SUPERSEDED LCD Reference Article Billing and Coding Article

Billing and Coding: MolDX: Repeat Germline Testing

A57100

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Draft Articles are works in progress and not necessarily a reflection of the current billing and coding practices. Revisions to codes are carefully and thoroughly reviewed and are not intended to change the original intent of the LCD.
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Source Article ID
N/A
Article ID
A57100
Original ICD-9 Article ID
Not Applicable
Article Title
Billing and Coding: MolDX: Repeat Germline Testing
Article Type
Billing and Coding
Original Effective Date
06/14/2020
Revision Effective Date
10/01/2023
Revision Ending Date
12/31/2023
Retirement Date
N/A
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CMS National Coverage Policy

Title XVIII of the Social Security Act, §1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim

CMS Internet-Only Manual, Pub. 100-04, Medicare Claims Processing Manual, Chapter 16, §50.5 Jurisdiction of Laboratory Claims, §60.1.1 Independent Laboratory Specimen Drawing, §60.2 Travel Allowance

CMS Internet-Only Manual, Pub. 100-04, Medicare Claims Processing Manual, Chapter 23, §10 Reporting ICD Diagnosis and Procedure Codes

CMS Internet-Only Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15, §80.1.2 A/B MAC (B) Contacts With Independent Clinical Laboratories

Article Guidance

Article Text

The information in this article contains billing, coding or other guidelines that complement the Local Coverage Determination (LCD) MolDX: Repeat Germline Testing.

Response To Comments

Number Comment Response
1
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Coding Information

Bill Type Codes

Code Description
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Revenue Codes

Code Description
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CPT/HCPCS Codes

Group 1

(306 Codes)
Group 1 Paragraph

For the following CPT® codes associated with germline testing, a beneficiary may only be covered for one test per lifetime. This list does not imply coverage for any of the below codes; it identifies codes within scope of the Repeat Germline Testing Policy.

If non-duplicative testing is considered medically reasonable and necessary but utilizes the same billing codes as prior testing, please use a -77 modifier to trigger a medical review for coverage. This includes testing to identify different genetic content or information, such as different variant types or classes, or leveraging newer and more sensitive methodologies. Providers will be expected to provide a rationale for additional testing.

