[3] We solicited comments in the CY 2020 PFS proposed rule (84 FR 40716) and the CY 2020 HH PPS proposed rule (84 FR 34694), regarding the appropriate form, manner, and frequency that any physician must use to provide notification of the treatment options available to his/her patient for the furnishing of infusion therapy (home or otherwise) under Medicare Part B. In the November 9, 2006 Federal Register (71 FR 65935), we published a final rule to implement the pay-for-reporting requirement of the DRA, which was codified at § 484.225(h) and (i) in accordance with the statute. 13. With regard to payment under traditional Medicare, most home infusion drugs are generally covered under Part B or Part D. Certain infusion pumps, supplies (including home infusion drugs and the services required to furnish the drug, (that is, preparation and dispensing), and nursing are covered in some circumstances through the Part B durable medical equipment (DME) benefit, the Medicare home health benefit, or some combination of these benefits. Comment: Commenters generally supported the home health payment updates for CY 2021. See the Section 424.520(d) sets forth the applicable effective date for physicians, non-physician practitioners, physician and non-physician practitioner organizations, ambulance suppliers, and opioid treatment programs. Section 3708 of the CARES Act, amended section 1861(aa)(5) of the Act, allowing the Secretary regulatory discretion regarding the requirements for nurse practitioners (NPs), clinical nurse specialists (CNSs), and physician assistants (PAs). The overall economic impact of the HHVBP Model for CYs 2018 through 2022 is an estimated $378 million in total savings to Medicare from a reduction in unnecessary hospitalizations and SNF usage as a result of greater quality Start Printed Page 70350improvements in the HH industry. The President of the United States communicates information on holidays, commemorations, special observances, trade, and policy through Proclamations. publication in the future. The national per-visit rates are used to pay LUPAs and are also used to compute imputed costs in outlier calculations. 42 U.S.C. If a patient receiving home infusion therapy is also under a home health plan of care, and receives a visit that is unrelated to home infusion therapy, then payment for the home health visit would be covered by the HH PPS and billed on the home health claim. The outlier payment is defined to be a proportion of the wage-adjusted estimated cost that surpasses the wage-adjusted threshold. Our product will show you if the patient is in a rural area or not. 11. A summary of the comments and our responses are as follows: Comment: Commenters overwhelmingly supported CMS' acknowledgment that telecommunications technology has a place in home health for public health emergencies and beyond. Drugs that are “not usually self-administered,” are defined in our manual according to how the Medicare population as a whole uses the drug, not how an individual patient or physician may choose to use a particular drug. Home Health Quality Reporting Program (HH QRP), 3. Living Healthy at Home with Virtual and Smart Fitness Devices Feb-01-2021. The amended plan of care requirements at § 409.43(a) also state that these services cannot substitute for a home visit ordered as part of the plan of care and cannot be considered a home visit for the purposes of patient eligibility or payment, in accordance with section 1895(e)(1)(A) of the Act. of this rule adopts the OMB statistical area delineations outlined in a September 14, 2018, OMB bulletin No. Home Health Medicare Billing Codes Sheet. Additionally, section 1861(iii)(1)(B) of the Act requires that the patient be under a plan of care established and periodically reviewed by a physician, in coordination with the furnishing of home infusion drugs. Infusion drugs can be administered in multiple health care settings, including inpatient hospitals, skilled nursing facilities (SNFs), hospital outpatient departments (HOPDs), physicians' offices, and in the home. There are some drugs that are paid for under the transitional benefit but would not be defined as a home infusion drug under the permanent benefit beginning with 2021. We also note that our previously mentioned proposals to revise §§ 424.520(d) and 424.521(a) would permit home infusion therapy suppliers to back bill for certain services furnished prior to the date on which the MAC approved the supplier's enrollment application. While there are some minimal impacts on certain HHAs as a result of this 5-percent cap as shown in the regulatory impact analysis of this final rule, we decided that the 5-percent cap was a better option for the transition because it would mitigate potential negative impacts from the transition to the new OMB delineations and allow providers the opportunity to adjust to the changes in their wage index values gradually. Though we did not make any proposals regarding the rural add-on percentages in the CY 2021 HH PPS proposed rule, we did receive some comments as summarized in this section of this final rule. L. 105-277, enacted October 21, 