10286 Federal Register / Vol. 75, No. 43 / Friday, March 5, 2010 / Notices 

• U.S. Provisional Application No. 

61/004,940 filed 30 Nov 2007 (HHS 

Reference No. E–042–2007/0–US–01). 

• PCT Application No. PCT/US2008/ 

012064 filed 22 Oct 2008, which 

published as WO 2009/073068 on 11 

Jun 2009 (HHS Reference No. E–042– 

2007/0–PCT–02). 

Licensing Status: Available for 

licensing. 

Licensing Contact: Charlene Sydnor, 

PhD; 301–435–4689; 

sydnorc@mail.nih.gov. 

Collaborative Research Opportunity: 

The National Institute of Dental and 

Craniofacial Research, Craniofacial and 

Skeletal Diseases Branch, is seeking 

statements of capability or interest from 

parties interested in collaborative 

research to further develop, evaluate, or 

commercialize this technology. Please 

contact David W. Bradley, PhD at 301– 

402–0540 or bradleyda@nidcr.nih.gov 

for more information. 

Gamma Substituted Peptide Nucleic 

Acids 

Description of Invention: PNAs are 

nuclease/protease resistant synthetic 

nucleic acid analogs capable of forming 

very stable and highly sequence-specific 

complexes with DNA. Scientists at the 

NIH have developed novel peptide 

nucleic acids (PNAs) that contain a 

unique sidechain that can attach any 

small ligand, peptide, or carbohydrate to 

complementary DNA for rapid 

optimization. This invention could 

revolutionize the way in which 

multivalent display is used in research 

as well as help develop new 

medications. 

Applications: 

• Controlled interactions ensure only 

a single stoichiometry is attained. 

• Simple access to a wide range of 

multivalent platforms. 

Development Status: Early stage. 

Inventors: Daniel Appella (NIDDK) 

Patent Status: U.S. Provisional 

Application No. 61/162,175 filed 20 Mar 

2009 (HHS Reference No. E–151–2009/ 

0–US–01). 

Licensing Status: Available for 

licensing. 

Licensing Contact: Charlene Sydnor, 

PhD; 301–435–4689; 

sydnorc@mail.nih.gov. 

Collaborative Research Opportunity: 

The National Institute of Diabetes and 

Digestive and Kidney Diseases, 

Laboratory of Bioorganic Chemistry, 

Drug-Receptor Interactions Section, is 

seeking statements of capability or 

interest from parties interested in 

collaborative research to further 

develop, evaluate, or commercialize this 

technology. Please contact Dr. Daniel 

Appella at appellad@niddk.nih.gov for 

more information. 

Use of Modified Peptide Nucleic Acids 

for Visualizing DNA 

Description of Technology: The 

compounds described in this technology 

may be useful in the development of 

nucleic acid detection kits for various 

pathogens. 

Technologies for genomic detection 

most commonly use DNA probes to 

hybridize to target sequences, and 

require the use of Polymerase Chain 

Reaction (PCR) to amplify target 

sequences. Replacing the DNA probe 

with peptide nucleic acid (PNA) can 

greatly eliminate the need for PCR 

because the binding strength of PNAs to 

complementary DNA is stronger than 

DNA binding to complementary DNA. 

In addition, PNAs are nuclease and 

protease resistant, and form very stable 

and highly sequence-specific complexes 

with DNA. 

This technology describes a method of 

making pure enantiomers of trans-tertbutyl-2-aminocyclopentylcarbamate 

(tcycp) and methods of modifying PNAs 

by incorporating tcycp compounds into 

the PNA. This technology may also be 

practical for detecting infectious agents 

such as anthrax, avian flu, tuberculosis 

(TB), severe acute respiratory syndrome 

(SARS), human papilloma virus (HPV) 

and human immunodeficiency virus 

(HIV). 

Applications: 

• Very stable diagnostic method to 

detect nucleic acids without using 

Polymerase Chain Reaction (PCR). 

• Binding to complementary DNA 

can be seen by eye. 

• Visual detection of anthrax has 

been shown. 

• Useful for outside of a laboratory 

environment. 

Development Status: Early stage. 

