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Reaching Out to the Medicare Community KENTUCKY & OHIO PART B Medicare Bulletin Jurisdiction 15 MARCH 2017 WWW.CGSMEDICARE.COM © 2017 Copyright, CGS Administrators, LLC.

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Page 1: Medicare Bulletin - March 2017 · Effective Date: January 1, 2017 Implementation Date: January 3, 2017 Note: This article was revised on January 12, 2017, to correct in the table

Reaching Out to the Medicare

Community

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BMedicare BulletinJurisdiction 15

MARCH 2017 • WWW.CGSMEDICARE.COM

© 2017 Copyright, CGS Administrators, LLC.

Page 2: Medicare Bulletin - March 2017 · Effective Date: January 1, 2017 Implementation Date: January 3, 2017 Note: This article was revised on January 12, 2017, to correct in the table

Medicare BulletinJurisdiction 15

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Bold, italicized material is excerpted from the American Medical Association Current Procedural Terminology CPT codes. Descriptions and other data only are copyrighted 2017 American Medical Association. All rights reserved. Applicable FARS/DFARS apply.

MEDICARE BULLETIN • GR 2017-03 MARCH 2017 2

Articles contained in this edition are current as of January 29, 2017.

KENTUCKY & OHIO

AdministrationUpdate to the Interest Paid on Clean Non-PIP Claims Not Paid Timely 3

SE1516 Rescinded: Chronic Care Management (CCM) Services Frequently Asked Questions (FAQs) 24

Ambulatory Surgery CenterMM9923: January 2017 Update of the Ambulatory Surgical Center (ASC) Payment System 10

CodingMM9771 Revised: Annual Update of HCPCS Codes Used for Home Health Consolidated Billing Enforcement 4

2017 Healthcare Common Procedure Coding System (HCPCS) Update 26

Credentialing & EnrollmentProvider Enrollment Application Fee Amount for CY 2017 3

DMEPOSMM9903 Revised: 2017 Durable Medical Equipment Prosthetics, Orthotics, and Supplies Healthcare Common Procedure Coding System (HCPCS) Code Jurisdiction List 5

Drugs & BiologicalsMM9945: April 2017 Quarterly Average Sales Price (ASP) Medicare Part B Drug Pricing Files and Revisions to Prior Quarterly Pricing Files 20

LaboratoryMM9909: Calendar Year (CY) 2017 Annual Update for Clinical Laboratory Fee Schedule and Laboratory Services Subject to Reasonable Charge Payment 6

MM9934: Changes to the Laboratory National Coverage Determination (NCD) Edit Software for April 2017 17

MM9956: New Waived Tests 21

SE17002: Additional Guidance for Clinical Laboratories as Data Reporting Begins 24

Medical ReviewMM9940: The Process of Prior Authorization 18

http://go.cms.gov/MLNGenInfo

Reg

ister for myCG

S!

Registration is fast and easy. Go to the myCGS homepage at http://www.cgsmedicare.com/mycgs/index.html and click on the “Register for myCGS” button. Complete the online form with the requested information, check the “I agree” box, and click ‘Submit.’

To assist providers with the myCGS registration process, refer to the “myCGS Web Portal Registration Checklist” at http://www.cgsmedicare.com/partb/myCGS/myCGS_Checklist.pdf. Once registered, refer to the myCGS User Manual at http://www.cgsmedicare.com/mycgs/manual.html.

my

Page 3: Medicare Bulletin - March 2017 · Effective Date: January 1, 2017 Implementation Date: January 3, 2017 Note: This article was revised on January 12, 2017, to correct in the table

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This newsletter should be shared with all health care practitioners and managerial members of the provider/supplier staff. Newsletters issued after January 1997 are available at no cost from our website at http://www.cgsmedicare.com. © 2017 Copyright, CGS Administrators, LLC.

MEDICARE BULLETIN • GR 2017-03 MARCH 2017

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3

Kentucky & Ohio

Update to the Interest Paid on Clean Non-PIP Claims Not Paid Timely

According to the Medicare Claims Processing Manual, (Pub 100-04, Ch. 1., §80.2.2), interest is paid on clean claims, not paid under the periodic interim payment (PIP) method, if payment is not made within 30 days after the date of receipt. The interest rate is determined by the Treasury Department on a 6-mongh basis, effective every January and July 1. Effective, January 1, 2017, the interest amount is 2.500%.

For additional information about when interest is paid on a claim, and how to calculate the interest, refer to the Medicare Claims Processing Manual, (Pub 100-04, Ch. 1., §80.2.2) at http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c01.pdf on the Centers for Medicare & Medicaid Services (CMS) website. Current and past interest rate amounts can be viewed at http://fms.treas.gov/prompt/rates.html on the Treasury Department website.

Kentucky & Ohio

Provider Enrollment Application Fee Amount for CY 2017

This article was previously published in the January 19, 2017, issue of the MLN Connects® Provider eNews at: https://www.cms.gov/Outreach-and-Education/Outreach/FFSProvPartProg/Downloads/2017-01-19-eNews.pdf

On November 7, CMS issued a notice: Provider Enrollment Application Fee Amount for Calendar Year 2017 [CMS–6071–N] (https://www.federalregister.gov/documents/2016/11/07/2016-26828/medicare-medicaid-and-childrens-health-insurance-programs-provider-enrollment-application-fee-amount). Effective January 1, 2017, the CY 2017 application fee is $560 for institutional providers that are:

yy Initially enrolling in the Medicare or Medicaid program or the Children’s Health Insurance Program (CHIP);

yy Revalidating their Medicare, Medicaid, or CHIP enrollment; or

yy Adding a new Medicare practice location.

This fee is required with any enrollment application submitted from January 1, 2017 through December 31, 2017.

The Medicare Learning Network® (MLN), offered by the Centers for Medicare & Medicaid Services (CMS), includes a variety of educational resources for health care providers. Access web-based training courses, national provider conference calls, materials from past conference calls, MLN articles, and much more.

To stay informed about all of the CMS MLN products, refer to http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/MailingLists_FactSheet.pdf and subscribe to the CMS electronic mailing lists. Learn more about what the CMS MLN offers at http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNGenInfo/index.html on the CMS website.

Medicare Learning Network®A Valuable Educational Resource!

Page 4: Medicare Bulletin - March 2017 · Effective Date: January 1, 2017 Implementation Date: January 3, 2017 Note: This article was revised on January 12, 2017, to correct in the table

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This newsletter should be shared with all health care practitioners and managerial members of the provider/supplier staff. Newsletters issued after January 1997 are available at no cost from our website at http://www.cgsmedicare.com. © 2017 Copyright, CGS Administrators, LLC.

MEDICARE BULLETIN • GR 2017-03 MARCH 2017

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CGS Note: An institutional provider is defined as any provider or supplier that submit a paper Medicare enrollment application using the CMS-855A, CMS-855B (except physician and non-physician practitioner organizations), or CMS-855S or associated Internet-based PECOS enrollment application. Refer to the CMS Medicare Application Fee Web page at https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/MedicareProviderSupEnroll/MedicareApplicationFee.html for additional information.

Kentucky & Ohio

MM9771 Revised: Annual Update of HCPCS Codes Used for Home Health Consolidated Billing Enforcement

The Centers for Medicare & Medicaid Services (CMS) has issued the following Medicare Learning Network ® (MLN) Matters article. This MLN Matters article and other CMS articles can be found on the CMS website at: http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/2016-MLN-Matters-Articles.html

MLN Matters® Number: MM9771 RevisedRelated CR Release Date: October 7, 2016Related CR Transmittal #: R3618CP

Related Change Request (CR) #: CR 9771Effective Date: January 1, 2017Implementation Date: January 3, 2017

Note: This article was revised on January 12, 2017, to correct in the table on page 2. The table incorrectly listed HCPCS code 97177. The correct HCPCS code is HCPCS 97167 (OT EVAL HIGH COMPLEX 60 MIN). All other information is unchanged.

Provider Types AffectedThis MLN Matters® Article is intended for Home Health Agencies (HHAs) and other providers submitting claims to Medicare Administrative Contractors (MACs) for services to Medicare beneficiaries in a home health period of coverage.

Provider Action Needed Change Request (CR) 9771 provides the 2017 annual update to the list of HCPCS codes used by Medicare systems to enforce consolidated billing of home health services. Make sure that your billing staffs are aware of these changes.

BackgroundThe Centers for Medicare & Medicaid Services (CMS) periodically updates the lists of HCPCS codes that are subject to the consolidated billing provision of the Home Health Prospective Payment System (HH PPS).

With the exception of therapies performed by physicians, supplies incidental to physician services and supplies used in institutional settings, services appearing on this list that are submitted on claims to Medicare contractors will not be paid separately on dates when a beneficiary for whom such a service is being billed is in a home health episode (that is, under a home health plan of care administered by a home health agency). Medicare will only directly reimburse the primary home health agencies that have opened such episodes during the episode periods. Therapies performed by physicians, supplies incidental to physician services and supplies used in institutional settings are not subject to HH consolidated billing.

The HH consolidated billing code lists are updated annually, to reflect the annual changes to the HCPCS code set itself. Additional updates may occur as frequently as quarterly in order to reflect the creation of temporary HCPCS codes (for example, K codes) throughout the calendar year. The new coding identified in each update describes the same services that were used to determine the applicable HH PPS payment rates. No additional services will be added by these updates; that is, new updates are required by changes to the coding system, not because the services subject to HH consolidated billing are being redefined.

Page 5: Medicare Bulletin - March 2017 · Effective Date: January 1, 2017 Implementation Date: January 3, 2017 Note: This article was revised on January 12, 2017, to correct in the table

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This newsletter should be shared with all health care practitioners and managerial members of the provider/supplier staff. Newsletters issued after January 1997 are available at no cost from our website at http://www.cgsmedicare.com. © 2017 Copyright, CGS Administrators, LLC.

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Section 1842(b)(6) of the Social Security Act requires that payment for home health services provided under a home health plan of care is made to the home health agency.

The HCPCS codes in the table below are being added to the HH consolidated billing therapy code list, effective for services on or after January 1, 2017. These codes replace HCPCS codes: 97001, 97002, 97003, 97004.

HCPCS Code Descriptor97161 PT EVAL LOW COMPLEX 20 MIN97162 PT EVAL MOD COMPLEX 30 MIN97163 PT EVAL HIGH COMPLEX 45 MIN97164 PT RE-EVAL EST PLAN CARE97165 OT EVAL LOW COMPLEX 30 MIN97166 OT EVAL MOD COMPLEX 45 MIN97167 OT EVAL HIGH COMPLEX 60 MIN97168 T RE-EVAL EST PLAN CARE

G0279 and G0280 are deleted from the HH consolidated billing therapy code list. These codes were replaced with 0019T and should have been removed from the list in earlier updates. Effective January 1, 2015, these codes were redefined for another purpose. MACs will adjust claims denied due to HH consolidated billing with HCPCS codes G0279 and G0280 and line item dates of service on or after January 1, 2015, if brought to their attention.

Additional InformationThe official instruction, CR 9771 issued to your MAC regarding this change is available at http://www.cms.hhs.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R3618CP.pdf.

If you have any questions, please contact your MAC at their toll-free number. That number is available at https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/Review-Contractor-Directory-Interactive-Map/.

Document History

Date of Change DescriptionJanuary 12, 2017 This article was revised to correct in the table on page 2. The table incorrectly listed

HCPCS code 97177. The correct HCPCS code is HCPCS 97167 (OT EVAL HIGH COMPLEX 60 MIN).

