340B Health Comment Template for HRSA’s Proposed Guidance
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Template for Preparing Comments to
HRSA’s Proposed Mega-Guidance
For more than 20 years, the 340B program has allowed safety net providers to stretch scarce federal resources to provide more care to more patients. As the providers who serve low-income, uninsured, geographically isolated and other vulnerable patients, Congress selected your organizations for participation in the 340B program. On August 28, 2015 the Health Resources and Services Administration (HRSA) released its long-anticipated omnibus guidance, which proposes changes to virtually every aspect of the 340B program. Based on our analysis and conversations with numerous member hospitals, we are concerned that certain provisions in the proposed mega-guidance, if adopted, would significantly reduce 340B savings and ultimately limit the ability of 340B hospitals to continue to provide services to vulnerable patients. It is imperative that 340B Health members inform HRSA about their concerns with the mega-guidance, especially how it would negatively impact your ability to care for patients. This document instructs 340B Health members on how to prepare and submit comments to HRSA, which are due by October 27.
DRAFTING INSTRUCTIONS
Your hospital may submit comments on the proposed mega-guidance using one of three methods. First and preferred by HRSA, you may submit comments through the Federal eRulemaking Portal. You may also mail your comments to HRSA via a letter addressed to Captain Krista Pedley, Director, Office of Pharmacy Affairs, Health Resources and Services Administration, 5600 Fishers Lane, Mail Stop 08W05A, Rockville, MD 20857. Alternatively, you can e-mail your comments to HRSA at . If you email your hospital’s comments, include RIN 0906-AB08 in the subject line of the e-mail message. You should include the RIN number in your comments regardless of which method you use.
You should begin your comments by providing background information about your institution. Focus on various ways in which it functions as a safety net institution. A description of your hospital’s payer mix and/or uncompensated care levels would be helpful. Then describe your hospital’s outpatient pharmacy program. You can conclude this background section by explaining how the 340B program has benefited both your hospital and its patients, especially low-income patients and other vulnerable populations.
The next step would be to provide comments on specific provisions that would have a significant impact on your hospital. See 340B Health surveys, webinars, and tools to assist you in identifying the key areas of impact, all of which are available in the 340B Health Proposed Mega-Guidance Resource Center. You do not need to comment on all areas addressed in this template. We recommend that you review the possible areas for comment and focus on the most important issues for your hospital. Commenting on a single area of great impact to your hospital, especially with detail on how your patients could be affected, is more likely to be persuasive than providing brief comments on many aspects of the guidance.
Below we suggest comments on areas that appear to have the most significant impact for hospitals (both positive and negative). The general outline for these comments would be to identify the provision of concern, discuss why the provision is inconsistent with the purpose of the 340B program to allow safety-net providers to stretch resources and provide more services to more patients (sample bullet points are provided below), and then describe how the proposal would impact your ability to provide services to your low income patients.
HRSA will be interested in specific examples that explain how the mega-guidance will negatively impact your institution’s ability to treat vulnerable patients, so it is imperative that your hospital include specific examples of impact in your comments. This document highlights sample examples to help hospitals produce examples specific to your hospital that you could include in your letter to HRSA. We strongly encourage hospitals to include as many examples as possible in your comments that are specific to your hospital and the impact the proposed guidance would have on your low-income patient population.
In addition, we recommend the following:
1. Health systems submit individual letters for each of the system’s 340B hospitals that are specific to that hospital.
2. Copy your U.S. Senators and Congressional Representatives on your comments, so that they are aware of your concerns
3. Ask for a transition period before any new requirements would become effective. 340B Health intends to request a one year transition period, as that seems the minimum amount necessary for changes that may require development of new software systems
4. Include examples of how government spending could increase as a result of HRSA’s proposed limits on 340B use (e.g., increased Medicaid or Medicare spending because their reimbursement to your hospital will increase as your drug costs increase)
For questions please contact Maureen Testoni at 202-5525851 or , Jeff Davis at 202-552-5867 or , or Greg Doggett at 202-552-5859 or . To schedule a call with 340B Health staff, please contact Charlie Hayes at 202-536-2288 or .