Inventors: Daniel Appella et al. 

(NIDDK). 

Patent Status: U.S. Patent Application 

No. 12/441,925 filed 19 Mar 2009 (HHS 

Reference No. E–308–2006/2–US–02). 

Licensing Status: Available for 

licensing. 

Licensing Contact: Charlene Sydnor, 

PhD; 301–435–4689; 

sydnorc@mail.nih.gov. 

Collaborative Research Opportunity: 

The National Institute of Diabetes and 

Digestive and Kidney Diseases, 

Laboratory of Bioorganic Chemistry, 

Drug-Receptor Interactions Section, is 

seeking statements of capability or 

interest from parties interested in 

collaborative research to further 

develop, evaluate, or commercialize this 

technology. Please contact Dr. Daniel 

Appella at appellad@niddk.nih.gov for 

more information. 

Dated: March 1, 2010. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. 2010–4759 Filed 3–4–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Government-Owned Inventions; 

Availability for Licensing 

AGENCY: National Institutes of Health, 

Public Health Service, HHS. 

ACTION: Notice. 

SUMMARY: The inventions listed below 

are owned by an agency of the U.S. 

Government and are available for 

licensing in the U.S. in accordance with 

35 U.S.C. 207 to achieve expeditious 

commercialization of results of 

federally-funded research and 

development. Foreign patent 

applications are filed on selected 

inventions to extend market coverage 

for companies and may also be available 

for licensing. 

ADDRESSES: Licensing information and 

copies of the U.S. patent applications 

listed below may be obtained by writing 

to the indicated licensing contact at the 

Office of Technology Transfer, National 

Institutes of Health, 6011 Executive 

Boulevard, Suite 325, Rockville, 

Maryland 20852–3804; telephone: 301/ 

496–7057; fax: 301/402–0220. A signed 

Confidential Disclosure Agreement will 

be required to receive copies of the 

patent applications. 

Methods To Increase Stability of 

Recombinant Vaccinia-Vectored 

Vaccines and Increase Expression of a 

Foreign Gene Inserted in Such Vaccines 

Description of Invention: The 

technology offered for licensing is in the 

field of vaccinia-based recombinant 

vaccines. In particular the invention 

relates to methods of stabilizing the 

recombinant virus, thus resulting in 

efficient production of the vaccine and 

efficient expression of the inserted gene. 

Stabilization of the recombinant virus is 

achieved by the insertion of the 

exogenous gene into an intergenic 

region (IGR) of the viral genome (i.e. 

Modified Vaccinia Ankara, MVA), 

where the IGR is flanked by open 

reading frames of conserved poxvirus 

genes. Furthermore, the invention 

relates to plasmids vectors useful to 


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Federal Register / Vol. 75, No. 43 / Friday, March 5, 2010 / Notices 10287 

insert the exogenous DNA into the 

genome of a vaccinia virus. Stability can 

be further enhanced by incorporating 

silent mutations that decrease the 

lengths of homopolynucleotide runs in 

the foreign gene. 

Applications: 

• Efficient production of vacciniavectored vaccines for infectious diseases 

and other diseases such as cancer. 

• Efficient production of therapeutic 

proteins from vaccinia-vectored 

exogenous genes. 

Advantages: 

• Enhancing stability of foreign genes 

in vaccinia-vectored constructs. 

• Increasing efficiency of vaccine 

production and gene expression. 

Development Status: The invention is 

fully developed. 

Market: Vaccines development based 

on vaccinia (e.g. MVA) vector inserted 

with foreign gene of immunologic or 

therapeutic interest has become one of 

the most promising approaches for 

vaccine development. Several 

companies established vaccine 

development programs based on this 

approach and many research 

laboratories around the world conduct 

research in the area. Improvements in 

the production process and in 

production yields, such as provided by 

the subject invention, are therefore of 

great significance for successful 

accomplishments in this area. 

Commercial products for veterinary use 

already exist. Many applications for 

human use are now in various stages of 

clinical trials, in particular applications 

for HIV, HPV in the infectious disease 

area and as therapeutic vaccine in the 

cancer field. The market potential for 

the subject technology is therefore vast. 

