HIGHMARK COMMERCIAL MEDICAL POLICY - PENNSYLVANIA

 
 

Medical Policy:
I-88-032
Topic:
Granulocyte Colony-Stimulating Factors
Section:
Injections
Effective Date:
April 1, 2024
Issued Date:
April 1, 2024
Last Revision Date:
March 2024
Annual Review:
November 2023
 
 

The class of drugs known as granulocyte colony stimulating factors (G-CSFs) include: filgrastim (Neupogen®), filgrastim-sndz, (Zarxio®), filgrastim-aafi (Nivestym®), filgrastim-ayow (Releuko) pegfilgrastim (Neulasta®) (Neulasta® Onpro®), pegfilgrastim-jmdb (Fulphila™), pegfilgrastim-cbqv (Udenyca™), pegfilgrastim-bmez (Ziextenzo™), pegfilgrastim-apgf (Nyvepria™), pegfilgrastim-fpgk (Stimufend®), pegfilgrastim-pbbk (Fylnetra®), tbo-filgrastim (Granix®) eflapegrastim-xnst (Rolvedon™) and efbemalenograstim alfa-vuxw (Ryzneuta®). Sargramostim (Leukine®) is a granulocyte-macrophage colony-stimulating factor (GM-CSF).

Febrile neutropenia (FN) is defined as a single temperature equal to or greater than 38.3°C, or a temperature equal to or greater than 38.0°C over 1 hour, and neutrophils less than 500 mcL.

G-CSFs are a blood growth factor that stimulates the bone marrow to produce more infection-fighting white blood cells known as neutrophils. These neutrophils are then released into the blood stream where they aid in fighting infection. When neutrophil levels drop and an individual becomes neutropenic, the body is less able to fight off infection. Individuals at high risk to develop these types of conditions may be clinically indicated for the administration of G-CSFs.

Policy Position

Note: Risk assessment for use of G-CSFs includes (not an all-inclusive list) disease type, chemotherapy regimen (high-dose, dose-dense, or standard-dose), risk factors, and treatment intent (curative/adjuvant vs. palliative). Independent clinical judgment should be exercised based on the individual’s situation.

Preferred Pegfilgrastim Products

Pegfilgrastim (Neulasta), pegfilgrastim-jmdb (Fulphila), pegfilgrastim-bmez (Ziextenzo) are the preferred G-CSF pegfilgrastim products for all Food and Drug Administration (FDA) approved indications.

J2506

Q5108

Q5120

 

 

 

 




Non- Preferred Pegfilgrastim Eflapegrastim, and Efbemalenograstim Products

In order for a request for a non-preferred product [pegfilgrastim-cbqv (Udenyca), pegfilgrastim-apgf (Nyvepria) ™) pegfilgrastim-fpgk (Stimufend), pegfilgrastim-pbbk (Fylnetra) eflapegrastim-xnst (Rolvedon) or efbemalenograstim alfa-vuxw (Ryzneuta)] to be approved the individual must have had an adequate therapeutic trial and experienced a documented drug therapy failure or intolerance to the preferred product(s) or the preferred product is contraindicated.

Adequate therapeutic trial is defined as three (3) months following the injection series at FDA or compendia based therapeutic doses of preferred product.

Q5111

Q5122

Q5127

Q5130

J3590

 

 




Preferred Filgrastim Products

Filgrastim-sndz (Zarxio) and filgrastim-aafi (Nivestym) are the preferred G-CSF filgrastim products for all Food and Drug Administration (FDA) approved indications.

Q5101

Q5110

 

 

 

 

 




Non- Preferred Filgrastim  Products

In order for a request for a non-preferred product [filgrastim (Neupogen), filgrastim-ayow (Releuko), and tbo-filgrastim (Granix)] to be approved the individual must have had an adequate therapeutic trial and experienced a documented drug therapy failure or intolerance to the preferred product(s) or the preferred product is contraindicated.

Adequate therapeutic trial is defined as three (3) months following the injection series at FDA or compendia based therapeutic doses of preferred product.

