Case Information
*0 FILED IN 3rd COURT OF APPEALS AUSTIN, TEXAS 8/14/2015 2:26:54 PM JEFFREY D. KYLE Clerk
*1 ACCEPTED 03-15-00226-CV 6505541 THIRD COURT OF APPEALS AUSTIN, TEXAS 8/14/2015 2:26:54 PM JEFFREY D. KYLE CLERK CASE NO. 03-15-00226-CV IN THE COURT OF APPEALS FOR THE THIRD JUDICIAL DISTRICT AT AUSTIN, TEXAS Texas Health & Human Services Commission, Appellant, v. Linda Puglisi, Appellee. On Appeal from Cause No. D-1-GN-14-000381 53rd Judicial District Court of Travis County, Texas Honorable Judge Gisela D. Triana Presiding. APPELLANT’S REPLY BRIEF KEN PAXTON EUGENE A. CLAYBORN Attorney General of Texas State Bar No.: 00785767
Assistant Attorney General CHARLES E. ROY Deputy Chief, Administrative Law Division First Assistant Attorney General OFFICE OF THE ATTORNEY GENERAL OF TEXAS
P.O. Box 12548, Capitol Station JAMES E. DAVIS Austin, Texas 78711-2548 Deputy Attorney General for Telephone: (512) 475-3204 Civil Litigation Facsimile: (512) 320-0167
eugene.clayborn@texasattorneygeneral.gov DAV ID A. TALBOT, JR. Chief, Administrative Law Attorneys for Texas Health and Division Human Services Commission ORAL ARGUMENT REQUESTED August 14, 2015
*2 Table of Contents Table of Contents ...................................................................................................... ii Table of Authorities ................................................................................................. iii
I. ARGUMENT AND AUTHORITIES ................................................................ 1
A.
Puglisi’s definition for covered DME is misleading. ............................. 1
B.
Puglisi requires maximum assistance from her caregivers for all
activities of daily living. ......................................................................... 3 C. Compliance with Tex. Hum. Res. Code §§ 32.04242, 32.050(b) ........... 4 D. Puglisi subverts the substantial evidence review standard. .................... 6 E. Detgen is controlling authority regarding HHSC’s categorical
exclusion of mobile standers based on the availability of a cost- effective alternative. ............................................................................... 7
F. Puglisi received adequate due process. ................................................11 II. CONCLUSION ................................................................................................11 PRAYER ..................................................................................................................12 CERTIFICATE OF COMPLIANCE .......................................................................13 CERTIFICATE OF SERVICE ..........................................................................14 APPENDICES .........................................................................................................15
ii *3 Table of Authorities
Cases
City of El Paso v. Pub. Util. Comm’n , 883 S.W.2d 179 (Tex. 1994) .................................................................................. 6 DeSario v. Thomas , 139 F.3d 80 (2nd Cir. 1998) ...............................................................................3, 5 Detgen ex. rel. Detgen v. Janek , 752 F.3d 627 (5th Cir. 2014) ....................................................................... 8, 9, 10 Lavine v. Milne , 424 U.S. (1976) ...................................................................................................... 6 Slekis v. Thomas , 525 U.S. 1098 S.Ct. 864 L.Ed.2d 767 (1998) ........................................................ 6 Tex. Health Facilities Comm’n v. Charter Med.-Dall. , 665 S.W.2d 446 (Tex. 1984) .................................................................................. 6 Tex. Rivers Prot. Ass’n v. Tex. Natural Res. Conservation Comm’n , 910 S.W.2d 147 (Tex. App.—Austin 1995, writ denied) ...................................... 6 Univ. of Tex. Med. Sch. at Houston v. Than , 901 S.W.2d 926 (Tex. 1995) ................................................................................11 Statutes Texas Government Code § 2001.175 ............................................................................................................12 Rules 1 Tex. Admin. Code § 354.1039(a)(4)(D) ............................................................................................... 8 § 354.1041 ..................................................................................................... 4, 5, 6
iii *4 Tex. Hum. Res. Code §§ 32.04242, .050(b) ..................................................................................... 4, 5, 6 Other Authorities 42 C.F.R. Part 431 Subpart E .................................................................................................. 9 TMPPM § 2.2.14.22 .............................................................................................................. 8 § 2.2.14.26 ..........................................................................................................8, 9 § 2.3.1.2 .................................................................................................................. 5 § 2.3.1.3 .................................................................................................................. 5 Fed. Reg. Vol. 76, No. 133, Tuesday, July 12, 2011, Page 41032 ......................................... 3
iv *5 CASE NO. 03-15-00226-CV IN THE COURT OF APPEALS FOR THE THIRD JUDICIAL DISTRICT AT AUSTIN, TEXAS Texas Health & Human Services Commission, Appellant, v. Linda Puglisi, Appellee. On Appeal from Cause No. D-1-GN-14-000381 53rd Judicial District Court of Travis County, Texas, Honorable Judge Gisela D. Triana Presiding.
APPELLANT’S REPLY BRIEF
TO THE HONORABLE JUDGE OF THIS COURT: COMES NOW the Texas Health and Human Services Commission (HHSC) and submits Appellant’s Reply Brief. I. ARGUMENT AND AUTHORITIES A. Puglisi’s definition for covered DME is misleading. Puglisi erroneously alleges that “[a]n item of medical equipment is covered if it meet HHSC’s definition of DME.” Br. of Appellee, p. 3. Puglisi’s definition of covered DME, however, is derived from her fundamental misreading of the May 21,
2013 CMS letter. Br. of Appellee;
App. 1. The May 21, 2013 CMS letter states
that “[a]s such, items of DME meeting
the state’s definition of such coverage is to *6 be provided to individuals (of any age) meeting the State’s medical necessity
criteria.” (emphasis added). Br. of Appellee;
App. p. 1. This statement shows that
an item defined as DME may or may not meet the State’s definition of
covered DME.
In fact, there is no dispute about whether any of Puglisi’s requested items are defined as DME. The facts are that the power wheel chair, the integrated standing feature, and the power seat system are all defined as DME. Similarly, there is no dispute about which of Puglisi’ requested items are covered. The facts are that the power wheelchair and the power seat system are covered DME. However, the integrated standing feature is not covered. However, the parties dispute whether the requested items are medically necessary since the items do not facilitate any additional MRADLs activities.
Despite these immutable facts, Puglisi asserts that the integrated standing feature should be covered DME solely because it satisfies the definition of DME. But the
definition of
covered DME is determined by the process and procedures prescribed in applicable statutes, rules, and policies. Appellant’s Br. App. 4, 5. In essence, Puglisi’s improperly conflates the definition of DME and the definition of covered DME in order to reach an erroneous conclusion. As a result, Puglisi cannot rely solely on the definition of DME to determine whether certain DME is covered DME or not. “There is no requirement that a state fund every medically necessary procedure or item falling within a service it covers under its plan. To begin with, *7 medical necessity and coverage are distinct concepts; a patient’s medical necessity
does not determine whether a particular item or service is covered.”
DeSario v.
Thomas
, 139 F.3d 80 (2nd Cir. 1998).
In addition, the May 21, 2013 CMS letter also states that its “Notice of Proposed Rulemaking issued July 12, 2011” include proposals that define “a medical supply, equipment, and appliance” and also provide “that any item meeting any of those definitions must be covered under the state plan.…”. Br. of Appellee; App. 1. It is true that CMS published proposed policy changes and clarifications to certain Home Health Services, however, CMS’s proposals have not been formally adopted. Fed. Reg. Vol. 76, No. 133, Tuesday, July 12, 2011, Page 41032; Appellant’s Reply Br.; App. p. 13. Regardless, nothing in the proposed changes appears to restrict the HHSC’s authority to define the scope of coverage for Medicaid DME. B. Puglisi requires maximum assistance from her caregivers for all activities
of daily living. Puglisi states that “[s]he requires a custom power wheelchair for all mobility.”
Br. of Appellee, p. 5. Based on statements of Molina Healthcare’s Rehab Review, Nurse Review, and Medical Doctor Review, however, the Hearing Officer determined the following:
*8 On or about June 4, 2013, Molina Healthcare forwarded the DME request to Rehab Review for a third party review for medical necessity of the DME requested. Rehab Review is a Rehabilitation Engineering and Assistive Technology Society (RESNA) certified entity contracted to conduct independent reviews for medical necessity of DME. . . . . Appellant requires maximum assistance with all activities of daily living including transfers. Appellant requires caregiver assistance to transfer in and out of her bed and wheelchair. Molina healthcare recommended approval of a group 3 power wheelchair with a stand-alone dynamic stander to meet the Appellant’s needs; however Appellant is unable to transfer independently and would require assistance from one or two caregivers to transfer to the dynamic stander.
A.R. at 334. In short, Puglisi needs maximum assistance from her caregivers for all MRADLs with or without a power wheelchair, integrated standing feature, or power seat elevation system. Therefore, a group 4 custom power wheelchair with an integrated mobile stander is not medically necessary to correct or ameliorate Puglisi’s disability, condition, or illness, given that her caregivers must assist her with transfers, feeding, and dressing. C. Compliance with Tex. Hum. Res. Code §§ 32.04242, 32.050(b) and Tex.
Admin. Code § 354.1041 is important. Puglisi states that “[i]t does not matter that ‘Texas law requires HHSC to
analyze claims submitted first under Medicare the extent allowed by law.’” Br. of Appellee p. 12. Also, Puglisi states that this case is not about the payment of claims.” Br. of Appellee, p. 12. Further, Puglisi states that “Medicare’s primary *9 payor status does not dictate any particular order for securing prior authorization of the recommended wheelchair.” Br. of Appellee, p. 12. However, compliance with Tex. Hum. Res. Code §§ 32.04242, .050(b) and 1 Tex. Admin. Code § 354.1041 is important. To a state agency, compliance with the law cannot be so easily disregarded.
On the one hand, absent a clear delegation of authority, it is nonsensical to expect a state Medicaid program to provide prior authorizations of DME for a Federal Medicare program and vice versa. On the other hand, TMPPM § 2.3.1.2 (Benefits for Medicare/Medicaid Clients) provides that “[f]or eligible Medicare/Medicaid clients, Medicare is the primary coinsurance and providers must contact Medicare first for prior authorization and reimbursement .” (emphasis
added). Appendix 14. Further,
TMPPM § 2.3.1.3 (Medicare and Medicaid Prior
Authorization) provides that
“[f]or MQMB clients, do not submit prior authorization requests to TMHP if the Medicare denial reason states ‘not medically necessary.’ Medicaid only will consider prior authorization requests if the Medicare denial states ‘not a benefit of Medicare.’” Appellant’s Reply Br.; Appendix 14. Hence, Puglisi’s MQMB status is a significant intervening event that renders the underlying issues of this suit unfit for judicial review because applicable law and policy requires her to present her prior authorization to Medicare before presenting her request to HHSC. See DeSario v. Thomas , 139 F.3d 80, 96 (2nd Cir. *10 1998),
cert. granted, judgment vacated
, Slekis v. Thomas , 525 U.S. 1098, 119 S.Ct. 864, 142 L.Ed.2d 767 (1998) (“In general, the ‘normal assumption [is] that an applicant is not entitled to benefits unless and until he proves his eligibility.’” (Quoting Lavine v. Milne , 424 U.S. (1976)). Therefore, compliance with Tex. Hum. Res. Code §§ 32.04242, .050(b) and 1 Tex. Admin. Code § 354.1041 is an essential prerequisite to seeking prior authorization or reimbursement from Medicaid. D. Puglisi subverts the substantial evidence review standard.
