AGENCY: HRSA 340B Drug Pricing Program Omnibus Guidance - Proposed http://www.gpo.gov/fdsys/pkg/FR-2015-08-28/pdf/2015-21246.pdf
Released: 8/28/2015
Due date: 10/27/2015
HRSA administers section 340B of the Public Health Service Act (PHS Act), referred to as the “340B Drug Pricing Program” or the “340B Program.” This notice proposes guidance for covered entities enrolled in the 340B Program and drug manufacturers required by section 340B to make their drugs available to covered entities under the 340B Program. When finalized after consideration of public comments solicited by this notice, the guidance will assist 340B covered entities and drug manufacturers in complying with the statute.
A Modern Healthcare article on this notice is available at http://www.modernhealthcare.com/article/20150827/NEWS/150829882.
A Politico Pro article on this notice is available at https://www.politicopro.com/health-care/story/2015/08/hhs-clamping-down-on-huge-drug-discount-program-051827 (subscription required).
Analysis
This notice includes one Indian-specific provision regarding individuals eligible to receive 340B drugs (Part C). Under this notice, for “Indian Tribes or Tribal Organizations whose 340B Program eligibility arises solely from the Indian Self-Determination and Education Assistance Act, Public Law 93-638 (ISDEAA), use of 340B drugs is limited to those individuals that the tribe or tribal organization is authorized to serve under its ISDEAA contract, in accordance with the requirements in Section 813 of the Indian Health Care Improvement Act.”
This notice does not otherwise specifically mention Indian health care providers. One mention of the encounter rate appears in the discussion of a provision that defines drugs eligible for purchase under 340B (Part B). According to this notice a “covered outpatient drug, as defined in section 1927(k)(2) and (3) of the Social Security Act, is eligible for purchase under the 340B Program. For purposes of the 340B Program, only drugs bundled for and receiving such bundled reimbursement under Title XIX of the Social Security Act described in section 1927(k)(3) will be considered excluded from the definition of covered outpatient drug.”
Section 1927(k)(3) Act (limiting definition) reads: “The term ‘covered outpatient drug’ does not include any drug, biological product, or insulin provided as part of, or as incident to and in the same setting as, any of the following (and for which payment may be made under this title as part of payment for the following and not as direct reimbursement for the drug): (A) Inpatient hospital services; (B) Hospice services; (C) Dental services, except that drugs for which the State plan authorizes direct reimbursement to the dispensing dentist are covered outpatient drugs; (D) Physicians’ services; (E) Outpatient hospital services; (F) Nursing facility services and services provided by an intermediate care facility for the mentally retarded; (G) Other laboratory and x-ray services; and (H) Renal dialysis. Such term also does not include any such drug for which a National Drug Code number is not required by the Food and Drug Administration or a drug or biological used for a medical indication which is not a medically accepted indication.”
According to HRSA, on May 13, 1994, HHS published guidance clarifying that, in the settings identified in the limiting definition, “if a covered drug is included in the per diem rate (i.e., bundled with other payments in an all-inclusive, a per visit, or an encounter rate), it will not be included in the [340B Program]. However, if a covered drug is billed and paid for instead as a separate line item as an outpatient drug in a cost basis billing system, this drug will be included in the program.”
This notice proposes that a drug satisfying both conditions of the limiting definition will not qualify as a covered outpatient drug in the 340B Program. Under this notice, the limiting definition applies only when the drug is bundled for payment under Medicaid as part of a service in the settings described in the limiting definition. In contrast, a drug provided as part of a hospital outpatient service and billed to any other third party or directly billed to Medicaid still would qualify as a covered outpatient drug.
8/31/2015: Please see analysis to the left.
10/8/2015: Will be coming out in 3 parts. It is something we want to keep on our radar for further analysis.
AGENCY: HHS OCR Nondiscrimination in Health Programs and Activities
http://www.gpo.gov/fdsys/pkg/FR-2015-09-08/pdf/2015-22043.pdf
Released: 9/8/2015
Due date: 11/9/2015
Section 1557 of ACA prohibits discrimination on the basis of race, color, national origin, sex, age, or disability in certain health programs and activities. Section 1557(c) of ACA authorizes the HHS Secretary to promulgate regulations to implement the nondiscrimination requirements of Section 1557. In addition, the HHS Secretary can prescribe regulations for department governance, conduct, and performance of its business, including, as addressed in this proposed rule, how HHS will apply the standards of Section 1557 to department-administered health programs and activities. This proposed rule applies to health programs and activities administered by CMS, HRSA, CDC, IHS, and SAMHSA. Examples include tribal hospitals and clinics operated by IHS (about 876 hospitals and clinics) and the National Health Service Corps.
