evekhm/cms_iom_500 huggingface dataset:
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HCPCS code G2076: Intake activities, including initial medical examination that is a complete, fully documented physical evaluation and initial assessment conducted by a program physician or a primary care physician,  or an authorized  healthcare  professional  under  the supervision of a program  physician or qualified personnel that includes preparation of a treatment plan that includes the patients short -term goals and the tasks the patient must perform to complete the short -term goals; the patients requirements for education, vocational rehabilitation, and employment; and the medical, psycho-  social, economic, legal, or other  supportive services that a patient needs, conducted by qualified personnel (provision of the services by a Medicare -enrolled Opioid Treatment Program); List separately in addition to code for primary procedure.   HCPCS code G2077: Periodic assessment; assessing periodically  by qualified personnel to determine the most  appropriate  combination of services  and treatment  (provision of the services  by a Medicare-enrolled Opioid Treatment Program); List separately in addition to code for primary procedure.   HCPCS code G2078: Take -home supply of methadone; up to 7 additional day supply (provision of the services  by a Medicare- enrolled Opioid Treatment Program); List separately  in addition to code  for primary procedure.   HCPCS  code  G2079:  Take- home  supply of buprenorphine  (oral);  up to  7 additional  day supply (provision of the services by a Medicare- enrolled Opioid Treatment Program); List separately in addition to code for primary procedure.   HCPCS  code  G2080:  Each  additional  30 minutes  of counseling or group or individual  therapy  in a week  of medication assisted treatment, (provision of the services by a Medicare -enrolled Opioid Treatment  Program);  List separately  in addition to  code  for primary  procedure.
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HCPCS code G2215: Take- home supply of nasal naloxone; 2- pack of 4mg per 0.1 mL nasal spray (provision of the services by  a Medicare- enrolled Opioid Treatment  Program); List separately  in addition to code for primary procedure.  HCPCS  code  G2216:  Take- home  supply of injectable naloxone  (provision of  the services  by a Medicare - enrolled Opioid Treatment Program); List separately in addition to code for primary procedure.  HCPCS code G1028: Take -home supply of nasal naloxone; 2- pack of 8mg per 0.1 mL nasal spray (provision of the services by  a Medicare- enrolled Opioid Treatment  Program); List separately  in addition to code for primary procedure.   HCPCS code G0137:  Intensive outpatient services; minimum of nine services over a 7 - contiguous day period, which can include individual and group therapy with physicians or psychologists (or other mental health professionals to the extent authorized under State law); occupational therapy requiring the skills of a qualified occupational therapist; services of social  workers, trained psychiatric nurses, and other staff trained to work with psychiatric patients; drugs and biologicals furnished for therapeutic purposes, excluding opioid agonist and antagonist medications that are FDA -approved for use in treatment of OUD or opioid antagonist medications for the emergency treatment of known or suspected opioid overdose; individualized activity therapies that are not primarily recreational or diversionary; family counseling (the primary purpose of which is treatment of the indivi duals condition); patient training and education (to the extent that training and educational activities are closely and clearly related to individuals care and treatment); diagnostic services (not including toxicology testing); (provision of the service s by a Medicare- enrolled Opioid Treatment Program); List separately in addition to code for primary procedure, if applicable .  Only  an entity  enrolled  with Medicare as an OTP  can bill these codes.  OTPs are limited  to billing  only these codes  describing  bundled payments,  and may not bill  for other  codes,  such as  those  paid under  the Medicare Physician Fee Schedule (PFS).
