Memrandum T: Ken Van Pl, Vice President f Gvernment Affairs Natinal Hme Infusin Assciatin Frm: Crwell & Mring, LLP Date: July 6, 2018 Re: Summary: CMS Prpsed Rule Implementing Hme Infusin Therapy Services Temprary Transitinal Payment and Permanent Payment On Mnday, July 2, 2018, CMS made available fr public inspectin a prpsed rule 1 that, amng ther things, prpses payment fr hme infusin therapy services, bth n a temprary transitinal basis, fr calendar years 2019 and 2020, and permanently fr 2021 and future years. The prpsed rule takes psitins that we believe raise significant cncerns fr NHIA and its members. The tw areas f immediate and bvius cncern we identified in the prpsed rule are: Definitin f Infusin Drug Administratin Calendar Day CMS defined an infusin drug administratin calendar day in a way that wuld significantly limit hme infusin suppliers pprtunities fr reimbursement. The definitin requires that a nurse be physically present at the patient s hme n the day the cde is billed, and des nt prvide fr separate billing fr the nt-in-persn services assciated with hme infusin. (See preamble discussin beginning at p. 400 and crrespnding text at 486.505 at pp. 568-69.) Evidence that Prpsed Rule was Rushed As a general matter, the prpsed rule seems t evidence a lack f attentin n CMS s part t the implementatin f the hme infusin benefit. A cmbinatin f typs and the incnsistent structure f the hme infusin sectin suggests that CMS may have rushed the hme infusin prtin f the larger rle, rushed its analysis r therwise failed t devte sufficient resurces t plicy develpment. The relevant prtins f the regulatin with regard t NHIA and the services payment are summarized belw. Sme parts f CMS s prpsal d nt appear in regulatry text, specifically the discussin f CMS s prpsal fr the temprary transitinal payment. Therefre, the summary belw is rganized by reference t the preamble text with discussin f the prpsed regulatry text where appsite. The main sectins are health and safety standards, apprval and versight f accrediting 1 The fr-inspectin versin f the regulatin is available at https://s3.amaznaws.cm/publicinspectin.federalregister.gv/2018-14443.pdf. The frmal Ntice f Prpsed Rulemaking (NPRM) is scheduled t be published in the Federal Register n July 12, 2018. 1
rganizatins, and payment. In the appendices t this dcument, we briefly summarize the statutry authrity fr the prpsed rule and CMS s infrmatin requests. I. Prpsed Health and Safety Standards fr Hme Infusin Therapy (Prpsed Part 486, 2 Subpart I, 42 C.F.R. 486.500, et seq.) There are a number f imprtant prvisins cntained in this sectin, including the fllwing: CMS Fcus Three Things CMS prpses t fcus n three main areas in the rule, which include (1) utlining hme infusin therapy supplier requirements, (2) prviding a framewrk fr CMS t apprve hme infusin therapy accreditatin rganizatins; and (3) including in that framewrk fr accreditatin rganizatins the authrity t apprve Medicare certificatin fr hme infusin therapy suppliers. Definitins ( 486.505) Fr the definitins f the terms applicable prvider, hme infusin drug, and qualified hme infusin therapy supplier, CMS adpted r clsely tracked statutry definitins. Fcus n Plan f Care ( 486.520) CMS fcuses in n sme details related t a Plan f Care and hme infusin therapy suppliers, including the fllwing: Cntent f the Plan f Care As required by statute, CMS prpsed that patients be under the care f an applicable prvider with a plan f care established by a physician. The rule states that the plan f care shuld utline and include: 1. The type f treatment, amunt, and duratin f hme infusin therapy services fr the patient. 2. The specific medicatin, the prescribed dsage and frequency as well as the prfessinal services t be utilized fr treatment f the patient. 3. A descriptin f the specific care and services necessary t meet the patientspecific needs. Review f the Plan f Care CMS prpses that the Plan f Care be peridically reviewed by the physician. But all f the details are nt clear. Fr example, in this sectin CMS says the fllwing: 2 In sme places, the preamble text instead cites Part 485, Subpart I, but the regulatry text cntains n cntent fr Part 485. Part 485 sets frth Cnditins f Participatin: Specialized Prviders, and Part 486 sets frth Cnditins fr Cverage f Specialized Services Furnished by Suppliers. CMS s intentin with the structure f these requirements is unclear. 2