COMMENT TEMPLATE
This template addresses the following areas of the proposed mega-guidance. Please do not feel you need to address each area and feel free to comment on topics not addressed below that you believe are of concern to your hospital:
1. Hospital relationships with their providers ………………………………………………………………..3
2. Infusion orders written outside the hospital ………………………………………………………………4
3. Discharge prescriptions….………………………………………………………………………………….5
4. Drugs administered to outpatients that are not billed as outpatient …………………………………...6
5. Bundled Medicaid drugs ……………………………………………………………………………………7
6. Scripts written in connection with services furnished outside the hospital ……………………………9
a. Affiliated clinics
b. Referrals
7. Medicaid Managed Care ………………………………………………………………………………….10
8. GPO Prohibition …………………………………………………………………………………………...10
9. Self-disclosure ……………………………………………………………………………………………..13
10. Repayment …………………………………………………………………………………………………13
11. Hospital eligibility ....……………………………………………………………………………………….14
12. Child site eligibility ………………………………………………………………………………………...14
a. Options for improving registration process
b. Inclusion of locations that do not treat Medicare patients
13. Contract pharmacy ……………………………………………………………………………………...... 17
14. Audits ……………………...………………………………………………………………………………..17
15. Inventory management …………………………………………………………………………………...18
16. Manufacturer provisions ………………………………………………………………………………….19
1. Hospital Relationships with Their Providers
a. We do not understand what HRSA intends with the requirement that we have employment or independent contractor relationships with our providers such that we may bill for their services
b. We request that HRSA remove this requirement, as the remaining requirements in this area already limit 340B use to services and prescriptions that are written in the hospital or one of its registered locations, thereby ensuring hospital responsibility for the services
c. If HRSA intends to maintain this requirement, then we request that HRSA revise and republish it for comment. As written, we do not believe we have a meaningful opportunity to comment because the language used is too vague
d. If HRSA intends for this provision to impose new standards for the health industry regarding provider contracting (e.g., outside of what is currently required by health programs and the Joint Commission), HRSA needs to more clearly articulate what would be required
e. Issues related to who is an “independent contractor” of the hospital:
i. The guidance would require that for a provider to be able to write a prescription or order for a 340B drug, the provider must be an employee or “independent contractor” of the hospital.
ii. Using an “independent contractor” standard is not appropriate for guidelines, as the legal rules in this area are not subject to a national standard and vary significantly by state and even within states.
1. I am located in a state that prohibits hospitals from billing for the professional services for our physicians, so we could never meet this requirement.
iii. HRSA audits have permitted privileging arrangements to validate 340B use when the patient’s service or prescription was provided on the premises of the hospital or a registered child site. This current standard permits 340B use for individuals who are clearly hospital outpatients. It is unclear to us whether HRSA is proposing a different test under this proposal.
iv. One interpretation of this proposal would be that hospitals must have employment or written contractual arrangements in addition to privileging arrangements with their providers. Such a requirement would have a significantly detrimental impact on our participation in the 340B program. We employ just __% of our providers. We have privileging but no other arrangements with __% of our providers. If these new rules were to go in place, we would have to enter into new arrangements with all of our providers, which would be operationally challenging, if not impossible. If some providers would not agree to enter into new types of contracts, we would not be able to use 340B for individuals that are clearly hospital patients.
f. Issues related to what HRSA means by “may bill for services on behalf of the provider”:
i. The language stating that hospitals must have arrangements such that they “may bill for services on behalf of the provider” is even more unclear. Does this refer to services that hospitals bill in connection to services furnished by a provider (e.g., the facility fee)? Or does it refer to billing for the professional services furnished by our providers? We currently bill for the professional services provided by just __% of our providers.
ii. We do not believe that we would ever be in a position to bill for 100% of the professional services of our physicians because _____ (e.g., physicians prefer to bill for their own services; we are in a state that prohibits hospitals from billing for physician services, etc.)
