2019-03621. Medicare Program; Solicitation of Independent Accrediting Organizations To Participate in the Home Infusion Therapy Supplier Accreditation Program

AGENCY:

Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION:

Notice.

SUMMARY:

This notice informs national accrediting organizations that accredit home infusion therapy suppliers of an opportunity to submit applications to participate in the home infusion therapy supplier accreditation program. This notice contains information on how to apply for CMS approval.

DATES:

Complete applications will be considered for the January 1, 2021 designation deadline if received at the address, provided in the ADDRESSES section of this notice, by 5 p.m. eastern daylight time (e.d.t.) on February 1, 2020.

ADDRESSES:

Applications should be sent to: Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244. Mail stop C2-21-16, Attention: Christina Mister-Ward.

FOR FURTHER INFORMATION CONTACT:

Christina Mister-Ward [phone].

SUPPLEMENTARY INFORMATION:

I. Background

Section 1861(iii)(1) of the Social Security Act (“the Act”) defines “home infusion therapy” as the items and services described furnished by a qualified home infusion therapy supplier which are furnished in the individual's home. The individual must be—

• Under the care of an applicable provider; and
• With respect to whom a plan prescribing the type, amount, and duration of infusion therapy services that are to be furnished such individual has been established by a physician and is periodically reviewed by a physician in coordination with the furnishing of home infusion drugs under part B.

According to section 1861(iii)(3)(A) of the Act, “Applicable provider” means a physician, a nurse practitioner, or a physician assistant. In accordance with section 1834(u)(5) of the Act, we defined “National accrediting organization” at 42 CFR 488.1005 as an organization that accredits provider or supplier entities under a specific program and whose accredited provider or supplier entities under each program are widely dispersed geographically across the United States. In addition, the specific program is active, fully implemented, and operational.

In the November 13, 2018 Federal Register (83 FR 56406),we published a final rule titled, “Medicare and Medicaid Programs; CY 2019 Home Health Prospective Payment System Rate Update and CY 2020 Case-Mix Adjustment Methodology Refinements; Home Health Value-Based Purchasing Model; Home Health Quality Reporting Requirements; Home Infusion Therapy Requirements; and Training Requirements for Surveyors of National Accrediting Organizations.” The November 2018 final rule implemented health and safety standards that home infusion therapy suppliers must meet; the temporary transitional payments for home infusion therapy services for CYs 2019; and an approval and oversight process for accrediting organizations (AOs) that accredit home infusion therapy suppliers. For more detailed information on the home therapy organization accreditation requirements see the November 2018 final rule (83 FR 56563 through 56584).

Section 1861(iii)(3)(D)(i)(III) of the Act, as added by section 5012(b) of the 21st Century Cures Act, requires that a home infusion therapy supplier be accredited by an AO designated by the Secretary in accordance with section 1834(u)(5) of the Act. Section 1834(u)(5)(A) of the Act identifies factors for designating AOs and modifying the list of designated AOs. These statutory factors are as follows:

• The ability of the organization to conduct timely reviews of accreditation applications.
• The ability of the organization take into account the capacities of suppliers located in a rural area (as defined in section 1886(d)(2)(D) of the Act).
• Whether the organization has established reasonable fees to be charged to suppliers applying for accreditation.
• Such other factors as the Secretary determines appropriate.

Section 1834(u)(5)(B) of the Act requires the Secretary to designate AOs to accredit home infusion therapy suppliers furnishing home infusion therapy not later than January 1, 2021.

II. Provisions of the Notice

This notice solicits applications from AOs with the ability to accredit home infusion therapy suppliers.

A. Eligible Organizations

An accreditation organization that can show evidence of the ability to accredit qualified home infusion therapy suppliers as defined in section 1861(iii)(3)(D)(i) of the Act are eligible to apply for approval as a designated accreditation organization.

To be considered for approval as a Medicare-designated home infusion therapy AO under 42 CFR part 488, subpart L (§§ 488.1000 through 488.1050), an accrediting organization must meet the following requirements:

• The AO must have a home infusion therapy accreditation program that it separates and distinguishes from any of its other accreditation programs (if applicable).
• The AO must have home infusion therapy accreditation standards that meet or exceed the Medicare home infusion therapy health and safety standards codified at §§ 486.500 through 486.525 of our regulations.

