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Medicare Coverage for HPN…An Oxymoron?
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Penny Allen, RD, CNSC, National Director, Nutrition Support, BriovaRx Infusion Services (formerly AxelaCare)

This article is adapted and used with permission from Allen P. Medicare Coverage for Home Parenteral Nutrition—An Oxymoron? Part I, Practical Gastroenterology. 2016;(12)34. Much of the information is directed at health care professionals. However, there is a lot of information here that may apply to you if you are on home enteral and/or parenteral nutrition (and Medicare) now, and/or may be on home parenteral nutrition (and Medicare) in the future. We hope you will find it useful. Additional tables are available online or by calling (518) 262-5079.


Physicians face increasing pressure to discharge patients earlier from the acute care setting. If there is any possibility that a patient* (see note page 14) may require home parenteral nutrition (HPN) post-discharge, the process of clearing insurance to determine coverage for HPN should be started immediately so the health care team and the patient are aware of what is required. This should be the case for any insurance plan a patient may have, but especially with Medicare. It is often a surprise at the time of discharge that a patient does not have coverage for HPN and other related infusion therapies under Medicare. This is because Medicare policy is not always understood or interpreted correctly, and/or the objective tests and studies required have not been done or are not available in the medical record.

Why is this important to you if you are already on HPN and/or home enteral nutrition (HEN, or tube feeding)? We want you to be aware of existing Medicare laws that may affect you now, or could affect you if you transition to straight Medicare in the future. We also want you to understand the Medicare qualification process for coverage (why you might need to undergo a tube feeding trial, for example), so you can work with your health care and infusion providers as a partner in this process.

Medicare HPN Policy: Background

Medicare is the federal health care program enacted by Congress as part of the Social Security Act of 1965. It is the largest health insurance program in the United States. Medicare HPN policy has remained the same for almost thirty years!

Medicare coverage is divided into Parts A, B, C, and D and each part provides different benefits. For almost thirty years, parenteral (PN) and enteral nutrition (EN) therapies have fallen under the Prosthetic Device Benefit of Part B. The Center for Medicare and Medicaid Services’ (CMS) rationale is that a device used to administer PN or EN serves as a prosthesis by replacing an organ or function of an organ that is permanently impaired.

If specific criteria related to any one of seven GI conditions have “permanently” (defined as three months or longer) prevented absorption of nutrients needed to maintain weight and strength commensurate with the patient’s health status, AND it is documented objectively in the manner required, then Medicare may cover HPN accessories and/or supplies under Part B. Professional services, clinical assessment, monitoring, and actual ongoing management of the patient by the HPN provider** have never been covered by Medicare.

The Medicare concept of “permanent” impairment of the small intestine is often challenging for clinicians and consumers* who approach HPN with the hope that over time a consumer’s dependence on PN may be reduced through bowel adaptation, as well as diet and medication management. Medicare policy says, “Permanence does not require a determination that there is no possibility that the beneficiary’s* condition may improve sometime in the future. If the judgment of the attending physician, substantiated in the medical record, is that the condition is of long and indefinite duration (ordinarily at least 3 months), the test of permanence is considered met.”

Table 1 provides a checklist of the clinical situations (A–H) where Medicare will cover HPN. In addition to meeting the test of “permanence,” there must be clear objective evidence that the GI tract, specifically the small intestine, is non-functioning. A completed Durable Medical Equipment Medicare Administrative Contractor (DME MAC) Information Form, formerly referred to as a Certificate of Medical Necessity, a Detailed Written Order, and extensive objective documentation from the medical record to support the criteria is the minimum required by CMS. Table 2, the original version published by the former DMERC (now called DME MAC) Region D over a decade ago, outlines the necessary documentation required for each situation.

Medicare requires an attempt at tube feeding when there is a “moderate abnormality” of a condition in situations A–F (see Table 1), i.e., in cases where the documentation does not exactly meet criteria for coverage, so additional information, such as documented weight loss, a low albumin, attempts at medication and diet modifications, and a tube feeding trial is required. Currently, the policy makes no exception for situations where a tube feeding trial may not be clinically appropriate or possible. (Additional tables available online or upon request to Oley outline examples of “moderate abnormalities” and Medicare’s definition of a tube-feeding trial.)