Group 1 Codes
Code Description
81105 Hpa-1 genotyping
81106 Hpa-2 genotyping
81107 Hpa-3 genotyping
81108 Hpa-4 genotyping
81109 Hpa-5 genotyping
81110 Hpa-6 genotyping
81111 Hpa-9 genotyping
81112 Hpa-15 genotyping
81161 Dmd dup/delet analysis
81162 Brca1&2 gen full seq dup/del
81163 Brca1&2 gene full seq alys
81164 Brca1&2 gen ful dup/del alys
81165 Brca1 gene full seq alys
81166 Brca1 gene full dup/del alys
81167 Brca2 gene full dup/del alys
81171 Aff2 gene detc abnor alleles
81172 Aff2 gene charac alleles
81173 Ar gene full gene sequence
81174 Ar gene known famil variant
81177 Atn1 gene detc abnor alleles
81178 Atxn1 gene detc abnor allele
81179 Atxn2 gene detc abnor allele
81180 Atxn3 gene detc abnor allele
81181 Atxn7 gene detc abnor allele
81182 Atxn8os gen detc abnor allel
81183 Atxn10 gene detc abnor allel
81184 Cacna1a gen detc abnor allel
81185 Cacna1a gene full gene seq
81186 Cacna1a gen known famil vrnt
81187 Cnbp gene detc abnor allele
81188 Cstb gene detc abnor allele
81189 Cstb gene full gene sequence
81190 Cstb gene known famil vrnt
81200 Aspa gene
81201 Apc gene full sequence
81202 Apc gene known fam variants
81203 Apc gene dup/delet variants
81204 Ar gene charac alleles
81205 Bckdhb gene
81209 Blm gene
81212 Brca1&2 185&5385&6174 vrnt
81215 Brca1 gene known famil vrnt
81216 Brca2 gene full seq alys
81217 Brca2 gene known famil vrnt
81220 Cftr gene com variants
81221 Cftr gene known fam variants
81222 Cftr gene dup/delet variants
81223 Cftr gene full sequence
81224 Cftr gene intron poly t
81225 Cyp2c19 gene com variants
81226 Cyp2d6 gene com variants
81227 Cyp2c9 gene com variants
81228 Cytog alys chrml abnr cgh
81229 Cytog alys chrml abnr snpcgh
81230 Cyp3a4 gene common variants
81231 Cyp3a5 gene common variants
81232 Dpyd gene common variants
81233 Btk gene common variants
81234 Dmpk gene detc abnor allele
81238 F9 full gene sequence
81239 Dmpk gene charac alleles
81240 F2 gene
81241 F5 gene
81242 Fancc gene
81243 Fmr1 gene detection
81244 Fmr1 gene charac alleles
81247 G6pd gene alys cmn variant
81248 G6pd known familial variant
81249 G6pd full gene sequence
81250 G6pc gene
81251 Gba gene
81252 Gjb2 gene full sequence
81253 Gjb2 gene known fam variants
81254 Gjb6 gene com variants
81255 Hexa gene
81256 Hfe gene
81257 Hba1/hba2 gene
81258 Hba1/hba2 gene fam vrnt
81259 Hba1/hba2 full gene sequence
81260 Ikbkap gene
81269 Hba1/hba2 gene dup/del vrnts
81271 Htt gene detc abnor alleles
81274 Htt gene charac alleles
81283 Ifnl3 gene
81284 Fxn gene detc abnor alleles
81285 Fxn gene charac alleles
81286 Fxn gene full gene sequence
81288 Mlh1 gene
81289 Fxn gene known famil variant
81290 Mcoln1 gene
81291 Mthfr gene
81292 Mlh1 gene full seq
81293 Mlh1 gene known variants
81294 Mlh1 gene dup/delete variant
81295 Msh2 gene full seq
81296 Msh2 gene known variants
81297 Msh2 gene dup/delete variant
81298 Msh6 gene full seq
81299 Msh6 gene known variants
81300 Msh6 gene dup/delete variant
81302 Mecp2 gene full seq
81303 Mecp2 gene known variant
81304 Mecp2 gene dup/delet variant
81306 Nudt15 gene common variants
81307 Palb2 gene full gene seq
81309 Pik3ca gene trgt seq alys
81312 Pabpn1 gene detc abnor allel
81317 Pms2 gene full seq analysis
81318 Pms2 known familial variants
81319 Pms2 gene dup/delet variants
81321 Pten gene full sequence
81322 Pten gene known fam variant
81323 Pten gene dup/delet variant
81324 Pmp22 gene dup/delet
81325 Pmp22 gene full sequence
81326 Pmp22 gene known fam variant
81328 Slco1b1 gene com variants
81329 Smn1 gene dos/deletion alys
81330 Smpd1 gene common variants
81331 Snrpn/ube3a gene
81332 Serpina1 gene
81333 Tgfbi gene common variants
81335 Tpmt gene com variants
81336 Smn1 gene full gene sequence
81337 Smn1 gen nown famil seq vrnt
81343 Ppp2r2b gen detc abnor allel
81344 Tbp gene detc abnor alleles
81345 Tert gene targeted seq alys
81346 Tyms gene com variants
81350 Ugt1a1 gene common variants
81355 Vkorc1 gene
81361 Hbb gene com variants
81362 Hbb gene known fam variant
81363 Hbb gene dup/del variants
81364 Hbb full gene sequence
81401 Mopath procedure level 2
81402 Mopath procedure level 3
81403 Mopath procedure level 4
81404 Mopath procedure level 5
81405 Mopath procedure level 6
81406 Mopath procedure level 7
81407 Mopath procedure level 8
81408 Mopath procedure level 9
81410 Aortic dysfunction/dilation
81411 Aortic dysfunction/dilation
81412 Ashkenazi jewish assoc dis
81413 Car ion chnnlpath inc 10 gns
81414 Car ion chnnlpath inc 2 gns
81415 Exome sequence analysis
81416 Exome sequence analysis
81417 Exome re-evaluation
81418 Rx metab gen seq alys pnl 6
81419 Epilepsy gen seq alys panel
81420 Fetal chrmoml aneuploidy
81422 Fetal chrmoml microdeltj
81425 Genome sequence analysis
81426 Genome sequence analysis
81427 Genome re-evaluation