The trial court erred by ignoring the substantial evidence review standard and the proper burden of proof. In this suit for judicial review, Puglisi has the burden of proof. “[F]indings, inferences, conclusions, and decisions of an administrative agency are presumed to be supported by substantial evidence, and the burden is on the contestant to prove otherwise.” City of El Paso v. Pub. Util. Comm’n , 883
S.W.2d 179, 185 (Tex. 1994) (citing
Tex. Health Facilities Comm’n v. Charter
Med.-Dall.
, 665 S.W.2d 446, 452–53 (Tex. 1984)). As long as a properly supported finding given in the order supports an agency’s action, the court will uphold the action despite the existence of other findings that are irrelevant or unsupported by the record. Tex. Rivers Prot. Ass’n v. Tex. Natural Res. Conservation Comm’n , 910 S.W.2d 147, 155 (Tex. App.—Austin 1995, writ denied).
*11 Puglisi makes several statements throughout her brief that demonstrate her failure to meet the burden of proof under the substantial evidence test. Br. of Appellee, p. 24-34. In one example, Puglisi states that “[t]he bottom line is that the administrative record contains no credible evidence refuting the professional opinions of Linda’s medical providers.” Br. of Appellee, p. 31. This statement, however, follows several pages of argument dedicated to discounting the evidence in the record that supports the findings and conclusions contained in the orders upholding Molina’s decision. The bottom line is that there is more than a mere scintilla of evidence in the record to support the Hearing Officer’s and the Reviewing Attorney’s findings and conclusions. Appellant’s Br. p. 16-44. E. Detgen is controlling authority regarding HHSC’s categorical exclusion
of mobile standers based on the availability of a cost-effective alternative. Puglisi asserts that “TMHP’s policy excluding wheelchair standing features
from Medicaid coverage …, is an invalid basis for HHSC’s decision” and that “TMHP’s exclusion of wheelchair standing features meets all of the criteria of a ‘rule’ identified in the Texas Administrative Procedures Act (APA), but was not promulgated in compliance with the Act.” Br. of Appellee, p. 40-41. These assertions fail because HHSC is not prohibited from categorically excluding certain types of DME and Puglisi cannot claim a private right to DME that has been categorically excluded from Medicaid coverage.
*12 In fact, Puglisi fails to assert a private right to a mobile stander in her legal analysis alleging how TMPPM § 2.2.14.26 is a rule. The most that Puglisi could possibly claim is a right to exceptional circumstances review because mobile standers are categorically excluded from Medicaid coverage. Exceptional circumstances review applies to unlisted DME. See 1 TAC § 354.1039(a)(4)(D). However, Puglisi never requested exceptional circumstances review.
In this case, TMPPM § 2.2.14.22 provides a less costly, yet equally effective alternative to the categorically excluded mobile power stander. Appellant’s Br. App. 5, DM-78. As to the reasonableness of HHSC’s categorical exclusion of certain DME (i.e. ceiling lifts), the Fifth Circuit recently stated the following:
It is hardly unreasonable for a state to exclude—even categorically— any medical device whose purpose can be served by a more cost- effective method. Not only has Texas not violated the plain language of the statute, but also the reasonableness standard in the text likely supports its imposition of reasonable categorical exclusions. The plaintiffs’ notion that it would be unreasonable for a state not to provide particular equipment within its definition of DME sounds plausible, except that the state can choose by definition to exclude ceiling lifts. FN6. Moreover, a categorical exclusion based on the availability of cost-effective alternatives cannot mean that the state has denied a medically necessary device, even if the statute did impose such a standard.
Detgen ex. rel. Detgen v. Janek , 752 F.3d 627, 632 (5th Cir. 2014) (Medicaid recipient brought suit against HHSC challenging the denial of their request for the installation of ceiling lifts to transfer the recipient to and from bed, bath, etc.). Appellant’s Br. App. 8.
*13 Nevertheless, Puglisi asserts that
Detgen
is “wrong.” Br. of App. p. 36. TMPPM § 2.2.14.26, however, does not violate federal and state Medicaid requirements because “[a] State may develop a list of pre-approved items of ME [Medical Equipment] as an administrative convenience because such a list eliminates the need to administer an extensive application process for each ME request submitted.” (emphasis added ) . CMS letter dated September 4, 1998; Appellant’s Brief; Appendix 6. Moreover, CMS guidance provides that:
. . . [A] State will be in compliance with federal Medicaid requirements only if, with respect to an individual applicant’s request for an item of ME, the following conditions are met: • The process is timely and employs reasonable and specific criteria by which an individual item of ME will be judged for coverage under the State’s home health services benefit. These criteria must be sufficiently specific to permit a determination of whether an item of ME that does not appear on a State’s pre-approved list has been arbitrarily excluded from coverage based solely on a diagnosis, type of illness, or condition. • The State’s process and criteria, as well as the State’s pre- approved list of items, are made available to beneficiaries and the public. • Beneficiaries are informed of their right under 42 C.F.R. Part 431 Subpart E, to a fair hearing to determine whether an adverse decision is contrary to the law cited above.
CMS letter dated September 4, 1998; Appellant’s Br. App. 6. In addition to the federal guidance described in the DeSario Letter , Detgen v. Janek provides that: “[t]he rule the court employs is this: where a State has explicit guidance from CMS *14 that FFP will not be available for an item of DME, that State acts reasonably when it categorically excludes such an item from coverage in its Medicaid policies.” Detgen ex. rel. Detgen v. Janek , 945 F.Supp.2d 746, 759 (N. D. Tex. 2013) (“The court finds that Texas Medicaid’s policy categorically excluding ceiling lifts from coverage does not conflict with the Medicaid Act’s ‘reasonable standards’ requirement, the ‘amount, duration, and scope’ regulation, or the DeSario letter’s guidance.”). Appellant’s Br. App. p. 12. Furthermore, recent CMS guidance provides that “items of DME meeting the state’s definition of coverage is to be provided to individuals (of any age) meeting the State’s medical necessity criteria.” CMS letter dated May 21, 2013 (“This means that medically necessary ceiling lifts will be reimbursed by CMS as part of the Texas home health benefit if these lifts meet the state’s definition of DME [coverage].” (emphasis added). A.R. at 303. Furthermore, Detgen states that”
It would be perfectly consistent with federal law and this letter to adopt a list of pre-approved devices for convenience and a list of categorical exclusions if based on reasonable grounds, such as the availability of more cost-effective alternatives, and to permit a beneficiary to demonstrate need for an item on neither list. In short nothing in the DeSario letter prohibits categorical exclusions, which might even be eminently reasonable and thus consistent with the statutory language.
Detgen ex. rel. Detgen v. Janek , 752 F.3d 627, 633 (5th Cir. 2014); Appellant’s Br. App. p. 8. HHSC’s categorical exclusion of mobile standers, therefore, is consistent with state and federal statutes, rules, and guidance. *15 F. Puglisi received adequate due process.
After Puglisi requested the DME, Molina reviewed, analyzed, and denied the request. HHSC reviewed and affirmed Molina’s decision. The trial court judicially reviewed HHSC’s decision. Now this Court is judicially reviewing the trial court’s decision. Nevertheless, Puglisi is alleging a denial of due process even though she has participated in hearings at multiple levels of administrative and judicial review. Her experiences before the administrative and judicial tribunals define adequate due process. If this Court concludes that Puglisi is entitled to more due process, the clear solution is to remand this case back to Molina and begin due process anew. See Univ. of Tex. Med. Sch. at Houston v. Than , 901 S.W.2d 926 (Tex. 1995) (“In general, the remedy for a denial of due process is due process.”).
II. CONCLUSION This case should have been dismissed for lack of subject matter jurisdiction or remanded to the agency to take and adjudicate additional evidence regarding Puglisi’s dual eligibility status. Regardless, substantial evidence supports the Hearing Officer and Reviewing Attorney findings and conclusions. Moreover, Molina, the Hearing Officer, and the Reviewing Attorney properly interpreted and applied agency rules, policies, and procedures. In the final analysis, Puglisi has received all the process that she was due.
*16 PRAYER WHEREFORE, PREMISES CONSIDERED, Appellant respectfully asks that this Court: a) reverse the trial court and dismiss this suit for lack of subject matter jurisdiction; b) reverse the trial court and render judgment in favor of HHSC because Molina Healthcare’s and HHSC’s decisions are supported by substantial evidence; or c) reverse the trial court and remand the case to Molina Healthcare and HHSC to take additional evidence pursuant to Texas Government Code § 2001.175, to allow Puglisi the opportunity to seek prior authorization from Medicare, and to allow Puglisi the opportunity to request exceptional circumstances review.