J1442

J1447

Q5125

 

 

 

 




Filgrastim (Neupogen) may be considered medically necessary for ANY of the following indications:

  • For individuals with nonmyeloid malignancies receiving myelosuppressive anticancer drug therapy associated with significant incidence of severe neutropenia with fever to decrease incidence of infection; or
  • Individuals with acute myeloid leukemia (AML) following induction or consolidation chemotherapy to reduce the time to neutrophil recovery and duration of fever; or
  • Individuals with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT) to reduce duration of neutropenia and neutropenia-related clinical sequelae; or
  • Individuals undergoing autologous peripheral blood progenitor cell collection and therapy for mobilization of hematopoietic progenitor cells into peripheral blood for collection by leukapheresis; or
  • For chronic administration in individuals with severe chronic neutropenia to reduce incidence and duration of sequelae of neutropenia in symptomatic individuals with congenital neutropenia, cyclic neutropenia, or idiopathic neutropenia; or
  • Individuals acutely exposed to myelosuppressive doses of radiation in hematopoietic acute radiation syndrome (H-ARS) to increase survival; or

Compendia Sources

Filgrastim (Neupogen) may be considered medically necessary for treatment of any of the current category 1, 2A, or 2B NCCN recommendations

J1442

 

 

 

 

 

 




Filgrastim-sndz (Zarxio) and filgrastim-aafi (Nivestym) may be considered medically necessary for ANY of the following:

  • To decrease the incidence of infection as manifested by febrile neutropenia in individuals with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever; or
  • For individuals with AML following induction or consolidation chemotherapy to reduce the time to neutrophil recovery and duration of fever following treatments; or
  • For individuals with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by BMT to reduce duration of neutropenia and neutropenia-related clinical sequelae; or
  • For individuals undergoing autologous peripheral blood progenitor cell collection and therapy for mobilization of hematopoietic progenitor cells into peripheral blood for collection by leukapheresis; or
  • For chronic administration in individuals with severe chronic neutropenia to reduce incidence and duration of sequelae of neutropenia in symptomatic individuals with congenital neutropenia, cyclic neutropenia, or idiopathic neutropenia; or

Compendia Sources

Filgrastim-sndz (Zarxio) and filgrastim-aafi (Nivestym) may be considered medically necessary for treatment of any of the current category 1, 2A, or 2B NCCN recommendations.

Q5101

Q5110

 

 

 

 

 




Tbo-filgrastim (Granix) may be considered medically necessary for ANY of the following:

  • To reduce the duration of severe neutropenia in adult and pediatric individuals one (1) month and older with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of FN; or

Compendia Sources

Tbo-filgrastim (Granix) may be considered medically necessary for treatment of any of the current category 1, 2A, or 2B NCCN recommendations.

J1447

 

 

 

 

 

 




Filgrastim-ayow (Releuko) may be considered medically necessary for ANY of the following:

  • Individuals with nonmyeloid malignancies receiving myelosuppressive anti- cancer drugs associated with a significant incidence of severe neutropenia with fever to reduce the incidence of infection‚ as manifested by febrile neutropenia; or
  • For individuals with AML following induction or consolidation chemotherapy treatment to reduce the time to neutrophil recovery and the duration of fever; or
  • For individuals with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by BMT to reduce duration of neutropenia and neutropenia-related clinical sequelae; or
  • For chronic administration in individuals with severe chronic neutropenia to reduce incidence and duration of sequelae of neutropenia in symptomatic individuals with congenital neutropenia, cyclic neutropenia, or idiopathic neutropenia; or

Compendia Sources

Filgrastim-ayow (Releuko) may be considered medically necessary for treatment of any of the current category 1, 2A, or 2B NCCN recommendations.

Q5125

 

 

 

 

 

 




Pegfilgrastim (Neulasta) and (Neulasta Onpro) may be considered medically necessary for ANY of the following:

  • Individuals with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of FN to decrease the incidence of infection; or
  • Individuals acutely exposed to myelosuppressive doses of radiation in H-ARS to increase survival;or

Compendia Sources

Pegfilgrastim (Neulasta) and (Neulasta Onpro) may be considered medically necessary for treatment of any of the current category 1, 2A, or 2B NCCN recommendations; or

 Other Compendia Supported Recommendations, Class 2b and Higher

  • For harvesting peripheral blood stem cells prior to autologous stem-cell transplantation

J2506

96377

 

 

 

 

 




Pegfilgrastim-jmdb (Fulphila), pegfilgrastim-apgf (Nyvepria) pegfilgrastim-pbbk (Fylnetra) eflapegrastim-xnst (Rolvedon) and efbemalenograstim alfa-vuxw (Ryzneuta) may be considered medically necessary for ANY the following:

  • To decrease the incidence of infection as manifested by febrile neutropenia in individuals with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever.

