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Home Infusion Coverage, FDA Regulation, and Your Care
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By: Kendall Van Pool, National Home Infusion Association, Vice President of Legislative Affairs

 

At the Oley Annual Consumer/Clinician Conference in 2016 in Newport Beach, California, I had the chance to interface with many of the other attendees. It was my first Oley conference, and being there for me was educational on many levels. First, just getting to know everyone there really solidified for me what people who need enteral [tube feeding] and parenteral [IV] nutrition go through on a daily basis. It certainly isn’t easy!

I also got to know what is important to you in your daily lives—like getting the health care services you need covered, problems with the insurance coverage you already have, and ensuring that drugs and services you need are ultimately available.

I want to thank everyone who came by the National Home Infusion Association (NHIA) exhibit or others that I met along the way for bringing me into your lives and telling your story. Without that firsthand experience, it’s easy to assume you know what you really don’t know.

This is why advocacy is so important. Just like me, members of Congress and the Administration have no way of knowing what goes on in your daily lives and what your struggles are unless you tell them. As Bettemarie Bond and I noted in our talk during the general session on Wednesday, you just need to take the first step to advocacy and it all goes from there.

Regulatory Advocacy Issues: The Food and Drug Administration’s Memorandum of Understanding

 

NHIA has serious concerns with the Food and Drug Administration’s 2015 released “Memorandum of Understanding (MOU) Addressing Certain Distributions of Compounded Human Drug Products Between the States and the Food and Drug Administration; New Proposed Draft; Availability.” If the Food and Drug Administration (FDA) finalizes the draft MOU as it is currently written, NHIA believes patient access to parenteral nutrition (PN) will be unreasonably harmed.

This MOU was written because the Drug Quality and Security Act requires the FDA to issue a new standard MOU for the states, in consultation with the National Association of Boards of Pharmacy, that “addresses the distribution of inordinate amounts of compounded drug products interstate and provides for appropriate investigation by a State agency of complaints relating to compounded drug products distributed outside such State.”

This MOU, however, restricts not only the “distribution” of compounded drug products (such as PN), but also restricts the “dispensing” of these compounded products. “Dispensing” is different from “distribution.” “Dispensing” a compounded drug product is the act of providing that drug product directly from the pharmacy to the individual, whereas “distribution” is providing that drug product to another health care provider to then dispense to an individual.

As a result, the MOU could restrict the quantity of PN a pharmacy could dispense to you if you are not located in the state where that PN is compounded. In addition, the amount deemed “inordinate” in the MOU is arbitrary, and this arbitrary cap on the interstate dispensing of compounded products could result in a shortage of home infusion drugs and a lack of competition among providers in certain areas of the country.

We are urging the FDA to alter the MOU so that the final MOU will be limited to interstate distribution (not dispending) of compounded drugs. We are also urging you to take action and to advocate on this issue by submitting comments to the FDA open docket. Go to www.regulations.gov/#!submitComment;D=FDA-2015-N-0030-0001, then submit your message and your information. Here is a draft comment to get you started; we recommend you personalize this message:

“I am commenting to the FDA to note my concern with the draft Memorandum of Understanding (MOU). As someone that needs parenteral nutrition, this draft MOU could harm my care. By limiting the number of compounded products a pharmacy can ship interstate for direct dispensing to people like myself, the MOU could cause me to lose my current parenteral nutrition provider. It is vitally important that dispensing over state lines not be included in the calculation to determine what an inordinate amount of distributed compounded products is. Thank you for considering my perspective as someone that could be adversely affected by this issue.”