B. Application Requirements

To be considered for approval by Medicare as a home infusion therapy accrediting organization, an accrediting organization must submit an application to CMS requesting approval of its home infusion therapy accreditation program. The home infusion therapy accrediting organization's application must contain all of the following information to demonstrate that the AO's home infusion therapy accreditation program meets or exceeds the applicable Medicare requirements:

• Documentation to demonstrate that they meet the definition of a “national accrediting organization” as required by 42 CFR 488.1010(a)(1).
• The Medicare provider or supplier type for which the organization is requesting approval or re-approval (§ 488.1010(a)(2)).
• Documentation that demonstrates the home infusion therapy accrediting organization's ability to take into account the capacities of rural home infusion therapy suppliers (as required by section 1834(u)(5)(A)(ii) of the Act and 42 CFR 488.1010(a)(3)).
• Information that demonstrates the home infusion therapy accrediting organization's knowledge, expertise, and experience in home infusion therapy (see § 488.1010(a)(4)).
• A detailed crosswalk (in table format) that identifies, for each of the applicable Medicare requirements, the exact language of the organization's comparable accreditation requirements and standards (see § 488.1010(a)(5)).
• A detailed description of the home infusion therapy accrediting organization's survey processes to confirm that a home infusion therapy supplier's processes are comparable to those of Medicare (see § 488.1010(a)(6)). This description must include all of the following:

++ The types and frequency of surveys performed, and a rationale for which accreditation requirements will be evaluated via onsite surveys and which will be evaluated via offsite audits, or other strategies for ensuring accredited home infusion therapy suppliers maintain adherence to the home infusion therapy accreditation program requirements, including an explanation of how the accrediting organization will maintain the schedule it proposes (§ 488.1010(a)(6)(i)).

++ Copies of the home infusion therapy accrediting organizations survey and audit forms, guidelines, and instructions to surveyors (§ 488.1010(a)(6)(ii)).

++ Documentation demonstrating that the home infusion therapy accrediting organization's onsite survey or offsite audit reports identify, for each finding of non-compliance with accreditation standards, the comparable Medicare home infusion therapy accreditation requirements, as applicable (§ 488.1010(a)(6)(iii)).

++ A description of the home infusion therapy accrediting organization's accreditation survey review process (§ 488.1010(a)(6)(iv)).

++ A description of the home infusion therapy accrediting organization's procedures and timelines for notifying a surveyed or audited home infusion therapy supplier of non-compliance with the home infusion therapy accreditation program's standards (§ 488.1010(a)(6)(v)).

++ A description of the home infusion therapy accrediting organization's procedures and timelines for monitoring the home infusion therapy supplier's correction of identified non-compliance with the accreditation program's standards (§ 488.1010(a)(6)(vi)).

++ The ability of the home infusion therapy accrediting organization to conduct timely reviews of accreditation applications (§ 488.1010(a)(6)(vii)).

++ A statement acknowledging that, as a condition for CMS approval of a national accrediting organization's accreditation program, the home infusion therapy accrediting organization agrees to provide CMS with information extracted from each home infusion therapy accreditation onsite survey, offsite audit or other evaluation strategies as part of its data submissions required under § 488.1010(a)(19), and, upon request from CMS, a copy of the most recent accreditation onsite survey, offsite audit, or other evaluation strategy together with any other information related to the survey as CMS may require (including corrective action plans) (§ 488.1010(a)(6)(viii)).

++ A statement acknowledging that the home infusion therapy accrediting organization will provide timely notification to CMS when an accreditation survey or complaint investigation identifies an immediate jeopardy as that term is defined at § 488.1005. Using the format specified by CMS, the home infusion therapy accrediting organization must notify CMS within 2 business days from the date the accrediting organization identifies the immediate jeopardy (§ 488.1010(a)(6)(ix)).

• Procedures to ensure either of the following:

++ Unannounced onsite surveys, as appropriate, will be conducted periodically, including procedures that protect against unannounced surveys becoming known to the provider or supplier in advance of the visit (§ 488.1010(a)(7)(i)).

