82 FR 3006 - Request for Information From Organizations Utilizing Business Models Supporting Private Sector Vaccine Management

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 82, Issue 6 (January 10, 2017)

This is a Request for Information (RFI) about business models, existing, under development or planned, that support health care providers for any of the components related to private-sector immunization services (e.g., excluding vaccines provided through federal and state programs, such as the Vaccines for Children Program, Children's Health Insurance Program, Medicaid, and Medicare): Vaccine purchase, distribution, storage and handling, inventory management, reporting to Immunization Information Systems (IIS), including models for populating IIS directly/automatically from electronic health records (EHRs), immunization coverage assessment, forecasting vaccine demand, and billing. The RFI is being issued by the National Vaccine Program Office (NVPO) of the U.S. Department of Health and Human Services. The NVPO is located in the Office of the Assistant Secretary for Health (ASH), Office of the Secretary (OS), U.S. Department of Health and Human Services (HHS). The NVPO is responsible for coordinating and ensuring collaboration among the many federal agencies involved in vaccine and immunization activities. The National Vaccine Program was established in compliance with Title XXI of the Public Health Service Act (Pub. L. 99-660) (Sec. 2101) (42 U.S. Code 300aa-et seq (PDF--78 KB)) to achieve optimal prevention of human infectious diseases through immunization and to achieve optimal prevention against adverse reactions to vaccines. Development of a National Vaccine Plan (NVP) has been mandated to the NVPO as a mechanism for the Director of the National Vaccine Program (the Assistant Secretary for Health) to communicate priorities for both federal and non-federal stakeholders regarding vaccine research and the development, testing, licensing, production, procurement, distribution, and effective use of vaccines in order to carry out the program's responsibilities. Goal 4 of the plan, Ensure a Stable Supply of, Access to, and Better Use of Recommended Vaccines in the United States, focuses in part on increasing and improving access to vaccines in health care provider settings. This RFI seeks information on innovative business models to support health care providers to increase and improve their ability to provide immunization services, as described below. In its efforts to promote vaccination coverage across the lifespan, the NVPO is seeking information about business models, existing, under development or planned, that enable health care providers to offer vaccines to their privately-insured/private-pay patients. The NVPO is most interested in innovative business models aimed at reducing any of the barriers to implementing vaccination services such as vaccine purchase, billing, storage and handling, IIS reporting, including models for populating IIS directly/automatically from EHRs, forecasting vaccine demand, and managing private vaccine inventories. In addition, the NVPO is interested in models that can demonstrate improvements in the immunization coverage rates of the patients seen in the health care settings utilizing such models as well as improvements in reporting to IIS.

[Federal Register Volume 82, Number 6 (Tuesday, January 10, 2017)]
[Notices]
[Pages 3006-3007]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-00245]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Request for Information From Organizations Utilizing Business 
Models Supporting Private Sector Vaccine Management

AGENCY: National Vaccine Program Office, Office of the Assistant 
Secretary for Health, Office of the Secretary, Department of Health and 
Human Services.

ACTION: Notice.

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SUMMARY: This is a Request for Information (RFI) about business models, 
existing, under development or planned, that support health care 
providers for any of the components related to private-sector 
immunization services (e.g., excluding vaccines provided through 
federal and state programs, such as the Vaccines for Children Program, 
Children's Health Insurance Program, Medicaid, and Medicare): Vaccine 
purchase, distribution, storage and handling, inventory management, 
reporting to Immunization Information Systems (IIS), including models 
for populating IIS directly/automatically from electronic health 
records (EHRs), immunization coverage assessment, forecasting vaccine 
demand, and billing. The RFI is being issued by the National Vaccine 
Program Office (NVPO) of the U.S. Department of Health and Human 
Services.
    The NVPO is located in the Office of the Assistant Secretary for 
Health (ASH), Office of the Secretary (OS), U.S. Department of Health 
and Human Services (HHS). The NVPO is responsible for coordinating and 
ensuring collaboration among the many federal agencies involved in 
vaccine and immunization activities.
    The National Vaccine Program was established in compliance with 
Title XXI of the Public Health Service Act (Pub. L. 99-660) (Sec.  
2101) (42 U.S. Code 300aa-et seq (PDF--78 KB)) to achieve optimal 
prevention of human infectious diseases through immunization and to 
achieve optimal prevention against adverse reactions to vaccines. 
Development of a National Vaccine Plan (NVP) has been mandated to the 
NVPO as a mechanism for the Director of the National Vaccine Program 
(the Assistant Secretary for Health) to communicate priorities for both 
federal and non-federal stakeholders regarding vaccine research and the 
development, testing, licensing, production, procurement, distribution, 
and effective use of vaccines in order to carry out the program's 
responsibilities. Goal 4 of the plan, Ensure a Stable Supply of, Access 
to, and Better Use of Recommended Vaccines in the United States, 
focuses in part on increasing and improving access to vaccines in 
health care provider settings. This RFI seeks information on innovative 
business models to support health care providers to increase and 
improve their ability to provide immunization services, as described 
below.
    In its efforts to promote vaccination coverage across the lifespan, 
the NVPO is seeking information about business models, existing, under 
development or planned, that enable health care providers to offer 
vaccines to their privately-insured/private-pay patients. The NVPO is 
most interested in innovative business models aimed at reducing any of 
the barriers to implementing vaccination services such as vaccine 
purchase, billing, storage and handling, IIS reporting, including 
models for populating IIS directly/automatically from EHRs, forecasting 
vaccine demand, and managing private vaccine inventories. In addition, 
the NVPO is interested in models that can demonstrate improvements in 
the immunization coverage rates of the patients seen in the health care 
settings utilizing such models as well as improvements in reporting to 
IIS.