Tribal Consultation Call
HHS OCR will hold a tribal consultation call on this proposed rule on November 2, 2015. Information about the call appears below.
DATE: Monday, November 2, 2015
TIME: 2:00 p.m. ET
CALL-IN NUMBER: 888-390-3401
PARTICIPANT PASSCODE: 5256541
9/9/2015: This proposed rule may have a significant impact on how Indian-specific provisions are enforced and/or permitted.
10/9: Notes from 10/7 reg call: “ Need to read more in depth. It is not due until November 9th but we need to start writing comments.”
10/14/2015: HCR will hold a tribal consultation call on this proposed rule on 11/2/2015. See the column to the left for details.
Merit-Based Incentive Payment System, et al.
CMS-3321-NC
AGENCY: CMS Request for Information Regarding Implementation of the Merit-Based Incentive Payment System, Promotion of Alternative Payment Models, and Incentive Payments for Participation in Eligible Alternative Payment Models
http://www.gpo.gov/fdsys/pkg/FR-2015-09-04/pdf/2015-22033.pdf
Released: 10/1/2015
Due date: 11/2/2015
Section 101 of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) repeals the Medicare sustainable growth rate (SGR) methodology for updates to the physician fee schedule (PFS) and replaces it with a new Merit-Based Incentive Payment System (MIPS) for MIPS eligible professionals (MIPS EPs) under the PFS. Section 101 of the MACRA sunsets payment adjustments under the current Physician Quality Reporting System (PQRS), the Value-Based Payment Modifier (VM), and the Electronic Health Records (EHR) Incentive Program. It also consolidates aspects of the PQRS, VM, and EHR Incentive Program into the new MIPS. Additionally, section 101 of the MACRA promotes the development of Alternative Payment Models (APMs) by providing incentive payments for certain eligible professionals (EPs) who participate in APMs, by exempting EPs from MIPS if they participate in APMs, and by encouraging the creation of physician-focused payment models (PFPMs). In this request for information (RFI), CMS seeks public and stakeholder input to inform its implementation of these provisions.
A recent Health Affairs article on new incentive payment systems for Medicare providers under MACRA is available at http://healthaffairs.org/blog/2015/09/28/macra-new-opportunities-for-medicare-providers-through-innovative-payment-systems-3/.
10/2/2015: Tribal representatives may wish to submit comments on the suggested interaction of the alternative payment models under consideration by CMS with the current payment methodologies for Indian health care providers.
See detail in entry under the Priority roster items above.
10/9: Notes from 10/7 reg call: Released last Thursday and we have a month to comment. May also be of interest to the Payment Reform Group. Devin will reach out to see.”
Medicare Clinical Diagnostic Laboratory Tests Payment System
This proposed rule would significantly revise the Medicare payment system for clinical diagnostic laboratory tests and would implement other changes required by section 216 of the Protecting Access to Medicare Act of 2014.
10/2/2015: A thorough review of the proposed payment changes is recommended to determine the potential impact on Tribal health programs.
10/9: Notes from 10/7 reg call: Released last week and is due at the end of November. Not much information is provided. We need to keep it on our radar but we have some time.
Sharing What Works--Best Practice, Promising Practice, and Local Effort Form
IHS (OMB 0917-0034)
AGENCY: IHS PRA Request for Comment
http://www.gpo.gov/fdsys/pkg/FR-2015-10-09/pdf/2015-25733.pdf
Released: 10/9/2015
Due date: 12/8/2015
Type of Information Collection Request: Extension without change of a currently approved collection; Title: IHS Sharing What Works--Best Practice, Promising Practice, and Local Effort (BPPPLE) Form; Use: IHS seeks to raise the health status of the AI/AN population to the highest possible level by providing comprehensive health care and preventive health services. To support the IHS mission and encourage the creation and utilization of performance driven products/services by IHS, tribal, and urban Indian health (I/T/U) programs, Office of Preventive and Clinical Services program divisions (i.e., behavioral health, health promotion/disease prevention, nursing, and dental) have developed a centralized program database of best practices, promising practices, and local efforts (BPPPLE) and resources. This collection serves to further the development of a database of BPPPLE, resources, and policies available to the public on the IHS Web site. This database will serve as a resource for program evaluation and for modeling examples of various health care projects occurring in AI/AN communities.
More information on BPPPLE is available on the IHS Web site at http://www.ihs.gov/bppple/.
10/9/2015: This is a request to continue a “currently approved collection”.
Given the topic, comments may be warranted to determine if the data collected are the most useful and least burdensome.