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F. Payment  Rates  The codes describing the OTP bundled services (HCPCS codes G2067- G2075) are assigned flat dollar payment amounts. The payment rates for OUD treatment services are derived by combining the cost of the drug and the non-drug components  (as applicable)  into a single  bundled payment  as described  in more  detail below.   1. Drug  component   As part of determining a payment rate for the bundles for OUD treatment services, a dosage of the applicable medication  was selected  in order  to calculate  the cost of the drug component  of the bundle.  In order  to determine  the drug costs  for the weekly  bundles, the following typical  or average maintenance dosages were used:    a 100 mg daily  dose for methadone,   a 16 mg daily  dose for oral buprenorphine   a 100 mg monthly dose for the extended -release  buprenorphine  injection,   four rods each containing  74.2 mg of buprenorphine  for the  6-month buprenorphine  implant, and   a 380 mg monthly dose for extended -release injectable  naltrexone)   Nasal naloxone is supplied as a single -dose intranasal spray containing 2mg, 4mg, or 8mg of naloxone hydrochloride  in 0.1mL.3 Nasal  naloxone  is packaged  in a carton  containing two doses  to allow  for repeat dosing if needed.   Effective January  1, 2021, injectable  naloxone  is contractor  priced. CMS  may establish  national  pricing for injectable naloxone through future rulemaking. According to the package insert45, an initial dose of 0.4 mg to 2 mg of injectable naloxone may be administered through intravenous, intramuscular, or subcutaneous routes. If needed, it may be repeated at two - to three -minute intervals up to a total dose of 10mg.  Drug  Pricing  Data  Source  For Part B  drugs, use the methodology in section  1847A  of the Act (which bases  most  payments  on average sales price (ASP)) to set the payment rates for the incident to drugs and limit the payment amounts for these  drugs  to 100 percent  of the volume -weighted ASP  for a drug category  or code,  and beginning January 1, 2021, the payment must be 100 percent of wholesale acquisition cost (WAC), if WAC is used.
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For oral drugs, use ASP -based payment to set the payment rates for the oral product categories when CMS receives manufacturer -submitted ASP data for these drugs and limit the payment amounts for oral drugs to 100 percent  of the volume -weighted  ASP.  When ASP  data are not available for the oral drugs  used in OTPs, use the National Average Drug Acquisition Cost (NADAC) data to set the payment for the drug component of the oral buprenorphine bundle.   For CY 2022, CMS  established  a limited  exception  to the current  methodology for determining  the payment amount for the drug component of an episode of care in order to freeze the payment amount for methadone furnished during an episode of care in CY 2022 at the payment amount that was determined for CY 2021.   Beginning January 1, 2023, the methodology for pricing the drug component of the methadone weekly bundle  and the  add-on code  for take -home  supplies of methadone  will be  based on and updated annually by the  Producer  Price Index (PPI) for Pharmaceuticals  for Human  Use (Prescription).  The TRICARE  rate will no longer be an alternative pricing methodology for methadone after January 1, 2023.  2. Non-drug  component   The payment  rate for the non-drug component  is calculated  based  on a building block methodology using the Medicare payment rates for similar services furnished in the non -facility setting. Additionally, the non-drug component  rate is adjusted  to account  for different  administration  and dispensing costs of the drug that is used in the episode of care (either oral, injectable, or implantable. The rate for dispensing oral drugs is determined using an approximation of the average dispensing fees under state Medicaid programs, which is $10.50, since there is no Medicare Part B rate for oral MAT drugs. The payment for the non- drug component of weekly bundles that include injectable drugs (buprenorphine and naltrexone) will include the Medicare non- facility rate for administration of an injection.  Medication  not otherwise specified    The payment for the non- drug component of the medication not otherwise specified bundle is based on whether the drug is oral, injectable, or implantable. This payment uses the building block payment methodology to determine  the non-drug component  of the bundled payments  for medications  that have  the same mode of administration.   3. Place of Service (POS) Code  for Services Furnished at  OTPs
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3. Place of Service (POS) Code  for Services Furnished at  OTPs   POS code  specific to OTPs  was created  since  there were no existing POS codes  that specifically  describe OTPs:    Place of Service  code 58 (Non -residential  Opioid Treatment  Facility a location  that provides  treatment for OUD on an ambulatory basis. Services include methadone and other forms of MAT).   CMS expects that POS code 58 will be noted on claims submitted for the HCPCS G codes describing OTP services. Additionally, the G codes describing the OTP bundled payments and add- on codes can only be billed by OTPs  and cannot  be billed  by other  providers. POS  codes  are not limited  to Medicare use and may be used by other payers.  In regards to non- OTP pharmacies dispensing MAT drugs included in an OTP bundle, CMS encourages pharmacies  and prescribing OTPs  to be in close communication  in order  to ensure  proper  billing  procedures are followed and to prevent duplicative payments. The presence of POS code 58 on retail pharmacy claims will not mean that the pharmacy should process MAT claims any differently than they do now.  3 https://www.narcan.com/static/Gen2 -Prescribing -Information.pdf  4 http://labeling.pfizer.com/ShowLabeling.aspx?id=4541 5 https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=f0932877- 1f3b- 4d5e -82d2- dd6c53db4730&type=display.      40.1.2 - Duplicative Payments Under Parts B or D  (Rev. 11219; Issued: 01- 27-22; Effective: 01 -01-22; Implementation: 03 -01-22)   Section 1834(w)(1) of the Act, added by section 2005(c) of the SUPPORT Act, requires the Secretary to ensure, as determined appropriate by the Secretary, that no duplicative payments are made under Part B or Part D for items and services furnished by an OT P.