DATES: Information from Organizations Utilizing Business Models 
Supporting Private Sector Vaccine Management responsive to this RFI 
should be submitted as described in the ADDRESSES section below no 
later than midnight, 12:00 a.m. EDT on January 25, 2017.

ADDRESSES: Information from Organizations Utilizing Business Models 
Supporting Private Sector Vaccine Management responsive to this RFI 
should be submitted in Portable

[[Page 3007]]

Document Format (PDF) only and be submitted via email to [email protected]. 
The name(s) of all PDF files uploaded should begin with 
``NVPO_RFI_MODEL'' followed by the organization name and the sequential 
number of the file, if more than one file is submitted. All submissions 
responsive to this RFI must be made as indicated above. Mailed paper 
submissions will not be reviewed.

FOR FURTHER INFORMATION CONTACT: National Vaccine Program Office, 
Office of the Assistant Secretary for Health, Department of Health and 
Human Services; telephone (202) 690-5566; email: [email protected].

SUPPLEMENTARY INFORMATION: Responses to this RFI should include the 
organization's full name and headquarters location. They should also 
include the name of a point-of-contact and his/her email and 
conventional mailing addresses. Companies are invited to respond to the 
following request for information:
    1. Description of the business model, existing, under development 
or planned, and how it addresses any of the following:
    a. Purchase of vaccines for privately-insured/private pay patients
    b. Bill private insurers for vaccines and vaccine administration
    c. Proper storage and handling of privately-purchased vaccines
    d. Management of private vaccine inventories separate from public 
vaccine inventories
    e. Report vaccine administration to IIS, including models for 
populating IIS directly/automatically from EHRs
    f. Forecast vaccine demand
    g. Quality improvement efforts to improve vaccination coverage
    h. Ability to conduct mass vaccination clinics as part of an 
emergency response
    i. Implementation of vaccination as part of occupational health 
clinics (including federally-sponsored occupational health clinics).
    2. Description of the practices served, or planned to be served, 
including geographic locations, patients served (e.g., pediatrics, 
specialists, health care providers serving adults, etc.), and practice 
types (e.g., large health system, private practices, group practices, 
etc.).
    3. Summary of any evaluations of the business model's effectiveness 
in expanding accessibility to vaccines for privately-insured patients 
to new groups of health care providers who did not previously provide 
immunizations or to existing health care providers to expand their 
immunization services and/or improvements in vaccination coverage for 
patients served by participating practices.

This request for information is for informational purposes only and 
shall not be construed as a solicitation for funding applications/
proposals or as creating an obligation on the part of the government. 
The government will not pay for the preparation costs of any 
information submitted in response to this RFI. Responses to any of the 
above areas are welcome; respondents should not feel compelled to 
address all the issues identified in the request. Responses will be 
compiled without company identifiers and shared with HHS Operating 
Divisions (e.g., the Centers for Disease Control and Prevention) and 
advisory committees as appropriate. Public release of the data 
submitted is governed by the Freedom of Information Act (https://www.hhs.gov/foia/). Response to the RFI will not be returned.
    Information collection sponsored by the NVPO required for the 
purposes of informing the National Vaccine Program and the National 
Vaccine Plan is not subject to Chapter 35 of title 44, United States 
Code [the Paperwork Reduction Act] as indicated in 42 U.S.C. 300aa-1 
note (section 321 of Pub. L. 99-660).

    Dated: January 4, 2017.
Roula K. Sweis,
Chief of Operations and Management, National Vaccine Program Office.
[FR Doc. 2017-00245 Filed 1-9-17; 8:45 am]
 BILLING CODE 4150-44-P