++ Offsite survey audits are performed to evaluate the quality of services provided which may be followed up with periodic onsite visits (§ 488.1010(a)(7)(ii)).

• The criteria for determining the size and composition of the home infusion therapy accrediting organization's survey, audit and other evaluation strategy teams for individual supplier onsite surveys. The home infusion therapy accrediting organization's criteria should include, but not be limited to the following information:

++ The expected number of individual home infusion therapy supplier locations to be surveyed using an onsite survey (§ 488.1010(a)(8)(i)).

++ The number of home infusion therapy suppliers to be surveyed using off-site audits (§ 488.1010(a)(8)(ii)).

++ A description of other types of home infusion therapy accreditation review activities to be used (§ 488.1010(a)(8)(iii)).

++ The reasons for each type of survey (that is, initial accreditation survey, reaccreditation survey, and complaint survey) (§ 488.1010(a)(8)(iv)).

• The overall adequacy of the number of the home infusion therapy accrediting organization's surveyors, auditors, and other staff available to perform survey related activities, including how the organization will increase the size of the survey, audit, and other evaluation staff to match growth in the number of accredited facilities or programs while maintaining re-accreditation intervals for existing accredited facilities or programs (§ 488.1010(a)(9)).
• Detailed information about the individuals who perform onsite surveys, offsite audits or other strategies for ensuring accredited home infusion therapy suppliers maintain adherence to the home infusion therapy accreditation program requirements, including all of the following information:

++ The number and types of professional and technical staff available for conducting onsite surveys, offsite audits, or other strategies for ensuring accredited home infusion therapy suppliers maintain adherence to the home infusion therapy accreditation program requirements. (§ 488.1010(a)(10)(i)).

++ The education, employment, and experience requirements surveyors an auditors must meet (§ 488.1010(a)(10)(ii)).

++ The content and length of the orientation program (§ 488.1010(a)(10)(iii)).

• The content, frequency and types of in-service training provided to survey and audit personnel (§ 488.1010(a)(11)).
• The evaluation systems used to monitor the performance of individual surveyors, auditors and survey teams (§ 488.1010(a)(12)).
• The home infusion therapy accrediting organization's policies and procedures to avoid conflicts of interest, including the appearance of conflicts of interest, involving individuals who conduct surveys, audits or participate in accreditation decisions (§ 488.1010(a)(13)).
• The policies and procedures used when a home infusion therapy supplier has a dispute regarding survey or audit findings, or an adverse decision (§ 488.1010(a)(14)).
• Procedures for the home infusion therapy supplier to use to notify the home infusion therapy accrediting organization when the accredited home infusion therapy supplier does the either of the following (§ 488.1010(a)(15)):

++ Removes or ceases furnishing services for which they are accredited.

++ Adds services for which they are not accredited.

• The home infusion therapy accrediting organization's procedures for responding to, and investigating complaints against accredited facilities, including policies and procedures regarding referrals, when applicable, to appropriate licensing bodies, ombudsmen offices, and CMS (§ 488.1010(a)(16)).
• A description of the home infusion therapy accrediting organization's accreditation status decision-making process. The home infusion therapy accrediting organization must furnish the following (§ 488.1010(a)(17)):

++ Its process for addressing deficiencies identified with accreditation program requirements, and the procedures used to monitor the correction of deficiencies identified during an accreditation survey and audit process.

++ A description of all types and categories of accreditation decisions associated with the program, including the duration of each of the organization's accreditation decisions.

++ Its policies and procedures for the granting, withholding or removal of accreditation status for facilities that fail to meet the accrediting organization's standards or requirements, assignment of less than full accreditation status or other actions taken by the organization in response to non-compliance with its standards and requirements.

++ A statement acknowledging that the home infusion therapy accrediting organization agrees to notify CMS (in a manner CMS specifies) of any decision to revoke, terminate, or revise the accreditation status of a home infusion therapy supplier, within 3 business days from the date the organization takes an action.