81430 Hearing loss sequence analys
81431 Hearing loss dup/del analys
81432 Hrdtry brst ca-rlatd dsordrs
81433 Hrdtry brst ca-rlatd dsordrs
81434 Hereditary retinal disorders
81435 Hereditary colon ca dsordrs
81436 Hereditary colon ca dsordrs
81437 Heredtry nurondcrn tum dsrdr
81438 Heredtry nurondcrn tum dsrdr
81439 Hrdtry cardmypy gene panel
81440 Mitochondrial gene
81441 Ibmfs seq alys pnl 30 genes
81442 Noonan spectrum disorders
81443 Genetic tstg severe inh cond
81448 Hrdtry perph neurphy panel
81460 Whole mitochondrial genome
81465 Whole mitochondrial genome
81470 X-linked intellectual dblt
81471 X-linked intellectual dblt
81493 Cor artery disease mrna
81554 Pulm ds ipf mrna 190 gen alg
0004M Scoliosis dna alys
0001U Rbc dna hea 35 ag 11 bld grp
0029U Rx metab advrs trgt seq alys
0030U Rx metab warf trgt seq alys
0031U Cyp1a2 gene
0032U Comt gene
0033U Htr2a htr2c genes
0034U Tpmt nudt15 genes
0070U Cyp2d6 gen com&slct rar vrnt
0071U Cyp2d6 full gene sequence
0072U Cyp2d6 gen cyp2d6-2d7 hybrid
0073U Cyp2d6 gen cyp2d7-2d6 hybrid
0074U Cyp2d6 nonduplicated gene
0075U Cyp2d6 5' gene dup/mlt
0076U Cyp2d6 3' gene dup/mlt
0078U Pain mgt opi use gnotyp pnl
0079U Cmprtv dna alys mlt snps
0084U Rbc dna gnotyp 10 bld groups
0094U Genome rapid sequence alys
0101U Hered colon ca do 15 genes
0102U Hered brst ca rltd do 17 gen
0103U Hered ova ca pnl 24 genes
0129U Hered brst ca rltd do panel
0130U Hered colon ca do mrna pnl
0131U Hered brst ca rltd do pnl 13
0132U Hered ova ca rltd do pnl 17
0133U Hered prst8 ca rltd do 11
0134U Hered pan ca mrna pnl 18 gen
0135U Hered gyn ca mrna pnl 12 gen
0136U Atm mrna seq alys
0137U Palb2 mrna seq alys
0138U Brca1 brca2 mrna seq alys
0156U Copy number sequence alys
0157U Apc mrna seq alys
0158U Mlh1 mrna seq alys
0159U Msh2 mrna seq alys
0160U Msh6 mrna seq alys
0161U Pms2 mrna seq alys
0162U Hered colon ca trgt mrna pnl
0169U Nudt15&tpmt gene com vrnt
0170U Neuro asd rna next gen seq
0173U Psyc gen alys panel 14 genes
0175U Psyc gen alys panel 15 genes
0180U Abo gnotyp abo 7 exons
0181U Co gnotyp aqp1 exon 1
0182U Crom gnotyp cd55 exons 1-10
0183U Di gnotyp slc4a1 exon 19
0184U Do gnotyp art4 exon 2
0185U Fut1 gnotyp fut1 exon 4
0186U Fut2 gnotyp fut2 exon 2
0187U Fy gnotyp ackr1 exons 1-2
0188U Ge gnotyp gypc exons 1-4
0189U Gypa gnotyp ntrns 1 5 exon 2
0190U Gypb gnotyp ntrns 1 5 seux 3
0191U In gnotyp cd44 exons 2 3 6
0192U Jk gnotyp slc14a1 exon 9
0193U Jr gnotyp abcg2 exons 2-26
0194U Kel gnotyp kel exon 8
0195U Klf1 targeted sequencing
0196U Lu gnotyp bcam exon 3
0197U Lw gnotyp icam4 exon 1
0198U Rhd&rhce gntyp rhd1-10&rhce5
0199U Sc gnotyp ermap exons 4 12
0200U Xk gnotyp xk exons 1-3
0201U Yt gnotyp ache exon 2
0203U Ai ibd mrna xprsn prfl 17
0205U Oph amd alys 3 gene variants
0209U Cytog const alys interrog
0212U Rare ds gen dna alys proband
0213U Rare ds gen dna alys ea comp
0214U Rare ds xom dna alys proband
0215U Rare ds xom dna alys ea comp
0216U Neuro inh ataxia dna 12 com
0217U Neuro inh ataxia dna 51 gene
0218U Neuro musc dys dmd seq alys
0221U Abo gnotyp next gnrj seq abo
0222U Rhd&rhce gntyp next gnrj seq
0230U Ar full sequence analysis
0231U Cacna1a full gene analysis
0232U Cstb full gene analysis
0233U Fxn gene analysis
0234U Mecp2 full gene analysis
0235U Pten full gene analysis
0236U Smn1&smn2 full gene analysis
0237U Car ion chnlpthy gen seq pnl
0238U Onc lnch syn gen dna seq aly
0246U Rbc dna gnotyp 16 bld groups
0258U Ai psor mrna 50-100 gen alg
0260U Rare ds id opt genome mapg
0264U Rare ds id opt genome mapg
0265U Rar do whl gn&mtcdrl dna als
0266U Unxpl cnst hrtbl do gn xprsn
0267U Rare do id opt gen mapg&seq
0268U Hem ahus gen seq alys 15 gen
0269U Hem aut dm cgen trmbctpna 22
0270U Hem cgen coagj do 20 genes
0271U Hem cgen neutropenia 24 gen
0272U Hem genetic bld do 60 genes
0273U Hem gen hyprfibrnlysis 8 gen
0274U Hem gen pltlt do 62 genes
0276U Hem inh thrombocytopenia 42
0277U Hem gen pltlt funcj do 40
0278U Hem gen thrombosis 14 genes
0282U Rbc dna gntyp 12 bld grp gen
0286U Cep72 nudt15&tpmt gene alys
0289U Neuro alzheimer mrna 24 gen
0290U Pain mgmt mrna gen xprsn 36
0291U Psyc mood do mrna 144 genes
0292U Psyc strs do mrna 72 genes
0293U Psyc suicidal idea mrna 54
0294U Lngvty&mrtlty rsk mrna 18gen
0318U Ped whl gen mthyltn alys 50+
0345U Psyc genom alys pnl 15 gen
0347U Rx metab/pcx dna 16 gen alys
0348U Rx metab/pcx dna 25 gen alys
0349U Rx metab/pcx dna 27gen rx ia
0350U Rx metab/pcx dna 27 gen alys
0355U Apol1 risk variants
0378U Rfc1 repeat xpnsj vrnt alys
0380U Rx metb advrs trgt sq aly 20
0389U Ped fbrl kd ifi27&mcemp1 rna
0392U Rx metab gen-rx ia 16 genes
0400U Ob xpnd car scr 145 genes
0401U Crd c hrt ds 9 gen 12 vrnts
0411U Psyc genom alys pnl 15 gen
0417U Rare ds alys 335 nuc genes
0419U Nrpsyc gen seq vrnt aly 13