Congressional Advocacy Issues: The Medicare Home Infusion Site of Care Act

 

The Medicare Home Infusion Site of Care Act of 2015 (S. 275 / H.R. 605), introduced by Senators Johnny Isakson (R-GA) and Mark Warner (D-VA) and Representatives Eliot Engel (D-NY) and Pat Tiberi (R-OH), ensures that Medicare beneficiaries can receive infusion treatments in the home. Infusion therapy is fully covered by Medicare in hospitals, skilled nursing facilities, hospital outpatient departments, and physician offices, but not in the home. While IV antibiotics may be covered in the home, for example, the nursing services and tubing to administer the antibiotics may not be covered. This bill provides a pathway for reimbursement for the professional services, supplies, and equipment associated with infusion therapy in the home under Medicare Part B, thus enabling the current Part D and limited Part B coverage of infusion drugs to become meaningful for Medicare beneficiaries.

The Medicare fee-for-service program stands virtually alone among payers in the United States in not fully recognizing the clinical and cost benefits of providing infusion drug therapy to patients in their homes. As a result, Medicare beneficiaries in need of infusion therapy often must receive their treatments in health care facilities rather than in the setting that is the most desirable, convenient, and by far the most cost effective—their homes.

This lack of coverage can lead to substantial beneficiary lifestyle disruptions and costs. The Medicare beneficiary either has to travel to a health care facility to receive infusion treatments—sometimes multiple times a day—or remain in a facility for the duration of the treatment episode in order to receive coverage.

Currently, all signs point to the technical assistance process on the Medicare Home Infusion Site of Care Act (MHISCA) coming to a close. This process is a way for Congress to work with the Centers for Medicare and Medicaid Services (CMS) to ensure the federal agency can implement the legislation they are writing. This process can be long and arduous, but it streamlines implementation later on.

After technical assistance is finalized, the MHISCA will undergo an economic analysis called scoring. This practice, conducted by the Congressional Budget Office, will most likely take up the balance of this summer. The resulting “score” is a cost estimate of the proposed legislation’s effect on the federal budget, and could very well determine the prospects for passage of the MHISCA. During this time, furthering congressional education on the bill and garnering cosponsors remain vital to passage.

Although we are optimistic about the way these steps are progressing, we need to keep the pressure on Congress to get this done. Recess is often thought of as a time to relax. But, for members of Congress, recess is a time to go home and meet with constituents and stakeholders. This is a period when they interface with constituents and tap into the local buzz of their community. While in Washington, they often hear from lobbyists and other advocates, but they don’t interface as much with the individuals they represent and the voters who put them in office. While lobbyists and advocates can inform elected officials on specific issues, the most vocal constituents often drive their actions, especially in an election year.

Lawmakers’ schedules are almost always packed during recess. The typical recess schedule will include town hall meetings, listening sessions, visits to local businesses, and meetings with individual constituents. This is also true for the many staff members working for our members of Congress. The staff is often from the state or district of the member of Congress and they usually take the time to return home to attend events and meetings with their boss or on their own. They may be in the district or state for less time, but they are certainly active during this time period, often exploring areas of policy in which they specialize.

Resources


NHIA has materials to support you in this work on our website at nhia.org/resource/legislative. You don’t have to do it alone. We stand prepared to help on a personal level also. Now is the time to work to get the Medicare Home Infusion Site of Care Act passed. That means educating elected officials on the value of home infusion therapy and asking them to cosponsor this legislation for the benefit of their constituents who need access to IV services at home.

Most members of Congress have not forgotten that “all politics is local.” Let’s let them know that America’s Medicare beneficiaries deserve the option to receive infusion in their home and that they can provide this option while saving the government money.

It Is About You


At the Oley meeting, I spoke with several people on long-term home nutrition support who are dealing with Medicare’s failing coverage structure for home infusion. Many of them had stories to tell regarding the challenges they faced getting hydration covered under Medicare.

One of the young women I met who has short bowel syndrome is advocating in her home state on several issues. She was kind enough to share with me her concern about a possible future where she is on disability and unable to access home infusion therapy due to a lack of Medicare coverage. To her, MHISCA not passing represents a real fear.

She is telling her story and you need to do the same. It is your stories that will affect change!

Kendall Van Pool is NHIA’s Vice President of Legislative Affairs. He can be reached at (703) 838-2664 or Kendall.VanPool@nhia.org.


LifelineLetter, July/August 2016

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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