1. Time Frame fr Review f Plan f Care Requirements by Physician - CMS establishes n specific time frame fr review requirements by physicians, but des require physician review. 2. Details r Metrics t Judge Physician Rle in Plan f Care CMS says that the expectatin is that the physician will be active in the patient s care and shuld make apprpriate decisins related t the curse f therapy, but prvides n further details, guidance r metrics. 3. Request fr Cmments n the Plan f Care this sectin is a gd indicatr that CMS put ut the rule as much t slicit input as t set regulatry plicy. CMS invites cmments, specifically as t whether it shuld include specific review timeframes fr the plan f care. Required Services ( 486.525) -CMS prpses t ech the statutry definitin f items and services, which recgnizes the fllwing as necessary hme infusin services n a 24-hur-a-day and 7-day-a-week basis: 1. The prvisin f prfessinal services, including nursing services, furnished in accrdance with the plan f care; and 2. The prvisin f patient training and educatin nt therwise paid fr as durable medical equipment; 3. The prvisin f remte mnitring and mnitring services fr the prvisin f hme infusin therapy services. II. Apprval and Oversight f Accrediting Organizatins fr Hme Infusin Therapy Suppliers 3 (Prpsed Part 488, Subpart L, 42 C.F.R. 488.1000-1050) There are a number f imprtant prvisins cntained in this sectin, including the fllwing: Fcus n Accrediting Organizatins (AOs) The rule and CMS spend cnsiderable time fcusing n the issue f accrediting rganizatins fr hme infusin therapy suppliers. Definitin f Qualified Hme Infusin Therapy Supplier The regulatry text at prpsed 486.505 includes a definitin f qualified hme infusin therapy supplier. Amng ther things, that definitin includes a requirement that the supplier be accredited by an rganizatin designated by the Secretary.... Designatin f AOs by the Secretary f Health and Human Services The Act requires the Secretary t designate AOs by 2021. 3 This sectin is designated as VI.C. in the preamble text, but as VI.D. in the preamble table f cntents. The fllwing sectin n payment is als labeled VI.C. in the preamble text, but it fllws the apprval and versight cntent. 3
Slicitatin fr AOs t Apply t be Designated a Hme Infusin Therapy AO CMS says it will issue a slicitatin in the Federal Register t invite natinal Accreditatin Organizatins (AOs) t apply. Distinctin between AOs CMS says that accreditatin fr a hme infusin therapy supplier by an AO wuld be distinct frm the AO s hme health accreditatin prgram (if it has ne), and must be at least as stringent as its health and safety standards (as discussed abve). The Prcess fr Apprving AOs fr Hme Infusin Therapy Suppliers CMS sets frth prcesses and prcedures fr apprval f AOs. These prcesses and prcedures include: a) Applicatin and reapplicatin prcedures fr AOs; b) Resubmissin prcedures fr denied/withdrawn applicatins; c) Public ntice and cmment regarding each applicant AO; d) Release f accreditatin surveys frm AO t CMS; e) Onging review f AOs; f) Onging respnsibilities f AOs; g) Onsite reviews by CMS f AOs; h) Terminatin f AO status; and i) Recnsideratin f CMS determinatins. Current AOs fr Hme Infusin Therapy Suppliers In the preamble, CMS ntes that six rganizatins currently ffer accreditatin fr hme infusin therapy suppliers, but prpses t require thse rganizatins t apply and be certified as AOs t cnfer with their accreditatins the ability f the accredited supplier t bill Medicare fr hme infusin therapy services. III. Payment fr Hme Infusin Therapy Services This sectin fcuses in n the services payment as fllws: A. Temprary Transitinal Payment fr Hme Infusin Therapy Services fr CYs 2019 and 2020 What Des the Hme Infusin Services Payment Cver? As required by Sectin 50401 f The Bipartisan Budget Act f 2018 (BBA f 2018), a temprary transitinal payment wuld cver payment fr hme infusin items and services (as defined in sectin 1861(iii)(2)(A) and (B) f the Act). The temprary transitinal payment wuld be available frm January 1, 2019 t January 1, 2021 when the permanent payment becmes available. 4 Definitin f Transitinal Hme Infusin Drug CMS s prpsed definitin f transitinal hme infusin drug clsely tracks the statute. Definitin f Infusin Drug Administratin Calendar Day In its definitin f infusin drug administratin calendar day, CMS prpses t limit payment t a calendar day n which a nurse is in the patient s hme when an infusin drug is administered. 4 The text f the BBA f 2018 is available at https://www.cngress.gv/bill/115th-cngress/husebill/1892/text#tc-hfde57fddc9714574bfeef9bf935ef488. 4