• A list of all currently accredited home infusion therapy suppliers, the type and category of accreditation, currently held by each, and the expiration date for each home infusion therapy supplier's current accreditation (§ 488.1010(a)(18)).
• A schedule of all survey activity (such as onsite surveys, offsite audits and other types if survey strategies) expected to be conducted by the organization during the 6-month period following submission of an initial or renewal application (§ 488.1010(a)(19)).
• A written presentation that demonstrates the organization's ability to furnish CMS with electronic data (§ 488.1010(a)(20)).
• A description of the home infusion therapy accrediting organization's data management and analysis system with respect to its surveys and accreditation decisions, including all of the following (§ 488.1010(a)(21)):

++ A detailed description of how the home infusion therapy accrediting organization uses its data to assure the compliance of its home infusion therapy accreditation program with the Medicare home infusion therapy accreditation program requirements.

++ A written statement acknowledging that the home infusion therapy accrediting organization agrees to submit timely, accurate, and complete data that CMS has determined is both necessary to evaluate the accrediting organization's performance and is not unduly burdensome for the accrediting organization to submit.

++ The organization must submit necessary data according to the instructions and timeframes CMS specifies.

++ Data to be submitted includes the following:

—Accredited home infusion therapy supplier identifying information.

—Survey findings.

—Quality measures.

—Notices of accreditation decisions.

• The three most recent annual audited financial statements of the home infusion therapy accrediting organization that demonstrate that the organization's staffing, funding, and other resources are adequate to perform the required surveys, audits, and related activities to maintain the accreditation program (§ 488.1010(a)(22)).
• A written statement acknowledging that, as a condition for approval, the home infusion therapy accrediting organization agrees to the following (§ 488.1010(a)(23)):

++ Voluntary termination. Provide written notification to CMS and all home infusion therapy suppliers accredited under its CMS-approved home infusion therapy accreditation program at least 180 calendar days in advance of the effective date of a decision by the home infusion therapy accrediting organization to voluntarily terminate its CMS-approved home infusion therapy accreditation program and the implications for the suppliers' payment status once their current term of accreditation expires in accordance with the requirements at § 488.1045(a).

++ Involuntary termination. Provide written notification to all accredited home infusion therapy suppliers accredited under its CMS-approved home infusion therapy accreditation program no later than 30 calendar days after the notice is published in the Federal Register announcing that CMS is withdrawing its approval of its accreditation program and the implications for the home infusion therapy supplier's payment status in accordance with the requirements at § 488.1045(b) once their current term of accreditation expires.

—For both voluntary and involuntary terminations, provide a second written notification to all accredited home infusion therapy suppliers 10 calendar days prior to the organization's accreditation program effective date of termination.

—Notify CMS, in writing (electronically or hard copy), within 2 business days of a deficiency identified in any accredited home infusion therapy supplier from any source where the deficiency poses an immediate jeopardy to the home infusion therapy supplier's beneficiaries or a hazard to the general public.

++ Summary accreditation activity data and trends. Provide, on an annual basis, summary accreditation activity data and trends including the following:

—Deficiencies.

—Complaints.

—Terminations.

—Withdrawals.

—Denials.

—Accreditation decisions.

—Other survey-related activities as specified by CMS.

++ Termination of an accreditation organization. If CMS terminates a home infusion therapy accrediting organization's approved status, the home infusion therapy accrediting organization must work collaboratively with CMS to direct its accredited home infusion therapy suppliers to the remaining CMS-approved accrediting organizations within a reasonable period of time.

++ Notification of proposed changes. Notify CMS at least 60 days in advance of the implementation date of any significant proposed changes in its CMS-approved home infusion therapy accreditation program and that it agrees not to implement the proposed changes without prior written notice of continued program approval from CMS, except as provided for at § 488.1040(b)(2).

++ Response to a written notice from CMS. A statement acknowledging that, in response to a written notice from CMS to the home infusion therapy accrediting organization of a change in the applicable home infusion therapy accreditation requirements or survey process, the organization will provide CMS with proposed corresponding changes in the accrediting organization's home infusion therapy accreditation requirements for its CMS-approved home infusion therapy accreditation program to ensure that its accreditation standards continue to meet or exceed those of Medicare, or survey process remains comparable with that of Medicare. The home infusion therapy accrediting organization must comply with the following requirements:

—The proposed changes must be submitted within 30 calendar days of the date of the written CMS notice to the home infusion therapy accrediting organization or by a date specified in the notice, whichever is later. CMS gives due consideration to a home infusion therapy accrediting organization's request for an extension of the deadline as long as it is submitted prior to the due date.