Inventors: Bernard Moss et al. 

(NIAID). 

Related Publication: LS Wyatt, PL 

Earl, W Xiao, J Americo, C Cotter, J 

Vogt, B Moss. Elucidating and 

minimizing the loss by recombinant 

vaccinia virus of human 

immunodeficiency virus gene 

expression resulting from spontaneous 

mutations and positive selections. J 

Virol. 2009 Jul;83(14):7176–7184. 

[PubMed: 19420086]. 

Patent Status: U.S. Provisional 

Application No. 61/252,326 filed 

October 16, 2009, entitled ‘‘Plasmid 

Shuttle Vector for Insertion of Foreign 

Genes into Del III Site of Modified 

Vaccinia Ankara (MVA) to Increase 

Stability of Foreign Gene Expression in 

This Site’’ (HHS Reference No. E–018– 

2010/0–US–01). 

Related Technologies: 

• WO 2008/142479 A2 (PCT/IB2007/ 

004575)—‘‘Intergenic Sites between 

Conserved Genes In The Genome of 

Modified Vaccinia Ankara (MVA) 

Vaccinia Virus,’’ Bernard Moss et al. 

• US Patent 6,998,252; US Patent 

7,015,024; US Patent 7,045,136; US 

Patent 7,045,313—‘‘Recombinant 

Vaccinia Virus Containing a Chimeric 

Gene Having Foreign DNA Flanked by 

Vaccinia Regulatory DNA,’’ Bernard 

Moss et al. 

Licensing Status: Available for 

licensing. 

Licensing Contacts: Uri Reichman, 

PhD, MBA; 301–435–4616; 

UR7a@nih.gov; or John Stansberry, 

Ph.D.; 301–435–5236; 

stansbej@mail.nih.gov. 

Compounds That Interfere With the 

Androgen Receptor Complex: Use in 

Treating Prostate Cancer or 

Enlargements, Diabetes, and as 

Contraceptives 

Description of Invention: Investigators 

at the National Institutes of Health (NIH) 

have discovered compounds that have 

potential as novel anti-androgen 

therapeutics. The immunophilin protein 

FKBP52 is part of a protein complex 

that helps fold the androgen receptor 

(AR) protein, a target for treating 

prostate cancer, and enhances its 

activity. Disruption of the FKPB52–AR 

interaction greatly reduces the activity 

of the AR. With the goal of finding 

potential therapeutic compounds that 

inhibit the FKBP52-mediated activation 

of AR, several small molecules were 

tested and found to be antagonists of 

FKBP52 and to inhibit AR activity in 

prostate cells. These compounds can 

serve as therapeutics for the treatment of 

prostate cancer and benign prostate 

enlargement. Moreover, FKBP52 is also 

implicated in the regulation of other 

hormone receptors so these compounds 

could be used to treat other hormonedependent diseases such as diabetes or 

even used as contraceptives. 

One of the standard treatments for 

prostate cancer makes use of antiandrogens, like bicalutamide, which 

compete for binding with the natural 

male hormones to AR and inhibit their 

proliferative activity. The problem with 

available anti-androgen drugs is that 

prostate tumors eventually become drug 

resistant resulting in so-called 

androgen-resistant prostate cancer. One 

cause of this is an increase in the levels 

of AR produced by the prostate cancer 

cells. A solution to this problem may lie 

in disrupting the protein folding of AR 

by interfering with its interaction with 

FKBP52 using these compounds. 

Applications: 

• Use of the compounds for treatment 

of prostate cancer and benign prostate 

enlargement 

• Use of the compounds in treating 

insulin-independent diabetes 

• Use of the compounds as male or 

female contraceptives 

• Use in screening for compounds 

that inhibit of FKBP52-enhanced AR 

activity 

Advantages: 

• The compounds do not compete 

with androgens and specifically inhibit 

FKBP52-enhanced AR function 

• Potential for synergistic use with 

conventional anti-androgens for 

treatment of androgen resistant prostate 

cancer 

Development Status: Pre-clinical. 

Market: Prostate cancer is the second 

most common type of cancer among 

men in the United States and is the 

second leading cause of cancer death in 

men. It was estimated that in 2009 there 

would be 192,280 new cases and 27,360 

deaths from prostate cancer in the U.S. 