Impact f Requiring a Nurse This wuld limit payment in tw significant ways: a) A nurse must be present nt a tech, assistant, r persn with anther designatin. b) The prfessinal must be in the patient s hme n the day infusin ccurs, rather than remtely available r therwise prviding services in cnnectin with the patient s hme infusin. Payment fr Days Nurse Present Designed t Cver All Services Over Multiple Days When Nurse Nt Present T the secnd pint, CMS acknwledges that services may ccur n ther days, but states that the ne payment (equal t 4 hurs f physician s ffice infusin services) is designed t cmpensate fr services n thse additinal days. Skilled Services Must be Cmplex In additin, CMS adds a requirement that the skilled services prvided n such day must be s inherently cmplex that they can nly be safely and effectively perfrmed by, r under the supervisin f, prfessinal r technical persnnel. Cngressinal Intent We believe this interpretatin wuld frustrate Cngress s intent in prviding fr the transitinal payment. Definitin f Eligible Hme Infusin Suppliers Wh Can Receive the Transitinal Payment Fr the transitinal payment, eligible hme infusin suppliers are defined as suppliers (1) that are enrlled in Medicare as pharmacies (maintaining state licensure requirements); (2) that prvide external infusin pumps; and (3) that prvide external infusin pump supplies. This means that existing DME suppliers that are enrlled as pharmacies that prvide external infusin pumps and supplies are cnsidered eligible hme infusin suppliers, as are ptential pharmacy suppliers that enrll and cmply with the Medicare prgram s supplier standards and quality standards t becme accredited fr furnishing external infusin pumps and supplies. Billing and Payment CMS ntes that the fllwing will be the billing and payment cde regime per the statute and CMS: Payment Categries J-cdes The statute calls fr payment under three separate payment categries, with each categry crrespnding t a set f J-cdes. Payment Categries Three New Cdes CMS will create three new HCPCS G-cdes fr each f the three payment categries fr eligible hme infusin suppliers t bill fr hme infusin therapy services. These G-cdes culd be billed separately frm r n the same claim as the DME, supplies, and infusin drug; and wuld be prcessed thrugh the DME MACs. One Supplier Must Prvide the Prfessinal Services The supplier furnishing the DME, pump, the infusin drug, and ther supplies must als prvide the prfessinal services under the hme infusin therapy benefit during the temprary transitinal payment perid. Payment Guidance Payment guidance wuld be issued via Change Request. 5
B. Permanent Payment fr Hme Infusin Therapy Services Permanent Payment Requirements CMS separately prpses requirements fr the permanent payment fr hme infusin therapy services fr CY 2021 & subsequent years. Definitin f Infusin Drug Calendar Day The prpsed definitin f infusin drug calendar day fr the permanent benefit is the same as CMS s unfavrable definitin discussed abve under the transitinal payment. Submitting Claims Thrugh A/B MACs Althugh nt required by law, CMS prpses that a Part B qualified hme infusin therapy supplier culd ptentially submit a claim fr hme infusin therapy services n a Part B practitiner claim and prcessed thrugh the A/B MACs, rather than the DME MACs. CMS is sliciting cmment n its apprach, particularly in the cntext f the types f entities that may meet the definitin f qualified hme infusin therapy supplier. Interactin Between Hme Infusin Therapy Services and Hme Health Services CMS slicits cmments regarding the interactin between hme infusin therapy services and hme health services. Services Payment Separate Frm DME Benefit There is n separate Medicare Part B DME payment fr prfessinal services assciated with the administratin f hme infusin drugs, including nursing services, r fr training and educatin, mnitring, and remte mnitring services. Therefre, CMS cnsiders the hme infusin therapy benefit principally t be a separate payment in additin t the existing payment made under the DME benefit, thus explicitly and separately paying fr the hme infusin therapy services. Medicare Enrllment Requirements fr Hme Infusin Therapy Services CMS clarifies that, t prvide bth hme infusin and DME services, a supplier wuld need t enrll in Medicare bth as a Part B Hme Infusin Therapy supplier and as a DME supplier. Cverage f the Benefit The items and services cvered under the hme infusin therapy benefit are: (1) Prfessinal services, including nursing services, furnished in accrdance with the plan; (2) Training and educatin (nt therwise paid fr as DME); and (3) Remte mnitring and mnitring services fr the prvisin f hme infusin drugs furnished by a qualified hme infusin therapy supplier. 6