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Many of the individual items or services provided by OTPs that would be included in the bundled payment rates may also be appropriately available to beneficiaries outside of the OTP benefit. Although CMS recognizes the potential for significant program int egrity concerns when similar items or services are payable under separate Medicare benefits, CMS believes it is important that any efforts to prevent duplicative payments not inadvertently restrict Medicate beneficiaries access to other Medicare benefits even for the time period they are being treated by an OTP.  For example, a beneficiary receiving counseling or therapy as part of an OTP bundle of services may also be receiving medically reasonable and necessary counseling or therapy as part of a physicians service during the same time period.  Similarly, there c ould be circumstances where Medicare beneficiaries with OUD could receive treatment and/or medication from non- OTP entities that would not result in duplicative payments, presuming that both the OTP and the other entity appropriately furnished separate medically -necessary services or items.  Consequently, CMS does not believe that provision of the same kinds of services by both an OTP and a separate provider or supplier would itself constitute a duplicative payment.     However, payment for medications delivered, administered or dispensed to a beneficiary as part of the bundled payment or an adjustment to the bundled payment is considered a duplicative payment if a claim for delivery, administration or dispensing of the s ame medication for the same beneficiary on the same date of service was also separately paid under Medicare Parts B or D. If this occurs, CMS will recoup the duplicative payment made to the OTP.  40.1.3 - Cost Sharing  (Rev. 268: Issued; 02- 14-20: Effective; 01 -01-20: Implementation: 03 -16-20)  The Medicare Part B deductible applies for OUD treatment services, as mandated for all Part B services by section 1833(b) of the Act.   The copayment for OUD treatment services furnished by OTPs under fee -for-service Medicare Part B is set at zero ($0).   50 - Adjustments to Bundled Payment Rates for OUD Treatment Services  (Rev. 268: Issued; 02- 14-20: Effective; 01 -01-20: Implementation: 03 -16-20)
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50 - Adjustments to Bundled Payment Rates for OUD Treatment Services  (Rev. 268: Issued; 02- 14-20: Effective; 01 -01-20: Implementation: 03 -16-20)  The costs of providing OUD treatment services will likely vary over time and depend on the geographic location where the services are furnished.   50.1 - Locality Adjustment  (Rev. 268: Issued; 02- 14-20: Effective; 01 -01-20: Implementation: 03 -16-20)  Section 1834(w)(2) of the Act, as added by section 2005(c) of the SUPPORT Act, provides that the Secretary may implement the bundled payment for OUD treatment services furnished by OTPs through one or more bundles based on the type of medication provided, the frequency of services, the scope of services furnished, characteristics of the individuals furnished such services, or other factors as the Secretary determines appropriate. The cost for the provision of OUD treatment services, like many other healthca re services covered by Medicare, will likely vary across the country based upon the differing cost in a given geographic locality. Therefore, a geographic locality adjustment will be applied to the bundled payment rate for OUD treatment services as describ ed below:   A. Drug Component   Because pricing for the MAT drugs included in the bundles reflects national pricing, and because there is no geographic adjustment faction (GAF) applied to the payment of Part B drugs under the ASP methodology, there will not be any geographic adjustment t o the drug component of the bundled payment rates.   B.  Non -Drug Component   The GAF will be applied to:   the non- drug component of the OTP bundled payment for OUD treatment, and   the add -on payment adjustments for non- drug services.  50.2 - Annual Update  (Rev. 268: Issued; 02- 14-20: Effective; 01 -01-20: Implementation: 03 -16-20)  A. Drug Component   The drug component of the bundled payment rates will be updated using the most recently available data from the applicable pricing mechanism finalized for drug pricing, as described above, to annually update the drug component of the bundled payment.   B. Non-Drug Component   The non- drug component of the bundled payment for OUD treatment services, and the add- on payments for non-drug services, will be updated based upon the Medicare Economic Index.                            Transmittals Issued for this Chapter