iii. This would reduce our 340B savings by $______or ___%, which would limit our ability to provide the following services/programs to our low income patients: ______
iv. Disallowing 340B for scripts written by providers in our hospital is unworkable operationally. We would have to consider dropping out of the 340B program. [describe the operational challenges you would face if you could only use 340B for scripts/orders when your hospital was also billing for the professional services furnished by the provider]
2. Orders for Infusion
a. The proposed guidance would only allow 340B for infusion orders if they were written as a result of services provided in the hospital or a registered child site.
b. Describe your hospital’s use of infusion, particularly how you are able to provide low-income individuals with infusion and/or able to save your patients from traveling great distances to receive infusion. For example, if you have a large caseload of Medicaid and self-pay patients, you may not be able to continue your infusion clinic without access to 340B discounts to offset low reimbursement rates. Other hospitals may use savings from their infusion clinics to support discounted drugs or other services for low income individuals in other areas of the hospital.
c. Individuals receiving infusion at the hospital are unquestionably hospital patients, even if the order is written in a location outside the hospital. The individuals are registered as hospital patients and the hospital is responsible for administering the infusion and is required to provide health care services in conjunction with the drug’s administration. [describe hospital’s procedure for registering and maintaining records for such patients]
d. No other government program or other health care payer requires infusion orders to be written at the hospital as a condition of payment. HRSA is proposing a 340B-specific requirement for infusion orders that does not exist anywhere in health care policy.
e. Administration of infusion drugs are highly complex services, requiring skill and direct attention, and may only be performed by trained health care professionals. Failure to administer infusion drugs appropriately can result in severe consequences for the patient, for which the hospital is responsible. [provide examples of clinical care furnished during administration, e.g., monitoring of infusion rate, blood pressure, conferring with supervising physician, etc.]
f. For hospitals subject to the GPO prohibition: The concerns about this proposal exist even if GPO pricing were permitted for these drugs.
g. Imposing this unique 340B standard would require hospitals to develop new tracking systems to distinguish their outpatients for whom an order was written on the premises of the hospital and those for whom the order was written outside the hospital. Since the individuals receive the same hospital outpatient services in both cases, this tracking is not currently necessary and would impose a new burden on safety-net hospitals and is one that may not even be feasible. [describe concerns you have about complying with this standard from an operational perspective]
Examples of how the inability to use 340B for infusion orders written outside the hospital would impact your institution’s ability to treat vulnerable patients could include:· I would lose $____ in savings by not being able to use 340B for infusion orders written outside the hospital. This loss of savings would limit my hospital’s ability to provide the following services: ______.
· Provide a patient-specific example of what your hospital does in this area. One hospital shared with us the example of low-income patients who receive regular infusions of Simponi for their rheumatoid arthritis. This hospital significantly discounts this very expensive medication, which it would not be able to do without 340B savings.
· My hospital is staffed by primary care providers and we do not have specialists or oncologists on site, so the orders for the infusion services we provide come from outside the hospital. The 340B savings we obtain from infusion orders allow us to provide infusion services to low income or vulnerable patients. [include number or percent of patients that fall into this category, or the value of uncompensated care in this area.] If my hospital were not able to use 340B for infusion orders written outside the hospital, we may no longer be able to provide these infusion services.
· We are in a rural area and provide the only infusion services for __ miles. If this provision goes into effect, we may not be able to maintain our infusion clinic, and our low-income, vulnerable patients would have to travel __ miles away to receive infusions.
· The majority of the infusions administered in my hospital’s infusion clinics are for orders written outside the hospital because we treat low-income patients sent to us by providers in the community. The community providers do not want to treat these patients. If we were not able to use 340B for these infusion orders, we may no longer be able to sustain the levels of free and discounted care in this area that we currently provide.
· If we can’t use 340B for infusion orders written outside the hospital, we will likely withdraw from the program because savings from these orders account for __% of our 340B savings. We currently use these savings to ______.
3. Discharge Prescriptions