November 17, 2016 Initial article released

Kentucky & Ohio

MM9903 Revised: 2017 Durable Medical Equipment Prosthetics, Orthotics, and Supplies Healthcare Common Procedure Coding System (HCPCS) Code Jurisdiction List

The Centers for Medicare & Medicaid Services (CMS) has revised the following Medicare Learning Network ® (MLN) Matters article. This MLN Matters article and other CMS articles can be found on the CMS website at: http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/2016-MLN-Matters-Articles.html

MLN Matters® Number: MM9903 RevisedRelated CR Release Date: January 5, 2017Related CR Transmittal #: R3689CP

Related Change Request (CR) #: CR 9903Effective Date: January 1, 2017Implementation Date: January 24, 2017

Page 6: Medicare Bulletin - March 2017 · Effective Date: January 1, 2017 Implementation Date: January 3, 2017 Note: This article was revised on January 12, 2017, to correct in the table

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This newsletter should be shared with all health care practitioners and managerial members of the provider/supplier staff. Newsletters issued after January 1997 are available at no cost from our website at http://www.cgsmedicare.com. © 2017 Copyright, CGS Administrators, LLC.

MEDICARE BULLETIN • GR 2017-03 MARCH 2017

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Note: This article was revised on January 6, 2017, to reflect the revised CR9903 issued on January 5. In the article, the CR release date, transmittal number and the Web address for accessing the CR are revised. All other information remains the same.

Provider Types AffectedThis MLN Matters® Article is intended for providers and suppliers submitting claims to Medicare Administrative Contractors (MACs) for Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) items or services paid under the DMEPOS fee schedule.

What You Need to KnowChange Request (CR) 9903 notifies suppliers that the spreadsheet containing the jurisdiction list of Healthcare Common Procedure Coding System (HCPCS) codes is updated annually to reflect codes that have been added or discontinued (deleted) each year. Changes in Chapter 23, Section 20.3 of the “Medicare Claims Processing Manual” are reflected in the recurring update notification. The document for the 2017 DMEPOS Jurisdiction List is an Excel® spreadsheet and is available at http://www.cms.gov/Center/Provider-Type/Durable-Medical-Equipment-DME-Center.html and is also attached CR9903.

Additional InformationThe official instruction, CR9903, issued to your MAC regarding this change, is available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2017Downloads/R3689CP.pdf. If you have any questions, please contact your MAC at their toll-free number. That number is available at https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/Review-Contractor-Directory-Interactive-Map/.

Document History

Date of Change DescriptionJanuary 6, 2017 Article revised to reflect revised CR9903. In the article, the CR release date, transmittal

number and the Web address for accessing the CR are revised. All other information remains the same.

December 26, 2016 Initial Issuance

Kentucky & Ohio

MM9909: Calendar Year (CY) 2017 Annual Update for Clinical Laboratory Fee Schedule and Laboratory Services Subject to Reasonable Charge Payment

The Centers for Medicare & Medicaid Services (CMS) has issued the following Medicare Learning Network ® (MLN) Matters article. This MLN Matters article and other CMS articles can be found on the CMS website at: http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/2016-MLN-Matters-Articles.html

MLN Matters® Number: MM9909Related CR Release Date: December 29, 2016Related CR Transmittal #: R3687CP

Related Change Request (CR) #: CR 9909Effective Date: January 1, 2017Implementation Date: January 3, 2017

Provider Types AffectedThis MLN Matters® Article is intended for clinical diagnostic laboratories submitting claims to Medicare Administrative Contractors (MACs) for services provided to Medicare beneficiaries.

Page 7: Medicare Bulletin - March 2017 · Effective Date: January 1, 2017 Implementation Date: January 3, 2017 Note: This article was revised on January 12, 2017, to correct in the table

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This newsletter should be shared with all health care practitioners and managerial members of the provider/supplier staff. Newsletters issued after January 1997 are available at no cost from our website at http://www.cgsmedicare.com. © 2017 Copyright, CGS Administrators, LLC.

MEDICARE BULLETIN • GR 2017-03 MARCH 2017

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Provider Action NeededChange Request (CR) 9909 provides instructions for the Calendar Year (CY) 2017 clinical laboratory fee schedule, mapping for new codes for clinical laboratory tests, and updates for laboratory costs subject to the reasonable charge payment. This update applies to Chapter 16, Section 20 of the “Medicare Claims Processing Manual.”

BackgroundIn accordance with Section 1833(h)(2)(A)(i) of the Social Security Act (the Act), the annual update to the local clinical laboratory fees for CY 2017 is 0.70 percent. The annual update to payments made on a reasonable charge basis for all other laboratory services for CY 2017 is 1.00 percent (See 42 CFR 405.509(b)(1)).

Section 1833(a)(1)(D) of the Act provides that payment for a clinical laboratory test is the lesser of the actual charge billed for the test, the local fee, or the National Limitation Amount (NLA). The Part B deductible and coinsurance do not apply for services paid under the clinical laboratory fee schedule.

Key Points of CR9909

National Minimum Payment Amounts

For a cervical or vaginal smear test (pap smear), Section 1833(h)(7) of the Act requires payment to be the lesser of the local fee or the NLA, but not less than a national minimum payment amount (described below). However, for a cervical or vaginal smear test (pap smear), payment may also not exceed the actual charge.

The CY 2017 national minimum payment amount is $14.49 ($14.39 times 0.70 percent update for CY 2017). The affected codes for the national minimum payment amount are 88142, 88143, 88147, 88148, 88150, 88152, 88153, 88154, 88164, 88165, 88166, 88167, 88174, 88175, G0123, G0143, G0144, G0145, G0147, G0148, G0476, and P3000.

National Limitation Amounts (Maximum)

For tests for which NLAs were established before January 1, 2001, the NLA is 74 percent of the median of the local fees. For tests for which the NLAs are first established on or after January 1, 2001, the NLA is 100 percent of the median of the local fees in accordance with Section 1833(h)(4)(B)(viii) of the Act.

Access to Data File

Internet access to the CY 2017 clinical laboratory fee schedule data file will be available at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/index.html. Other interested parties, such as the Medicaid state agencies, the Indian Health Service, the United Mine Workers, and the Railroad Retirement Board, should use the Internet to retrieve the CY 2017 clinical laboratory fee schedule. It will be available in multiple formats: Excel, text, and comma delimited.

Data File Format

For each test code, if your system retains only the pricing amount, load the data from the field named “60% Pricing Amt.” For each test code, if your system has been developed to retain the local fee and the NLA, you may load the data from the fields named “60% Local Fee Amt” and “60% Natl Limit Amt” to determine payment. For test codes for cervical or vaginal smears (pap smears), you should load the data from the field named “60% Pricing Amt” which reflects the lower of the local fee or the NLA, but not less than the national minimum payment amount. MACs should use the field “62% Pricing Amt” for payment to qualified laboratories of sole community hospitals.

Page 8: Medicare Bulletin - March 2017 · Effective Date: January 1, 2017 Implementation Date: January 3, 2017 Note: This article was revised on January 12, 2017, to correct in the table

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This newsletter should be shared with all health care practitioners and managerial members of the provider/supplier staff. Newsletters issued after January 1997 are available at no cost from our website at http://www.cgsmedicare.com. © 2017 Copyright, CGS Administrators, LLC.

MEDICARE BULLETIN • GR 2017-03 MARCH 2017

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Public Comments and Final Payment Determinations

On July 18, 2016, the Centers for Medicare & Medicaid Services (CMS) hosted a public meeting to solicit input on payment methods for reconsidered CY 2016 codes and new CY 2017 codes. Notice of the meeting was published in the Federal Register on May 13, 2016 and on the CMS web site on approximately May 18, 2016. Recommendations were received from many attendees, including individuals representing laboratories, manufacturers, and medical societies. CMS posted a summary of the meeting and the tentative payment determinations at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/index.html.

Additional written comments from the public were accepted until October 31, 2016. CMS has posted a summary of the public comments and the rationale for the final payment determinations at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Downloads/CY2017-CLFS-Codes-Final-Determinations.pdf.

Pricing Information

The CY 2017 clinical laboratory fee schedule includes separately payable fees for certain specimen collection methods (codes 36415, P9612, and P9615). The fees have been established in accordance with Section 1833(h)(4)(B) of the Act.

The fees for clinical laboratory travel codes P9603 and P9604 are updated on an annual basis. The clinical laboratory travel codes are billable only for traveling to perform a specimen collection for either a nursing home or homebound patient. If there is a revision to the standard mileage rate for CY 2017, CMS will issue a separate instruction on the clinical laboratory travel fees.

The CY 2017 clinical laboratory fee schedule also includes codes that have a “QW” modifier to both identify codes and determine payment for tests performed by a laboratory having only a certificate of waiver under the Clinical Laboratory Improvement Amendments (CLIA).

Organ or Disease Oriented Panel Codes

Similar to prior years, the CY 2017 pricing amounts for certain organ or disease panel codes and evocative/suppression test codes were derived by summing the lower of the clinical laboratory fee schedule amount or the NLA for each individual test code included in the panel code. The NLA field on the data file is zero-filled.

Mapping Information

New codes:

yy G0659 is priced at the same rate as code G0479.yy 80305 is priced at the same rate as code G0477.yy 80306 is priced at the same rate as code G0478.yy 80307 is priced at the same rate as code G0479.yy 81327 is priced at the same rate as code 81287.yy 81413 is priced at the same rate as code 81435.yy 81414 is priced at the same rate as code 81436.yy 81422 is priced at the same rate as code 81436.

yy 81439 is priced at the same rate as code 81435.yy 81539 is priced at the same rate as code 0010Myy 84410 is priced at the same rate as the sum of codes 84402 and 84403yy 87483 is priced at the same rate as code 87633.yy 87338QW is priced at the same rate as code 87338.yy 87631QW is priced at the same rate as code 87631.

Existing Codes:yy 81420 is priced at the same rate as code 81435.yy G0475 is priced at the same rate as code 87389.yy G0476 is priced at the same rate as code 87624.yy G0480 is priced at the same rate as 4.75 times code 82542.yy G0481 is priced at the same rate as 6.50 times code 82542.

yy G0482 is priced at the same rate as 8.25 times code 82542.yy G0483 is priced at the same rate as 10.25 times code 82542.yy G0477, G0478, G0479, 0010M, and 82272QW are all to be deleted.

Page 9: Medicare Bulletin - March 2017 · Effective Date: January 1, 2017 Implementation Date: January 3, 2017 Note: This article was revised on January 12, 2017, to correct in the table

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This newsletter should be shared with all health care practitioners and managerial members of the provider/supplier staff. Newsletters issued after January 1997 are available at no cost from our website at http://www.cgsmedicare.com. © 2017 Copyright, CGS Administrators, LLC.

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Laboratory Costs Subject to Reasonable Charge Payment in CY 2017

For outpatients, the following codes are paid under a reasonable charge basis (See Section 1842(b)(3) of the Act). In accordance with 42 CFR 405.502 through 42 CFR 405.508, the reasonable charge may not exceed the lowest of the actual charge or the customary or prevailing charge for the previous 12-month period ending June 30, updated by the inflation-indexed update. The inflation-indexed update is calculated using the change in the applicable Consumer Price Index for the 12-month period ending June 30 of each year as set forth in 42 CFR 405.509(b)(1). The inflation-indexed update for CY 2017 is 1.0 percent.

Chapter 23, Sections 80 through 80.8 (https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c23.pdf) of the “Medicare Claims Processing Manual” contains instructions for determining the reasonable charge payment. If there is sufficient charge data for a code, the instructions permit considering charges for other similar services and price lists.

When services described by the HCPCS in the following list are performed for independent dialysis facility patients, Chapter 8, Section 60.3 of the “Medicare Claims Processing Manual” instructs that the reasonable charge basis applies. However, when these services are performed for hospital-based renal dialysis facility patients, payment is made on a reasonable cost basis. Also, when these services are performed for hospital outpatients, payment is made under the hospital Outpatient Prospective Payment System (OPPS).