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B. Non-Drug Component   The non- drug component of the bundled payment for OUD treatment services, and the add- on payments for non-drug services, will be updated based upon the Medicare Economic Index.                            Transmittals Issued for this Chapter   Rev #  Issue Date  Subject  Impl Date  CR#  R12418BP  12/21/2023 Updates to Medicare Benefit Policy Manual and Medicare Claims Processing Manual for Opioid Treatment Programs (OTPs)  01/24/2024 13470 R11792BP  01/19/2023 Updates to Medicare Benefit Policy Manual and Medicare Claims Processing Manual for Opioid Treatment Programs and Additional Claims Modifier for Audio -only Services  02/21/2023 13062 R11219BP  01/27/2022 Updates to Medicare Benefit Policy Manual and Medicare Claims Processing Manual for Opioid Treatment Programs and New Modifier for Audio- only Services  03/01/2022 12545 R10665BP  03/16/2021 Updates to Medicare Benefit Policy Manual and Medicare Claims Processing Manual for Opioid Treatment Programs (Manual Updates Only)  04/15/2021 12161  02/14/2020 Update to Medicare Benefit Policy Manual and Medicare Claims Processing Manual Adding New Chapters for Opioid Treatment Programs (Manual Updates Only)  03/16/2020 11620 Back to Top of Chapter
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22120 Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Rules and Regulations DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services Office of the Secretary 42 CFR Parts 417, 422, 423, 455, and 460 [CMS4201F] RIN 0938AU96 Medicare Program; Contract Year 2024 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly AGENCY : Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS). ACTION : Final rule. SUMMARY : This final rule will revise the Medicare Advantage (Part C), Medicare Prescription Drug Benefit (Part D), Medicare cost plan, and Programs of All-Inclusive Care for the Elderly (PACE) regulations to implement changes related to Star Ratings, marketing and communications, health equity, provider directories, coverage criteria, prior authorization, passive enrollment, network adequacy, and other programmatic areas. This final rule will also codify regulations implementing section 118 of Division CC of the Consolidated Appropriations Act, 2021, section 11404 of the Inflation Reduction Act, and includes provisions that will codify existing sub-regulatory guidance in the Part C, Part D, and PACE programs. DATES : Effective date: These regulations are effective on June 5, 2023. Applicability dates: The provisions in this rule are applicable to coverage beginning January 1, 2024, except as otherwise noted. The revisions to  422.166(a)(2)(i) and 423.186(a)(2)(i) regarding Tukey outlier deletion are applicable on June 5, 2023. The marketing and communications provisions at  422.2262 through 422.2274 and 423.2262 through 423.2274 are applicable for all contract year 2024 marketing and communications beginning September 30, 2023. The revisions to the definition of gross covered prescription drug costs in  423.308 are applicable on June 5, 2023. The removal of the Part C Diabetes CareKidney Disease Monitoring measure as described in sections V.D.1. of the final rule is applicable on June 5, 2023. The risk adjustment to the three Part D adherence measures based on
