feasible for patients. In the United States, the government is one of the major payers for home parenteral and enteral nutrition (HPEN). Thus, it is important for nutrition providers to have an understanding of the Medicare criteria that must be met in order for these services to be covered. It can be difficult for clinicians to sift through these requirements and decipher for whom and when HPEN is covered. As our nutrition science knowledge and delivery continue to grow and evolve, potential barriers to this coverage may arise. This article provides background on those currently on HPEN in the United States, the current Medicare HPEN coverage criteria, and challenges we may face in the future. (Nutr Clin Pract. XXXX;xx:xx-xx)
Keywords Medicare; nutritional support; parenteral nutrition; enteral nutrition; home care services; reimbursement
It has long been realized that nutrition plays an important role in health and healing. However, as a medical discipline, nutrition support is relatively young with many discoveries of micronutrients made in the past century.1 For hundreds of years, attempts had been made to feed patients either enterally or parenterally with varying degrees of success.2 It was not until the 1960s that an intravenous (IV) mixture of fat, protein, and carbohydrate was successfully used to deliver complete nutrition, which quickly proved to be a lifesaving and life-changing therapy.2–4 As advances were being made in the development of parenteral and enteral nutrition (PEN), the federal government of the United States was also working on improving healthcare coverage by creating Medicare and Medicaid in 1965.5,6 Over time, improvements were made in compounding formulations, development of novel fat emulsions, and administration of PEN, allowing more and more patients to safely use these therapies in their home environment.7 Unfortunately, over the same time, Medicare, which tends to have the most stringent criteria for coverage of home PEN (HPEN), has not modified its coverage criteria. This often leads to significant challenges in obtaining coverage for HPEN therapies, despite there being significant economic benefit to allowing patients to receive nutrition at home instead of a hospital setting.8 This article reviews current demographics of the HPEN population, the benefits that current Medicare guidelines provide, the challenges of meeting nutrition needs of patients who would benefit from these therapies but are not covered by these guidelines, and considerations that may be beneficial for future review and development of new Medicare coverage guidelines.
Demographics of HPEN Currently, there is not a complete database of HPEN patients in the United States. Shortly after the first patients were sent home on parenteral nutrition (HPN), a registry of these patients was started.1 Since then, multiple databases have been initiated by major organizations such as the Oley Foundation, American Society for Parenteral and Enteral Nutrition (ASPEN), and independent institutions and infusion companies.1,8–12 Unfortunately, these registries have met with challenges to not only capture all HPEN patients but to also remain current while depending on volunteers to upload/provide data.8,10–16 One such attempt was the North American Parenteral and Enteral Nutrition Registry, which collected yearly outcome information on >12,000 patients treated with HPEN from 1985 to 1992 from 217 volunteer home nutrition support programs.12 By comparing registry data to information available from Medicare, they were able to estimate that the prevalence of HPN From the 1Division of General Internal Medicine, Mayo Clinic, Rochester, Minnesota, USA; 2Division of Endocrinology, Diabetes, Metabolism and Nutrition, Mayo Clinic, Rochester, Minnesota, USA; and the 3Division of Gastroenterology, Mayo Clinic, Rochester, Minnesota, USA. Financial disclosure: None declared. Conflicts of interest: R. T. H. is a consultant for Nestlé Nutrition. Corresponding Author: Sara L. Bonnes, MD, Division of General Internal Medicine, Mayo Clinic, 200 First St SW, Rochester, MN 55905, USA. Email: [email protected]
2 and home enteral nutrition (HEN) was 40,000 and 152,000, respectively, in 1992.12 Our group recently performed a similar analysis using data from 3 large durable medical equipment providers and Medicare to report an estimated prevalence of 25,011 patients on HPN and 437,882 patients on HEN in 2013.17 This reflected a decrease in HPN use from 157 per million Americans in 1992 to 79 per million Americans in 2013.17 HEN use, on the other hand, has increased significantly, going from 597 per million in 1992 to 1382 per million in 2013.17 Although there may be a number of reasons for this change, the decline in HPN use could partly be explained by changing indications for HPN. In 1992, cancer was the most common diagnosis resulting in HPEN.12 Swallowing disorder was the second most common indication for HEN while Crohn’s disease followed by ischemic bowel and motility disorders were common indications for HPN.12 The Sustain registry provided more recent indication data and enrolled 1251 patients from 2011 to 2014 at 29 participating sites.10 The most common indication for HPN had changed to short bowel syndrome (SBS) (24%), with gastrointestinal (GI) obstruction a close second (23%). Fistula, motility disorders, and diarrhea/malabsorption not related to SBS were each >10% of the diagnoses represented in adults.10 Certainly, from 1992 to 2014, treatment for both cancer and Crohn’s disease has continued to evolve, leading to improved outcomes that may have decreased the need for HPN. Clinical trials favoring early EN initiation have also led to change in clinical practice and guideline recommendations.18 Given changes in medical practice, we anticipate that the indications for HPEN will continue to evolve over time. As an example, one of the largest changes in healthcare over the past few decades has been the rise in obesity. This has resulted in an increase in the number of bariatric surgery procedures performed, which can be associated with complications requiring HPN support.19 In an effort to prevent weight loss and malnutrition complications, many institutions now routinely place access for enteral feeds prior to treatment for head and neck cancer.20 Other conditions that were generally fatal such as massive ischemic bowel may now be survivable with HPEN support. With advances in neonatal and pediatric care, HPEN is being used to meet the nutrition needs of many patients who would not have survived in the past.