1998); and by sections 302, 305, and 306 of the Medicare, Medicaid, and SCHIP Balanced Budget Refinement Act of 1999, (BBRA) (Pub. We also reiterated the expectation that services provided by telecommunications technology are services that could also be provided through an in-person visit. And Temporary Transitional Payment FAQs. We stated that if there is a service that cannot be provided through telecommunications technology (for example, wound care which requires in-person, hands-on care), the HHA must make an in-person visit to furnish such services (85 FR 39428). High comorbidity adjustment: There are two or more secondary diagnoses on the home health-specific comorbidity subgroup interaction list that are associated with higher resource use when both are reported together compared to if they were reported separately. A 30-day period is not considered early unless there is a gap of more than 60 days between the end of one period of care and the start of another. Section 1895(b)(3)(B) of the Act addresses the annual update to the standard prospective payment amounts by the applicable home health percentage increase. Medicare, and Reporting and recordkeeping requirements. As outlined in section 1861(iii)(1) of the Act, to be eligible to receive home infusion therapy services under the home infusion therapy services benefit, the patient must be under the care of an applicable provider (defined in section 1861(iii)(3)(A) of the Act as a physician, nurse practitioner, or physician's assistant), and the patient must be under a physician-established plan of care that prescribes the type, amount, and duration of infusion therapy services that are to be furnished. Local Coverage Determination (LCD): External Infusion Pumps (L33794). Assuming an average reading speed of 250 words per minute, we estimate that it would take approximately 1.80 hours for the staff to review half of this final rule, which consists of approximately 54,079 words. Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Quality Standards. We explained that under this policy, to the extent CMS has granted an exception to the HH QRP (for 2019 Q4 and 2020 Qs 1 and 2 as noted in the May 2020 COVID-19 IFC and below in this section), or may grant any future exceptions or extensions under this same program for other CY 2020 reporting periods, HHAs in the nine HHVBP Model states do not need to separately report these measures for purposes of the HHVBP Model, and those same exceptions apply to the submission of those same data for the HHVBP Model. Overall, there are fewer Micropolitan Areas (542) under the new OMB delineations based on the 2010 Census than existed under the latest data from the 2000 Census (581). emphasizes non-pharmacological options for managing pain as critical in the efforts to reduce over-reliance on and misuse of opioids. Based on the more recent data available for this final rule, the current estimate of the 10-year moving average growth of MFP for CY 2021 is 0.3 percentage points. Applying these prospective fee amounts to the number of projected applicants in the rule's first 3 years, we estimated a total application fee cost to enrollees of $364,800 (or 600 × $608) in the first year, $31,050 (or 50 × $621) in the second year, and $31,700 (or 50 × $634) in the third year. Given these concerns, in the CY 2017 HH PPS final rule (81 FR 76702), we finalized changes to the methodology used to calculate outlier payments, using a cost-per-unit approach rather than a cost-per-visit approach. All Medicare certified HHAs providing services in Arizona, Florida, Iowa, Nebraska, North Carolina, Tennessee, Maryland, Massachusetts, and Washington are required to compete in the Model. Section 1834(u)(1) of the Act requires the Secretary to implement a payment system under which, beginning January 1, 2021, a single payment is made to a qualified home infusion therapy supplier for the items and services (professional services, including nursing services; training and education; remote monitoring, and other monitoring services). Implementation of New Labor Market Delineations, (d) Urban Counties Moving to a Different Urban CBSA, C. CY 2021 Home Health Payment Rate Updates, 1. A few commenters recommended to continue monitoring utilization during the post-implementation period and to extend or modify the rural add-on as necessary. Section 1895(b)(3)(B)(v) of the Act requires that the home health payment update percentage be decreased by 2.0 percentage points for those HHAs that do not submit quality data as required by the Secretary. Second, section 1861(iii)(3)(D)(i)(IV) of the Act permits the Secretary to establish requirements for qualified home infusion therapy suppliers that the Secretary determines appropriate. Response: Similar to our response to a previous NPI-related comment, we encourage these commenters to review the NPI Final Rule, NPI regulations, and Medicare Expectations Subpart Paper for guidance concerning the acquisition and use of NPIs. On February 28, 2013, OMB issued Bulletin No. In new § 424.68(d)(1)(i) and (ii), respectively, we proposed that CMS may deny a home infusion therapy supplier's enrollment