Compendia Sources

Pegfilgrastim biosimilars (Fulphila, Nyvepria, Fylnetra) eflapegrastim-xnst (Rolvedon) and efbemalenograstim alfa-vuxw (Ryzneuta) may be considered medically necessary for treatment of any of the current category 1, 2A, or 2B NCCN recommendations.

Note: Pegfilgrastim biosimilars (Fulphila, Ziextenzo, Nyvepria, Fylnetra), eflapegrastim-xnst (Rolvedon) and efbemalenograstim alfa-vuxw (Ryzneuta) are not indicated for the mobilization or peripheral blood progenitor cells for hematopoietic stem cell transplantation.

Q5108

Q5122

Q5130

J3590

 




Pegfilrastim-cbqv  (Udenyca) pegfilgrastim-fgpk (Stimufend) and pegfilgrastim-bmez (Ziextenzo) may be considered medically necessary for ANY the following:

  • Individuals with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of FN, to decrease the incidence of infection; or
  • Individuals acutely exposed to myelosuppressive doses of radiation in H-ARS, to increase survival; or

Compendia Sources

Pegfilrastim biosimilars (Udenyca, Stimufend, Ziextenzo) may be considered medically necessary for treatment of any of the current category 1, 2A, or 2B NCCN recommendations.

Q5111

Q5120

Q5127

 

 

 

 




Sargramostim (Leukine) may be considered medically necessary for ANY of the following indications:

  • Individuals 55 years and older with AML following induction chemotherapy to shorten time to neutrophil recovery and to reduce the incidence of severe and life-threatening infections and infections resulting in death; or
  • Adult individuals undergoing mobilization of hematopoietic progenitor cells into peripheral blood for collection by leukapheresis and autologous transplantation; or
  • Individuals 2 years of age or older for the acceleration of myeloid reconstitution following autologous bone marrow or peripheral blood progenitor cell transplantation; or
  • Individuals 2 years or age or older for the acceleration of myeloid reconstitution following allogeneic bone marrow transplantation; or
  • Individuals 2 years or age or older for treatment of delayed neutrophil recovery or graft failure after autologous or allogeneic bone marrow transplantation; or
  • Individuals acutely exposed to myelosuppressive doses of radiation in H-ARS  to increase survival; or

Compendia Sources

Sargramostim (Leukine) may be considered medically necessary for treatment of any of the current category 1, 2A, or 2B NCCN recommendations; or

Other Compendia Supported Recommendations, Class 2b and Higher

  • To decrease the incidence of infection as manifested by febrile neutropenia in individuals with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever.

J2820

 

 

 

 

 

 




The use of G-CSFs are considered not medically necessary for ANY of the following:

  • For uses not meeting the criteria above; or
  • As prophylaxis for FN, except when criteria above are met; or
  • As treatment of neutropenia in individuals who are afebrile, except when criteria above are met; or
  • As adjunctive therapy in individuals with uncomplicated FN, defined as: fever less than ten (10) days duration, no evidence of pneumonia, cellulitis, abscess, sinusitis, hypotension, multi-organ dysfunction, or invasive fungal infection; and no uncontrolled malignancies; or
  • Chemo sensitization of myeloid leukemias; or
  • As prophylaxis for FN during concomitant chemotherapy and radiation therapy; or
  • Continued use if no response is seen within 28-42 days (individuals who have failed to respond within this time frame are considered non-responders).

J1442

J1447

J2506

J2820

Q5101

Q5108

Q5110

Q5111

Q5120

Q5122

Q5125

Q5127

Q5130

 




NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines. Highmark may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.

Note: Filgrastim (Neupogen), J1442, excludes biosimilar reference in its definition and should therefore be reported with code Q5101 or Q5110 to report the biosimilarity of filgrastim. Pegfilgrastim (Neulasta), J2506, excludes biosimilar reference in its definition and should therefore be reported with code Q5108, Q5111, or Q5120 to report the biosimilarity of pegfilgrastim.