EHR Incentive Program--Stage 3 and Modifications to Meaningful Use
CMS-3310-FC and CMS-3311-FC
AGENCY: CMS Medicare and Medicaid Programs; Electronic Health Record Incentive Program--Stage 3 and Modifications to Meaningful Use in 2015 through 2017
https://s3.amazonaws.com/public-inspection.federalregister.gov/2015-25595.pdf
Released: 10/6/2015
Due Date: 12/15/2015 Published: 10/16/2015 (expected)
This final rule with comment period specifies the requirements that eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs) must meet to qualify for Medicare and Medicaid electronic health record (EHR) incentive payments and avoid downward payment adjustments under the Medicare EHR Incentive Program. In addition, it changes the Medicare and Medicaid EHR Incentive Programs reporting period in 2015 to a 90-day period aligned with the calendar year. This final rule with comment period also removes reporting requirements on measures that have become redundant, duplicative, or topped out from the Medicare and Medicaid EHR Incentive Programs. In addition, this final rule with comment period establishes the requirements for Stage 3 of the program as optional in 2017 and required for all participants beginning in 2018. This final rule with comment period continues to encourage the electronic submission of clinical quality measure (CQM) data, establishes requirements to transition the program to a single stage, and aligns reporting for providers in the Medicare and Medicaid EHR Incentive Programs.
CMS seeks comments on sections II.B.1.b.(3).(iii), II.B.1.b.(4).(a), II.B.2.b, II.D.1.e, and II.G.2 of preamble to this final rule with comment period ; paragraphs (1)(ii)(C)(3), (1)(iii), (2)(ii)(C)(3) and 2(iii) of the definition of an EHR reporting period at §495.4; and paragraphs (2)(ii)(C)(2) and (2)(iii) of the definition of an EHR reporting period for a payment adjustment year at §495.4.
NIHB and TTAG submitted comments on the proposed version of this rule (CMS-3310-P) on May 29, 2015. A summary of the recommendations from tribal organizations, as well as the responses from CMS, appears below.
Regulations/Definitions Across the Medicare Fee-for-Service, Medicare Advantage, and Medicaid Programs:
a. Single Reporting Period Aligned to Calendar Year: The proposed rule would create a single electronic health record (EHR) reporting period aligned to the calendar year would help achieve a stated goal of Stage 3 to realign and simplify the reporting process; CMS should retain this provision in the final rule.
Response: Accepted. CMS retained this provision.
b. Specification of Means of Data Transmission: For Stage 3, the proposed rule would continue to allow states to specify the means of transmission of the data and otherwise change the public health agency reporting objective; in the final rule, CMS should grant IHS, tribal health clinics, urban Indian clinics (I/T/Us) the same allowance, given the difficulties with Internet access in Indian Country.
Response: Not accepted. CMS did not address the specific concerns of I/T/Us.
c. “Topping Out”: The proposed rule would eliminate the need for providers to report individually on measures for which they have already met the meaningful use (MU) threshold (“topping out”), thereby lessening the reporting burden; CMS should retain this provision in the final rule but should take into consideration that I/T/Us might not “top out” on the most basic measures, calling for flexibility in the way the agency determines if a provider has met the MU threshold.
Response: Accepted in part. CMS retained this provision but did not address the specific concerns of I/T/Us.
d. Paper-Based Formats: The proposed rule would not allow the continued use of paper-based formats for certain objectives and measures in Stage 3; CMS should exclude I/T/Us from the provision because of the lack of Internet access in Indian Country.
Response: Not accepted. CMS did not address the specific concerns of I/T/Us but stated, “While we do not in any way seek to limit the methods by which a provider may engage with a patient or share information, we do not believe that requiring providers to measure paper-based actions is consistent with the long-term goals of the program. ... Some patients may prefer to receive a paper version of their clinical summary or may want to receive education items or reminders on paper or some other method that is not electronic. Our proposal would simply no longer require or allow providers to manually count and report on these paper-based exchanges.” [pages 92-93]
e. HIPAA Security Rules: HIPAA Security Rules require covered entities and business associates to conduct a security risk analysis to assess the potential risks to the electronic protected health information (ePHI) they create, receive, maintain, or transmit, but most, if not all, I/T/Us cannot afford the run this analysis as needed to meet the MU requirements in the proposed rule; CMS should take this into consideration in the final rule.
Response: Not accepted. CMS did not address the specific concerns of I/T/Us but stated, “We decline to consider exclusions, including for small practices, as we believe it is of utmost importance for all providers to protect ePHI.” [page 136]
f. Electronic Prescribing (eRx): eRx serves as one of eight objectives for MU in 2017 and subsequent years, and the proposed rule would require eligible professionals (EPs) to generate and transmit permissible prescriptions electronically and eligible hospitals and critical access hospitals (CAHs) to generate and transmit permissible discharge prescriptions electronically--requirements that I/T/U would have difficulty meeting because of the rural nature of Indian Country; CMS should exclude I/T/Us from these requirements in the final rule.