Note: Reasonable charge codes P9070, P9071, P9072 and 89337 may be included in the next calendar year’s reasonable charge update.

Blood Products

P9010 P9011 P9012 P9016 P9017 P9019 P9020 P9021 P9022 P9023 P9031 P9032P9033 P9034 P9035 P9036 P9037 P9038 P9039 P9040 P9044 P9050 P9051 P9052P9044 P9050 P9051 P9052 P9053 P9054 P9055 P9056 P9057 P9058 P9059 P9060P9070 P9071 P9072

Also, payment for the following codes should be applied to the blood deductible as instructed in Chapter 3, Sections 20.5 through 20.5.4 of the “Medicare General Information, Eligibility and Entitlement Manual.”

P9010 P9016 P9021 P9022 P9038 P9039 P9040 P9051 P9054 P9056 P9057 P9058

Note: Reasonable charge codes P9070, P9071, P9072 and 89337 may be included in the next calendar year’s reasonable charge update.

Transfusion Medicine

86850 86860 86870 86880 86885 86886 86890 86891 86900 86901 86902 8690486905 86906 86920 86921 86922 86923 86927 86930 86931 86932 86945 8695086960 86965 86970 86971 86972 86975 86976 86977 86978 86985

Reproductive Medicine Procedures

89250 89251 89253 89254 89255 89257 89258 89259 89260 89261 89264 8926889272 89280 89281 89290 89291 89335 89337 89342 89343 89344 89346 8935289353 89354 89356

Additional InformationThe official instruction, CR9909 issued to your MAC regarding this change is available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R3687CP.pdf.

Page 10: Medicare Bulletin - March 2017 · Effective Date: January 1, 2017 Implementation Date: January 3, 2017 Note: This article was revised on January 12, 2017, to correct in the table

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This newsletter should be shared with all health care practitioners and managerial members of the provider/supplier staff. Newsletters issued after January 1997 are available at no cost from our website at http://www.cgsmedicare.com. © 2017 Copyright, CGS Administrators, LLC.

MEDICARE BULLETIN • GR 2017-03 MARCH 2017

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If you have any questions, please contact your MAC at their toll-free number. That number is available at https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring- Programs/Medicare-FFS-Compliance-Programs/Review-Contractor-Directory-Interactive-Map/.

Kentucky & Ohio

MM9923: January 2017 Update of the Ambulatory Surgical Center (ASC) Payment System

The Centers for Medicare & Medicaid Services (CMS) has issued the following Medicare Learning Network ® (MLN) Matters article. This MLN Matters article and other CMS articles can be found on the CMS website at: http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/2016-MLN-Matters-Articles.html

MLN Matters® Number: MM9923Related CR Release Date: December 22, 2016Related CR Transmittal #: R3683CP

Related Change Request (CR) #: CR 9923Effective Date: January 1, 2017Implementation Date: January 3, 2017

Provider Types AffectedThis MLN Matters® Article is intended for Ambulatory Surgical Centers (ASCs) submitting claims to Medicare Administrative Contractors (MACs) for services provided to Medicare beneficiaries.

Provider Action NeededChange Request (CR) 9923 updates the ASC payment system, the payment rates for separately payable drugs and biologicals, including descriptors for newly created Level II HCPCS codes for drugs and biologicals (ASC DRUG files), the ASC Payment Indicator (PI) file, and the CY 2017 ASC payment rates for covered surgical and ancillary services (ASCFS file). Make sure that your billing staffs are aware of these changes that are effective on January 1, 2017.

BackgroundCR9923 describes changes to, and billing instructions for, various payment policies implemented in the January 2017 ASC payment system update, including:

1. The CY 2017 payment rates for separately payable drugs and biologicals along with descriptors for newly created Level II HCPCS codes for drugs and biologicals (ASC DRUG files), and

2. The CY 2017 ASC payment rates for covered surgical and ancillary services (ASCFS file). It also includes the CY2017 ASC Code pair file, and as appropriate, also includes updates to the Healthcare Common Procedure Coding System (HCPCS).

Many ASC payment rates under the ASC payment system are established using payment rate information in the Medicare Physician Fee Schedule (MPFS). The payment files provided in CR9923 reflect the most recent changes to CY 2017 MPFS payment.

Key Updates1. New Device Pass-Through Policies

Section 1833(t)(6)(B) of the Social Security Act (the Act) requires that, under the Outpatient Prospective Payment System (OPPS), categories of devices are eligible for transitional pass-through payments for at least 2, but not more than 3 years. Section 1833(t)(6)(B)(ii)(IV) of the Act requires that the Centers for Medicare & Medicaid Services (CMS) create additional categories for transitional pass-through payment of new medical devices not described by existing (or previously existing) categories of devices.

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Medicare implemented this policy in the 2008 revised ASC payment system. Therefore, additional payments may be made to the ASC for covered ancillary services, including certain implantable devices with pass-through status under the OPPS.

In the CY2017 OPPS/ASC final rule with comment period that was published in the Federal Register on November 14, 2016, CMS adopted a policy to revise the pass-through payment time period by having the pass-through start date begin with the date of first payment and by allowing pass-through status to expire on a quarterly basis, such that the duration of device pass-through payment will be as close to 3 years as possible. This policy is applicable in both the OPPS and ASC payment systems. Refer to the CY 2017 OPPS/ASC final rule with comment period at https://www.gpo.gov/fdsys/pkg/FR-2016-11-14/pdf/2016-26515.pdf for complete details about these policy changes for device pass-through that will become effective on January 1, 2017.

The three device categories that are currently eligible for pass-through payment in the OPPS and ASC payment systems are: (1) HCPCS code C2623 (Catheter, transluminal angioplasty, drug-coated, non-laser); (2) HCPCS code C2613 (Lung biopsy plug with delivery system); and (3) HCPCS code C1822 (Generator, neurostimulator (implantable), high frequency, with rechargeable battery and charging system). These codes and their ASC payment indicator are listed in Addendum BB at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ASCPayment/11_Addenda_Updates.html.

2. Argus Retinal Prosthesis Add-on Code (C1842)

Effective October 1, 2013, and expiring December 31, 2015, one device, listed in Table 1 (C1841 - Retinal prosthesis, includes all internal and external components) was eligible for pass-through payment in the OPPS and ASC payment systems. After pass-through status expires for a medical device, the payment for the device is packaged into the payment for the associated procedure.

Effective January 1, 2016, in the OPPS and ASC payment systems, payment for the device described by HCPCS code C1841 is packaged into payment for CPT code 0100T. Due to current ASC systems limitations, CMS cannot implement the identical policy in ASCs. As an administrative workaround to the field limit on ASC payments equal to or greater than $100,000, CMS is creating a second device code; HCPCS code C1842, and splitting payments in half across C1841 and C1842. Therefore, effective January 1, 2017, HCPCS code C1842 (Long descriptor -Retinal prosthesis, includes all internal and external components; add on to C1841; short descriptor - Retinal prosth, add-on) must be reported with both C1841 and 0100T when a retinal prosthesis is implanted in the ASC (see Table 1 below).

Since CMS’s device payment will be equally split between C1841 and C1842. ASCs must split the submitted device charges equally between C1841 and C1842, to ensure that Medicare pays what they intended to pay. Likewise, when appropriate, the use of the FB modifier (Item provided without cost to provider, supplier or practitioner (examples, but not limited to: covered under warranty, replaced due to defect, free samples)) and FC modifier (Partial credit received for replaced device) would apply to both C1841 and C1842.

Table 1 − Argus Retinal Prosthesis Add-on Code (C1842)CY 2017 HCPCS Code CY 2017 Long Descriptor CY 2017 Short Descriptor ASC PIC1842 Retinal prosthesis, includes all internal and

external components; add on to C1841Retinal prosth, add-on J7

3. Drugs, Biologicals, and Radiopharmaceuticals

a. New CY 2017 HCPCS Codes and Dosage Descriptors for Certain Drugs, Biologicals, and Radiopharmaceuticals

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For CY 2017, several new HCPCS codes have been created for reporting drugs and biologicals in the ASC payment system, where there have not previously been specific codes available. These new codes are listed in Table 2, below.

Table 2 - New CY 2017 HCPCS Codes Effective for Certain Drugs, Biologicals, and RadiopharmaceuticalsCY 2017 HCPCS Code CY 2017 Long Descriptor CY 2017 Short Descriptor ASC PIA9587 Gallium ga-68, dotatate, diagnostic, 0.1 millicurie Gallium ga-68 K2A9588 Fluciciovine f-18, diagnostic, 1 millicurie Fluciclovine f-18 K2C9140 Injection, Factor VIII (antihemophilic factor,

recombinant) (Afstyla), 1 I.U.Afstyla factor viii recomb K2

J0570 Buprenorphine implant, 74.2 mg Buprenorphine implant 74.2mg K2J7175 Injection, factor x, (human), 1 i.u. Inj, factor x, (human), 1iu K2J7179 Injection, von willebrand factor (recombinant),

(Vonvendi), 1 i.u. vwf:rcoVonvendi inj 1 iu vwf:rco K2

J9034 Injection, bendamustine hcl (Bendeka), 1 mg Inj., bendeka 1 mg K2

b. Other Changes to CY 2017 HCPCS and CPT Codes for Certain Drugs, Biologicals, and Radiopharmaceuticals

Many HCPCS and CPT codes for drugs, biologicals, and radiopharmaceuticals have changes in their HCPCS and CPT code descriptors that will be effective in CY 2017. In addition, several temporary HCPCS C-codes have been deleted effective December 31, 2016, and replaced with permanent HCPCS codes in CY 2017. ASCs should pay close attention to accurate billing for units of service consistent with the dosages contained in the long descriptors of the CY 2017 HCPCS and CPT codes.

Table 3, below, notes those drugs, biologicals, and radiopharmaceuticals that have changes in their HCPCS/CPT code, their long descriptor, or both. Each product’s CY 2016 HCPCS/CPT code and long descriptor are noted in the two left hand columns and the CY 2017 HCPCS/CPT code and long descriptor are noted in the adjacent right hand columns.

Table 3 − Other CY 2017 HCPCS Changes for Certain Drugs, Biologicals, and RadiopharmaceuticalsCY 2016 HCPCS Code CY 2016 Long Descriptor

CY 2017 HCPCS Code CY 2017 Long Descriptor

C9461 Choline C 11, diagnostic, per study dose

A9515 Choline c-11, diagnostic, per study dose up to 20 millicuries

C9121 Injection, argatroban, per 5 mg J0883 Injection, argatroban, 1 mg (for non- esrd use)C9137 Injection, Factor VIII (antihemophilic

factor, recombinant) PEGylated, 1 I.U.J7207 Injection, factor viii, (antihemophilic factor,

recombinant), pegylated, 1 i.u.C9138 Injection, Factor VIII (antihemophilic

factor, recombinant) (Nuwiq), 1 I.U.J7209 Injection, factor viii, (antihemophilic factor,

recombinant), (nuwiq), 1 i.u.C9139 Injection, factor ix, albumin fusion

protein (recombinant), idelvion, 1 i.u.J7202 Injection, factor ix, albumin fusion protein,

(recombinant), idelvion, 1 i.u.C9349 Puraply, and puraply antimicrobial, any

type, per square centimeterQ4172 Puraply or puraply am, per square centimeter

C9470 Injection, aripiprazole lauroxil, 1 mg J1942 Injection, aripiprazole lauroxil, 1 mgC9471 Hyaluronan or derivative, Hymovis, for

intra-articular injection, 1 mgJ7322 Hyaluronan or derivative, hymovis, for intra-

articular injection, 1 mgC9472 Injection, talimogene laherparepvec, 1

million plaque forming units (PFU)J9325 Injection, talimogene laherparepvec, per 1

million plaque forming unitsC9473 Injection, mepolizumab, 1 mg J2182 Injection, mepolizumab, 1 mgC9474 Injection, irinotecan liposome, 1 mg J9205 Injection, irinotecan liposome, 1 mgC9475 Injection, necitumumab, 1 mg J9295 Injection, necitumumab, 1 mgC9476 Injection, daratumumab, 10 mg J9145 Injection, daratumumab, 10 mg