Respectfully Submitted, KEN PAXTON Attorney General of Texas CHARLES E. ROY First Assistant Attorney General JAMES E. DAVIS Deputy Attorney General for Litigation DAV ID A. TALBOT, JR. Chief, Administrative Law Division *17 /s/ Eugene A. Clayborn EUGENE A. CLAYBORN State Bar No.: 00785767 Assistant Attorney General Deputy Chief, Administrative Law Division O FFICE OF THE A TTORNEY G ENERAL OF T EXAS P.O. Box 12548, Capitol Station Austin, Texas 78711-2548 Telephone: (512) 475-3204 Facsimile: (512) 320-0167 eugene.clayborn@ texasattorneygeneral.gov Attorneys for Texas Health & Human Services Commission
CERTIFICATE OF COMPLIANCE I certify that the reply brief submitted complies with Texas Rule of Appellate
Procedure 9 and the word count of this document is 2,621. The word processing
software used to prepare this filing and calculate the word count of the document was Microsoft Word 97-2003. Dated: August 14, 2015
/s/ Eugene A. Clayborn EUGENE A. CLAYBORN Assistant Attorney General
*18 CERTIFICATE OF SERVICE I hereby certify that a true and correct copy of the foregoing document has been served on this the 14th day of August, 2015 on the following: Maureen O’Connell Via: Electronic Service State Bar No.: 00795949 S OUTHERN D ISABILITY L AW C ENTER 1307 Payne Avenue Austin, Texas 78757 moconnell458@gmail.com Attorneys for Appellee
/s/ Eugene A. Clayborn EUGENE A. CLAYBORN Assistant Attorney General
*19 CASE NO. 03-15-00226-CV ___________________________________________________________ IN THE COURT OF APPEALS FOR THE THIRD JUDICIAL DISTRICT AT AUSTIN, TEXAS ____________________________________________________________ Texas Health & Human Services Commission, Appellant, v. Linda Puglisi, Appellee. ____________________________________________________________ On Appeal from Cause No. D-1-GN-14-000381 53rd Judicial District Court of Travis County, Texas Honorable Judge Gisela D. Triana Presiding. ____________________________________________________________ APPELLANT’S REPLY BRIEF _________________________________________________________________ APPENDICES No. 13. Fed. Reg. Proposed Rules No. 14. TMPPM 2.3 *20 DEPARTMENT OF ÉIEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 7500 Security Boulevard, Mail Stop S2-26-12
øAñfverÊaMDg|ø Baltimore, MD 21244-1850 Center for Medicaid, CHIP, and Survey & Certification CMCS Informational Bulletin DATE:
July 13, 2011 FROM: Cindy Mann, Director Center for Medicaid, CHIP and Survey and & Certification (CMCS) SUBJECT: Updates on Medicaid/CHIP This Informational Bulletin covers several important topics of interest to States:
o New Initiative for Medicare-Medicaid Enrollees; o Proposed Regulations Regarding Affordable Insurance Exchanges o Home Health Services NPRM; o PRA Package for Medicaid and CHIP State Plan, Waiver, and Program Submissions; o CMS Second National Background Check Program Conference; o Inclusion of Training Costs in Rate Development: o Pharmacy Pricing Survey
New Initiative for Medicare-Medicaid Enrollees CMCS and the Office of Medicare-Medicaid Coordination is pleased to announce the release of a State Medicaid Director's letter providing guidance on opportunities to test new financial models designed to help States improve quality and share in the lower costs that result from better coordinatingcare for individuals enrolled in both Medicare and Medicaid (Medicare- Medicaid enrollees). A longstanding barrier to coordinating care for Medicare-Medicaid enrollees has been the financial misalignment between Medicare and Medicaid. To address this, and in response to State requests CMS is eager to collaborate with States to test two models to better align the financing of these two programs and integrate primary, acute, behavioral health and long term services and supports for their Medicare-Medicaid enrollees. We will be setting up calls with States to review these opportunities. For more information, please visit: f Proposed Regulations Regard in g Affo rdable Insurance Exchan ges On July ll,20Il, CMS issued the a proposed rule setting forth a framework to assist States in building Affordabte Insurance Exchanges, state-based competitive marketplaces where individuals and small businesses will be able to purchase affordable private health insurance. Starting in2014, Exchanges will make it easy for individuals and small businesses to compare health plans, get answers to questions, find out if they are eligible for tax credits for private
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*21 Inforrnational Bulletin insurance or health programs like Medicaid and the Children's Health fnsurance Program (CHIP), and enroll in a health plan that meets their needs. The proposed rules offer States guidance and options on how to structure their Exchanges in two key areas:
. Setting standards for establishing Exchanges, setting up a Small Business Health Optioñs Program (SHOP), performing the basic functions of an Exchange, and certiffing health plans for participation in the Exchange, and;
. Ensuring premium stability for plans and enrollees in the Exchange, especially in the early yeàri as new people come in to Exchanges to shop for health insurance. These proposed rules set minimum standards for Exchanges, give States the flexibility they need to desiþ Èxchanges that best fit their unique insurance markets, and are consistent with steps States ñave already taken to move forward with Exchanges. The proposed rules build on over a year,s worth of wórk with States, small businesses, consumers and health insurance plans and ãffer Søtes substantial flexibility. For example, it allows States to decide whether their Exchanges should be local, regional, or operated by a non-profit organization, how to select phns tJparticipate, and whethã to partner with the Department of Health and Human Services GIIIS) to split up the work. To reduce duplication of effort and the administrative burden on the states, HHS also announced that the federãl government will partner with States to make Exchange development and operations morJeflicient. States can choose to develop an Exchange in partnership with the féderal government or develop these systems themselves. This provides States more flexibility to focus their resources on designing the right Exchanges for their local insurance markets. To review the proposed rule yisi¡; http://www.ofr.gov/OFRUoload/OFRData/2011-1761O-Pl.pdf
. The comment period closes on September 28,2011. HHS will also convene a series of regional listening sessións and meetings tofacilitate pubic comments. Additional guidance-including propo."ã rules related to eligibility and enrollment procedures for Exchanges and Medicaid- will be issued in the future. For more information on Exchanges, includingfact sheets, visit http ://www.healthcare. gov/exchanges' Home Health Services; Policy Changes and Clarifications Related to Home Health On Tuesday, July 5, 2011, CMS released a Notice of Proposed Rule Making (NPRM) providing additional guidance to States on the implementation of section 6407 of the Affordable Care Act which adds a requirement that in the course of authorizing home health services, physicians must document the exlstence of a face-to-face encounter (including through the use of telehealth) with the Medicaid eligible individual within specified timeframes. This proposed rule aligns Medicaid implementation õf face-to-face encounteis with Medicare's regulatory guidance. This will improve facilitation of services for individuals dually eligible for both programs, and make it "*i.. for providers participating in both programs to understand the rules. This provision was effective ón January 1,2010, but this is a proposed rule and comments are welcome.
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*22 lnforrxational Bulletin ln addition, this proposed rule clarifies that home health services, including medical supplies, equipment and appliances may not be restricted to the home, and if medically necessary, should be provided in any non-institutional setting in which normal life activities take place. It includes in regulation the definition of medical supplies, equipment and appliances. For more information and instructions on how to submit comments on this rule, please visit: http://www.gpo.gov/fdsys/pkg/FR-201l-07-12/pdf/201l-16937.pdf. All comments are due by September 12,2011. PRA Package for Medicaid and CHIP State Plan, Waiver, and Program Submissions On Friday, July 1, 2011, CMS published a generic Paperwork Reduction Act (PRA) package in the Federal Register that includes forms necessary for CMCS to conduct ongoing business with our State partners to continue the implementation of the Affordable Carc Act provisions related to Medicaid and the CHIP. These forms include State plan amendments, waiver, demonstration and reporting templates that will be developed over the 3-year approval period. This PRA package provides support to both States and CMS by:
o Developing streamlined submissions for States to implement health reform initiatives in Medicaid and CHIP; o Enhancing collaboration and partnerships by documenting CMS policy for States to use as they are developing program changes; and o Improving the efficiency of administration by creating a common and user friendly understanding of the information needed by CMS to process requests for State plan amendments, waiver, demonstrations and reporting.
For more information and instructions on how to submit comments on this rule, please visit: http://www.qÞo.sov/fdsys/pke/FR-201 1-07-01/pdf/201 I -16600.pdf. Comments and recommendations must be submitted by August 30,2011. Encouraging States to Attend the CMS Second National Bacþround Check Program Conference We are pleased to announce that the second CMS National Background Check Program (NBCP) Conference is scheduled for2.5 days, September 13-15,2011attheCrownePlazaHotel, St. Louis-Downtown located at200 N. Fourth Street, St. Louis, Missouri. This conference will provide education to NBCP gtantee States as well as non-grantee States interested in establishing or improving their background check programs for long term care providers and facilities. Although grantee States are required to use grant funds to send at least three attendees to each of the NBCP conferences, we also hope States who have not yet received a grantwill attend. The NBCP conference is part of the technical assistance efforts CMS is providing to States in support of section 6201 of the Affordable Care Act of 20l},which directs the Secretary ofthe Department of Health and Huma¡r Services to establish a nationwide program to identiff efficient
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*23 Inforlnational Bulletin eflective, and economical procedures for long term care facilities and providers to conduct background checks on a statewide basis on all prospective direct patient access employees. The NBCP will enhance the safety of residents and clients of long term care providers by disqualiffing certain offenders from positions that would bring them into contact with vulnerable populations served in long term care settings. Non-grantee States interested in attending the second CMS NBCP Conference at their own expense, should contact Lisa Byrd, CMS Training Coordinator, via email at lisa.byrd@cms.hhs.gov by Monday, August l,20ll for registration assistance. If you are a non-grantee State with travel funding issues that may prohibit attendance at this conference, please contact the Background Check Team at Background_Checks@cms.hhs.gov to discuss the potential for CMS assistance. For all other questions related to conference registration, please contact lisa.byrd@cms.hhs. gov. Inclusion of Training Costs in Rate Development In light of questions we have received, CMCS is providing this information regarding the mechanism by whioh provider-related training costs may be considered in the development of the rate of payment for medical services. Questions have come up particularly in the area of home health services. Medicaid statute and regulations (sectio n 1902 of the Social Security Act and 42 Code of Federal Regulations 430 and 447) allow reimbursement for covered services delivered by a qualified p.ovider to an eligible beneficiary. Costs associated with requirements that are prerequisite to being a qualified Medicaid provider are not reimbursable by Medicaid. However, costs associated with maintaining status as a qualified provider may be included in determining the rate for services. Specifically, if as part of its provider qualification requirements, a State requires a provider to acquire a certain minimum number of hours of specified types of continuing education (CE) each period (annually or quarterly, for example), the State may recognize such CE expenses as a cost to the provider of doing business and may consider such costJ in developing the rate paid for the service. The cost of CE may only be included as part of the rate paid for the service and may not be claimed separately by the Medicaid agency as an administrative expense. For example, a State's provider qualification standards could require the direct service provider to: 1) have a high school diploma (or its equivalent) and be at least 18 years of age, and2) complete a certain number of specified CE hours or credits during the calendar or fiscal year (or quarter¡ in order to maintain eligible provider status. The State could not pay, or include in its rates, costs for individuals to obtain a high school diploma or its equivalent. However, the State may include the estimated costs of meeting ongoing CE requirements in determining the rate paid for the service. If the provider fails to acquire the minimum required number of CE hours òr credits, the provider would no longer be qualified, and no Medicaid payment could be made either for services or for the CE that would be needed as a prerequisite to regaining status as a qualified provider. *24 5lPage- lnf<lrrnational Bul letin Similarly, should a State wish to promote advanced provider skills training to increase the availability of providers qualifred to serve beneficiaries with more compliiated or difhcult medical needs, costs associated with that advanced training could also be inqluded in the development of rates paid for services requiring more complex levels of care. The State could set provider qualification requirements at a separate and distinct level for those advanced level providers, and pay rates commensurate with their higher skill levels. The qualifications and rates could be higher than those for services furnished by less skilled individuals such as family members. If you have additional questions, please contact Dianne Heffron, Director, Tinancial Management Group, who may be reached at (410) 786-3247. Pharmacy Pricing Survey CMS is pleased to announce that Myers and Stauffer, LC has been awarded a contract to conduct a Survey of Pharmacy Retail Prices. The survey, which was initially requested by States and which Secretary Sebelius committed to in her February 3,201'l letter to GovernQrs, is part of CMS' commitment to working with States to ensure that they have accurate information about drug costs in order to make prudent purchasing decisions. The contractor will develop a monthly survey of retail community pharmacy prescription drug prices and generate of publicly available pricing files tq help States. We anticipate that these files will afford State Medicaid agencies with a valid array of covered outpatient drug information, regarding retail prices for the ingredient costs of prescription drugs and consumer purchase prices for such drugs. We expect that St¿te Medicaid agencies will be able to use this information to compare their own pricing methodologies and payments to those derived from this survey. Additionally, on an annual basis, CMS will obtain from State Medicaid agencies information on their prescription drug payment and utilization rates and prepare a comparative report regarding the performance of the States' reimbursement prices and the national retail price data collected in the survey. I hope that this information will be helpful to you.