Cost of HPEN While it is difficult to accurately assess the true expense of HPEN, several studies have evaluated these costs.8,21,22 In 1992, it was estimated that the annual cost of HPN may be up to $150,000, and this was the basis for reimbursement for Medicare expenses.8 However, over time, the reimbursement has declined, with allowable charges being up to $122,000 per year and patients increasingly being responsible for the remainder.8 The expense of HEN, on the other hand, has been calculated to be much lower, closer to $20,000 per year, but there is wide variation in cost of both therapies.22 In addition to estimates of the cost of administration of HPEN, time lost from work, medical visits, hospital stays from
Nutrition in Clinical Practice XX(X) complications, and many other factors contribute to the true cost of HPEN.8,22 Thus, the actual monetary cost of these therapies is presumably much greater. As providers, we are also entrusted with caring not only for the physical but also the psychological well-being of our patients. Many factors contribute to psychosocial well-being, but concerns over payment for HPEN may certainly factor into the concerns of our patients and thus should be considered when these therapies are initiated.21
Who Pays for HPEN? In addition to the difficulty in determining who is on HPEN, it is challenging to determine who is actually paying for HPEN in the United States given our nonnationalized healthcare system. The North American Parenteral and Enteral Nutrition Registry reported that between 1986 and 1992, Medicare accounted for 27% of HPN and 46% of HEN patients in the registry.12,17 By 2013, the HPN Medicare coverage had remained at 27% while the HEN Medicare percentage had decreased to 26%.17 Our analysis further noted that for HPN, 13% of patients were covered by Medicaid and close to 60% of HPN patients were covered by commercial or other insurance plans. For HEN, 21% were covered by Medicaid and 53% were covered by commercial or other insurance plans. Despite these declines, it is clear that Medicare and Medicaid combined make up one of the largest insurers to cover HPEN.8,10
Government-Funded Healthcare The first president to voice the need for government-funded healthcare was President Truman in 1945.23 It was not until July 30, 1965, that President Lyndon Johnson signed the bill that funded Medicare and Medicaid.5,24 The initial plans were to help provide medical coverage to those older than 65 years or disabled, but coverage has broadened over time.5,6,25 Different components of Medicare cover different medical care costs: Part A covers inpatient expenses; Part B covers medical nutrition therapy, prosthetic devices (including HPEN), durable medical equipment, and outpatient hospital services; Part C (Medicare Advantage) provides coverage for additional services not covered in Part A or B; and Part D covers prescription drug costs.6,26,27 Enrollment in Parts B, C, and D is optional with a variety of plans available that vary in coverage of services and medications. Enrollment for some of these plans may have time restrictions, and delaying enrollment from when first eligible may result in a penalty fee if you choose to enroll later.28,29 HPEN is generally covered under Medicare Part B in the prosthetic device act as an “artificial intestine.” The duration of need is required to be “long term or indefinite,” further clarified as at least 3 months or greater, and patients must meet strict medical need criteria. If the patient does not have a Part B qualifying diagnosis, Part D may help defray some of the cost of prescription HPN therapy.6,30,31 Unfortunately, Part D coverage may not include infusion pumps or other supplies, making HPEN unaffordable for many patients. Certain
Bonnes et al Medicare Part C plans may provide coverage for HPEN, without needing to meet the strict criteria for Medicare Part B. However, given variation on plans, this benefit would need to be investigated within a patient’s specific plan.