—The proposed changes are not to be implemented without prior written notice of continued program approval from CMS, except as provided for at § 488.1040(b)(2)(ii).

• The organization's proposed fees for accreditation, including any plans for reducing the burden and cost of accreditation to small and rural suppliers (§ 488.1010(a)(2)).
• Acknowledgement agreeing to release of accreditation surveys. The home infusion accreditation organization must include a statement within its accreditation application and accreditation agreement with each home infusion therapy supplier, agreeing to release its most current accreditation survey and any information related to the survey that CMS may require, including the home infusion therapy supplier's corrective action plans (§ 488.1025).

Acknowledgement of Onsite Observation of Accrediting Organizations. The home infusion accreditation organization must include a statement its accreditation application to permit CMS to conduct an onsite inspection of the home infusion therapy accreditation organizations operations and offices at any time to verify the organization's representation and to assess the organizations compliance with its own policies and procedures (§ 488.1040).

Acknowledgement of Reconsideration Process. The home infusion therapy accreditation organization must include a statement acknowledging understanding of the reconsideration process. The home infusion therapy accreditation organization may request reconsideration of an unfavorable decision made by CMS, as stated at (§ 488.1050).

C. Requests for Additional Information by CMS (§ 488.1010(b))

If CMS determines that additional information is necessary to make a determination for approval or denial of the home infusion therapy accrediting organization's initial application (or reapplication) for CMS-approval of an accreditation program, CMS may require that the home infusion therapy accrediting organization submit any additional documentation and attestations necessary as a condition of approval of accreditation. If such additional information is required, CMS will notify the home infusion therapy accrediting organization and afford it an opportunity to provide the additional information.

D. Withdrawal of an Application (§ 488.1010(c))

A home infusion therapy accrediting organization may withdraw its initial application seeking CMS' approval of its home infusion therapy accreditation program at any time before CMS publishes the final notice as provided in § 488.1020(b).

E. Evaluation of Applications

An application review team will evaluate all applications submitted by accrediting organizations seeking designation as CMS-approved home infusion therapy accrediting organizations under section 1834(u)(5)(B) of the Act using the processes for consideration set forth in part 488, subpart L.

F. Notice of Approval or Disapproval of Application (§ 488.1010(d))

We are required to send a notice of its decision to approve or disapprove the home infusion therapy accrediting organization's application within 210 calendar days from the date CMS determines the home infusion therapy accrediting organization's application is complete. The final notice will specify the following:

• The basis for the decision.
• The effective date.
• The term of the approval (not exceed 6 years).

G. Public Notice and Comment (§ 488.1020)

We are required to publish a notice in the Federal Register when the following conditions are met:

Proposed notice. CMS publishes a notice after the receipt of a completed application from a national home infusion therapy accrediting organization seeking CMS's approval of a home infusion therapy accreditation program. The notice identifies the home infusion therapy accrediting organization, the type of suppliers covered by the home infusion therapy accreditation program, and provides at least a 30-day public comment period (beginning on the date of publication) (§ 488.1020(a)).

Final notice. The final notice announces CMS decision to approve or deny a national accrediting organization application. The notice specifies the basis for the CMS decision (§ 488.1020(b)).

++ Approval or re-approval. If CMS approves or re-approves the home infusion therapy accrediting organization's home infusion therapy accreditation program, the final notice at a minimum includes the following information:

++ A description of how the home infusion therapy accreditation program meets or exceeds Medicare home infusion therapy accreditation program requirements.

++ The effective date of approval (no later than the publication date of the notice).

++ The term of the approval (6 years or less).

• Denial. If CMS does not approve the home infusion therapy accrediting organization's accreditation program, the final notice describes the following:

++ How the home infusion therapy accrediting organization fails to meet Medicare home infusion therapy accreditation program requirements.

++ The effective date of the decision.

III. Collection of Information Requirements

This document does not impose information collection requirements, that is, reporting, recordkeeping or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

Dated: February 19, 2019.

Seema Verma,

Administrator, Centers for Medicare & Medicaid Services.