The prevalence of benign prostate 

enlargement is much greater as 50% 

men age 50 are affected and continues 

to increase with age. 

Diabetes is a growing health problem 

in the U.S. and the world. The most 

recent estimate (2007 National Diabetes 

Fact Sheet) in the U.S. was that 7.8% of 

the population had diabetes and 1.6 

million new cases per year would be 

diagnosed. In the population of people 

over 60 the prevalence of diabetes is 

even higher (23%). 

Among the 64 million women of 

reproductive age in the U.S., the leading 

contraceptive method is hormonal 

contraceptives. Presently, there are no 

hormonal contraceptives to reversibly 

block fertility in men and there is a need 

for safe and effective hormonal methods 

as exist for women. 

Inventors: Leonard M. Neckers (NCI), 

Marc Cox (UTEP) et al. 

Relevant Publication: J Cheung-Flynn 

et al. Physiological role for the 

cochaperone FKBP52 in androgen 

receptor signaling. Mol Endocrinol. 

2005 Jun;19(6):1654–1666. [PubMed: 

15831525]. 

Patent Status: U.S. Provisional 

Application No. 61/242,541 filed 15 Sep 

2009 (HHS Reference No. E–162–2009/ 

0–US–01). 

Licensing Status: Available for 

licensing. 

Licensing Contact: Sabarni Chatterjee, 

Ph.D.; 301–435–5587; 

chatterjeesa@mail.nih.gov. 

Collaborative Research Opportunity: 

The Center for Cancer Research, 

Urologic Oncology Branch, is seeking 

statements of capability or interest from 

parties interested in collaborative 

research to further develop, evaluate, or 

commercialize antagonists of FKBP52- 

dependent remodeling of the androgen 


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10288 Federal Register / Vol. 75, No. 43 / Friday, March 5, 2010 / Notices 

receptor. Please contact John D. Hewes, 

Ph.D. at 301–435–3121 or 

hewesj@mail.nih.gov for more 

information. 

Radioprotectants and Tumor 

Radiosensitizers Targeting 

Thrombospondin-1 and CD47 

Description of Invention: Radiation 

therapy not only damages cancer cells, 

but it also damages healthy cells and 

can cause serious side effects for 

patients. One effort to enhance the 

therapeutic potential of radiotherapy, 

while reducing its detrimental effects on 

normal tissue and maintaining tumor 

sensitivity, is centered upon the 

development of radioprotective agents. 

NIH inventors previously discovered 

that when the secreted protein, 

thrombospondin-1 (TSP1) binds to its 

receptor CD47, this signaling pathway 

prevents nitric oxide from dilating 

blood vessels and increasing blood flow 

to organs and tissues. They found that 

blocking TSP1–CD47 interaction 

through the use of antisense morpholino 

oligonucleotides, peptides or antibodies 

has several therapeutic benefits; one of 

them being increased blood flow to 

ischemic tissues. 

In the present technology, the 

inventors discovered that hindlimb 

irradiated TSP1 and CD47 null mice 

have less hair loss, and decreased cell 

death in muscle and bone marrow than 

untreated TSP1 and CD47 null mice. 

They also discovered that when 

irradiated human vascular cells are 

treated with antibodies towards TSP1 or 

CD47, viability and proliferative 

capacity are preserved. Furthermore, the 

inventors determined that irradiation of 

wild type mice following treatment with 

CD47 antisense morpholino resulted in 

decreased apoptosis in irradiated tissues 

at 24 hours, preservation of 

hematopoietic stem cell proliferative 

capacity in irradiated bone marrow, and 

less alopecia, ulceration, and 

desquamation at the end of eight weeks. 

These results led the inventors to 

propose that antagonists of TSP1 and/or 

CD47 preserve cell viability and tissue 

function following radiation treatment, 

and these antagonists may be useful as 

radioprotective agents to reduce side 

effects associated with radiation 

therapy. Remarkably, the same 

treatment dramatically enhanced the 

delay in melanoma and squamous 

carcinoma tumor regrowth following 

irradiation. Thus, these agents are 

radioprotective agents for normal tissue 

but radiosensitizers for tumor tissue. 