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Table 3 − Other CY 2017 HCPCS Changes for Certain Drugs, Biologicals, and RadiopharmaceuticalsCY 2016 HCPCS Code CY 2016 Long Descriptor

CY 2017 HCPCS Code CY 2017 Long Descriptor

C9477 Injection, elotuzumab, 1 mg J9176 Injection, elotuzumab, 1 mgC9478 Injection, sebelipase alfa, 1 mg J2840 Injection, sebelipase alfa, 1 mgC9479 Instillation, ciprofloxacin otic

suspension, 6 mgJ7342 Installation, ciprofloxacin otic suspension, 6 mg

C9480 Injection, trabectedin, 0.1 mg J9352 Injection, trabectedin, 0.1 mgC9481 Injection, reslizumab, 1 mg J2786 Injection, reslizumab, 1 mgJ3357 Injection, ustekinumab, 1 mg J3357 Ustekinumab, for subcutaneous injection, 1 mgJ1745 Injection, infliximab, 10 mg J1745 Injection, infliximab, excludes biosimilar, 10 mgJ7201 Injection, factor ix, fc fusion protein

(recombinant), per iuJ7201 Injection, factor ix, fc fusion protein

(recombinant), Alprolix, per iuJ7340 Carbidopa 5 mg/levodopa 20 mg

enteral suspensionJ7340 Carbidopa 5 mg/levodopa 20 mg enteral

suspension, 100 mlQ9981 Rolapitant, oral, 1 mg J8670 Rolapitant, oral, 1 mgQ4105 Integra dermal regeneration template

(drt), per square centimeterQ4105 Integra dermal regeneration template (drt) or

integra omnigraft dermal regeneration matrix, per square centimeter

c. Drugs and Biologicals with Payments Based on Average Sales Price (ASP) Effective January 1, 2017

For CY 2017, payment for nonpass-through drugs, biologicals and therapeutic radiopharmaceuticals continues to be made at a single rate of ASP + 6 percent, which provides payment for both the acquisition cost and pharmacy overhead costs associated with the drug, biological or therapeutic radiopharmaceutical. In addition, in CY 2017, a single payment of ASP + 6 percent continues to be made for pass-through drugs, biologicals and radiopharmaceuticals is made to provide payment for both the acquisition cost and pharmacy overhead costs of these pass-through items. Payments for drugs and biologicals based on ASPs will be updated on a quarterly basis as later quarter ASP submissions become available.

Effective January 1, 2017, payment rates for many drugs and biologicals have changed from the values published in the CY 2017 OPPS/ASC final rule with comment period as a result of the new ASP calculations based on sales price submissions from the third quarter of CY 2016. In cases where adjustments to payment rates are necessary, CMS is not publishing the updated payment rates in this Change Request. However, all ASC payable drugs and biologicals effective January 1, 2017, including those that were updated as a result of the new ASP calculations, can be found in the January 2017 ASC Addendum BB at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ASCPayment/11_Addenda_Updates.html.

d. Drugs and Biologicals Based on ASP Methodology with Restated Payment Rates

Some drugs and biologicals based on ASP methodology may have payment rates that are corrected retroactively. These retroactive corrections typically occur on a quarterly basis. The list of drugs and biologicals with corrected payments rates will be accessible on the first date of the quarter at http://cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ASCPayment/index.html.

Suppliers who think they may have received an incorrect payment for drugs and biologicals impacted by these corrections may request their MAC to adjust the previously processed claims.

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e. Biosimilar Biological Product Payment Policy

Effective January 1, 2017, the payment rate for biosimilars, approved for payment in the ASC payment system, will be the same as the payment rate in the OPPS and physician office setting; calculated as the Average Sales Price (ASP) of the biosimilar(s) described by the HCPCS code + 6 percent of the ASP of the reference product. Payment will be made at the single ASP + 6 percent rate.

You should remember that ASC claims for separately paid biosimilar biological products are required to include a modifier (see table 4, below) that identifies the specific product’s manufacturer. The modifier does not affect payment determination, but is used to distinguish between biosimilar products that appear in the same HCPCS code but are made by different manufacturers.

Table 4 − Biosimilar Biological Product Payment and Required ModifiersHCPCS Code Short Descriptor Long Descriptor

ASC PI

FDA Approval Date Modifier

Modifier Effective Date

Q5101 Inj filgrastim g-csf biosim

Injection, Filgrastim (G-CSF), Biosimilar, 1 microgram

K2 03/06/2015 ZA-Novartis/Sand oz

01/01/2016

Q5102 Inj., infliximab biosimilar

Injection, Infliximab, Biosimilar, 10 mg

K2 04/05/2016 ZB-Pfizer/Hospira

04/05/2016

f. Billing and Payment for New Drugs, Biologicals, or Radiopharmaceuticals Approved by the Food and Drug Administration (FDA) but Before Assignment of a Product- Specific HCPCS Code

As in the OPPS, ASCs are allowed to bill for new drugs, biologicals, and therapeutic radiopharmaceuticals that are approved by the Food and Drug Administration (FDA) on or after January 1, 2004, for which OPPS pass-through status has not been approved and a C- code and APC payment have not been assigned using the “unclassified” drug/biological HCPCS code C9399 (Unclassified drugs or biological). Drugs, biologicals, and therapeutic radiopharmaceuticals that are assigned to HCPCS code C9399 are MAC priced.

Diagnostic radiopharmaceuticals and contrast agents are policy packaged under both the OPPS and ASC payment system unless they have been granted pass-through status.

Therefore, new diagnostic radiopharmaceuticals and contrast agents are an exception to the above policy and should not be billed with C9399 prior to the approval of pass-through status but, instead, are packaged in the ASC setting with payment already included in the surgical procedure performed, and are not billed.

g. Skin Substitute Procedure Edits

The payment for skin substitute products that do not qualify for hospital OPPS pass-through status are packaged into the OPPS payment for the associated skin substitute application procedure. This policy is also implemented in the ASC payment system.

The skin substitute products are divided into two groups: 1) high cost skin substitute products and 2) low cost skin substitute products for packaging purposes. Table 5, below, lists the skin substitute products and their assignment as either a high cost or a low cost skin substitute product, when applicable. ASCs should not separately bill for packaged skin substitutes (ASC PI=N1). High cost skin substitute products should only be used in combination with the performance of one of the skin application procedures described by CPT codes 15271-15278. Low cost skin substitute products should only be used in combination with the performance of one of the skin application procedures described by HCPCS code C5271-C5278. All OPPS pass-

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through skin substitute products (ASC PI=K2) should be billed in combination with one of the skin application procedures described by CPT code 15271-15278.

Table 5 - Skin Substitute Product Assignment to High Cost/Low Cost Status for CY 2016CY 2017 HCPCS Code CY 2017 Short Descriptor CY 2017 SI Low/High Cost Skin SubstituteC9363 Integra Meshed Bil Wound Mat N1 HighQ4100 Skin Substitute, NOS N1 LowQ4101 Apligraf N1 HighQ4102 Oasis Wound Matrix N1 LowQ4103 Oasis Burn Matrix N1 HighQ4104 Integra BMWD N1 HighQ4105 Integra DRT N1 HighQ4106 Dermagraft N1 HighQ4107 GraftJacket N1 HighQ4108 Integra Matrix N1 HighQ4110 Primatrix N1 HighQ4111 Gammagraft N1 LowQ4115 Alloskin N1 LowQ4116 Alloderm N1 HighQ4117 Hyalomatrix N1 LowQ4121 Theraskin N1 HighQ4122 Dermacell N1 HighQ4123 Alloskin N1 HighQ4124 Oasis Tri-layer Wound Matrix N1 LowQ4126 Memoderm/derma/tranz/integup N1 HighQ4127 Talymed N1 HighQ4128 Flexhd/Allopatchhd/Matrixhd N1 HighQ4131 Epifix N1 HighQ4132 Grafix Core N1 HighQ4133 Grafix Prime N1 HighQ4134 hMatrix N1 LowQ4135 Mediskin N1 LowQ4136 Ezderm N1 LowQ4137 Amnioexcel or Biodexcel, 1cm N1 HighQ4138 Biodfence DryFlex, 1cm N1 HighQ4140 Biodfence 1cm N1 HighQ4141 Alloskin ac, 1cm N1 HighQ4143* Repriza, 1cm N1 HighQ4146* Tensix, 1CM N1 HighQ4147 Architect ecm, 1cm N1 HighQ4148 Neox 1k, 1cm N1 HighQ4150 Allowrap DS or Dry 1 sq cm N1 HighQ4151 AmnioBand, Guardian 1 sq cm N1 HighQ4152 Dermapure 1 square cm N1 HighQ4153 Dermavest 1 square cm N1 HighQ4154 Biovance 1 square cm N1 HighQ4156 Neox 100 1 square cm N1 HighQ4157* Revitalon 1 square cm N1 HighQ4158* MariGen 1 square cm N1 HighQ4159 Affinity 1 square cm N1 HighQ4160 NuShield 1 square cm N1 High

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Table 5 - Skin Substitute Product Assignment to High Cost/Low Cost Status for CY 2016CY 2017 HCPCS Code CY 2017 Short Descriptor CY 2017 SI Low/High Cost Skin SubstituteQ4161 Bio-Connekt per square cm N1 LowQ4162 Amnio bio and woundex flow N1 LowQ4163* Amnion bio and woundex sq cm N1 HighQ4164 Helicoll, per square cm N1 HighQ4165 Keramatrix, per square cm N1 LowQ4166* Cytal, per square cm N1 LowQ4167* Truskin, per square cm N1 LowQ4168* Amnioband, 1 mg N1 LowQ4169* Artacent wound, per square cm N1 LowQ4170* Cygnus, per square cm N1 LowQ4171* Interfyl, 1 mg N1 LowQ4172 PuraPly, PuraPly antimic K2 HighQ4173* Palingen or palingen xplus, per sq cm N1 LowQ4175* Miroderm, per square cm N1 Low

* HCPCS codes Q4166, Q4167, Q4168, Q4169, Q4170, Q4171, Q4173, and Q4175 were assigned to the low cost group in the CY 2017 OPPS/ASC final rule with comment period. Upon submission of updated pricing information, Q4143, Q4146, Q4157, Q4158, and Q4163 are assigned to the high cost group for CY 2017.

h. Reassignment of Skin Substitute Products from the Low Cost Group to the High Cost Group – Retroactive Change

One existing skin substitute product has been reassigned from the low cost skin substitute group to the high cost skin substitute group based on updated pricing information. The start date on this change is retroactive to October 1, 2016. ASCs should not separately bill for packaged skin substitutes (ASC PI=N1). The product is listed in Table 6 below.

Table 6 - Updated Skin Substitute Product Assignment to High Cost Status Retroactive to October 1, 2016HCPCS Code Short Descriptor ASC PI Low/High Cost StatusQ4158 MariGen 1 square cm N1 High

4. Coverage Determinations

The fact that a drug, device, procedure or service is assigned a HCPCS code and a payment rate under the ASC payment system does not imply coverage by the Medicare program, but indicates only how the product, procedure, or service may be paid if covered by the program. Medicare Administrative Contractors (MACs) determine whether a drug, device, procedure, or other service meets all program requirements for coverage. For example, MACs determine that it is reasonable and necessary to treat the beneficiary’s condition and whether it is excluded from payment.