Medicare HPEN Criteria Until 1984, Medicare coverage for HPEN was based on medical diagnosis.32 At that time, it was recognized that there was a significant rise in the medical indications being cited for HPN coverage, and this was leading to significant inflation of the cost to Medicare for HPN.32 In July 1984, guidelines for the coverage of HPN were clarified to help curb the rising costs of HPEN.32–34 These guidelines caused controversy at the time and continue to do so.30,33–35 Anecdotally, not much has changed regarding eligibility, but enforcement of the criteria has been recommended to be more strict given the high cost.36 Medicare provides guidance on multiple medical situations by which a patient can qualify for HPEN.37–40 These criteria have been developed into flowsheets and checklists created by the companies contracted by Medicare to provide HPEN and used by those working to determine a patient’s eligibility for coverage (Figures 1 and 2).41–44 While nutrition support providers have a responsibility to help ensure that patients have coverage for HPEN, since these providers are not reimbursed for the additional nonvisit care required for HPEN and the home infusion company is taking the risk of not getting reimbursed, their Medicare experts are generally crucial in determining if a patient meets coverage criteria. If it is expected that Medicare coverage for HPN will be denied, it is the responsibility of the home infusion company to provide the patients with an Advance Beneficiary Notice (ABN) to provide them with information about estimated cost of these services.45 We highly recommend working closely with the infusion company to verify benefits prior to initiating HPEN as the cost without coverage is often prohibitive.
Benefits of the Guidelines Many providers experienced with using the Medicare guidelines have dealt with the challenges that can be encountered. However, there are multiple benefits to having guidelines that are standard across the United States to help ensure appropriate use of HPEN. The field of nutrition is truly a multidisciplinary field with healthcare providers from many different backgrounds—nurses, pharmacists, dietitians, physicians, nurse practitioners, physician assistants, and others. It is generally recognized that nutrition education is lacking among the health professionals in our country, and this education varies by health profession.46–51 In addition, as opposed to Europe where nutrition support is centralized and managed by specialized centers, HPEN in the United States is typically prescribed by providers who may cover only 1 or 2 HPEN patients annually.17 This lack of experience limits the development of proficiency in HPEN support. Due to this, the strict criteria outlined in the Medicare guidelines help ensure that
3 all Medicare patients have equal access to HPEN, regardless of region of the United States, home infusion provider, or healthcare provider training, background, and proficiency. While lifesaving for many, HPEN does have risk of lifethreatening complications.7,8,52–59 Advances in nutrition care options have helped decrease risk of bloodstream infection, but patients can still experience bloodstream or skin and soft tissue infection with either enteral or parenteral access.53,56,60 Repeated loss of access can result in no further access options for artificial nutrition and is considered an indication to consider intestinal transplant.61 Use of standard guidelines can help ensure that the safest routes to meet nutrition needs are attempted prior to pursuing those with higher risk for serious complication. While patient preference and choice is important, patients sometimes request artificial nutrition because they view it as “easier” than alternative therapies. When surveyed, 1 study found that patients expressed a preference for PN as opposed to EN in the hospital setting.62 However, these patients had no previous experience with these forms of nutrition, thus possibly influencing these results.62 There are also situations where there is not clear evidence for use of HPEN, such as prolonged use in the perioperative setting, and use of strict guidelines may help prevent unnecessary use in these situations.63
Challenges of the Guidelines While providing guidance and limiting inappropriate use, these guidelines are not without challenges. Many patients do not easily fit into these algorithms, leading to difficulty in obtaining coverage for HPEN and frustration in trying to meet the nutrition needs of these patients.
Challenges in Obtaining Coverage for HPEN The first challenge in meeting coverage requirements for HPEN is the need for the intestinal dysfunction to be “permanent.” Many patients would benefit from HPEN for a shorter period of time but are not able to go home because of the shorter term need for nutrition support. Providers may also anticipate that patients will require HPEN for >3 months, but a change in clinical status or condition may change that plan. While we have not yet had coverage denied because of such a change in clinical status, there is real concern that coverage may be more closely scrutinized in the future and not reimbursed in these situations. Providers are also put in an ethically challenging situation when asked to estimate the length of need. The Medicare guidelines for HPEN are widely available, and the knowledge that length of need has to be >3 months for HPEN coverage may prompt providers to overestimate the length of need to help get patients covered, and if coverage is provided, it may prompt providers to keep patients on HPEN longer than needed so that coverage is not denied or scrutinized because the need for HPEN was actually 50% day IV of oral or enteral intake
Situation C Bowel rest
Situation D Complete mechanical small bowel obstruction
Surgery occurred in the last 3 months
Situation B Short bowel syndrome
Figure 1. Criteria for Medicare coverage for home parenteral nutrition. The following links present similar information in alternative formats: http://www.nhia.org/ac15/ handouts/documents/23-FSUPPLEMENTALHandout2aTPNDecisionTree.pdf and https://med.noridianmedicare.com/documents/2230703/6750839/Documentation+Checklist++Parenteral+Nutrition. GI, gastrointestinal; IV, intravenous; NOS, not otherwise specified; SIBO, small intestinal bacterial overgrowth.