The present technology describes the 

use of morpholinos, peptides and 

antibodies that block the TSP1/CD47 

signaling pathway as radioprotectants 

for normal tissue, radioenhancers for 

tumor tissue, and methods of selectively 

protecting normal tissue from damage 

caused by radiation exposure by 

contacting the tissue with these agents. 

Applications: 

• Protect normal tissue from damage 

following radiation therapy. 

• Enhance tumor responses to 

radiotherapy. 

• Enable use of higher therapeutic 

doses for radiotherapy of cancer. 

• Protect personnel from radiation 

injuries resulting from occupational 

exposure to ionizing radiation, military 

exposure, or terrorist acts. 

Development Status: Mouse data 

available. In vitro data available in 

mouse, bovine, porcine, and human 

cells. 

Inventors: Jeffery S. Isenberg, David D. 

Roberts, Justin B. Maxhimer (NCI) 

Related Publications: 

1. JB Maxhimer, DR Soto-Pantoja, LA 

Ridnour, HB Shih, WG DeGraff, M 

Tsokos, DA Wink, JS Isenberg, DD 

Roberts. Radioprotection in normal 

tissue and delayed tumor growth by 

blockade of CD47 signaling. Sci Transl 

Med. 21 October 2009; Vol 1, Issue 3, 

pg. 3ra7; DOI:10.1126/ 

scitranslmed.3000139. 

2. JS Isenberg, G Martin-Manso, JB 

Maxhimer, DD Roberts. Regulation of 

nitric oxide signaling by 

thrombospondin-1: implications for 

anti-angiogenic therapies. Nat Rev 

Cancer. 2009 Mar;9(3):182–194. 

[PubMed: 19194382] 

3. JS Isenberg, JB Maxhimer, F Hyodo, 

ML Pendrak, LA Ridnour, WG DeGraff, 

M Tsokos, DA Wink, DD Roberts. 

Thrombospondin-1 and CD47 limit cell 

and tissue survival of radiation injury. 

Am J Pathol. 2008;173(4):1100–1112. 

[PubMed: 18787106] 

Patent Status: PCT/US2009/052902 

filed 05 Aug 2009 (HHS Reference No. 

E–153–2008/0–PCT–02). 

Licensing Status: Available for 

licensing. 

Licensing Contact: Charlene A. 

Sydnor, Ph.D.; 301–435–4689; 

sydnorc@mail.nih.gov. 

Collaborative Research Opportunity: 

The Center for Cancer Research, 

Laboratory of Pathology, is seeking 

statements of capability or interest from 

parties interested in collaborative 

research to further develop, evaluate, or 

commercialize CD47-targeting agents as 

radioprotectants and tumor sensitizers. 

Please contact John D. Hewes, Ph.D. at 

301–435–3121 or hewesj@mail.nih.gov 

for more information. 

Mouse Lacking the Chemokine 

Receptor CX3CR1 

Description of Invention: This mouse 

has been generated by targeted gene 

disruption. The mouse provides a model 

to investigate the function of the 

chemokine receptor CX3CR1, which is a 

proinflammatory receptor for the 

leukocyte chemoattractant CX3CL1 (aka 

fractalkine). As an example, the mouse 

is in use in the study of atherosclerosis. 

Further, the mouse may serve as a 

model study the role of the immune 

system during infection with pathogens 

as well as other immunologically 

mediated diseases and responses to 

tumors. 

Inventors: Philip Murphy, Christopher 

Combadie`re, Ji-liang Gao (NIAID). 

Related Publication: C Combadie`re et 

al. Decreased atheroscelerotic lesion 

formation in CX3R1/ApoE double 

knockout mice. Circulation 2003 Feb 

25;107(7):1009–1016. [PubMed: 

12600915]. 

Patent Status: HHS Reference No. E– 

216–2003/0—Research Tool. Patent 

protection is not being pursued for this 

technology. 

Licensing Status: Available for 

licensing under a biological materials 

license. 