Appendix A: Statutry Basis fr the Prpsed Rule Statutry Requirement fr Accreditatin Accrding t Sectin 5012 f the Cures Act, which established requirements fr a hme infusin therapy supplier t receive payment under the Medicare hme infusin therapy benefit, the hme infusin therapy supplier must select a CMSapprved accreditatin rganizatin (AO) and underg an accreditatin review prcess t demnstrate that the hme infusin therapy supplier meets the AO s standards. Statutry Requirements fr Hme Infusin Therapy Sectin 1861(iii) f the Act, as added by sectin 5012 f the Cures Act, establishes fur elements fr hme infusin therapy in the fllwing areas: 1. Requiring that the patient be under the care f a physician, nurse practitiner, r physician assistant; 2. Requiring that all patients have a plan f care established and updated by a physician that sets ut the care and prescribed infusin therapy necessary t meet the patient specific needs; 3. Prviding patients with educatin and training n the effective use f medicatins and equipment in the hme (nt therwise paid fr as durable medical equipment); and 4. Prviding mnitring and remte mnitring services assciated with administering infusin drugs in a patient s hme. Standards fr AOs CMS, thrugh the Hme Health Rule, establishes basic universal standards fr AOs and Medicare-participating qualified hme infusin suppliers. Health and Safety Standard CMS asserts that a private sectr framewrk, already in existence, may suffice in establishing a basic health and safety standard. Request fr Cmment n Health and Safety Standards CMS, still hwever requests stakehlder feedback n the determinatin, asking, Are the standards sufficient fr Medicare beneficiaries, shuld CMS cnsider additinal standards and wuld additinal standards impse additinal burden? Dcuments Reviewed by CMS in Preparing Rule In develping and determining these standards, CMS reviewed the fllwing dcuments: 1. Requirements established under Sectin 5012 f the Cures Act 2. Standards frm the six AOs that accredit hme infusin suppliers: a. The Jint Cmmissin b. Accreditatin Cmmissin fr Health Care c. Cmpliance Team, d. Cmmunity Health Accreditatin Partner, Healthcare Quality Assciatin n Accreditatin e. Natinal Assciatin f Bards f Pharmacy 3. Dcuments related t cverage: a. Gvernment Accuntability Office-10-426 reprt b. Medicare and Hme Infusin white paper written by the Natinal Hme Infusin Assciatin (NHIA) 7
c. American Sciety f Health System Pharmacists Guidelines n Hme Infusin Pharmacy Services d. MA-PD, Medicare FFS, and Private Health insurance requirements 8
Appendix B: Infrmatin Cllectin Requests ICRs Regarding Hme Infusin Therapy Hme infusin therapy suppliers are already required by accrediting rganizatins t prvide care in accrdance with a plan f care, thus this prpsed requirement wuld nt impse a burden upn accredited agencies. ICRs Regarding the Apprval and Oversight f Accrediting Organizatins fr Hme Infusin Therapy The rule articulates a New Set f Regulatins fr apprval and versight f accrediting rganizatins. This burden wuld include, but is nt limited t the time and csts assciated with the fllwing activities: 1. Preparatin and filing f an initial applicatin seeking CMS apprval f the AOs hme infusin therapy accreditatin prgram; 2. Participatin in the applicatin review prcess (that is, meetings, prvide additinal infrmatin and materials that may be required, participate in a site visit, etc.); 3. Seeking new accreditatin clients; 4. Perfrming n-site surveys, ff-site survey audits r the perfrmance f ther types f survey activities; 5. Participatin in CMS nging accreditatin prgram review activities; 6. Perfrmance f peridic re-accreditatin activities; 7. Investigatin f cmplaints and perfrming cmplaint surveys; 8. Administratin f the appeals prcess fr prviders that have been denied accreditatin; 9. Staff training, in-services and cntinuing educatin; and 10. Ensuring that surveyr staff have the prper educatin, training, and credentials. 9