"'-i!::;"'::4
*25 Federal Register/Vol. zo, No. 1.33/Tuesday, ]uly 12,201.1./Proposed Rules
41.O32
2348-P, P.O. Box 8016, Baltimore, viewing by the public, including any
DEPARTMENT
OF HEALTH AND personally identifiable or confidential MD 21.244-8076.
HUMAN
SERVICES business information that is included in Please alÌow sufficient time for mailed Centers for Medicare & Medicaid a comment. We post all comments comments to be received before the received befo¡e the close of the Services close of the comment period. comment period on the following Web 3. By express or overnight moil. You 42CFRPart44O site as soon as possible after they have may send written comments to the been received http:// following address ONLY: Centers for lcMs 2348-Pl w'vvw.reguÌ oti ons, gov. Follow the search Medicare & Medicaid Services, RIN 0938-4Q36 instructions on that Web site to view Department of Health and Human public comments. Services, Attention: CMS-234S-P, Mail Medicaid Program; Face-to-Face Comnents received timely will also Stop C4-26-05, 7500 Security Requirements for Home Health be available for pubÌic inspection as Bouleva¡d, Baltimore, MD 27244-1850. Services; Policy Changes and they are received, generally beginning 4. By hand or courier. If you prefer, Clarifications Related to Home Health approximately 3 weeks after publication you may deliver (by hand or courier) of a document, at the headquarters of AGENCY: Centers for Medicare & your written comments before the close the Centers for Medicare & Medicaid Medicaid Services (CMS), HHS. of the comment period to either of the Services, 75oo Security Boulevard, ACTION: Proposed rule. following addresses: Baltimore, Maryland 21244, Mor.òay a. For delivery in Washington, DC- SUMMARY: This proposed ¡ule would through Friday of each week from 8:30 Centers for Medicare & Medicaid revise the Medicaid home health service a.m. to 4 p.m. To schedule an Services, Department of Health and appointment to view public comments, definition as required by section 64O7 of. Human Services, Room 445-G, Hubert the Affordable Care Act to add a phone 1-800-7 43-3951.. H. Humphrey Building, 200 requirement that physicians document Independence Avenue, SW., I. Background the existence of a face-to-face encounter Washington, DC 2O2O7. A. General Information (including through the use of telehealth) (Because access to the interior of the witlr the Medicaid eÌigible individual Title XIX of the Social Security Act Hubert H. Humphrey BuiÌding is not within reasonable timeframes. This (the Act) requires that, in order to readily available to persons without proposal would align the timeframes receive Federal Medicaid matching Federal Government identification, with similar regulatory requirements for funds, a State must offer certain basic commenters are encouraged to leave Medicare home health services in services to the categorically needy their comments in the CMS drop slots accordance with section 6407 of the populations specified in the Act. Home located in the main lobby of the Affordable Care Act and reflects CMS' health care for Medicaid-eligible building. A stamp-in clock is available commitment to the general principles of individuals who are entitìed to nursing for persons wishing to retain a proof of the President's Executive Order 13563 facility services is one of these filing by stamping in and retaining an released fanuary 1,8, 201,1,, entitled mandatory setvices. Individuals extra copy of the comments being filed.) "Improving Regulation and Regulatory "entitled to" nursing facility services b. For delivery in Baltimore, MD- Review." In addition, this rule proposes include the basic categorically needy Centers for Medicare & Medicaid to amend home health services populations that receive the standard Services, Department of Health and regulations to clarify the definitions of Medicaid benefit package, and can Human Services, 7500 Security included medical supplies, equipment include medically needy populations if Boulevard, Baltimore, MD 27244-7850. and appliances, and clarify that States nursing facility services are offered to Ifyou intend to deliver your may not limit home health services to the medically needy within a State. comments to the Baltimore address, services delivered in the home, or to Home health services include skilled please call telephone number (410) 786- services furnished to individuals who nursing, home health aide services, 7195 in advance to schedule your are homebound. medical supplies, equipment, and arrival with one of our staff members. DATES: To be assured consideration, appliances, and may include Comments mailed to the addresses comments must be received at one of therapeutic services. Current Medicaid indicated as appropriate for hand or the addresses provided below, no later regulations require an individual's courier delivery may be delayed and than 5 p.m. September 12,2O't'l-.. physician to order home health services received after the bomment period, ADDRESSES: In commenting, please refer as part of a written plan of care Submissio¡ of comments on to file code CMS-2348-P. Because of reviewed every 60 days. paperwork requirements. You may staff and resource limitations, we cannot submit comments on this document's B. Summary of New Medicare Flone accept comments by facsimile (FAX) paperwork requirements by following Health Foce-to-Foce Stotutory transmission. the instructions at the end of the Requirements You may submit comments in one of "Collection of Information four ways (please choose only one of the Section 6407 of the Patient Protection Requirements" section in this and Affordable Care Act of zoro (the wavs listed): document. i. Electronically. You may submit Affordable Care Act), (Pub. L. 1.11.-748, For information on viewing public electronic comnents on this regulation enacted on March 23,2o"1o), as comments, see the beginning of the Lo http : / /ruww.re gu I ati on s. gorz. Follow amended by section 10605 of the INFORMATION sECtiON, the "Submit a comment" instructions. SUPPLEMENTARY Affordable Care Act, affects the home health benefit under both the Medicare
2. By regttlar moil.Yott may maiì FOB FURTHER INFORMATION CONTACT: Melissa Harris, (41.o) 786-33s7. and Medicaid programs. written comments to the following Section 6407(a) of the Affordable Care address ONLY: SUPPLEMENTARY INFORMATION: Inspection of Public Comnents: All Act (as anended by section 10605 of the Centers for Medicare & Medicaid Affordable Care Act) acìded new
Services, Department of Flealth and comments received before the close of requirements to section rar+(a)(z)(C) of Human Services, Attention: CMS- the comment period are availabìe for *26 4L033
Federal Register/Vol. Zo, No. 133/Tuesday, July 1'2,2o1'1'lProposed Rules of the Affordabìe Care Act, we take into D. Other Medicaid Home Health Policy the Act under Part A of the Medicare program, and section 1S35(a)(2)(A) of consideration the existing regulatory Chonges the Act, under Part B of the Medicare requirements under S 440.70 that
1. CÌarification That Home Health program, that the physician, or certain provide that a physician must order an Services Cannot Be Restricted to allowed nonphysician practitioners individuaÌ's services under the Individuals Who Are Homebound or to (NPPs), document a face-to-face Medicaid home health benefit. We read Services Furnished in the Home encounter with the individual the term "order" to be synonymous with We are proposing to incorporate in (inctuding through the use of telehealth,
the Medicare term "certify." For regulation that home health services subject to the requirements in section purposes of this rule, we use the term may not be subject to a requirement that 1834(m) of the Act), prior to making a "order" in place of the Affordable Care the individual be "homebound." In certification that home health services Act's use of "certify." addition, we are proposing to clarify are required under the Medicare home We do not view implementation of health benefit. Section 1814(a)(2)(C) of that home health services cannot section 6407 of the ,tffordable Care Act the Act indicates that in addition to a otherwise be restricted to services as supplanting the existing Medicaid furnished in the home itself. physician, a nurse practitioner or regulatory requirements related to clinical nurse specialist (as those terms On luly 25,2ooo, we issued a letter physician orders but as consistent with are defined in section raor(aa)(s) ofthe to State Medicaid Directors, Olmstead those requirements. The provisions of Act) who is working in collaboration Update No: 3, in which we discussed with the physician in accordance with section 6407 of the Affordable Care Act Federal policies relevant to State efforts State law, or a certified nurse-midwife make clear that the physician's order to comply with the requirements of the (as defined in section 1861(gg) ofthe Americans with Disabilities Act (ADA)
must be based on a face-to-face Act, as authorized by State law), or a in light of the Supreme Court decision encounter. In addition, section 64o7 of physician assistant (as defined in
in Olmstead v. L.C., 527 U.S. 581 (1ssg). the Affordable Care Act provides that iection 1861(aa)(5) of the Act), under In attachments to that letter, we set forth specific NPP may perform the face-to- the supervision of the physician, may specific policy clarifications to allow face encounter with the individual in conduct the face-to-face encounters States more flexibility to serve
lieu of the physician, and inform the prior to the start of home health individuals with disabilities in various physiciar making the initial order for services. ways and in different settings. service under tìe Medicaid home health Section 6407(b) of the Affordable Care Attachment 3-g of the letter: benefit. Act amended section rs3a(a)(1L)(B) of "Prohibition of Homebound Consistent with that view, in the the Act to require documentation of a Requirements in Home Health" clarified similar face-to-face encounter with a proposed regulation, we would provide that the use of a "homebound" physician or specific NPPs by a that the physician must document the requirement under the Medicaid home physician ordering durable medical face-to-face encounter regardless of health benefit violates Federal equipment (DlvIE). The NPPs autlorized whether the physician himself or herself regulatory requirements at S 440.230(c) to conduct a face-to-face encounter on or one of tÏe permitted NPPs performed and S 440.240(b). These requirements behalf of a physician are the same for tlre face-to-face encounter. The timing of provide that mandatory benefits must be this provision as for the provision this face-to-face encounter is specified sufficient in amount, duration and described above, with one exception. as being within the 6-month period scope to reasonabìy achieve their We interpret sections 64o7(b) and preceding the written order for home purpose, may not be arbitrarily denied 6407(d) of the Affordable Care Act to or reduced in scope based on diagnosis, health services, or other reasonable prohibit certified nurse-midwives from timeframe specified by the Secretary. type ofilÌness, or condition, and that conducting the face-to-face encounter the same amount, duration and scope Similarly, in implementing the prior to the physician ordering DME. must be available to any individual requirements under section 6407(b) of within the group of categoricalÌy needy the Affordable Care Act, relating to individuals and within any group of DME, we take into account existing medically needy individuals. In the Medicaid regulatory requirements under attachment, we stated that the specified by the Secretary. This S 440.70 requiring physician orders. restriction of home health services to provision also maintains the role of the Because DME is not a term used in individuals who are homebound to the physician in the ¿ictual ordering of DME. Medicaid in the same manner as in exclusion of other individuals in need Medicare, we use the Medicaid term C. Application of Home Health Face-to- of these services ignores the reality that "medical supplies, equipment and Face Requirements to Medicaid individuals with disabilities can and do appliances" or the shortened version live and function in the community. We Section 6407(d) ofthe Affordable Care "medical equipment." The NPPs further noted that developments in Act provides that the requirements for authorized to conduct a face-to-face technology and service delivery made it face-to-face encounters in the provisions encounter on behalf of a physician are possible for individuals with even the described above "shall apply in the case the same for this provision as for the most severe disabilities to participate in of physicians making certifications for provision described above, with one a wide variety of activities in the home health services under title XIX of the Social Security Act in the same exception. Certified nurse-midwives are community with appropriate supports. not permitted to conduct the face-to-face We also expressed the importance of
manner and to the same extent as such encounter prior to the physician ensuring that Medicaid is available to requirements apply in the case of ordering medical equipment. Therefore, provide medically necessary home physicians making such certifications we are proposing to amend the health services to inclividuals in need of under title XVIII of such Act." The Medicaid regulations at $ 440.70 to those services who are not homebound purpose of this regulation is to incorporate both the general home and continue to be an important part of implement that statutory directive. efforts to offer individuals with health and the medical equipment face- In implementing the face-to-face disabilities services in the most encounter requirements of section 6407 to-face requirements. *27 Federal Register/Vol. ZO, No. 133/Tuesday, July 1'2, 2O1'1'lProposed Rules 47034 tìat a State could use such lists or integrated setting appropriate to their appliances under the home health presumptions, but must provide needs, in accordance with the ADA. benefit, other than the language discussed in the prior paragraph. States individuals the opportunity to rebut the We are clarifying in this rule that list or presumption with a process that Medicaid home health services may not have adopted reasonable definitions of be limited to services furnished in the those terms, for exampìe, based on the employs reasonable and specific criteria Medicare definition. But in the absence to assess coverage for an item based on home. This policy reflects prior court of a generalìy applicable definition of cases on the subject. In Skubel v. individual medical needs, and determine whether the list or FuoroLi, 113 F.sd 330 (2d. Ctu. 1997) the the term, there has been confusion as to presumption is based on an arbitrary court found that the Medicaid statute the oroner scooe of the benefit. We bälieve that a consistent approach did not address the site of care for the exclusion based on diagnosis, type of to categorizing home health medical illness, o¡ condition. We have not mandatory home health benefit. The supplies, equipment, and appliances court found that the State could not proposed any language to reflect this will ensure beneficiaries are receiving limit coverage of home health sewices policy in part because the principles at to those provided at the individual's needed items and provide clear and issue are not specific to home health consistent guidance to States to ensure medical equipment. We invite comment residence. In 1990, the same court ruled the use of the appropriate benefit invalid an interpretation that limited the on this issue. king this provision ofprivate duty nursing In addition, in the May 5, 2010 criteria defining services to an individual's residence' Federal Register (75 FR 24437), we quiPment, and The case, Detselv. Sullivon,895 F.2d 58 issued the "Medicare and Medicaid