The Claims Process

The initial claims submission process is different today than in years past, which causes confusion among some providers and could potentially place families at significant financial risk. In the past, coverage was approved or denied by CMS from the start. Today, initial analysis of whether Medicare will cover the PN falls completely on the infusion provider, who then informs the physician if the consumer is “approved” for HPN coverage at time of discharge. If that provider does not fully understand the policy or interpret it correctly, it could have significant financial impact on the consumer later on when the provider realizes the consumer actually has no coverage and is then responsible for payment.

Supporting medical records should be obtained by the infusion/HPN provider prior to the start of care so the provider can submit required records when a claim is audited. CMS can audit a claim up to three years after a claim has been paid, which could potentially end up being as many as five years after an incident of care or an HPN shipment was provided. If documents cannot be produced in an audit, the government recoups all payments and the beneficiary could be at risk for the total amount, which could be tens of thousands of dollars.

If a claim is denied after an audit has been conducted, there are five levels of appeal within CMS that infusion providers and beneficiaries can pursue. According to statistics from the Office of Medicare Hearing and Appeals, the average time frame to reach a Level 3 Administrative Law Judge adjudication in 2014 was 547 days, indicating a significant backlog. Since audits are very common, infusion providers should carefully adhere to Medicare PN policy by collecting necessary qualifying documents prior to discharge, which should help to protect the consumer financially in the long run. The consumer should keep copies of their medical records as well, in case they can help provide missing documentation in the future.

Challenges with Medicare and Home Infusion Therapies

Medicare is the only payer in the United States that fails to recognize the clinical and cost benefits of providing infusion in the home setting. Currently, most infusion therapies related to HPN are not covered by Medicare, even when medically necessary (see table 3).

The Oley Foundation, the American Society for Parenteral and Enteral Nutrition (ASPEN), and the National Home Infusion Association (NHIA) have lobbied CMS for years in an attempt to change existing law so that meaningful coverage for home infusion therapy for Medicare beneficiaries is available. In addition, current policy for HPN severely limits access to the therapy, with few patients meeting the government’s criteria, either due to the test of permanence required, or non-qualifying conditions for PN such as malnutrition, GI/nutritional complications due to cancer treatments or bariatric surgery.

An abstract published in 2007 reported that only 16 percent of Medicare PN referrals (over a large geographically and medically diverse sample) received by a national infusion provider met Medicare HPN policy requirements (Allen P. Medicare TPN coverage criteria. Nutr Clin Pract. 2007;22[1]:106). Ten years later, another national infusion provider with similar referral statistics demonstrated that even fewer Medicare beneficiaries referred for HPN (10.5 percent) met the restrictive policy requirements (Allen P. Medicare parenteral nutrition policy 20 years later. Clinical Nutrition Week 2016, ASPEN, Abstract S21:25).

Patients who do not qualify for coverage and do not have a secondary major medical insurance policy are left with few desirable options, however Medicare beneficiaries do have coverage for PN in a skilled nursing facility (with Part A restrictions). If HPN does not meet coverage criteria because length of need was not permanent, the patient may have coverage in the skilled nursing facility setting (see table 4).

Transitioning to Medicare

A significant challenge for HPN consumers and infusion providers is when the consumer transitions from a commercial payer to Medicare when they meet disability criteria or turn 65 years old. There is no such thing as “grandfathering” of HPN coverage when a consumer flips to Medicare from another insurance company. Further, there are no clear guidelines from CMS on how to “qualify” consumers who are already on HPN who enroll into the Medicare program.

Sometimes physicians and providers must examine medical records and documented clinical situations from when the patient first started on PN, if these even exist, and attempt to qualify the patient retroactively. Most insurance providers require only a statement of “medical necessity” for HPN coverage. This means the Medicare criteria, including testing, objective studies, and length-of-need documentation, may never have been completed when HPN was started months or years before. It may be advantageous for consumers just starting on HPN to maintain a file of records in the event they may need them if/when they switch to Medicare.