The safety and efficacy of sargramostim (Leukine) have not been assessed in individuals with AML less than 55 years of age.

Liquid solutions containing benzyl alcohol (including liquid sargramostim or lyophilized Leukine reconstituted with bacteriostatic water for injection, USP (0.9% benzyl alcohol)) should not be administered to neonates.


Related Policies

Refer to Medical Policy I-249 Pennsylvania Cancer Treatment Mandate, for additional information.

 


Covered Diagnosis Codes for Procedure Code J1442

B20

C92.00

C92.02

C92.10

C92.40

C92.42

C92.50

C92.52

C92.60

C92.62

C92.90

C92.92

C92.A0

C92.A2

C93.00

C93.02

C93.10

C94.00

C94.02

C94.20

C94.22

D46.0

D46.1

D46.20

D46.21

D46.22

D46.4

D46.9

D46.A

D46.B

D46.C

D46.Z

D47.1

D47.4

D61.1

D61.2

D61.3

D61.810

D61.811

D61.818

D61.89

D70.0

D70.1

D70.2

D70.3

D70.4

D70.8

D70.9

T45.1X5A

T45.1X5D

T45.1X5S

T66.XXXA

T66.XXXD

T66.XXXS

W88.1XXA

W88.1XXD

W88.1XXS

W88.8XXA

W88.8XXD

W88.8XXS

Z51.11

Z51.12

Z51.89

Z52.011

Z94.81

Z94.84

 

 

 

 

Covered Diagnosis Codes for Procedure Code Q5101

B20

C92.00

C92.02

C92.10

C92.40

C92.42

C92.50

C92.52

C92.60

C92.62

C92.90

C92.92

C92.A0

C92.A2

C93.00

C93.02

C93.10

D46.0

D46.1

D46.20

D46.21

D46.22

D46.4

D46.9

D46.A

D46.B

D46.C

D46.Z

D47.1

D47.4

D61.1

D61.2

D61.3

D61.810

D61.811

D61.818

D61.89

D70.0

D70.1

D70.2

D70.3

D70.4

D70.8

D70.9

T45.1X5A

T45.1X5D

T45.1X5S

T66.XXXA

T66.XXXD

T66.XXXS

W88.1XXA

W88.1XXD

W88.1XXS

W88.8XXA

W88.8XXD

W88.8XXS

Z51.11

Z51.12

Z51.89

Z52.011

Z94.81

Z94.84

 

Covered Diagnosis Codes for Procedure Code Q5110

C92.00

C92.02

C92.10

C92.40

C92.42

C92.50

C92.52

C92.60

C92.62

C92.90

C92.92

C92.A0

C92.A2

C93.00

C93.02

D61.1

D61.2

D61.3

D61.810

D61.811

D61.818

D61.89

D70.0

D70.1

D70.2

D70.3

D70.4

D70.8

D70.9

T45.1X5A

T45.1X5D

T45.1X5S

T66.XXXA

T66.XXXD

T66.XXXS

W88.1XXA

W88.1XXD

W88.1XXS

W88.8XXA

W88.8XXD

W88.8XXS

Z51.11 

Z51.12

Z51.89

Z52.011

Z94.81 

Z94.84

 

 

Covered Diagnosis Codes for Procedure Code J2506, 96377

D61.810

D61.811

D61.818

D70.1

D70.2

D70.3

D70.9

T45.1X5A

T45.1X5D

T45.1X5S

T66.XXXA

T66.XXXD

T66.XXXS

W88.1XXA

W88.1XXD

W88.1XXS

W88.8XXA

W88.8XXD

W88.8XXS

Z51.11 

Z51.12

Z51.89  

Z94.81

Z94.84

 

 

 

 

Covered Diagnosis Codes for Procedure Codes Q5108, Q5111, Q5120, Q5122, Q5127, Q5130

D61.810

D61.811

D61.818

D70.1

D70.2

D70.9

T45.1X5A

T45.1X5D

T45.1X5S

T66.XXXA

T66.XXXD

T66.XXXS

W88.1XXA

W88.1XXD

W88.1XXS

W88.8XXA

W88.8XXD

W88.8XXS

Z51.11 

Z51.12

Z51.89  

Z94.81

Z94.84

 