appìiances, to better align with the (2d Cir.1990), involved children Programs: Changes in Provider and Medicare program's definition of suffering from severe medical Supplier Enrollment, Ordering and
durable medical equipment found at conditions. Following the Delse.l case, Referring, and Documentation CMS, then the Health Care Financing 541,4.202. We propose that supplies are defined as "health care related items Administration, ultimately adopted the that are consumable or disposable, or court's standard and issued nationwide
cannot witÏstand repeated use by more guidance eliminating the at-home we have not incorporated changes to the than one individual." We propose that restriction on private duty nursing, To scope of providers that may order medical equipment and appliances are date, we have not issued similar medical supplies, equipment and "items that are primarily and guidance requiring nationwide adoption appliances in the Medicaid program, as customarily used to serve a medical of the Skubel ruling. We are using our section 6405(a) ofthe Affordable Care authority through tìis rulemaking purpose, generally not useful to an Act was not applicable to Title XIX, we individual in the absence of an illness opportunity to do so. are specifically soliciting comments or injury, can withstand repeated use, through this rule on the merits of doing 2. Clarification of the Definition of and can be reusabìe or removable." Medical Supplies, Equipment and We believe these standard definitions Appliances will ensure that such items will be IL Provisions ofthe Proposed available to all who are entitled to the An important component of the Regulations Medicaid home health benefit is home health benefit, and not restricted Please note that although the medical supplies, equipment and to individuaÌs eligible for targeted Affordable Care Act uses the term benefits through home and community- appliances, under S 447.70(b)(3). The "individual" to refer to the Medicaid cuirent wording of the regulation does based services (HCBS) waivers or the benefi ciary, throughout this proposed not further define these terms, except to section 1915(i) HCBS State Plan option, rule we have used "recipient" to mirror Items that meet the criteria for coverage indicate that these items should be the regulation text in the current "suitable for use in tle home." under the home health benefit must be Medicaid home health regulations. At covered as such. States will not be Although this phrase could be read to this time, we do not intend to modify refer only to the type of items included precluded from covering items meeting this term. in the benefit, it has been susceptible to this definition through a section 1915(c) For the reasons discussed above, we reading as a prohibition on use of HCBS waiver service, such as a home propose to modify $ 4a0.70(b)(3) to say covered items outside the home' We are modification, or through a section the following: "Medical supplies, using this opportunity to revise that 1915(Ð State PIan option. However, the equipment and appliances suitable for phrase to make clear that it is not a State must also offer those items as use in any non-institutional setting in limitation on the location in which home health supplies, equipment and which normal life activities take place," items are used, but rather refers to items appliances. In S aao.7o(b)(3)(i) and (ii), we that are necessary for everyday activities 3. Other Issues propose revising the current text to and not specialized for an institutional define what constitutes medical We note that we are considering setting. Thus we would indicate that supplies, equipment, and appliances. whether other clarifications to the home these items must be "suitable for use in
health regulations are warranted. In We propose to indicate that supplies are any non-institutional setting in which defined as "health care related items particular, we are considering whether normal life activities take place." This that are consumable or disposable, or it would be useful to include language would clarify that although States may to reflect the policies set forth in a cannot withstand repeated use by more continue to establish medical necessity than one individual." We propose to September 4, 1998 letter to State criteria to determine the authorization Medicaid Directors, responding in part indicate that medical equipment and of these items, States may not denY appliances are "items that are primarily to a Second Circuit decision in Desario requests for these items based on the and customarily used to serve a medical v. Thomos, l3s F, 3d 80 (1998), about grounds that they are for use outside of the use of lists or other presumptions in purpose, generally not useful to an the home. individual in the absence of an illness determining coverage of items under the Current Medicaid regulations do not or injury, can withstand repeated use, home health benefit for medical contain any specific definition of equipment. In that letter, we indicated and can be reusable or removable." We medical supplies, equipment, and *28 41035 Federal Register/Vol. zo, No. 133/Tuesday, Iuly 1'2, 2o1'1'lProposed Rules working in collaboration with the achieve this goal, the encounter must are specifically soliciting comment on physician in accordance with State law, occur close enough to the start of home these nrooosed orovisions. or a certified nurse-midwife (as defined For ihe'reasoris discussed above, we health services to ensure that the in section 186r(gg) of the Act, as propose to modify S 440.70(c), to add clinical conditions exhibited by the authorized by State law), or a physician the folìowing text to the end of the recipient during the encounter are current provision: "Nothing in this section should be read to prohibit a assistant (as defined in section related to the primary reason for the 1861(aa)(5) of the Act), under the
recipient's need for home health suoervision of the ohvsician. recipient from receiving home health services. As such, we believe that îhe statutory prôviÉion allows the setvices in any non-institutional setting encounters would need to occur closer to the start of home healtl services permitted NPPs to perform the face-to- in which normal life activities take face encounter and inform the rather than the 6-month period initially place." Although the Court indicated physician, who documents the ihat individuals would be limited to the indicated, but not required by the same number of service hours they Affordable Care Act. encounter. Based on the same reasoning set out would have received if the home health Consistent with the Medicare in the Medicare proposed rule, se¡vices were provided only in their program's implementation of this Medicare Program; Home Health provision, we propose to indicate in a place ofresidence, in an effort to not new $ 440.70(f)(1) that for the initial Prospective Payment System Rate limit the ability of States to offer a more Update for Calendar Year 2O72i ordering of home health services, the robust home health benefit, we propose
published elsewhere in this Federal physician must document ürat a face-to- to allow States the option to authorize Register, for individuals admitted to face encounter that is related to the additional services or hours of services home health upon discharge from a primary reason the individual requires to account for this new flexibility. We
hospital or post-acute setting, we also propose to add more text at the end home health services has occurred no propose to also allow the physician who of this provision as follows: "Additional more than 90 days prior to the start of attended to the individual in the services under the Medicaid home services or service hours may, at the hospital or post-acute setting to inform health benefit. We believe that in most State's option, be authorized to account the ordering physician regarding their cases, a face-to-face encounter with a for medical needs that arise in these
encounters with the individuaÌ to satisfy settings". This will incorporate both the recipient within the 90 days prior to the start of home health services will the face-to-face encountet requirement, Skubel and Olmstead decisions into the much like an NPP currently can. provision of home health services. This provide the physician and/or specified We propose to add a new NPPs with a current clinical State flexibility would be applied to the S 440.70(Ð(2) to list the practitioners presentation of the recipient's condition State's Medicaid program as a whole, that may perform the face-to-face such that the physician can accurately and would not be a person-specific encounters. These practitioners include order home healtl services and fl exibiÌity. State medical necessity the physician aìready referenced in criteria would continue to be applied establish an effective care plan, based S aao.70(a)(z), and the following NPPs: uniformly to all Medicaid individuals. on the encounter conducted by either A nurse practitioner or clinical nurse the physician or allowed NPP. We also We note that any such additional hours specialist (as those terms are defined in believe that a face-to-face encounter of service that are authorized by the section 186L(aa)(5) of the Act) who is which occurs within 90 days prior to State would be matched at the State's working in collaboration with the the start of services would be generally current Federal Medical Assistance physician in accordance with State law, relevant to the reason for the recipient's Percentage (FMAP). or a certified nurse-midwife (as defined The remainder of this section pertains need for home health services, and in section 1ao1(gg) ofthe Act, as to proposed changes to S 440.70 to therefore such a face-to-face encounter authorized by State law), or a physician incorporate provisions of the Affordable would be sufficient to meet the goals of assistant (as defined in section this statutory requirement. We Care Act. 1861(aa)(5) of the Act), under the Section 6407 of the Affordable Care recognize, however, that there may be supervision ofthe physician, and for Act requires, as a condition for payment circumstances when it may not be recipients admitted to home health for home health services, possible to meet this general immediately after an acute or post-acute documentation of a face-to-face requirement, and the individual's access stay, the attending acute or post-acute encounter prior to an order for such to needed services must be protected. ohvsician. services. Section 6407 of the Affordable To account for these circumstances, we ' fre aìso propose to add a new Care Act requires that the timing of the also propose in Saa0.70(f)(1) to allow an
S 440.70(Ð(3) to indicate that if an face-to-face encounter for home health opportunity to meet the face-to-face attending acute or post-acute physician services must occur within the 6-month encounter requirement through an or allowed NPP conducts the face-to- period preceding certification, or other encounter with the recipient within 30
face visit, the attending acute or post- ieasonable timeframe determined by the days after the start of home health acute physician or practitioner is Secretary. Based on the same reasoning servtces. required to communicate the clinical set out in the Medicare final rule, While we recognize the necessity of findings of the face-to-face encounter to Medicare Program; Home Heaìth permitting face-to-face encounters to the physician, in order for the physician occur after the start of services in the Prospective Payment System Rate to document the face-to-face encounter Update for Calendar Year 2011; Changes instances described above, we accordingly. This requirement is in Certification Requirements for Home emphasize that the timing of the face-to- necessary to ensure that the physician face encounter in normal circumstances Health Agencies and Hospices as has sufficient information to determine published in the November 1.7,2o1o, should occur within the 90 days prior
the need for home health services, in the Federal Register, we propose to to the start of home health services. absence of conducting the face-to-face determine a reasonable timeframe for The statute describes NPPs who may encounter himself or herself. We are the face-to-face encounter that is shorter perform this face-to-face encounter as a also proposing to specify that these than 6 months. The statutory goal is to nurse practitioner or clinical nurse
specialist, as those terms are defined in clinical findings must be reflectecl in a achieve greater physician accountability written or electronic document included section 1861(aa)(5) of the Act, who is in ordering home health services. To *29 Federal Register/Vol. zO, No. 1.33/Tuesday, Iuly 1'2, 2o11lProposed Rules 41036
in a way that embraces a person- in the recipient's medical record does not permit certified nurse centered philosophy. For clarification midwives to conduct face-to-face (whether by the physician or by the and consistency among programs, our encounters required for these items. NPP). We are not prescribing at the
This is reflected in our proposed expectation regarding the person- Federal level the specific elements centered philosophy is that the plan of necessary to document the face-to-face g ++0,70(g)(2). The proposal to limit the face-to-face care reflects what is important to the encounter, as that is a matter of clinical requirements to items that would be recipient and for the recipient. The judgment that could vary according to
subject to such requirements as durable person-centered approach is a process, the individual circumstance. However, directed by the recipient with long-term medical equipment under the Medicare States may choose to implement a progran is based on the aim of support needs, or by another person minimum list of required information to