5. CY 2017 Wage Index

In the CY2017 OPPS/ASC final rule with comment period, we informed readers that generally, the Office of Management and Budget (OMB) issues major revisions to statistical areas every 10 years, based on the results of the decennial census. However, OMB occasionally issues minor updates and revisions to statistical areas in the years between the decennial censuses. On July 15, 2015, OMB issued OMB Bulletin No. 15–01, which provides updates to and supersedes OMB Bulletin No. 13–01 that was issued on February 28, 2013. The attachment to OMB Bulletin No. 15–01 provides detailed information on the update to statistical areas since February 28, 2013. The updates provided in OMB Bulletin No. 15–01 are based on the application of the 2010 Standards

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for Delineating Metropolitan and Micropolitan Statistical Areas to Census Bureau population estimates for July 1, 2012 and July 1, 2013. Please refer to page 79562 of the final rule for more details. OMB Bulletin No. 15–01 made the following changes that are relevant to the ASC wage index:

- Garfield County, OK, with principal city Enid, OK, which was a Micropolitan (geographically rural) area, now qualifies as an urban new Core Based Statistical Area (CBSA) 21420 called Enid, OK.

- The county of Bedford City, VA, a component of the Lynchburg, VA CBSA 31340, changed to town status and is added to Bedford County. Therefore, the county of Bedford City (SSA State county code 49088, FIPS State County Code 51515) is now part of the county of Bedford, VA (SSA State county code 49090, FIPS State County Code 51019). However, the CBSA remains Lynchburg, VA, 31340.

- The name of Macon, GA, CBSA 31420, as well as a principal city of the Macon- Warner Robins, GA combined statistical area, is now Macon-Bibb County, GA. The CBSA code remains as 31420.

These changes are effective January 1, 2017. For CY 2017, the final CY 2017 ASC wage indexes fully reflect the new OMB labor market area delineations. The final CY2017 ASC wage indices are included in Attachment B of CR 9923.

Additional InformationThe official instruction, CR9923, issued to your MAC regarding this change is available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R3683CP.pdf.

If you have any questions, please contact your MAC at their toll-free number. That number is available at https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/Review-Contractor-Directory-Interactive-Map/.

Kentucky & Ohio

MM9934: Changes to the Laboratory National Coverage Determination (NCD) Edit Software for April 2017

The Centers for Medicare & Medicaid Services (CMS) has issued the following Medicare Learning Network ® (MLN) Matters article. This MLN Matters article and other CMS articles can be found on the CMS website at: http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/2016-MLN-Matters-Articles.html

MLN Matters® Number: MM9934Related CR Release Date: January 13, 2017Related CR Transmittal #: R3691CP

Related Change Request (CR) #: CR 9934Effective Date: October 1, 2016Implementation Date: April 3, 2017

Provider Types AffectedThis MLN Matters® Article is intended for physicians, other providers, and suppliers submitting claims to Medicare Administrative Contractors (MACs) for services provided to Medicare beneficiaries.

Provider Action NeededChange Request (CR) 9934 informs MACs about the changes that will be included in the April 2017 quarterly release of the edit module for clinical diagnostic laboratory services. Make sure that your billing staffs are aware of these changes.

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BackgroundThe national coverage determinations (NCDs) for clinical diagnostic laboratory services were developed by the laboratory negotiated rulemaking committee and the final rule was published on November 23, 2001. Nationally uniform software was developed and incorporated in the Medicare shared systems so laboratory claims subject to one of the 23 NCDs (“Medicare National Coverage Determinations Manual,” Sections 190.12 - 190.34, available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/ncd103c1_Part3.pdf) were processed uniformly throughout the nation effective April 1, 2003.

In accordance with Chapter 16, Section 120.2 of the “Medicare Claims Processing Manual,” the laboratory edit module is updated quarterly as necessary to reflect ministerial coding updates and substantive changes to the NCDs developed through the NCD process. This manual chapter is available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c16.pdf. The changes are a result of coding analysis decisions developed under the procedures for maintenance of codes in the negotiated NCDs and biannual updates of the ICD-10-CM codes. CR9934 lists numerous changes to the codes applicable to the various laboratory NCDs code lists for April 2017. Those changes are too numerous to repeat in this article, but the changes are detailed in the spreadsheet attachments to CR9934.

Additional InformationThe official instruction, CR 9934, issued to your MAC regarding this change is available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2017Downloads/R3691CP.pdf.

If you have any questions, please contact your MAC at their toll-free number. That number is available at https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/Review-Contractor-Directory-Interactive-Map/.

Kentucky & Ohio

MM9940: The Process of Prior Authorization

The Centers for Medicare & Medicaid Services (CMS) has issued the following Medicare Learning Network ® (MLN) Matters article. This MLN Matters article and other CMS articles can be found on the CMS website at: http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/2016-MLN-Matters-Articles.html

MLN Matters® Number: MM9940Related CR Release Date: January 20, 2017Related CR Transmittal #: R698PI

Related Change Request (CR) #: CR 9940Effective Date: February 21, 2017Implementation Date: February 21, 2017

Provider Types AffectedThis MLN Matters® Article is intended for providers ordering certain DMEPOS items and suppliers submitting claims to Medicare Administrative Contractors (MACs) for items furnished to Medicare beneficiaries.

What You Need to KnowChange Request (CR) 9940 updates the Centers for Medicare & Medicaid Services (CMS) “Program Integrity Manual” to permit the MACs to conduct prior authorization processes, as so directed by CMS through individualized operational instructions. As of January 2017, Prior Authorization of Certain Durable Medical Equipment, Prosthetic, Orthotic, and Supply Items, frequently subject to unnecessary utilization, is the only permanent (non-demonstration) prior authorization program approved for implementation. Make sure your billing staff is aware of these changes.

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BackgroundPrior authorization is a process through which a request for provisional affirmation of coverage is submitted to a medical review contractor for review before the item or service is furnished to the beneficiary and before the claim is submitted for processing. It is a process that permits the submitter/requester (for example, provider, supplier, beneficiary) to send in medical documentation, in advance of the item or service being rendered, and subsequently billed, in order to verify its eligibility for Medicare claim payment.

For any item or service to be covered by Medicare it must:

yy Be eligible for a defined Medicare benefit category

yy Be medically reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member

yy Meet all other applicable Medicare coverage, coding and payment requirements

Contractors shall, at the direction of CMS or other authorizing entity, conduct prior authorizations and alert the requester/submitter of any potential issues with the information submitted.

A prior authorization request decision can be either a provisional affirmative or a non-affirmative decision.

yy A provisional affirmative decision is a preliminary finding that a future claim submitted to Medicare for the item or service likely meets Medicare’s coverage, coding, and payment requirements.

yy A non-affirmative decision is a finding that the submitted information/ documentation does not meet Medicare’s coverage, coding, and payment requirements, and if a claim associated with the prior authorization is submitted for payment, it would not be paid. MACs shall provide notification of the reason for the non-affirmation, if a request is non-affirmative, to the submitter/requester. If a prior authorization request receives a non-affirmative decision, the prior authorization request can be resubmitted an unlimited number of times.

yy Prior authorization may also be a condition of payment. This means that claims submitted without an indication that the submitter/requester received a prior authorization decision (that is, Unique Tracking Number (UTN)) will be denied payment.

Each prior authorization program will have an associated Operational Guide that will be available on the CMS website. In addition, MACs will educate stakeholders each time a new prior authorization program is launched. That education will include the requisite information and timeframes for prior authorization submissions and the vehicle to be used to submit such information to the MAC.

Prior Authorization Program for DME MACs

A prior authorization program for certain Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) items that are frequently subject to unnecessary utilization is described in 42 CFR 414.234. Among other things, this section establishes a Master List of certain DMEPOS items meeting inclusion criteria and potentially subject to prior authorization. CMS will select Healthcare Common Procedure Coding System (HCPCS) codes from the Prior Authorization Master List to be placed on the Required Prior Authorization List, and such codes will be subject to prior authorization as a condition of payment. In selecting HCPCS codes, CMS may consider factors such as geographic location, item utilization or cost, system capabilities, administrative burden, emerging trends, vulnerabilities identified in official agency reports, or other data analysis.

yy The Prior Authorization Master List is the list of DMEPOS items that have been identified using the inclusion criteria described in 42 CFR 414.234.

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yy The List of Required DMEPOS Prior Authorization Items contains those items selected from the Prior Authorization Master List to be implemented in the Prior Authorization Program. The List of Required DMEPOS Prior Authorization Items will be updated as additional codes are selected for prior authorization.

yy CMS may suspend prior authorization requirements generally or for a particular item or items at any time and without undertaking rulemaking. CMS provides notification of the suspension of the prior authorization requirements via Federal Register notice and posting on the CMS prior authorization website.

The Master and Required Prior Authorization Lists, as well as other pertinent information and supporting documents regarding this program, are available at https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/Prior-Authorization-Initiatives/Prior-Authorization-Process-for-Certain-Durable-Medical-Equipment-Prosthetic-Orthotics-Supplies-Items.html.

Additional InformationThe official instruction, CR9940, issued to your MAC regarding this change, is available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2017Downloads/R698PI.pdf.

If you have any questions, please contact your MAC at their toll-free number. That number is available at https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/Review-Contractor-Directory-Interactive-Map/.

Kentucky & Ohio

MM9945: April 2017 Quarterly Average Sales Price (ASP) Medicare Part B Drug Pricing Files and Revisions to Prior Quarterly Pricing Files

The Centers for Medicare & Medicaid Services (CMS) has issued the following Medicare Learning Network ® (MLN) Matters article. This MLN Matters article and other CMS articles can be found on the CMS website at: http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/2016-MLN-Matters-Articles.html

MLN Matters® Number: MM9945Related CR Release Date: January 13, 2017Related CR Transmittal #: R3692CP

Related Change Request (CR) #: CR 9945Effective Date: April 1, 2017Implementation Date: April 3, 2017

Provider Types AffectedThis MLN Matters® Article is intended for physicians, providers, and suppliers submitting claims to Medicare Administrative Contractors (MACs) for services provided to Medicare beneficiaries.

What You Need to KnowChange Request (CR) 9945 provides the April 2017 quarterly update and instructs MACs to download and implement the April 2017 ASP drug pricing files and, if released by the Centers for Medicare & Medicaid Services (CMS), the revised January 2017, October 2016, July 2016, and April 2016 Average Sales Price (ASP) drug pricing files for Medicare Part B drugs. Medicare will use these files to determine the payment limit for claims for separately payable Medicare Part B drugs processed or reprocessed on or after April 3, 2017, with dates of service April 1, 2017, through June 30, 2017. MACs will not search and adjust claims previously processed unless brought to their attention.

For claims with a date of service on or after January 1, 2017, and consistent with Section 5004 of the 21st Century Cures Act, which was signed into law on December 13, 2016, payment for

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infusion drugs furnished through a covered item of Durable Medical Equipment (DME) will be based on Section 1847A of the Social Security Act, meaning that most of the payments will be based on the ASP of these drugs. Payment for DME infusion drugs that do not appear on the ASP Drug Pricing Files will be determined by the MACs in accordance with the “Medicare Claims Processing Manual,” Chapter 17, Section 20.1.3, which is available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c17.pdf.

Make sure your billing staffs are aware of these changes.

BackgroundThe ASP methodology is based on quarterly data submitted to CMS by manufacturers. CMS will supply MACs with the ASP and Not Otherwise Classified (NOC) drug pricing files for Medicare Part B drugs on a quarterly basis. Payment allowance limits under the Outpatient Prospective Payment System (OPPS) are incorporated into the Outpatient Code Editor (OCE) through separate instructions that are in Chapter 4, Section 50 of the “Medicare Claims Processing Manual” at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c04.pdf.