Documentation: May include - operative reports - hospital summary - radiology reports - physician documentation of need
Medicare Situation
Situation A Small bowel resection
Bonnes et al
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Figure 2. This is a decision tree to help determine if patients meet Medicare home enteral nutrition criteria. BUN, blood urea nitrogen; CKD, chronic kidney disease; Cr, creatinine; EN, enteral nutrition; GFR, glomerular filtration rate; MCR, Medicare. Reprinted with permission from Martin K, McGinnis C. Home nutrition support: ethics and reimbursement. Nutr Clin Pract. 2016;31(3):325-333.
sarcopenia, obesity, and other conditions that affect caloric needs are not outlined in the Medicare criteria. If patients are being provided with an appropriate amount of calories to maintain or promote weight but not the amount of calories that Medicare requires for HPEN, there is risk that coverage will be denied or that patients may be overfed to meet the Medicare criteria. When working to gain coverage for HPEN, transition from EN to PN, or obtain a specialized EN formula, you may be required to document a failed enteral trial. However, there is lack of clarity as to what is a true “failure.” This may require an attempt to place a tube in a patient that is anatomically risky given recent surgery or other anatomic changes. Tube placement may require sedation, repeat radiographic imaging, or frequent adjustments. If the patient is having difficulty with diarrhea, bloating, vomiting, gas distension, and so on, attempts need to be made to decrease the rate, dilute the concentration, and optimize medications prior to changing formulas or considering it a failed trial.35 These attempts can lead to significant discomfort and frustration in patients, as well as creating a challenging patient-healthcare team relationship as patients may struggle to trust a team that continues to try to make these adjustments instead of more quickly progressing to an alternate route to meet nutrition needs. While these trials are occurring, patients, who are often already malnourished continue to fall further behind in their nutrition needs.
Determining the ability of the GI tract to meet nutrition needs may not be feasible. It may be difficult to determine radiographically that a patient has an obstruction of the GI tract that would require HPEN, as symptoms do not always correlate with clinical imaging. While some patients with partial obstructions can be fed with EN, many are not able to completely meet their nutrition needs in this way. In addition, in patients who have recently undergone surgery, it may not be safe to place an enteric tube or try to feed right away. While these situations may not be common, they may prevent coverage in some patients who would potentially benefit from HPEN. In addition, following the algorithm may require additional testing to be completed that is otherwise considered unnecessary to prove impaired digestion or absorption. Frequently, patient history when considered in addition to weight loss and micronutrient deficiencies indicates malabsorption. Some patients undergo further evaluation with a 48-hour fecal fat test to prove this diagnosis. However, this test leads to worsening discomfort for these patients with true malabsorption and does not meet the Medicare standard of a 72-hour fecal fat test to prove malabsorption for HPN coverage and may necessitate a second test for malabsorption being done if HEN cannot meet the patients’ nutrition needs.
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HPN-Specific Challenges Situation A: Small bowel resection. It is difficult to provide documentation of the exact length of small bowel remaining. Surgeons vary significantly in practices to report bowel resections, and frequently the length removed is documented but not the length remaining. At times, surgeons will estimate the length of bowel remaining, but given the complexity of abdominal surgeries, it is not practical to expect surgeons to routinely measure the amount of small bowel remaining, and given bowel edema, the length removed is more frequently reported. Incorrect estimations or lack of documentation may result in lack of Medicare coverage for patients who need HPN. Situation B: SBS. Patients may meet length criteria for SBS, but if HPN was not started within the first 3 months, they are required to undergo further testing to meet criteria for HPN under situation B. Documentation of strict intake and output is quite challenging for patients to perform, not only to consume the volume required but accurately measure and report it. In addition, if patients do experience