 

 

 

 

Covered Diagnosis Codes for Procedure Code J1447

C93.10

D46.0

D46.1

D46.20

D46.21

D46.4

D46.9

D46.A

D46.B

D46.Z

D61.810

D61.811

D61.818

D70.1

D70.2

D70.9

T45.1X5A

T45.1X5D

T45.1X5S

T66.XXXA

T66.XXXD

T66.XXXS

W88.1XXA

W88.1XXD

W88.1XXS

W88.8XXA

W88.8XXD

W88.8XXS

Z51.11 

Z51.12

Z51.89

Z94.81 

Z94.84

 

 

Covered Diagnosis Codes for Procedure Code J2820

C92.00

C92.02

C92.10

C92.40

C92.42

C92.50

C92.52

C92.60

C92.62

C92.90

C92.92

C92.A0

C92.A2

C93.10

D61.1

D61.2

D61.3

D61.810

D61.811

D61.818

D61.89

D70.0

D70.1

D70.2

D70.3

D70.4

D70.8

D70.9

T45.1X5A

T45.1X5D

T45.1X5S

T66.XXXA

T66.XXXD

T66.XXXS

W88.1XXA

W88.1XXD

W88.1XXS

W88.8XXA

W88.8XXD

W88.8XXS

Z51.11 

Z51.12

Z94.81 

Z94.84

 

 

 

 

 

Covered Diagnosis Codes for Procedure Code Q5125

C92.00

C92.02

C92.50

C92.52

C92.60

C92.62

C92.A0

C92.A2

C93.00

C93.02

C93.10

D61.81

D70.1

D70.2

D70.9

T45.1X5A

T45.1X5D

T45.1X5S

T66.XXXA

T66.XXXD

T66.XXXS

T80.82XA

T80.82XS

T80.89XA

T80.89XS

W88.1XXA

W88.1XXD

W88.1XXS

W88.8XXA

W88.8XXD

W88.8XXS

Z51.11 

Z51.12

Z51.89

Z94.81 

Z94.84

 

 

 

 

 

 



Place of Service: Outpatient

The administration of G-CSFs is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.



The policy position applies to all commercial lines of business



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This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical or other circumstances may warrant individual consideration, based on review of applicable medical records, as well as other regulatory, contractual and/or legal requirements.

Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

Highmark retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.

Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
    • Qualified sign language interpreters
    • Written information in other formats (large print, audio, accessible electronic formats, other formats)
  • Provides free language services to people whose primary language is not English, such as:
    • Qualified interpreters
    • Information written in other languages

If you need these services, contact the Civil Rights Coordinator.

If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

U.S. Department of Health and Human Services
200 Independence Avenue, SW
Room 509F, HHH Building
Washington, D.C. 20201
1-800-368-1019, 800-537-7697 (TDD)

Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.

This information is issued by Highmark Blue Shield on behalf of its affiliated Blue companies, which are independent licensees of the Blue Cross Blue Shield Association.  Highmark Inc. d/b/a Highmark Blue Shield and certain of its affiliated Blue companies serve Blue Shield members in the 21 counties of central Pennsylvania. As a partner in joint operating agreements, Highmark Blue Shield also provides services in conjunction with a separate health plan in southeastern Pennsylvania.  Highmark Inc. or certain of its affiliated Blue companies also serve Blue Cross Blue Shield members in 29 counties in western Pennsylvania, 13 counties in northeastern Pennsylvania, the state of West Virginia plus Washington County, Ohio, the state of Delaware[ and [8] counties in western New York and Blue Shield members in [13] counties in northeastern New York].  All references to Highmark in this document are references to Highmark Inc. d/b/a Highmark Blue Shield and/or to one or more of its affiliated Blue companies.





Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
  • Qualified sign language interpreters
  • Written information in other formats (large print, audio, accessible electronic formats, other formats)

  • Provides free language services to people whose primary language is not English, such as:
  • Qualified interpreters
  • Information written in other languages
  • If you need these services, contact the Civil Rights Coordinator.

    If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295 , TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

    You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

    U.S. Department of Health and Human Services
    200 Independence Avenue, SW
    Room 509F, HHH Building
    Washington, D.C. 20201
    1-800-368-1019, 800-537-7697 (TDD)

    Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.