The following table shows how the quarterly payment files will be applied:

Files Effective Dates of ServiceApril 2017 ASP and ASP NOC April 1, 2017, through June 30, 2017January 2017 ASP and ASP NOC January 1, 2017, through March 31, 2017October 2016 ASP and ASP NOC October 1, 2016, through December 31, 2016July 2016 ASP and ASP NOC July 1, 2016, through September 30, 2016April 2016 ASP and ASP NOC April 1, 2016, through June 30, 2016

Additional InformationThe official instruction, CR9945, issued to your MAC regarding this change is available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2017Downloads/R3692CP.pdf.

If you have any questions, please contact your MAC at their toll-free number. That number is available at https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/Review-Contractor-Directory-Interactive-Map/.

Kentucky & Ohio

MM9956: New Waived Tests

The Centers for Medicare & Medicaid Services (CMS) has issued the following Medicare Learning Network ® (MLN) Matters article. This MLN Matters article and other CMS articles can be found on the CMS website at: http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/2016-MLN-Matters-Articles.html

MLN Matters® Number: MM9956Related CR Release Date: January 20, 2017Related CR Transmittal #: R3696CP

Related Change Request (CR) #: CR 9956Effective Date: April 1, 2017Implementation Date: April 3, 2017

Provider Types AffectedThis MLN Matters® Article is intended for clinical diagnostic laboratories submitting claims to Medicare Administrative Contractors (MACs) for services provided to Medicare beneficiaries.

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Provider Action NeededChange Request (CR) 9956 informs MACs of new Clinical Laboratory Improvement Amendments of 1988 (CLIA) waived tests approved by the Food and Drug Administration (FDA). Since these tests are marketed immediately after approval, the Centers for Medicare & Medicaid Services (CMS) must notify MACs of the new tests so that they can accurately process claims. Make sure that your billing staffs are aware of these CLIA-related changes.

BackgroundThe CLIA regulations require a facility to be appropriately certified for each test performed. To ensure that Medicare & Medicaid only pay for laboratory tests categorized as waived complexity under CLIA in facilities with CLIA certificate of waiver, laboratory claims are currently edited at the CLIA certificate level.

Listed below are the latest tests approved by the FDA as waived tests under CLIA. The Current Procedural Terminology (CPT) codes for the following new tests must have the modifier QW to be recognized as a waived test. However, the tests mentioned on the first page of the list attached to CR9956 (CPT codes: 81002, 81025, 82270, 82272, 82962, 83026, 84830, 85013, and 85651) do not require a QW modifier to be recognized as a waived test.

The CPT code, effective date and description for the latest tests approved by the FDA as waived tests under CLIA are the following:

yy G0477QW [from July 7, 2016, to December 31, 2016], 80305QW [on and after January 1, 2017], July 7, 2016, TransMed Company, CLIA Screen In-Vitro Multi-Drug Urine Test Dip Card

yy G0477QW [from July 7, 2016, to December 31, 2016], 80305QW [on and after January 1, 2017], July 7, 2016, TransMed Company, CLIA Screen In-Vitro Multi-Drug Urine Test Dip Cup

yy 82274QW, G0328QW, July 27, 2016, Pinnacle BioLabs Second Generation FIT Fecal Occult Blood (FOB) Self-Test {Cassette}

yy G0477QW [from August 11, 2016, to December 31, 2016], 80305QW [on and after January 1, 2017], August 11, 2016, Nobel Medical Inc., AEON Multi-Drug Urine Test Cup

yy G0477QW [from August 11, 2016, to December 31, 2016], 80305QW [on and after January 1, 2017], Nobel Medical Inc., August 11, 2016, AEON Multi-Drug Urine Test Dip Card

yy G0477QW [from August 11, 2016, to December 31, 2016], 80305QW [on and after January 1, 2017], August 11, 2016, Nobel Medical Inc., INSTA-SCREEN Multi-Drug Urine Test Dip Card

yy 82274QW, G0328QW, September 6, 2016, ProAdvantage Immunochemical Fecal Occult Blood Test

yy 87880QW, September 16, 2016, Cardinal Health Strep A Cassette Rapid Test

yy G0477QW [from September 16, 2016, to December 31, 2016], 80305QW [on and after January 1, 2017], September 16, 2016, Premier Biotech, Inc., MDETOX Multi-Drug Urine Test Cup

yy G0477QW [from September 16, 2016, to December 31, 2016], 80305QW [on and after January 1, 2017], September 16, 2016, Premier Biotech, Inc., MDETOX Multi-Drug Urine Test Dip Card

yy 81003QW, October 7, 2016. Moore Medical LLC mooremedical U120 Urine Analyzer

yy 87633QW, October 7, 2016, BioFire Diagnostics, FilmArray 2.0 EZ Configuration Instrument (Viral and Bacterial Nucleic Acids) {Nasopharyngeal Swabs}

yy 87804QW, October 7, 2016, BioSign Flu A+B {Nasal and nasopharyngeal swabs}

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yy G0477QW [from October 24, 2016, to December 31, 2016], 80305QW [on and after January 1, 2017], October 24, 2016, Identify BioSciences Inc., Identifi Multi-Panel Drug Test Cups (Urine) {Cup Format}

yy G0477QW [from October 25, 2016, to December 31, 2016], 80305QW [on and after January 1, 2017], October 25, 2016, UCP Biosciences, Inc. U-Card Drug Test Screen (Urine) {Card Format}

yy G0477QW [from October 25, 2016, to December 31, 2016], 80305QW [on and after January 1, 2017], October 25, 2016, UCP Biosciences, Inc. U-Cup Drug Test Screen (Urine) {Cup Format}

yy G0477QW [from October 26, 2016, to December 31, 2016], 80305QW [on and after January 1, 2017], Intrinsic Interventions Inc., Vista Flow

yy 87804QW, November 15, 2016, LifeSign LLC, Status Flu A+B

yy 87804QW, November 21, 2016, Sekisui Diagnostics LLC, OSOM Ultra Flu A&B Test

yy G0477QW [from November 23, 2016, to December 31, 2016], 80305QW [on and after January 1, 2017], November 23, 2016, Medical Distribution Group Inc., Identify Diagnostics Drug Test Cards (UPC Biosciences, Inc.)

yy G0477QW [from November 23, 2016, to December 31, 2016], 80305QW [on and after January 1, 2017], November 23, 2016, Medical Distribution Group Inc., Identify Diagnostics Drug Test Cups (UPC Biosciences, Inc.)

yy 87804QW, November 25, 2016, OraSure QuickFlu Rapid A+B Test {Nasal and Nasopharyngeal Swabs

The HCPCS code G0477 [Drug tests(s), presumptive, any number of drug classes; any number of devices or procedures, (eg, immunoassay) capable of being read by direct optical observation only (eg, dipsticks, cups, cards, cartridges), includes sample validation when performed, per date of service] was discontinued on 12/31/2016. The new HCPCS code 80305 [Drug test(s), presumptive, any number of drug classes, any number of devices or procedures (eg, immunoassay); capable of being read by direct optical observation only (eg, dipsticks, cups, cards, cartridges) includes sample validation when performed, per date of service] was effective 1/1/2017. HCPCS code 80305QW describes the waived testing previously assigned the code G0477QW. All tests in the attachment that previously had HCPCS G0477QW are now assigned 80305QW.

The new waived complexity code 87633QW [Infectious agent detection by nucleic acid (DNA or RNA); respiratory virus (eg, adenovirus, influenza virus, coronavirus, metapneumovirus, parainfluenza virus, respiratory syncytial virus, rhinovirus), multiplex reverse transcription and amplified probe technique, multiple types or subtypes, 12-25 targets] was assigned for the testing performed by BioFire Diagnostics, FilmArray 2.0 EZ Configuration Instrument (Viral and Bacterial Nucleic Acids){Nasopharyngeal Swabs}.

The attachment to CR9956 has been re-organized. HCPCS codes with more than 20 test systems listed in previous transmittal attachments will now not mention the specific waived complexity test system. Instead, there will be a generic test system name and a statement to refer to the FDA waived analytes internet site (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/analyteswaived.cfm) for the specific test system name. The HCPCS codes mentioned on the attachment that will now only be mentioned in a generic manner are G0477QW (80305QW effective 1/1/2017), 81003QW, 82274QW, G0328QW, 86308QW, 86318QW, and 87880QW. For these codes, future New Waived Test transmittals will only mention the specific name of the latest FDA test system in the transmittal and not be included in the attachment.

MACs will not search their files to either retract payment or retroactively pay claims based on these changes. However, MACs should adjust claims that you bring to their attention.

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Additional InformationThe official instruction, CR9956, issued to your MAC regarding this change is available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2017Downloads/R3696CP.pdf.

If you have any questions, please contact your MAC at their toll-free number. That number is available at https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/Review-Contractor-Directory-Interactive-Map/.

Kentucky & Ohio

SE1516 Rescinded: Chronic Care Management (CCM) Services Frequently Asked Questions (FAQs)

The Centers for Medicare & Medicaid Services (CMS) has rescinded the following Medicare Learning Network ® (MLN) Matters article. This MLN Matters article and other CMS articles can be found on the CMS website at: http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/2016-MLN-Matters-Articles.html

MLN Matters® Number: SE1516 RescindedRelated CR Release Date: January 19, 2017Related CR Transmittal #: N/A

Related Change Request (CR) #: N/AEffective Date: N/AImplementation Date: N/A

Note: This article was rescinded on January 19, 2017, because CMS has implemented changes to the payment policy for Chronic Care Management beginning January 1, 2017. Those changes are outlined in the Calendar Year 2017 Physician Fee Schedule (PFS) Final Rule at https://www.gpo.gov/fdsys/pkg/FR-2016-11-15/pdf/2016-26668.pdf and the new guidance on the PFS Care Management Web page at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Care-Management.html.

Kentucky & Ohio

SE17002: Additional Guidance for Clinical Laboratories as Data Reporting Begins

The Centers for Medicare & Medicaid Services (CMS) has issued the following Medicare Learning Network ® (MLN) Matters article. This MLN Matters article and other CMS articles can be found on the CMS website at: http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/2016-MLN-Matters-Articles.html

MLN Matters® Number: SE17002Related CR Release Date: January 4, 2017Related CR Transmittal #: N/A

Related Change Request (CR) #: N/AEffective Date: N/AImplementation Date: N/A

Provider Types AffectedThis article is intended for Medicare Part B clinical laboratories that submit claims to Medicare Administrative Contractors (MACs) for services furnished to Medicare beneficiaries and are required to report private payor rate data to the Centers for Medicare & Medicaid Services (CMS).

Provider Action NeededThis article is intended to provide additional guidance to the laboratory community in meeting the new requirements under Section 1834A of the Social Security Act (the Act) for the Medicare Part B Clinical Laboratory Fee Schedule (CLFS). The data reporting period for the CLFS opened on January 1, 2017.

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To help determine if your laboratory is considered an applicable laboratory, please refer to the guidance in MLN Matters Article SE1619, “Medicare Part B Clinical Laboratory Fee Schedule: Guidance to Laboratories for Collecting and Reporting Data for the Private Payor Rate-Based Payment System,” which is available at https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/SE1619.pdf.

BackgroundCMS has developed an online data collection system to assist laboratories in submitting data to CMS, which are due by March 31, 2017. A detailed user guide on how to access and use this system is available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/PAMA-Regulations.html.

Laboratories must designate both a CLFS submitter and CLFS certifier in the data collection system. These must be two different individuals. The CLFS submitter must be registered in Medicare’s Provider Enrollment, Chain and Ownership System (PECOS) as a User or Authorized User on the PECOS Medicare Enrollment forms (in other words CLFS submitters must have their name appear within one of the following 855 application forms: A,B,C,I,R). The CLFS certifier does not need to be registered in PECOS.

A data reporting template is available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/PAMA-Regulations.html. Laboratories seeking to upload their data to the CLFS data collection system should use this template.