Group 2

(1 Code)
Group 2 Paragraph

For tests billed under the Not Otherwise Classified (NOC) CPT® code 81479:
Tests billed under the NOC CPT code 81479 that are used for germline testing and are further defined by a unique identifier (such as a Z-Identifier code) are limited to once per lifetime, as are such tests that are duplicative.

If non-duplicative testing of such a test is considered medically reasonable and necessary, please use a -77 modifier to trigger a medical review.

Group 2 Codes
Code Description
81479 Unlisted molecular pathology
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CPT/HCPCS Modifiers

Group 1

(1 Code)
Group 1 Paragraph

N/A

Group 1 Codes
Code Description
77 REPEAT PROCEDURE BY ANOTHER PHYSICIAN: THE PHYSICIAN MAY NEED TO INDICATE THAT A BASIC PROCEDURE OR SERVICE PERFORMED BY ANOTHER PHYSICIAN HAD TO BE REPEATED. THIS SITUATION MAY BE REPORTED BY ADDING MODIFIER -77 TO THE REPEATED PROCEDURE/SERVICE OR THE SEPARATE FIVE DIGIT MODIFIER CODE 09977 MAY BE USED.
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ICD-10-CM Codes that Support Medical Necessity

Group 1

Group 1 Paragraph

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Group 1 Codes

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ICD-10-CM Codes that DO NOT Support Medical Necessity

Group 1

Group 1 Paragraph

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Group 1 Codes

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ICD-10-PCS Codes

Group 1

Group 1 Paragraph

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Group 1 Codes

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Additional ICD-10 Information

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Bill Type Codes

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the article does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the article should be assumed to apply equally to all claims.

Code Description
N/A

Revenue Codes

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory. Unless specified in the article, services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the article should be assumed to apply equally to all Revenue Codes.