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The removal of the Part C Diabetes CareKidney Disease Monitoring measure as described in sections V.D.1. of the final rule is applicable on June 5, 2023. The risk adjustment to the three Part D adherence measures based on sociodemographic status characteristics as described in section V.D.2. of this final rule is applicable for 2028 Star Rates beginning January 1, 2026. The PACE provision on the contract year definition at  460.6 and the PACE provision on service determination requests at  460.121 are applicable on June 5, 2023. FOR FURTHER INFORMATION CONTACT : Lucia Patrone, (410) 7868621 General Questions. Carly Medosch, (410) 7868633Part C and Cost Plan Issues. Catherine Gardiner, (410) 7867638 Part D Issues. Sonia Eaddy, (410) 7865459Part D Issues. Kristy Nishimoto, (206) 6152367 Beneficiary Enrollment and Appeals Issues. Kelley Ordonio, (410) 7863453 Parts C and D Payment Issues. Hunter Coohill, (720) 8532804 Enforcement Issues. Lauren Brandow, (410) 7869765 PACE Issues. Sara Klotz, 4107860507DSNP Issues. PartCandDStarRatings@cms.hhs.govParts C and D Star Ratings Issues. SUPPLEMENTARY INFORMATION : CMS intends to address all of the remaining proposals from the December 2022 proposed rule in subsequent rulemaking. Therefore, CMS plans to make provisions adopted in the subsequent, second final rule applicable to coverage beginning no earlier than January 1, 2025. Notwithstanding the foregoing, for proposals from the December 2022 proposed rule that would codify statutory requirements that are already in effect, CMS reminds organizations, plan sponsors, and other readers that the statutory provisions apply and will continue to be enforced. CMS intends to implement the statutory requirements in section 118 of Division CC of the Consolidated Appropriations Act, 2021 (CAA) and section 11404 of the Inflation Reduction Act (IRA) consistent with their effective provisions. We received nearly one thousand timely pieces of correspondence containing multiple comments on the CY 2024 proposed rule. We note that some of the public comments were outside of the scope of the proposed rule. These
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Reduction Act (IRA) consistent with their effective provisions. We received nearly one thousand timely pieces of correspondence containing multiple comments on the CY 2024 proposed rule. We note that some of the public comments were outside of the scope of the proposed rule. These out-of-scope public comments are not addressed in this final rule. Summaries of the public comments that are within the scope of the proposed rule and our responses to those public comments are set forth in the various sections of this final rule under the appropriate heading. However, we note that in this final rule, we are not addressing comments received on the provisions of the proposed rule that we are not addressing or finalizing at this time. Rather, we will address them at a later time, in a subsequent rulemaking document, as appropriate. I. Executive Summary A. Purpose The primary purpose of this final rule is to amend the regulations for the Medicare Advantage (Part C), Medicare Cost Plan, and Medicare Prescription Drug Benefit (Part D) programs, and Programs of All-Inclusive Care for the Elderly (PACE). This final rule includes a number of new policies that would improve these programs as well as codify existing Part C and Part D sub- regulatory guidance. Additionally, this rule implements certain sections of the following Federal laws related to the Parts C and D programs: The Inflation Reduction Act (IRA) of 2022. The Consolidated Appropriations Act (CAA), 2021. B. Summary of the Major Provisions 1. Medicare Advantage/Part C and Part D Prescription Drug Plan Quality Rating System ( 422.162, 422.164, 422.166, 423.182, 423.184, and 423.186) We are finalizing a health equity index (HEI) reward for the 2027 Star Ratings to further incentivize Parts C and D plans to focus on improving care for enrollees with social risk factors (SRFs); as part of this change, we also are finalizing the removal of the current reward factor (a reward for consistently high performance). This policy supports CMS efforts to ensure attainment of the highest level of health for all people. We are finalizing the reduction in the weight of patient experience/complaints and access measures to further align efforts with other CMS quality programs and the current CMS Quality Strategy, as well as to better balance the contribution of the different types of measures in the Star Ratings program. We also are finalizing