Tips for Smooth Data Submissions:

yy Please follow the formatting guidelines outlined in the user guide and on the data collection template. The CLFS data collection system will identify formatting errors in your file before you are able to certify the data and submit it. However, for large volumes of data, this process may take several hours to validate. Thus, those files with fewer formatting errors will be processed more efficiently.

yy Please use the CLFS Applicable Information HCPCS Codes file available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/PAMA-Regulations.html. The system will only accept HCPCS codes listed on this file.

yy The cleaner the file, the smoother the upload process will be.

** Important information for large laboratories: If your laboratory expects to submit over 100,000 lines of data in the .csv template, please first contact the CMS/CLFS helpdesk at [email protected].

Additional InformationFor more information about the new private payor rate based payment system including the CLFS final rule, related press release and fact sheet, frequently asked questions on our final policies, and a PowerPoint slide presentation of the new CLFS, visit https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/PAMA-Regulations.html.

If you have questions about requirements for the new CLFS, please email them to the CLFS Inquiries mailbox at [email protected].

If you have any questions, please contact your MAC at their toll-free number. That number is available at https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/Review-Contractor-Directory-Interactive-Map/.

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CPTS/ HCPCS Codes/ Modifiers DateFX 01/01/2017PN 01/01/2017V1 01/01/2017V2 01/01/2017V3 01/01/2017ZB 01/01/20170437T 07/01/20160438T 07/01/20160439T 07/01/20160440T 07/01/20160441T 07/01/20160442T 07/01/20160443T 07/01/20160444T 07/01/20160445T 07/01/20160446T 01/01/20170447T 01/01/20170448T 01/01/20170449T 01/01/20170450T 01/01/20170451T 01/01/20170452T 01/01/20170453T 01/01/20170454T 01/01/20170455T 01/01/20170456T 01/01/20170457T 01/01/20170458T 01/01/20170459T 01/01/20170460T 01/01/2017

CPTS/ HCPCS Codes/ Modifiers Date0461T 01/01/20170461T 01/01/20170462T 01/01/20170463T 01/01/20170464T 01/01/20170465T 01/01/20170466T 01/01/20170467T 01/01/20170468T 01/01/201722853 01/01/201722854 01/01/201722859 01/01/201722867 01/01/201722868 01/01/201722869 01/01/201722870 01/01/201727197 01/01/201727198 01/01/201728291 01/01/201728295 01/01/201731551 01/01/201731552 01/01/201731553 01/01/201731554 01/01/201731572 01/01/201731573 01/01/201731574 01/01/201731591 01/01/201731592 01/01/201733340 01/01/2017

CPTS/ HCPCS Codes/ Modifiers Date33390 01/01/201733391 01/01/201736456 01/01/201736473 01/01/201736474 01/01/201736901 01/01/201736902 01/01/201736903 01/01/201736904 01/01/201736905 01/01/201736906 01/01/201736907 01/01/201736908 01/01/201736909 01/01/201737246 01/01/201737247 01/01/201737248 01/01/201737249 01/01/201743284 01/01/201743285 01/01/201758674 01/01/201762320 01/01/201762321 01/01/201762322 01/01/201762323 01/01/201762324 01/01/201762325 01/01/201762326 01/01/201762327 01/01/201762380 01/01/2017

Kentucky & Ohio

2017 Healthcare Common Procedure Coding System (HCPCS) Update

The annual update of CPT/HCPCS codes will be effective for services rendered on and after January 1, 2017. Services provided on or after January 1, 2017, should be filed using the 2017 codes. Services rendered in 2016 should be filed using 2016 codes.

HCPCS is a five-digit coding system using numbers and letters. There are two divisions of codes assigned and maintained by different organizations:

Level 1: The first division is the CPT codes established by the American Medical Association. These codes range from 00100-99999 and represent physician services such as examinations, radiology, pathology, and surgery.

Level 2: The second division of codes are assigned and maintained by CMS. These codes are a combination of one letter and four numbers that range from A0000-V9999. These codes are common to all carriers.

Medicare Part B 2017 HCPCS/CPT Code Adds

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CPTS/ HCPCS Codes/ Modifiers Date76706 01/01/201777065 01/01/201777066 01/01/201777067 01/01/201780305 01/01/201780306 01/01/201780307 01/01/201781327 01/01/201781413 01/01/201781414 01/01/201781422 01/01/201781439 01/01/201781539 01/01/201784410 01/01/201787483 01/01/201790674 08/01/201690682 01/01/201790750 01/01/201792242 01/01/201793590 01/01/201793591 01/01/201793592 01/01/201796160 01/01/201796161 01/01/201796377 01/01/201797161 01/01/201797162 01/01/201797163 01/01/201797164 01/01/201797165 01/01/201797166 01/01/201797167 01/01/201797168 01/01/201797169 01/01/201797170 01/01/201797171 01/01/201797172 01/01/201799151 01/01/201799152 01/01/201799153 01/01/201799155 01/01/201799156 01/01/201799157 01/01/2017A4224 01/01/2017A4225 01/01/2017A4467 01/01/2017A4553 01/01/2017A9285 01/01/2017

CPTS/ HCPCS Codes/ Modifiers DateA9286 01/01/2017A9515 01/01/2017A9587 01/01/2017A9588 01/01/2017A9597 01/01/2017A9598 01/01/2017C1842 01/01/2017C1889 01/01/2017C9140 01/01/2017C9482 01/01/2017C9483 01/01/2017C9744 01/01/2017D0414 01/01/2017D0600 01/01/2017D1575 01/01/2017D4346 01/01/2017D6081 01/01/2017D6085 01/01/2017D9311 01/01/2017D9991 01/01/2017D9992 01/01/2017D9993 01/01/2017D9994 01/01/2017G0490 01/01/2017G0491 01/01/2017G0492 01/01/2017G0493 01/01/2017G0494 01/01/2017G0495 01/01/2017G0496 01/01/2017G0499 01/01/2017G0500 01/01/2017G0501 01/01/2017G0502 01/01/2017G0503 01/01/2017G0504 01/01/2017G0505 01/01/2017G0506 01/01/2017G0507 01/01/2017G0508 01/01/2017G0509 01/01/2017G0659 01/01/2017G9481 01/01/2017G9482 01/01/2017G9483 01/01/2017G9484 01/01/2017G9485 01/01/2017G9486 01/01/2017

CPTS/ HCPCS Codes/ Modifiers DateG9487 01/01/2017G9488 01/01/2017G9489 01/01/2017G9490 01/01/2017G9678 01/01/2017G9679 01/01/2017G9680 01/01/2017G9681 01/01/2017G9682 01/01/2017G9683 01/01/2017G9684 01/01/2017G9685 01/01/2017G9686 01/01/2017G9687 01/01/2017G9688 01/01/2017G9689 01/01/2017G9690 01/01/2017G9691 01/01/2017G9692 01/01/2017G9693 01/01/2017G9694 01/01/2017G9695 01/01/2017G9696 01/01/2017G9697 01/01/2017G9698 01/01/2017G9699 01/01/2017G9700 01/01/2017G9701 01/01/2017G9702 01/01/2017G9703 01/01/2017G9704 01/01/2017G9705 01/01/2017G9706 01/01/2017G9707 01/01/2017G9708 01/01/2017G9709 01/01/2017G9710 01/01/2017G9711 01/01/2017G9712 01/01/2017G9713 01/01/2017G9714 01/01/2017G9715 01/01/2017G9716 01/01/2017G9717 01/01/2017G9718 01/01/2017G9719 01/01/2017G9720 01/01/2017G9721 01/01/2017

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CPTS/ HCPCS Codes/ Modifiers DateG9722 01/01/2017G9723 01/01/2017G9724 01/01/2017G9725 01/01/2017G9726 01/01/2017G9727 01/01/2017G9728 01/01/2017G9729 01/01/2017G9730 01/01/2017G9731 01/01/2017G9732 01/01/2017G9733 01/01/2017G9734 01/01/2017G9735 01/01/2017G9736 01/01/2017G9737 01/01/2017G9738 01/01/2017G9739 01/01/2017G9740 01/01/2017G9741 01/01/2017G9742 01/01/2017G9743 01/01/2017G9744 01/01/2017G9745 01/01/2017G9746 01/01/2017G9747 01/01/2017G9748 01/01/2017G9749 01/01/2017G9750 01/01/2017G9751 01/01/2017G9752 01/01/2017G9753 01/01/2017G9754 01/01/2017G9755 01/01/2017G9756 01/01/2017G9757 01/01/2017G9758 01/01/2017G9759 01/01/2017G9760 01/01/2017G9761 01/01/2017G9762 01/01/2017G9763 01/01/2017G9764 01/01/2017G9765 01/01/2017G9766 01/01/2017G9767 01/01/2017G9768 01/01/2017G9769 01/01/2017

CPTS/ HCPCS Codes/ Modifiers DateG9770 01/01/2017G9771 01/01/2017G9772 01/01/2017G9773 01/01/2017G9774 01/01/2017G9775 01/01/2017G9776 01/01/2017G9777 01/01/2017G9778 01/01/2017G9779 01/01/2017G9780 01/01/2017G9781 01/01/2017G9782 01/01/2017G9783 01/01/2017G9784 01/01/2017G9785 01/01/2017G9786 01/01/2017G9787 01/01/2017G9788 01/01/2017G9789 01/01/2017G9790 01/01/2017G9791 01/01/2017G9792 01/01/2017G9793 01/01/2017G9794 01/01/2017G9795 01/01/2017G9796 01/01/2017G9797 01/01/2017G9798 01/01/2017G9799 01/01/2017G9800 01/01/2017G9801 01/01/2017G9802 01/01/2017G9803 01/01/2017G9804 01/01/2017G9805 01/01/2017G9806 01/01/2017G9807 01/01/2017G9808 01/01/2017G9809 01/01/2017G9810 01/01/2017G9811 01/01/2017G9812 01/01/2017G9813 01/01/2017G9814 01/01/2017G9815 01/01/2017G9816 01/01/2017G9817 01/01/2017

CPTS/ HCPCS Codes/ Modifiers DateG9818 01/01/2017G9819 01/01/2017G9820 01/01/2017G9821 01/01/2017G9822 01/01/2017G9823 01/01/2017G9824 01/01/2017G9825 01/01/2017G9826 01/01/2017G9827 01/01/2017G9828 01/01/2017G9829 01/01/2017G9830 01/01/2017G9831 01/01/2017G9832 01/01/2017G9833 01/01/2017G9834 01/01/2017G9835 01/01/2017G9836 01/01/2017G9837 01/01/2017G9838 01/01/2017G9839 01/01/2017G9840 01/01/2017G9841 01/01/2017G9842 01/01/2017G9843 01/01/2017G9844 01/01/2017G9845 01/01/2017G9846 01/01/2017G9847 01/01/2017G9848 01/01/2017G9849 01/01/2017G9850 01/01/2017G9851 01/01/2017G9852 01/01/2017G9853 01/01/2017G9854 01/01/2017G9855 01/01/2017G9856 01/01/2017G9857 01/01/2017G9858 01/01/2017G9859 01/01/2017G9860 01/01/2017G9861 01/01/2017G9862 01/01/2017J0570 01/01/2017J0883 01/01/2017J0884 01/01/2017

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CPTS/ HCPCS Codes/ Modifiers DateJ1130 01/01/2017J1942 01/01/2017J2182 01/01/2017J2786 01/01/2017J2840 01/01/2017J7175 01/01/2017J7179 01/01/2017J7202 01/01/2017J7207 01/01/2017J7209 01/01/2017J7320 01/01/2017J7322 01/01/2017J7342 01/01/2017J8670 01/01/2017