Code Description
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Other Coding Information

Group 1

Group 1 Paragraph

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Group 1 Codes

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Coding Table Information

Excluded CPT/HCPCS Codes - Table Format
Code Descriptor Generic Name Descriptor Brand Name Exclusion Effective Date Exclusion End Date Reason for Exclusion
N/A N/A
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Non-Excluded CPT/HCPCS Ended Codes - Table Format
Code Descriptor Generic Name Descriptor Brand Name Exclusion Effective Date Exclusion End Date Reason for Exclusion
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Revision History Information

Revision History Date Revision History Number Revision History Explanation
10/01/2023 R7

Posted 10/26/2023 Under CPT/HCPCS Codes Group 1: Codes the description was revised for 0269U, 0271U, 0272U, 0274U, 0277U, and 0278U. Added 0411U, 0417U, and 0419U. This revision is due to the 2023 Q4 CPT/HCPCS Code Update and is effective on 10/1/2023.

07/01/2023 R6

Posted 07/27/2023: Under CMS National Coverage Policy updated section heading. Under CPT/HCPCS Codes Group 1: Codes added 0389U, 0392U, 0400U, and 0401U. This revision is due to the 2023 Q3 CPT/HCPCS Code Update and is effective on 7/1/2023.

04/01/2023 R5

Posted 04/27/2023 Under CPT/HCPCS Codes Group 1: Codes added 0378U and 0380U. This revision is due to the 2023 Q2 CPT/HCPCS Code Update and is effective on 04/01/2023. Review completed 03/27/2023.

01/01/2023 R4

Posted 01/26/2023 Under CPT/HCPCS Codes Group 1: Codes the description was revised for 0276U and 81330. Added 81418, 81441, and 0355U. This revision is due to the 2023 Annual/Q1 CPT/HCPCS Code Update and is effective on 01/01/2023. Review completed 01/04/2023.

10/01/2022 R3

Posts 10/27/2022 Under CPT/HCPCS Codes Group 1: Codes added 81307 and 81309. This revision is effective for dates of service on or after 10/1/2022. Under CPT/HCPCS Codes Group 1: Codes deleted 0012U. Added 0345U, 0347U, 0348U, 0349U, and 0350U. This revision is due to the Q4 CPT/HCPCS Code Update and is effective for dates of service on or after 10/01/2022.

05/12/2022 R2

Posted 05/26/2022 Under CPT/HCPCS Codes Group 1: Codes added 0318U. This revision is due to the Q2 CPT/HCPCS Code Update and is effective for dates of service on or after 04/01/2022.
Under CMS National Coverage Policy added regulation CMS Internet-Only Manual, Pub. 100-04, Medicare Claims Processing Manual, Chapter 16, §50.5 Jurisdiction of Laboratory Claims, §60.1.2 Independent Laboratory Specimen Drawing, §60.2 Travel Allowance. Under CPT/HCPCS Codes Group 1: Codes deleted 81340, 81341, and 81342. Added 81220, 81221, 81222, 81223, 81224, 81419, 81493, 81554, 0001U, 0004M, 0012U, 0029U, 0030U, 0031U, 0032U, 0033U, 0034U, 0070U, 0071U, 0072U, 0073U, 0074U, 0075U, 0076U, 0078U, 0079U, 0084U, 0094U, 0101U, 0102U, 0103U, 0129U, 0130U, 0131U, 0132U, 0133U, 0134U, 0135U, 0136U, 0137U, 0138U, 0156U, 0157U, 0158U, 0159U, 0160U, 0161U, 0162U, 0169U, 0170U, 0173U, 0175U, 0180U, 0181U, 0182U, 0183U, 0184U, 0185U, 0186U, 0187U, 0188U, 0189U, 0190U, 0191U, 0192U, 0193U, 0194U, 0195U, 0196U, 0197U, 0198U, 0199U, 0200U, 0201U, 0203U, 0205U, 0209U, 0212U, 0213U, 0214U, 0215U, 0216U, 0217U, 0218U, 0221U, 0222U, 0230U, 0231U, 0232U, 0233U, 0234U, 0235U, 0236U, 0237U, 0238U, 0246U, 0258U, 0260U, 0264U, 0265U, 0266U, 0267U, 0268U, 0269U, 0270U, 0271U, 0272U, 0273U, 0274U, 0276U, 0277U, 0278U, 0282U, 0286U, 0289U, 0290U , 0291U, 0292U, 0293U, and 0294U. This revision is effective 5/12/2022. Review completed 04/25/2022.

01/01/2022 R1

12/30/2021 Under CMS National Coverage Policy added regulation CMS Internet-Only Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15 §80.1.2 A/B MAC (B) Contacts With Independent Clinical Laboratories. CPT/HCPC’s annual code update under Group 1 Codes: description changes to codes 81228 and 81229. Formatting, punctuation, and typographical errors were corrected throughout the article. Review completed 11/08/2021.

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