application on either of the following grounds: In new § 424.68(d)(2), we proposed that a home infusion therapy supplier may appeal the denial of its enrollment application under 42 CFR part 498. Implementation of the Patient-Driven Grouping… of this final rule. Each 30-day period of care is classified into one of two admission source categories—community or institutional—depending on what healthcare setting was utilized in the 14 days prior to home health. Authority: The Bureau of Labor Statistics (BLS) is the agency that publishes the official measure of private nonfarm business MFP. In the CY 2019 HH PPS final rule with comment period (83 FR 56435), we finalized rebasing the home health market basket to reflect 2016 MCR data, the latest available and most complete data on the actual structure of HHA costs. This commenter suggested that some HHAs would then Start Printed Page 70343be forced to provide unreimbursed care to patients receiving home infusion drugs. We maintain that the provision of remote patient monitoring or other services furnished via a telecommunications system must be on the plan of care and such services must be tied to the patient-specific needs as identified in the comprehensive assessment; however, in response to comments from the public, we are not requiring as part of the plan of care, a description of how the use of such technology will help to achieve the goals outlined on the plan of care. However, we can examine overall costs once we have complete claims and cost report data for CY 2020. We may adjust a 30-day case-mix and wage-adjusted payment based on the information submitted on the claim to reflect the following: Section 1895(b)(3)(D)(i) of the Act, as added by section 51001(a)(2)(B) of the BBA of 2018, requires us to analyze data for CYs 2020 through 2026, after implementation of the 30-day unit of payment and new PDGM case-mix adjustment methodology, to annually determine the impact of the differences between assumed behavior changes and actual behavior changes on estimated aggregate expenditures. General Enrollment and Payment Requirement, c. Specific Requirements for Home Infusion Therapy Supplier Enrollment, (1) Submission of Form CMS-855 and Certification, (4) Home Infusion Therapy Supplier Standards, d. Denial of Enrollment and Appeals Thereof, e. Continued Compliance, Standards, and Reasons for Revocation, f. Effective and Retrospective Date of Home Infusion Therapy Supplier Billing Privileges, VII. Section 1895(b)(4)(B) of the Act requires the establishment of an appropriate case-mix change adjustment factor for significant variation in costs among different units of services. For HHAs that do not submit the required quality data for CY 2021, the home health payment update percentage would be 0.0 percent (2.0 percent minus 2.0 percentage points). References: Change Request (CR) 10782 (PDF, 387 KB) MLN Matters Number: MM10782 (PDF, 231 KB) Therefore, we created a new HCPCS G-code for each of the three payment categories and finalized the billing procedure for the temporary transitional payment for eligible home infusion suppliers. 15. LUPA thresholds and case-mix weights will remain the same for CY 2021. Payment Adjustments for CY 2021 Home Infusion Therapy Services, (a) Home Infusion Therapy Geographic Wage Index Adjustment, 5. We summarized the comments received in the CY 2020 PFS final rule (84 FR 62568) and the CY 2020 HH PPS final rule with comment period (84 FR 60478), and we stated we would take these comments into consideration as we continue developing future policy through notice-and-comment rulemaking. (ii) Any of the applicable denial reasons in § 424.530. Section 1895(b)(3)(A)(iv) of the Act requires that the calculation of the standard prospective payment amount (or amounts) for CY 2020 be made before the application of the annual update to the standard prospective payment amount as required by section 1895(b)(3)(B) of the Act. We also finalized a revision to the labor-related share to reflect the 2016-based home health market basket compensation (Wages and Salaries plus Benefits) cost weight. We all want to live healthy. To illustrate, suppose a supplier has a single practice location in State X. of this rule, we update the home health wage index, the CY 2021 national, standardized 30-day period of care payment amounts and the CY 2021 national per-visit payment amounts by the home health payment update percentage. daily Federal Register on FederalRegister.gov will remain an unofficial Only official editions of the of this rule, we discuss the background and overview of the home infusion therapy services benefit, as well as review the payment policies we finalized in the CY 2020 HH PPS final rule with comment period for the CY 2021 implementation (84 FR 60628). Infusion drugs, equipment, supplies, and administration are all covered by Medicare in the inpatient hospital, SNFs, HOPDs, and physicians' offices. October 1, 2019-December 31, 2019 (Q4 2019). The clinical grouping is based on the principal diagnosis reported on home health claims. Historically, we have used a value of 0.80 for the loss-sharing ratio, which, we