maximizing consistency with the important in the life of the recipient adeouatelv document the encounter. Medicare program's implementation of who the recipient has freely chosen to In'a nerú S 440.70(fX4)(i), we propose section 6407 of the Affordable Care Act direct this process, intended to identify to require that the physician's and reducing administrative burden on documentation of the face-to-face the strengths, capacities, preferences, the provider community. Thus we encounter must be either a separate and needs, and desired outcomes of the
would only require that, for items of distinct area on the written order, an recipient. The person-centered process durable medical equipment specified by CMS under the Medicare plogram as addendum to the order that is easily includes the opportunity for the identifiable and clearly titled, or a recipient to choose others to serve as subject to a face-to-face encounter separate document easily identifiable important contributors to the planning requirement, the physician must and clearly titled in the recipient's
Drocess. ' This process and the resulting service document that a face-to-face encounter
medical record. The documentation that is related to the primary reason the plan will assist the recipient in must also describe how the health status individual requires the item has of the recipient at the time of the face- achieving personally defined outcomes occurred no more than 90 days before in the most integrated community to-face encounter is related to the the order is written or within 30 days setting in a manner that reflects what is primary reason the recipient requires after the order is written. We intend to home health services. In a new important to the recipient to ensure issue guidance to States indicating how delivery of services in a manner that S 440.7O(fl(4xii), we propose to require that the physician's documentation of they, and providers, can access the reflects personaì preferences and current Medicare list of specific durable tlre face-to-face encounter be clearly choices, and what is important for the titled, and state that either the physician medical equipment items subiect to the recipient to meet identified support himself or herseìf, or the applicable face-to-face requirement.
needs. Medical supþlies, equipment and NPP, has conducted a face-to-face III. Collection of Information appÌiances for which a face-to-face encounter with the recipient and Requirements encounter would not be required under include the date of that encounter. Finally, we propose to add a new the Medicare program as durable Under the Paperwork Reduction Act medical equipment, would not require a of 1995, we are required to provide 60- S 440.70(Ð(5) to indicate that the face-to- face-to-face encounter prior to the face encounters may be performed day notice in the Federal Register and ordering of items under the Medicaid solicit public comment before a through the use of telehealth. We are
program. These items will be of a aware that many States currently make collection of information requirement is use of telehealth or telemedicine in the imaller dollar value, and at a decreased
submitted to the Office of Management delivery of Medicaid services. Medicaid risk for fraud, waste and abuse. We and Budget (OMB) for review and welcome public comment on this has issued informal guidance on the approval. In order to fairly evaluate parameters of telehealth and anoroach. whether an information collection
^ foe recognize the difficulty that some telemedicine that is modeled after should be approved by OMB, section recipients with complex medical needs Medicare requirements. We are 3506(c)(zXA) of the Paperwork may face in participating in a face-to- proposing to allow States to continue Reduction Act of 1995 requires that we face encounter (such as issues with utilizing their current telehealth solicit comment on the following issues: . The need for the information accessing transportation, obtaining technologies as they apply to the caregiver support, etc.,) particularly in implementation of this provision, collection and its usefulness in carrying rural areas. Once this rule ìs finalized, however we are cognizant that State out the proper functions of our agency.
. The accuracy of our eistimate of the we expect States to implement this Medicaid telehealth policies may not provision in a way that does not result align with Medicare's. We wish to information collection burden. . The quality, utility, and clarity of in barriers to service delivery, as this is minimize duplication and fragmentation not the intent of the legislation. The of services for beneficiaries who are the information to be collected.
. Recommendations to minimize the statute specifically references telehealth dually-eligible for Medicare and as an alternative for ensuring that this information collection burden on the Medicaid, and therefore we are new requirement is implemented in a affected public, including automated specificalìy soliciting comnent on way that protects continuity of services. collection techniques. approaches to telehealth policy that We encourage States to work with the We are soliciting public comment on would further this goal. each of these issues for the following
In a new S e+0.70(d, we propose to home health provider community to incorporate these face-to-face visits jn sections of this document that contain apply all of the requirements of creative and flexible ways to account for information collection requirements S 440.70(0 to the provision of supplies, equipment and appliances as described individual circumstances. We are (lCRs)r Proposed S 440.70(fJ(3) and (g)(r) in S aaO.70(b)(s) to the extent that a available to provide technical assistance to States in achieving this goal. require NPPs and attending acute or face-to-face encounter would be
In keeping with a movement across all post-acute physicians to communicate required under the Medicare program the clinical findings of the face{o-face for durable medical equipment, with Medicaid services, we expect the plans encounter to the ordering physician. of care deveÌoped to address a one exception from the requirements at The burden associated with these S 440,70(Ð. The Affordable Care Act recipient's home health needs be done
*30 Federal Register/Vol. Zo, No. L33/Tuesday, July 1,2,2o1'1'lProposed Rules 47037 similar face-to-face encounter with a ADDRESSES section of this proposed rule; d physician or specific NPPs by a or 2. Submit your comments to the physician ordering durable medicaÌ cians equipment (DME). The NPPs autlorized his is Office of lnformation and Regulatory to conduct a face-to-face encounter on
Affairs, Office of Management and behalf of a physician are the same for encounter. We estimate that there would Budget, Attention: CMS Desk Officer, this provision as for the provision be 1,1.43,443 initial home health ICMS-2348-Pl Fax: (zoz) 395-6974; or
described above, with one exception. episodes in a year based on our 2008 E -m ail : OIRA _subnt i s si on@omb. e op. gov. Certified nurse-midwives are not claims data. As such, the estimated IV. Response to Comments permitted to conduct the face-to-face burden for the NPP and attending acute encounter prior to tlre physician Because of the large number of public or post-acute physicians documenting,
ordering DME. The timing of tìis face- comments we normally receive on signing, and dating the recipient's face- to-face encounter is specified as being Federal Register docunents, we are not to-face encounter would be 1'so,574 within the 6-month period preceding
able to acknowledge or respond to them hours for CY 2071.. individuaìly. We will consider all Proposed S 440.70(f)(4) and (e)(r) the written order for DME, or other reasonable timeframe specified by the would require that physicians document comments we receive by the date and Secretary. This provision also maintains time specified in the DATES section of the existence of a face-to-face encounter
the role ofthe physician in the actual with the Medicaid eligible recipient. this preamble, and, when we proceed with a subsequent document, we will The burden associated with these ordering of DME. requirements would be the time and respond to the comments in the
B. Overall Impact effort required for the physician to preamble to that document. We have examined tlre impacts of t}ris complete and maintain this V. Regulatory Impact Statement rule as required by Executive Order documentation. The ordering 12866 on Regulatory Planning and physician's burden for composing the A. Statement of Need Review (September 30, 1993), Executive face-to-face documentation, which This regulation is necessary to Order 13563 on Improving Regulation would include determining how the implement Section 6407 of the Patient and Regulatory Review (lanuary 18, clinical findings ofthe encounter Protection and Affordable Care Act of 2011), the Regulatory Flexibility Act support eligibility; writing, typing, or 2009 (the Affordable Care Act), (Pub. L. (RFA) (September 19, 1980, Pub. L. s6- dictating the face-to-face 71.7-L48, enacted on March 23,2o1.o), as 354), section 1102(b) ofthe Social documentation; signing, and dating the amended by section 10605 of the Security Act, section 2O2 of ltre recipient's face-to-face encounter is Affordable Care Act which affects the Unfunded Mandates Reform Act of 1gg5 estimated at 10 minutes for each home health benefit under both the (March 22,ls95, Pub. L. 104--4), and encounter. We estimate that there would Medicare and Medicaid programs. Executive Order 13132 on Federalism be 1,143,443 initial home health Section 6407(a) ofthe Affordable Care (August 4, 1999), and the Congressional episodes in a year based on our 2008 Act (as amended by section 10605) Review Act (s U.S.C. s04(2)). claims data. As such, the estimated added new requirements to section Executive Orders 12866 and 13563 burden for the physician documenting, r81a(a)(2XC) of the Act under Part A of direct agencies to assess all costs and signing, and dating the recipient's face- the Medicare program, and section benefits of available regulatory to-face encounter would be 1,9O,574 1835(aX2)(A) of the Act, under Part B of aìternatives and, ifregulation is hours for Cy 20L1.. We acknowledge the Medicare program, that the necessary, to select regulatorY that this figure is inflated by the physician, or certain allowed approaches that maximize net benefits instances in which the physician nonphysician practitioners (NPPs), (including potential economic, himself or herself conducted the face-to- document a face-to-face encounter with environmental, public health and safety face encounter with the individual, the individual (including through the effects, distributive impacts, and making this second 1O-minute use of telehealth, subject to the equity). Executive Order 13563 documentation burden unnecessary. requirements in section 1834(m) of the emphasizes the importance of This notice of proposed rulemaking Act), prior to making a certification that quantifuing both costs and benefits, of also serves as the required oo-day home health services are required under reducing costs, of harmonizing rules, Federal Register notification for and of promoting flexibility. A the Medicare home health benefit. aforementioned information collection regulatory impact analysis (RIA) must Section 1814(aX2)(C) of the Act requirements. To obtain copies of the be prepared for major rules with indicates that in addition to a physician, supporting statement and any related a nurse practitioner or clinical nurse economicaÌly significant effects ($100 forms for the proposed paperwork specialist (as those terms are defined in million or more in any 1 year). We coìlections referenced above, access section 1861(aa)(5) of the Act) who is tentativeìy estimate that this rulemaking CMS' Web sile at http://vvww.ctns.gov/ working in collaboration with the may be "economically significant" as P op erworkÃe dtt cti on A ctof [1] I I [5] /PRAL/ physician in accordance with State law, measured by the $100 million threshold, list.osp#TopOfPoge or e-mail your and, therefore, may be a major rule or a certified nurse-midwife (as defined request, including your address, phone in section r861(gg) of the Act, as under the Congiessionaì Review Act. number, OMB number, and CMS authorized by State law), or a physician Accordingly, we have prepared a document identifier, to Regulatory Impact Analysis which to assistant (as defined in section Po perwork@cm s.hh s.gov, or caìl the 1861(aa)(5) of the Act), under the the best of our ability presents the costs Reports Clearance Office at 41.0-786- supervision of the physician, may and benefits of the rulemaking. 1326. The CMS Office of the Actuary conduct the face-to-face encounters If you comment on these information estimated Section 6407 as having no prior to the start of home health collection and recordkeeping potential impact on Federal Medicaid requirements, please do either of the servi ces. Section 6407(b) of the Affordable Care costs and savings. According to the CMS following: Actuarial estimates, Section 6407 wouìd Act amended section lsaa(a)(11)(B) of 1. Submit your comments bring an estimated $350 million in eìectronically as specified in the the Act to require documentation of a *31 Federal Register/Vol. zo, No. 133/Tuesday, July 1,2,201,1/Proposed Rules 41038 A. Redesignating paragraphs (bX3)(i) beds. We are not preparing an analysis savings to the Me&icare program from and (ii) as (bX3Xiii) and (iv), 2o7o-2o14 and $azo million in savings for section 1102(b) of the Act because the Secretary has determined that this respectively. from 2010-2019. Although this B. Revising the introductory text of provision applies to Medicaid in the proposed rule would not have a
aignificant impact on the operations of paragraph (b)(3). same manner and to the same extent as C. Adding new paragraphs (b[e)(i) a substantial number of small rural the Medicare program, no estimates and (ii). (costs or savings) were noted for the hosnitals. Säction 2o2 of Ihe Unfunded D. Adding paragraphs (cX1) and (2). Medicaid program. Mandates Reform Act (UMRA) of 1995 E. Adding paragraphs (0 and (g). Aìthough tliere is no quantitative data to arrive at a specific dollar figure to also requires that agencies assess The revisions and additions read as anticipated costs and benefits before attribute to the additional medical follows:
issuing any rule that may result in supplies, equipment, and appliances S440,70 Home health services, that may now be authorized in expenditure in any one year of $100 ***** accordance with S 440.70(b)(3), we million in 1995 dollars, updated (b)* * *
annually for inflation. In 2011, that acknowle (s) Medical supplies, equipment, and threshold level is approximately $136 provision appliances suitable for use in any non- economic million. This proposed rule will not
te however, lt institutional setting in which normal result in an impact of $136 million or life activities take place. in offsetting benefits to both more on State, local or tribal
(i) Supplies a¡e defined as health care beneficiaries and State budgets, governments, in the aggregate, or on the related items that are consumable or including the ability for individuals to nrivate sector.