CPTS/ HCPCS Codes/ Modifiers DateJ9034 01/01/2017J9145 01/01/2017J9176 01/01/2017J9205 01/01/2017J9295 01/01/2017J9325 01/01/2017J9352 01/01/2017L1851 01/01/2017L1852 01/01/2017Q4166 01/01/2017Q4167 01/01/2017Q4168 01/01/2017Q4169 01/01/2017Q4170 01/01/2017

CPTS/ HCPCS Codes/ Modifiers DateQ4171 01/01/2017Q4172 01/01/2017Q4173 01/01/2017Q4174 01/01/2017Q4175 01/01/2017Q5102 01/01/2017Q9982 01/01/2017Q9983 01/01/2017S0285 01/01/2017S0311 01/01/2017T1040 01/01/2017T1041 01/01/2017

Medicare Part B 2017 HCPCS/CPT Discontinued Codes

CPTS/ HCPCS Codes/ Modifiers DateL1 12/31/20160010M 12/31/20160019T 12/31/20160169T 12/31/20160171T 12/31/20160172T 12/31/20160281T 12/31/20160282T 12/31/20160283T 12/31/20160284T 12/31/20160285T 12/31/20160286T 12/31/20160287T 12/31/20160288T 12/31/20160289T 12/31/20160291T 12/31/20160292T 12/31/20160336T 12/31/20160392T 12/31/20160393T 12/31/201611752 12/31/201621495 12/31/201622305 12/31/201622851 12/31/201627193 12/31/201627194 12/31/201628290 12/31/201628293 12/31/201628294 12/31/201631582 12/31/2016

CPTS/ HCPCS Codes/ Modifiers Date31588 12/31/201633400 12/31/201633401 12/31/201633403 12/31/201635450 12/31/201635452 12/31/201635458 12/31/201635460 12/31/201635471 12/31/201635472 12/31/201635475 12/31/201635476 12/31/201636147 12/31/201636148 12/31/201636870 12/31/201662310 12/31/201662311 12/31/201662318 12/31/201675791 12/31/201675962 12/31/201675964 12/31/201675966 12/31/201675968 12/31/201675978 12/31/201677051 12/31/201677052 12/31/201677055 12/31/201677056 12/31/201677057 12/31/201680300 12/31/2016

CPTS/ HCPCS Codes/ Modifiers Date80301 12/31/201680302 12/31/201680303 12/31/201680304 12/31/201681280 12/31/201681281 12/31/201681282 12/31/201692140 12/31/201693965 12/31/201697001 12/31/201697002 12/31/201697003 12/31/201697004 12/31/201697005 12/31/201697006 12/31/201699143 12/31/201699144 12/31/201699145 12/31/201699148 12/31/201699149 12/31/201699150 12/31/201699420 12/31/2016A4466 12/31/2016A9544 12/31/2016A9545 12/31/2016B9000 12/31/2016C9121 12/31/2016C9137 12/31/2016C9138 12/31/2016C9139 12/31/2016

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CPTS/ HCPCS Codes/ Modifiers DateC9349 12/31/2016C9458 12/31/2016C9459 12/31/2016C9461 12/31/2016C9470 12/31/2016C9471 12/31/2016C9472 12/31/2016C9473 12/31/2016C9474 12/31/2016C9475 12/31/2016C9476 12/31/2016C9477 12/31/2016C9478 12/31/2016C9479 12/31/2016C9480 12/31/2016C9481 12/31/2016C9742 12/31/2016C9743 12/31/2016C9800 12/31/2016D0290 12/31/2016E0627 12/31/2016E0628 12/31/2016E0629 12/31/2016G0154 12/31/2016G0163 12/31/2016G0164 12/31/2016G0389 12/31/2016G0436 12/31/2016G0437 12/31/2016G0477 12/31/2016G0478 12/31/2016G0479 12/31/2016G3001 12/31/2016G8401 12/31/2016G8458 12/31/2016G8460 12/31/2016G8461 12/31/2016G8485 12/31/2016G8486 12/31/2016G8487 12/31/2016G8489 12/31/2016G8490 12/31/2016G8491 12/31/2016G8494 12/31/2016G8495 12/31/2016G8496 12/31/2016G8497 12/31/2016G8498 12/31/2016

CPTS/ HCPCS Codes/ Modifiers DateG8499 12/31/2016G8500 12/31/2016G8544 12/31/2016G8545 12/31/2016G8548 12/31/2016G8549 12/31/2016G8551 12/31/2016G8634 12/31/2016G8645 12/31/2016G8646 12/31/2016G8725 12/31/2016G8726 12/31/2016G8728 12/31/2016G8757 12/31/2016G8758 12/31/2016G8759 12/31/2016G8761 12/31/2016G8762 12/31/2016G8765 12/31/2016G8784 12/31/2016G8848 12/31/2016G8853 12/31/2016G8868 12/31/2016G8898 12/31/2016G8899 12/31/2016G8900 12/31/2016G8902 12/31/2016G8903 12/31/2016G8906 12/31/2016G8927 12/31/2016G8928 12/31/2016G8929 12/31/2016G8940 12/31/2016G8948 12/31/2016G8953 12/31/2016G8977 12/31/2016G9203 12/31/2016G9204 12/31/2016G9205 12/31/2016G9206 12/31/2016G9207 12/31/2016G9208 12/31/2016G9209 12/31/2016G9210 12/31/2016G9211 12/31/2016G9217 12/31/2016G9219 12/31/2016G9222 12/31/2016

CPTS/ HCPCS Codes/ Modifiers DateG9233 12/31/2016G9234 12/31/2016G9235 12/31/2016G9236 12/31/2016G9237 12/31/2016G9238 12/31/2016G9244 12/31/2016G9245 12/31/2016G9324 12/31/2016G9435 12/31/2016G9436 12/31/2016G9437 12/31/2016G9438 12/31/2016G9439 12/31/2016G9440 12/31/2016G9441 12/31/2016G9442 12/31/2016G9443 12/31/2016G9463 12/31/2016G9464 12/31/2016G9465 12/31/2016G9466 12/31/2016G9467 12/31/2016G9499 12/31/2016G9572 12/31/2016G9581 12/31/2016G9619 12/31/2016G9650 12/31/2016G9652 12/31/2016G9653 12/31/2016G9657 12/31/2016G9667 12/31/2016G9669 12/31/2016G9670 12/31/2016G9671 12/31/2016G9672 12/31/2016G9673 12/31/2016G9677 12/31/2016J0760 12/31/2016J1590 12/31/2016K0901 12/31/2016K0902 12/31/2016Q4119 12/31/2016Q4120 12/31/2016Q4129 12/31/2016Q9980 12/31/2016Q9981 12/31/2016S8032 12/31/2016

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Medicare Part B 2017 HCPCS/CPT Description Changes

CPTS/ HCPCS Codes/ Modifiers Date0274T 01/01/20170274T 01/01/20170274T 01/01/20170275T 01/01/20170295T 01/01/20170408T 01/01/20170409T 01/01/20170410T 01/01/20170411T 01/01/20170412T 01/01/20170413T 01/01/20170414T 01/01/20170415T 01/01/20170416T 01/01/20170417T 01/01/20170418T 01/01/20170419T 01/01/20170420T 01/01/20170421T 01/01/20170422T 01/01/20170435T 01/01/20170436T 01/01/201728289 01/01/201733405 01/01/201733406 01/01/201733410 01/01/201736476 01/01/201736479 01/01/201758958 01/01/201777003 01/01/201778351 01/01/201782105 01/01/201783704 01/01/201785220 01/01/201788381 01/01/201789055 01/01/201789342 01/01/201790644 01/01/201790655 01/01/201790656 01/01/201790657 01/01/201790658 01/01/201790661 01/01/201790685 01/01/201790686 01/01/201790687 01/01/201790688 01/01/2017

CPTS/ HCPCS Codes/ Modifiers Date90734 01/01/201790832 01/01/201790833 01/01/201790834 01/01/201790836 01/01/201790837 01/01/201790838 01/01/201790846 01/01/201790847 01/01/201792235 01/01/201792240 01/01/201794060 01/01/201795076 01/01/201799235 01/01/201799500 01/01/2017A4221 01/01/2017A9599 01/01/2017B9002 01/01/2017D4263 01/01/2017D4264 01/01/2017D4274 01/01/2017D7210 01/01/2017D7250 01/01/2017D7280 01/01/2017D7292 01/01/2017D7293 01/01/2017D7294 01/01/2017D7485 01/01/2017D7780 01/01/2017D7873 01/01/2017D7874 01/01/2017D7875 01/01/2017D7876 01/01/2017D7877 01/01/2017D9630 01/01/2017E0627 01/01/2017E0629 01/01/2017E0740 01/01/2017E0967 01/01/2017E0995 01/01/2017E2206 01/01/2017E2220 01/01/2017E2221 01/01/2017E2222 01/01/2017E2224 01/01/2017G0202 01/01/2017G0204 01/01/2017

CPTS/ HCPCS Codes/ Modifiers DateG0206 01/01/2017G0480 01/01/2017G0481 01/01/2017G8427 01/01/2017G8428 01/01/2017G8430 01/01/2017G8431 01/01/2017G8432 01/01/2017G8433 01/01/2017G8510 01/01/2017G8511 01/01/2017G8598 01/01/2017G8599 01/01/2017G8649 01/01/2017G8653 01/01/2017G8655 01/01/2017G8656 01/01/2017G8657 01/01/2017G8658 01/01/2017G8659 01/01/2017G8660 01/01/2017G8661 01/01/2017G8662 01/01/2017G8665 01/01/2017G8669 01/01/2017G8671 01/01/2017G8672 01/01/2017G8673 01/01/2017G8674 01/01/2017G8697 01/01/2017G8815 01/01/2017G8924 01/01/2017G8925 01/01/2017G8968 01/01/2017G9229 01/01/2017G9231 01/01/2017G9231 01/01/2017G9239 01/01/2017G9264 01/01/2017G9307 01/01/2017G9308 01/01/2017G9326 01/01/2017G9327 01/01/2017G9359 01/01/2017G9361 01/01/2017G9381 01/01/2017G9416 01/01/2017

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CPTS/ HCPCS Codes/ Modifiers DateG9417 01/01/2017G9497 01/01/2017G9500 01/01/2017G9501 01/01/2017G9519 01/01/2017G9520 01/01/2017G9531 01/01/2017G9532 01/01/2017G9547 01/01/2017G9549 01/01/2017G9551 01/01/2017G9554 01/01/2017G9555 01/01/2017G9556 01/01/2017G9557 01/01/2017G9584 01/01/2017G9585 01/01/2017G9595 01/01/2017G9596 01/01/2017G9607 01/01/2017G9609 01/01/2017G9610 01/01/2017G9611 01/01/2017

CPTS/ HCPCS Codes/ Modifiers DateG9625 01/01/2017G9626 01/01/2017G9627 01/01/2017G9628 01/01/2017G9629 01/01/2017G9630 01/01/2017G9632 01/01/2017G9633 01/01/2017G9642 01/01/2017J0573 01/01/2017J1745 01/01/2017J3357 01/01/2017J7201 01/01/2017J7297 01/01/2017J7298 01/01/2017J7301 01/01/2017J7340 01/01/2017J9033 01/01/2017K0019 01/01/2017K0037 01/01/2017K0042 01/01/2017K0043 01/01/2017K0044 01/01/2017

CPTS/ HCPCS Codes/ Modifiers DateK0045 01/01/2017K0046 01/01/2017K0047 01/01/2017K0050 01/01/2017K0051 01/01/2017K0052 01/01/2017K0069 01/01/2017K0071 01/01/2017K0072 01/01/2017K0077 01/01/2017K0098 01/01/2017K0552 01/01/2017L1906 01/01/2017P9072 01/01/2017Q2039 01/01/2017Q4105 01/01/2017Q4131 01/01/2017J7325 01/01/2017J7326 01/01/2017J7328 01/01/2017J8501 01/01/2017