believe, preserves incentives for agencies to attempt to provide care efficiently for outlier cases. Home Health Prospective Payment System (HH PPS), 2. HHAs or other practitioners should check with the relevant state licensing authority websites to ensure that practitioners are working within their scope of practice and prescriptive authority. Comment: Commenters gave their overall support for PAs and advanced practice registered nurses (APRNs) to order, certify, and recertify home health services. Section 484.225 Start Printed Page 70315sets forth the specific annual percentage update methodology. Another commenter noted support for the continued inclusion of the Influenza Immunization Received for the Current Flu Season quality measure and suggested the addition of the new composite adult immunizations measure being tested by the National Committee on Quality Assurance. CBSA codes are required on all 32X TOB. Table 18 represents how HHA revenues are likely to be affected by the policy changes in this final rule for CY 2021. Durable Medicare Equipment Medicare Administrative Contractors (DME MACs) process DMEPOS claims.) These per 15-minute unit rates are used to calculate the estimated cost of an episode to determine whether the claim will receive an outlier payment and the Start Printed Page 70322amount of payment for an episode of care. In these cases, HHAs should use special CBSA codes in the range 50xxx on their claim. Section 50401 of the Bipartisan Budget Act of 2018 (Pub. Under section 1895(b)(4)(C) of the Act, the wage adjustment factors used by the Secretary may be the factors used under section 1886(d)(3)(E) of the Act. documents in the last year, 312 That is to say, the law required that CMS calculate the 30-day payment amount for CY 2020 to ensure that the aggregate expenditures during CY 2020 under the new case-mix methodology and 30-day unit of payment would be the same as if the 153-group model was still in place in CY 2020. Third, section 1866(j) of the Act provides specific authority with respect to the enrollment process for providers and suppliers. If an HHA does not become accredited and enrolled as a qualified home infusion therapy supplier and is treating a patient receiving a home infusion drug, the HHA must contract with a qualified home infusion therapy supplier to furnish the services related to the home infusion drug. Therefore, in the CY 2020 HH PPS final rule with comment period, we noted that the infusion pump, drug, and other supplies, and the services required to furnish these items (that is, the compounding and dispensing of the drug) remain covered under the DME benefit. However, the commenter urged CMS to ensure that the measures are reasonable and equitable. Learn more here. The Committee reached consensus on a methodology that resulted in the hospice wage index. documents in the last year, 1501 This temporary payment covers the cost of most of the same items and services, as defined in section 1861(iii)(2)(A) and (B) of the Act, related to the administration of home infusion drugs. Depending on patient acuity or the complexity of the drug administration, certain infusions may require more training and education, especially those that require special handling or pre-or post-infusion protocols. 1727 0 obj <>/Encrypt 1705 0 R/Filter/FlateDecode/ID[<9450A4573577284D84DA17B59660C963>]/Index[1704 67]/Info 1703 0 R/Length 112/Prev 172046/Root 1706 0 R/Size 1771/Type/XRef/W[1 3 1]>>stream Comment: A few commenters provided several scenarios in which the HHA believed that the patient was covered under Medicare Advantage or another payer only to find out that the patient was actually covered under traditional Medicare and this could create a situation in which the RAP submission would be submitted after the timely-filing requirement. documents in the last year, 42 18-04 may be obtained at https://www.whitehouse.gov/wpcontent/uploads/2018/09/Bulletin-18-04.pdf. Any of the revocation reasons in § 424.535 applies. The costs of any equipment, set-up, and service related to the technology are allowable only as administrative costs. Another commenter suggested revising the requirement that home infusion drugs must be identified by the DME LCD for External Infusion Pumps (L33794) [23] Overview of the Home Health Prospective Payment System (HH PPS), B. 4 = Interim -last claim . Response: Section 5012 of the 21st Century Cures Act amended section 1861(m) of the Act to exclude home infusion therapy services from the definition of home health services, effective January 1, 2021, therefore, we are statutorily precluded from making payment for home infusion therapy services to entities other than “qualified home infusion therapy suppliers” for services needed to administer “home infusion drugs.” As described in section V.B of the proposed rule (85 FR 39442), the overarching purpose of the enrollment process is to help ensure that providers and suppliers that seek to bill the Medicare program for services or items furnished to Medicare beneficiaries are qualified to do so under federal and state laws.
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