' Executive Order 13132 establishes disposable, or cannot withstand return to or enter the workforce, thereby certain requirements that an agency repeated use by more than one oftaxpaYers, and must meet when it promulgates a individual. on other Medicaid proposed rule (and subsequent final (ii) Equipment and appliances are institutional care.
defined as items tlat are primarily and iule) that imposes substantial direct ,A,lthough there is no specific estimate customarily used to serve a medical regarding these benefits, they requirement costs on State and local purpose, generally not useful to an nonetheless should be taken into governments, preempts State law, or individual in the absence of an illness
otherwise has Federalism implications. ac or injury, can witlstand repeated use, Since this regulation does not impose co co ïU "i" be reusable or removable. any costs on State or local govemments,
the various the requirements of Executive Order (c)* * * the RIA. 13132 are not applicable, agencies to analYze
(1) Nothing in this section shouìd be C. Conclusion y relief for small read to prohibit a recipient from a significant imPact We tentatively estimate that this rule receiving home health services in any on a substantial number of small may be "economically significant" as non-institutional setting in which meàsured by the $100 million threshold entities. For purposes of the RFA, small normal life activities take place. entities include small businesses, as set forth by Executive Order 12866, (z) Additional services or service nonprofit organizations, and small as well as the Congressional Review hours may, at the State's option, be Act. The analysis above provides our authorized to account for medical needs initial Regulatory Impact Analysis. We tlrat arise in*these settings. have not prepared an analysis for the RFA, section 1102(b) of the Act, section
(fl No payment may be made for 2o2 of t]ne UMRA, and Executive Order se¡vices referenced in paragraphs (b)(r), 1 year. For details, see the Small 13132 because tlre provisions are not (z), and (4) of this section, unless the Business Administration's final rule that imoacted bv this rule. physician referenced in paragraph (a)(2) set forth size standards for healtl care Ii accordänce with the provisions of of this section documents that there was Executive O¡der 12866, this regulation industries, (65 FR 69432, November 17, a face-to-face encounter with the 2000). IndividuaÌs and States are not was reviewed by the Office of recipient that meets the following included in the definition of a small Mãnagement and Budget. requirements: entity. We are not preparing an iuralysis List ofSubjects in 42 CFR Part 44o (1) For the initiation of services, the for the RFA because the Secretary has face-to-face encounter must be related to Grant programs-health, Medicaid. determined that this proposed rule the primary reâson the recipient would not have a significant economic For the reasons set forth in the requires home health services and must impact on a substantial number of small preamble, the Centers for Medicare & occur within the 90 days prior to or entities, Medicaid Servíces proposes to amend within the 30 days after the start of the In addition, section 1102(b) ofthe 42 CFR chapter IV as set fortl below: servlces. Social Security Act requires us to prepare a regulatory impact analysis if
PART 440-5ERVICES: GENERAL (2) The face-to-face encounter may be conducted by one of the following a rule may have a significant impact on PROVISIONS practitioners: the operations of a substantial number
1. The authority citation for part 440 (i) The physician referenced in of small rural hospitals. This analysis continues to read as follows: paragraph (a)(2) ofthis section; must conform to the provisions of Authority: Sec.1102 ofthe Social Security (ii) A nurse practitioner or clinical section 603 of the RFA. For purposes of Act (42 u.s.c. 1302). nurse specialist, as those terms are section "11o2(b) of the Act, we define a defined in section 1s61(aa)(5) ofthe small rural hospital as a hospital that is Subpart A-Definitions Act, working in collaboration with the located outside of a Metropolitan 2. Section 44O.7O is amended bY- physician described in paragraph (a) of Statisticaì Area and has fewer than 100 *32 41039 Federal Register/Vol. 76, No. 133/Tuesday, July 1,2, 2o1'1'lProposed Rules equipment under the Medicare program, this section, in accordance with State the associated home health'services, the unless the physician referenced in physician responsible for ordering the law; (iii) A certified nurse midwife, as paragraph (a)(2) ofthis section services must: defined in section 1861(gg) of the Act, documents a face-to-face encounter with (i) Document the face-to-face the recipient consistent with the as authorized by State law; encounter as a separate and distinct area (iv) A physician assistant, as defined requirements of paragraph (Ð of this on the order itself, as an easily in section 1861(aa)(5) of the Act, under section except as indicated below. identifiable and clearìy titled addendum the supervision ofthe physician
to the order, or a separate document (2) The face-to-face encounter may be described in subparagraph (a) ofthis easily identifiable and clearly titled in performed by any of the practitioners section; or the recipient's medical record, to described in paragraph (Ð(2)of this (v) For recipients admitted to home describe how the health status of the section, with the exception of certified health immediately after an acute or recipient at the time of the face-to-face nurse-midwives, as described in post-acute stay, the attending acute or encounter is related to the primary paragraph (fX2Xiii)of this section. oost-acute nhvsician. reason the recipient requires home ^ (s) The allo'*"d nonphysician
(Catalog of Federal Domestic Assistance healtl services. practitioner, as described in paragraph Program No. 93.778, Medicaì Assistance (ii) Must indicate the practitioner who (fl(3xiÐ through (iv) of this section, or Program). conducted the encounter, and be clearly the attending acute or post-acute Dated: Ma¡ch 2,2oIl. titled and dated on the documentation physician, as described in paragraph of the face-to-face encounter. Donald M. Berwick, (fJ(sX") of this section, performing the (5) The face-to-face encounter may Administroto¡, Centers for Medicare t face-to-face encounter must occur through telehealth, as communicate the clinical findings of Medicoid Seruices. implemented by the State. that face-to-face encounter to the Approved: June 3, 2011, (gXr) No payment maY be made for ordering physician. Those clinical Kathleen Sebelius, medical equipment, supplies, or findings must be incorporated into a Secrelory, Department of Heolth antl Humon appliances referenced in paragraph written or electronic document included Senrices, (bX3) of this section to the extent that in the recioient's medical record. IFR Doc. 2011-16s37 Filed 7-s-11; 4:15 pm] a face-to-face encounter requirement (4) To as'sure clinical correlation would apply as durable medical between the face-to-face encounter and BILLING CODE 412O-O1-P *33 TEXAS MEDICÂID PROVIDER PROCEDURES MANUAL: VOL.2
2.2.25 Procedure Codes That Do Not Require Prior Authorization The procedure codes listed in the following table do not require prior authorization for clients who are receiving services under Home Health Services. Although prior authorization is not required, providers must retain a completed Home Health Services (Title XIX) Durable Medical Equipment (DME)/Medical Supplies Physician Order Form for these clients. For medical supplies not requiring prior authorization, a completed Home Health Services (Title XIX) Durable Medical Equipment (DME)/Medical Supplies Physician Order Form may be valid for a maximum of six months unless the physician indicates the duration ofneed is less. Ifthe physician indicates the duration ofneed is less than six months, then a new Home Health Services (Title XIX) Durable Medical Equipment (DME)/Medical Supplies Physician Order Form is required at the end ofthe duration ofneed. It is expected that reasonable, medically necessary amounts will be provided. The use of these services is subject to retrospective review. This is not an all inclusive list. Procedure Codes 80570 F,0575 E0580 s8101 L43t4 44313 /'43L6 44320 1'4327 44322 4431 r 1'4312 1'43L5 A.4310 /'435r /'433s 44338 ¡^4344 1'4346 /'4326 44327 44328 44330 1.4340 /'4355 /'4356 Asr02 1'4352 1'4354 1.4357 A'43s8 /^4402 1.4554 1^4353 45114 Asr22 45131 L5L12 45113 A'510s A5L2O
^5r27 L4614 44627 ' Prior authorizatio¡r is required for certlin diagnoses and ifliurit¡rtions ¡re exceeded. Refer to Subsection 2.2.l9,2, "Nebulizers" irl this handbook. " Prior autlrorization is required for solne procedure codes if the lnlxiutur¡t limitation is excectled, Refer to Subsectiolt 2.2.l2.9, "Irrcontirrencc Proce<lure Codes rvith Linlitations" il this handbool<. 2.3 Other/Special Provisions 2.3.1 Medicaid Relationship to Medicare 2.3.1.1 Possible Medicare Clients It is the provider's responsibility to determine the type of coverage (Medicare, Medicaid, or private insurance) that the client is entitled to receive. Home health providers must follow these guidelines:
. Clients who are 64years of age and younger without Medicare Part A or B: . If the agency erroneously submits an SOC notice to Medicare and does not contact TMHP for prior authorization, TMHP does not assume responsibility for any services provided before contacting TMHP. The SOC date is no more than three business days before the date the agency contacts TMHP, Visits made before this date are not considered a benefft of the Home Health Services Program.