Asking the physician to document an estimated length of need for PN therapy in the chart may also prove invaluable in the future. Most commercial payers do not follow a “permanent impairment” deal breaker for HPN coverage, so the documentation required by Medicare when PN was initiated, i.e., a statement of how long the attending physician thought the patient would need HPN, may not exist. Despite the fact that there is almost always medical necessity for HPN consumers switching to Medicare, there will be no coverage for HPN if: (1) there is no “qualifying” situation (A–H on table 1); (2) the objective evidence is not available to support the qualifying situation; or (3) there is no documented length of need of 90 days or longer, even in cases where a patient has been on HPN for many years.

Health care practitioners caring for HPN patients who will be turning 65 should guide those patients to examine all insurance options available regarding original Medicare, Medicare Advantage, or replacement plans before dropping existing insurance coverage.

Selecting a Provider

Selection of HPN/infusion providers who are fluent and compliant with Medicare law may protect beneficiaries from financial hardship down the road. Some providers will accept Medicare PN referrals quickly and without a thorough assessment, then later discontinue care when they learn there is no reimbursement from CMS. If an infusion provider quickly accepts a Medicare PN case without a complete review of the documentation prior to discharge, it should be a red flag to everyone involved, including the beneficiary. Qualified, reputable HPN providers offer consultative guidance in the way of a “records review” at the time of referral to help physicians navigate the complexity of the policy with the ultimate goal of protecting the beneficiary.

During open enrollment, consumers should investigate alternative insurance options and/or Medicare Advantage or replacement plans that offer more meaningful benefits if they will need home infusion now or in the future. Infusion providers should be able to provide guidance.

Conclusions

Until new laws are passed and coverage for HPN becomes more accessible under Medicare, referrals for HPN should be made as early as possible to allow for thorough examination and review of medical documentation and allow for the possibility that additional testing may be required by Medicare. This may help ensure that the beneficiary will have coverage for HPN and would not be at risk for denial of payment when an audit is conducted. As a consumer, it is important to understand the paperwork process when therapy is initiated. If your provider has assured you there is coverage under Medicare, there should be no need to sign an Advanced Beneficiary Notice (ABN) at the start of care. The ABN basically says the service may not be covered and you could potentially have financial liability. The ABN also allows the provider to bill a secondary insurance plan (if you have one), if Medicare denies coverage. If you are asked to sign, be sure you understand why.


Consumers and providers of HPN should develop a stronger understanding of the Medicare reimbursement system in order to advocate for access to care. Physicians should document the clinical necessity of HPN, backed up by objective evidence and testing, along with an estimated length of need for therapy for all patients going home on PN—as if they needed to meet Medicare criteria. Consumers who currently have private insurance may eventually transition to Medicare and this supporting documentation will be required for a successful transition and continuation of HPN therapy. Consumers switching to Medicare should not drop current insurance plans until they are familiar with Medicare options available should they require home infusion in the future. More information can be found at www.medicare.gov.

*In this article, patient, consumer, and Medicare beneficiary all refer to the person needing home parenteral nutrition (HPN).

**Provider refers to the home care company, or infusion company, that provides the HPN.


LifelineLetter, May/June 2017

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2/13/2020
Delmar NY Tube Feeding/TPN Support Group for Patients & Caregivers

This website is an educational resource. It is not intended to provide medical advice or recommend a course of treatment. You should discuss all issues, ideas, suggestions, etc. with your clinician prior to use. Clinicians in a relevant field have reviewed the medical information; however, the Oley Foundation does not guarantee the accuracy of the information presented, and is not liable if information is incorrect or incomplete. If you have questions please contact Oley staff.

 

Updated in 2015 with a generous grant from Shire, Inc. 

 

This website was updated in 2015 with a generous grant from Shire, Inc. This website is an educational resource. It is not intended to provide medical advice or recommend a course of treatment. You should discuss all issues, ideas, suggestions, etc. with your clinician prior to use. Clinicians in a relevant field have reviewed the medical information; however, the Oley Foundation does not guarantee the accuracy of the information presented, and is not liable if information is incorrect or incomplete. If you have questions please contact Oley staff.
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