Licensing Contact: Susan Ano, Ph.D.; 

301–435–5515; anos@mail.nih.gov. 

Oligonucleotides Which Specifically 

Bind Retroviral Nucleocapsid Proteins 

Description of Invention: The human 

immunodeficiency virus (HIV) is the 

causative agent of acquired 

immunodeficiency syndrome (AIDS). A 

retroviral protein species, the gag 

polyprotein, is involved in the assembly 

of retrovirus particles and capable of 

specific interactions with nucleic acids. 

After the virion is released from the cell, 

the polyprotein is cleaved by the virusencoded protease. One of the cleaved 

products, the nucleocapsid (NC) 

protein, then binds to genomic RNA, 

forming the ribonucleoprotein core of 

the mature particle. The interaction 

between gag and genomic RNA is 

known to involve the NC domain of the 

polyprotein. In addition, the NC protein 

plays crucial roles in both the reverse 

transcription and integration steps in 

the viral life cycle. 

The present invention relates to 

retroviral nucleocapsid proteins, such as 

NC and the gag precursor, and their 

ability to bind to specific nucleic acid 

sequences with high affinity. The high 

affinity of this interaction has potential 

applications in the design of new 

antiviral approaches and in sensitive 

detection of HIV particles. Accordingly, 

the invention provides for 

oligonucleotides which bind to 

nucleocapsid proteins with high 

affinity, molecular decoys for retroviral 

nucleocapsid proteins which inhibit 

viral replication, targeted molecules 


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comprising high affinity 

oligonucleotides, assays for selecting 

test compounds, and related kits. 

Inventors: Alan R. Rein et al. (NCI). 

Patent Status: U.S. Patent No. 

6,316,190 issued 13 Nov 2001 (HHS 

Reference No. E–107–1996/0–US–06). 

Licensing Status: Available for 

licensing. 

Licensing Contact: Sally Hu, PhD; 

301–435–5606; hus@mail.nih.gov. 

Dated: March 1, 2010. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. 2010–4757 Filed 3–4–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

Notice of Opportunity for a Hearing on 

Compliance of Missouri State Plan 

Provisions Concerning Payments for 

Home Health Services With Title XIX 

(Medicaid) of the Social Security Act 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice of Opportunity for a 

Hearing; Compliance of Missouri 

Medicaid State Plan Home Health 

Benefit. 

SUMMARY: This notice announces the 

opportunity for an administrative 

hearing to be held no later than 60 days 

following publication in the Federal 

Register at the CMS Kansas City 

Regional Office, 601 E. 12th Street, 

Kansas City, Missouri 64106, to 

consider whether Missouri State plan 

provisions concerning payments for 

home health services comply with the 

requirements of the Social Security Act 

as discussed in the February 26, 2010 

letter sent to the State and published 

herein. 

Closing Date: Requests to participate 

in the hearing as a party must be 

received by the presiding officer by 

April 5, 2010. 

FOR FURTHER INFORMATION CONTACT: 

Benjamin R. Cohen, Presiding Officer, 

CMS, 2520 Lord Baltimore Drive, Suite 

L, Baltimore, Maryland 21244, 

Telephone: (410) 786–3169. 

SUPPLEMENTARY INFORMATION: This 

notice announces the opportunity for an 

administrative hearing concerning the 

finding of the Administrator of the 

Centers for Medicare & Medicaid 

Services (CMS) that the approved State 

plan under title XIX (Medicaid) of the 

Social Security Act (the Act) for the 

State of Missouri is not in compliance 

with the provisions of sections 1902(a) 

of the Act and the proposed 

withholding of Federal financial 

participation for a portion of Missouri’s 

expenditures for home health services. 

In particular, CMS has found that the 

State plan does not provide for home 

health services for Medicaid 

beneficiaries who are not ‘‘confined to 

the home.’’ As a result of this 

‘‘homebound’’ requirement, certain 

Medicaid beneficiaries are not receiving 

the full benefit package required under 

the Act and applicable regulations. 

Consequently, Federal payments for a 

portion of the Federal funding for home 

health services will be withheld, subject 

to the opportunity for a hearing 

described below. This notice is being 

provided pursuant to the requirements 

of section 1904 of the Act, as 

implemented at 42 CFR 430.35 and 42 

CFR part 430, subpart D. 