. Clients who are 65 years of age and older without Medicare Part A or Part B and clients with Medicare Part A or B regardless of age: . In filing home health claims, home health providers maybe required to obtain Medicare denials
before TMHP can approve coverage. When TMHP receives a Medicare denial, the SOC is deter- mined by the date the agency requested coverage from Medicare. If necessary the 95-day claims filing deadline is waived for these claims, provided TMHP receives notice of the Medicare denial within 30 days of the date on the MRAN containing Medicare's final disposition.
DM-t24 CP'I'ONLY . COPYRfCHT 20I I AMERICAN MEDICAL ASSOCIATION ALL RIGHTS RESERVED *34 DURA,BLE MEDICAL EQUIPMENT, MEDICAL SUPPLIES, AND NUTRITIONAL PRODUCTS HANDBOOK . If the agency receives the MRAN and continues to visit the client without contacting TMHP by telephone, mail, or fax within 30 days from the date on the MRAN, TMHP will provide coverage only for services provided from the initial date of contact with TMHP. The SOC date is deter- mined accordingly. TMHP must have the MRAN before considering the request for prior authorization.
2.3.1.2 Benefits for Medicore/Medicaid ClÍents For eligible Medicare/Medicaid clients, Medicare is the primary coinsurance and providers must contact Medicare first for prior authorization and reimbursement. Medicaid pays the Medicare deductible on Part B claims for qualified home health clients. Home health service prior authorizations may be given for HHA services, certain medical supplies, equipment, or appliances suitable for use in the home in one of the following instances:
. When an eligible Medicaid client (enrolled in Medicare) who does not qualiS' for home health seryices under Medicare because SN care, PT, or OT are not a part of the client's care, . When the medical supplies, equipment, or appliances are not a benefìt of Medicare Part B and are a benefit of Home Health Services. Federal and state laws require the use of Medicaid funds for the payment of most medical services only after all reasonable measures have been made to use a client's third party resources or other insurance.
Note: If the client has Medicare Part B coverage, contact Medicarefor prior authorization require- ments and reimbursement. If the service is q Part B benefit, do not contact TMHP for prior authorization. Texas Medicaid will only pay the coinsurønce and deductible on the electronic crossover cloirn,
TMHP will not prior authorize or reimburse the difference between the Medicare payment and the retail price for Medicare Part B eligible clients.
Refer to: Subsection 4.13, "Third Party Liability (TPL)" in Section 4, "Client Eligibility' (Vol. 1, General Informøtion). 2.3.1,3 Medicare and Medicoid Prior Authofizat¡on Contact TMHP for prior authorization of Medicaid services (based on medical necessity and benefìts of Home Health Services) within 30 days of the date on the MRAN.
Note: For MQMB clients, do not submit prior authorization requests to TMHP if the Medicare denial reason states "not medically necessary." Medicaid only will consider prior øuthori- zation requests if the Medicøre denial states "not ø benefit" of Medicare.
Qualified Medicare Benefìciaries (QMB) are not eligible for Medicaid benefìts. Texas Medicaid is only responsible for premiums, coinsurance, or deductibles on these clients, Providers should not submit prior authorization requests to the TMHP Home Health Services Prior AuthorizationDepartment these clients. To ensure Medicare benefits are used ffrst in accordance with Texas Medicaid regulations, the following procedures apply when requesting Medicaid prior authorization and payment of home health services for clients. Contact TMHP for prior authorization of Medicaid services (based on medical necessity and benefits of Home Health Services) within 30 days of the date on the MR {N. Fax a copy of the original Medicare MRAN and the Medicare appeal reviewletter to the TMHP Home Health Services Prior Authorization Department for prior authorization.
Note: Claimsfor STAR+PLUS MQMB clients (those with Medicare and Medicøid) must always be submitted to TMHP as noted on these pøges. The STAR+PLUS health pløn is not responsible for these services if Medicare denies the service as not a benefit.
DM-125
CPT ONLY . COPYRICHT 20I I A.MERICAN MEDÍCAL ASSOCIATION, ALL RIGHTS RESERVED. *35 TEXAS MEDICAID PROVIDER PROCEDURES MANUAL: VOL' [2] When the client is 65 years of age and older or appears otherwise eligible for Medicare such as blind and disabled, but has no Part A or Part B Medicare, the TMHP Home Health Services Prior Authorization Department uses regular prior authorization procedures. In this situation, the claim is held for a midyear staius determined by HHSC. The maximum length of time a claim may be held in a "pending status" for Medicare determination is 120 days. After the waiting period, the claim is paid or denied. If denied, the EOB code on the R&S report indicates that Medicare is to be billed.
Refer to: Subsection 3.2.3,"Home Health Skilled Nursing Services" inNursing and Therapy Services Høndbook (Vol. 2, Provider Høndbool<s). 2.4 Claims Filing and Reimbursement 2.4.1 Claimslnformation Providers must use only type of bill (TOB) 331 in Form Locator (FL) 4 of the UB-04 CMS-1450. Other TOBs are i¡valid and result in claim denial. Home Health services must be submitted to TMHP in an approved electronic format or on a CMS-1500 or a UB-04 CMS-1450 paper claim form. Submit home health DME and medical supplies to TMHP in an approved electronic format, or on a CMS-1500 or on a UB-04 CMS-1450 paper claim form' Providers may purchase UB-04 CMS-1450 and CMS-1500 paper claim forms from the vendor of their choice. TMHP does not supply them. When completing a CMS-1500 or a UB-04 CMS 1450 paper claim form, providers must include all required information on the claim, as TMHP does not key information from attachments, Superbills, or itemized statements, are not accepted as claim supplements.
Refer to: Section 3: TMHP Electronic Data Interchange (EDI) (Vol. 1, General Informøtion) for information on electronic claims submissions' Section 6: Claims Filing (Vol. 1, General Information) for general information about claims filing. Subsection 6.6, "UB-04 CMS-1450 Paper Claim Filing Instructions" in Section 6, "Claims Filing" (Vol. I, General Informøtion), Subsection 6.5, "CMS-1500 Paper Claim Filing Instructions" in Section 6, "Claims Filing" (Vol. 1, General Information) for instructions on comPleting paper claims.
Ouþatient claims must have the appropriate revenue code and, if appropriate, thè corresponding HCPCS code or narrative description. The prior authorization number must appear on the UB-04 CMS- 1450 claim in Block 63 and in Block 23 of the CMS-1500 claim. The certifìcation dates or the revised request date on the POC must coincide with the DOS on the claim. Prior authorization does not waive the 95-day filing deadline requirement. 2.4.1.1 Benefìt Code Home health DME providers must use benefìt code DM2 on all claims and authorization requests. All other providers must use benefìt code CSN on all claims and authorization requests' 2.4.2 Reimbursement DME and expendable medical supplies are reimbursed in accordance with I TAC 5355'8021. Providers can refer to the Online Fee Lookup (OFL) or the applicable fee schedule on the TMHP website at www.tmhp.com. Providers may also request a hard copy of the fee schedule by contacting the TMHP Contact Center at L -800 -925 -9126' DME and expendable supplies, other than nutritional products, that have no established fee, are subject to manual pricing at the documented MSRP less 18 percent or the provider's documented invoice cost.
DM-126
CPT ONLY . COPYzuGHT 20I I AMERTCÂN MEDICÂL ASSOCIATION, ALL R¡CHTS RESERVED. *36 DURABLE MEDICAL EQUIPMENT, MEDICAL SUPPLIES, AND NUTRITIONAL PRODUCTS FI,ANDBOOK Nutritional products that have no established fee are subject to manual pricing at the documented AWP less 10.5 percent or at the provider's documented invoice cost. For reimbursement, providers must note the following: . Claims are approved or denied according to the eligibilily, prior authorization status, and medical
appropriateness. . Claims must represent a numerical quantity of I month for supplies according to the billing requirements. . DME/supplies mustbe provided by either a Medicaid enrolled home health agency's Medicaid/DME supply provider or an independently-enrolled Medicaid/DME supply provider, Both must enroll and bill using the provider identifier enrolled as a DME supplier. File these services on a CMS-I500 claim form,
Note: Medical social services and speech-language pathologl services are available to clients who are 20 yeørs of age and younger ønd are not ø benefit of Home Health Services. These services may be considered ø benefít for clients who quølify for CCP.
Texas Medicaid does not reimburse separately for associated DME charges, including but not limited to, battery disposal fees or state taxes. Reimbursement for any associated charges is included in the reimbursement for a specifìc piece of equipment.
Refer to: Subsection 2.2,"Fee-for-Service Reimbursement Methodology" in Section 2, "Texas Medicaid Fee-for-Service Reimbursement" (Vol, 7, General lnformation) for more infor- mation about reimbursement.
Texas Medicaid implemented mandated rate reductions for certain services. The Online Fee Lookup (OFL) and static fee schedules include a column titled "Adjusted Fee" to display the individual fees with all mandated percentage reductions applied. Additional information about rate changes is available on the TMHP website at www.tmhp.com/pages/topics/rates.aspx. 2.4.3 Prohibition of Medicaid Payment to Home Health Agencies Based on
Ownership Medicaid denies home health services claims when TMHP records indicate that the physician ordering treatment has a significant ownership interest in, or a significant fìnancial or contractual relationship with, the nongovernmental home health agency billing for the services. Federal regulation Title 42 CFR 5424.22 (d) states that "a physician who has a significant financial or contractual relationship with, or a significant ownership in a nongovernmental home health agency may not certiff or recertifr the need for home health services care seryices and may not establish or review a plan of treatment." A physician is considered to have a significant ownership interest in a home health agency if either of the following conditions appl¡
. The physician has a direct or indirect ownership of fìve percent or more in the capital, stock, or profits of the home health agency. . The physician has an ownership of five percent or more of any mortgage, deed of trust, or other obligation that is secured by the agency, if that interest equals five percent or more of the agency's assets,
A physician is considered to have a significant financial or contractual relationship with a home health agency if any of the following conditions apply:
. The physician receives any compensation as an oftìcer or director of the home health agency. . The physician has indirect business transactions, such as contracts, agreements, purchase orders, or
leases to obtain services, supplies, equipment, space, and salaried employment with the home health agencY.
DM-t27 CPT ONLY . COPYRICHT 20II AMERICAN MEDICAL ASSOCIAT¡ON. ALL RICHTS RESERVED.