Section 1902(a)(10)(D) requires that 

State plans provide for the coverage of 

home health services for any individual 

who, under the State plan, is entitled to 

nursing facility services. Nursing facility 

services are a required service for 

categorically needy populations under 

section 1902(a)(10)(A), as defined in 

section 1905(a)(4)(A). Under CMS 

regulations, a service included as a 

covered benefit under a State plan must 

be ‘‘sufficient in amount, duration and 

scope to reasonably achieve its purpose’’ 

(42 CFR 440.230(b)) and, for required 

services, cannot be denied or reduced to 

an eligible beneficiary ‘‘solely because of 

the diagnosis, type of illness, or 

condition’’ (42 CFR 440.230(c)). It is not 

consistent with these requirements to 

deny home health services to eligible 

individuals who need such services on 

the basis that they are not ‘‘homebound.’’ 

The CMS provided interpretive 

guidance indicating that these statutory 

requirements preclude denial of home 

health services to eligible individuals 

because they are not ‘‘homebound.’’ On 

July 25, 2000, CMS, then the Health 

Care Financing Administration, issued 

Olmstead Update #3 which clarified 

that the Medicare rule for home health 

services requiring an individual to be 

‘‘homebound’’ did not apply to the 

receipt of Medicaid home health 

services. Specifically, Olmstead Update 

#3 states that the ‘‘homebound’’ 

requirement violates Federal regulatory 

requirements at 42 CFR section 

440.230(c) and section 440.240(b). 

The ‘‘homebound’’ requirement in 

Missouri was raised during the review 

of Missouri State plan amendment 

(SPA) 05–09. At that time, Missouri 

chose to withdraw the page containing 

the ‘‘homebound’’ language but did not 

reverse the policy. Since that time, there 

have been numerous discussions 

between CMS and Missouri regarding 

this issue. On October 30, 2009, CMS 

provided Missouri with notice of the 

preliminary determination that it 

appeared to be out of compliance with 

Federal Medicaid requirements. In 

addition, CMS requested that Missouri 

submit a SPA to remove the 

‘‘homebound’’ requirement. 

In its response dated December 31, 

2009, Missouri indicated that it was 

operating under its approved State plan 

and that the requirements of Missouri’s 

home health program are the same as 

those of the Federal Medicare program. 

The State did not submit a SPA. CMS 

believes that Missouri has had 

numerous opportunities to come into 

compliance with Federal requirements. 

The notice to Missouri, dated 

February 26, 2010, containing the 

details concerning the compliance issue, 

the proposed withhold, and the 

opportunity for an administrative 

hearing reads as follows: 

CERTIFIED MAIL—RETURN RECEIPT 

REQUESTED 

Mr. Ronald J. Levy, Director, 

Department of Social Services, 

Broadway State Office Building, 

Jefferson City, MO 65102. 

Dear Mr. Levy: This letter provides 

notice that the Centers for Medicare & 

Medicaid Services (CMS) has found that 

Missouri is not providing all Medicaid 

beneficiaries with home health benefits 

that are required under title XIX of the 

Social Security Act (the Act) and that 

until this deficiency is corrected (by 

making home health services available 

to all beneficiaries entitled to such 

services), a portion of the Federal 

funding for home health services will be 

withheld, subject to the opportunity for 

a hearing. The details of the finding, 

proposed withholding, and opportunity 

for a hearing are described in detail 

below. 

Specifically, CMS has found that the 

approved Missouri State plan under title 

XIX (Medicaid) of the Act is not in 

compliance with the provisions of 

section 1902(a) of the Act with respect 

to the home health benefit. In particular, 

CMS has found that the State plan does 

not provide for home health services for 

Medicaid beneficiaries who are not 

‘‘confined to the home.’’ As a result of 

this ‘‘homebound’’ requirement, certain 

Medicaid beneficiaries are not receiving 

the full benefit package required under 

section 1902(a)(10) of the Act, which in 

subparagraph (D) provides for the 

inclusion of home health services in the 

standard Medicaid benefit package. 


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