Response: Not accepted. CMS did not address the specific concerns of I/T/Us.
g. Clinical Decision Support (CDS): CDS--which concerns positive impact on the quality, safety, and efficiency of care delivery--serves as another of the eight objectives for MU in 2017, but I/T/Us will have difficulty achieving MU if they must have computerized alerts and reminders for providers and patients, information displays or links, context-aware knowledge retrieval specifications, InfoButtons, clinical guidelines, condition-specific order sets, focused patient data reports and summaries, documentation templates, diagnostic support, and contextually relevant reference information as the proposed rule would require; CMS should exclude I/T/Us from these requirements in the final rule.
Response: Not accepted. CMS did not address the specific concerns of I/T/Us.
h. Computerized Provider Order Entry (CPOE): I/T/Us also would have difficulty meeting the proposed objective regarding CPOE for Stage 3, as the proposed rule would require including diagnostic imaging--such as ultrasound, magnetic resonance, and computed tomography in addition to traditional radiology--not commonly found in Indian Country; CMS should exclude I/T/Us from these requirements in the final rule.
Response: Not accepted. CMS did not address the specific concerns of I/T/Us but stated, “After consideration of the public comments received, at we are finalizing the objective and the measures for CPOE for laboratory orders and CPOE for diagnostic imaging orders and the exclusions for all measures as proposed.” [page 329]
i. Patient Electronic Access to Health Information: In addition, I/T/Us would have difficulty meeting the proposed objective that, as required by the proposed rule, allows patients to view, download, and transmit their health information to a third party and engage in patient-centered communication for care planning and care coordination, as well as have timely access to their full health record, as these providers (and their patients) lack the necessary tools; in the final rule, CMS should exclude I/T/Us and their patients from the “no paper allowed” doctrine for Stage 3 and reconsider requirements on application-program interfaces (APIs) for Indian Country.
Response: Not accepted. CMS did not address the specific concerns of I/T/Us but stated “We note that this proposed objective is entirely focused on the provision of access to patients or their authorized representatives and does not require the provider to be accountable for the patient using that access. ... We believe that no patient should be excluded from access to their health care information for any reason, especially reasons which would allow for a blanket exclusion of any patient based on a demographic factor.” [pages 340-341]
j. Patient Electronic Access to Health Information Exclusion: The proposed rule would exclude from this objective any clinic located in a county in which 50 percent or more of its housing units lack 4 Mbps broadband availability and in which a significant section of the patient population does not have access to broadband Internet; CMS should retain this exclusion in the final rule.
Response: Accepted. CMS retained this provision.
k. Coordination of Care Through Patient Engagement: CMS should retain in the final rule an exclusion from this objective for any clinic located in a county in which 50 percent or more of its housing units lack 4 Mbps broadband availability and in which a significant section of the patient population does not have access to broadband Internet.
Response: Accepted. CMS retained this provision.
l. Transitions of Care: This proposed objective seeks to ensure the electronic transmission or capture of a summary of care record and the incorporation of this record into the EHR for patients seeking care among different providers in the care continuum, as well as to encourage reconciliation of health information for the patient; the summary of care measure in this objective raises some concerns based on the current status of health information exchange and the ability to partner with other organizations at this time, and as such, CMS should consider a more practical approach that would allow for a demonstration of the capability of a facility and consider implementation of rates in the future.
Response: Not accepted. CMS stated, “We ... believe that this threshold is a reasonable and achievable goal for providers for an EHR reporting period in 2018. We understand the challenges providers and other stakeholders describe and recognize that the transition to interoperable health information exchange requires a paradigm shift across the health care industry. We believe the work providers are already engaged in and the HIE objectives and measures from Stage 2 are helping to actualize this change.” [pages 398-399]
m. Public Health and Clinical Data Registry Reporting: This objective focuses on the importance of the ongoing lines of communication that should exist between providers and public health agencies (PHAs) or between providers and clinical data registries (CDRs); this objective raises concerns because of the proposed requirement on bidirectional immunization exchange, a functionality that will require unanticipated additional development for vendors in the current year, and CMS as such, CMS should reconsider this requirement.
Response: Accepted. CMS stated, “We appreciate commenters' concerns regarding the addition of a bi-directionality requirement for the EHR reporting periods covered by the modified Stage 2 requirements. We agree with commenters that additional time may be needed for both public health agencies and providers to adopt the necessary technology to support bi-directional functionality. Therefore, we are not finalizing the bi-directionality proposal in the EHR Incentive Programs for 2015 through 2017.” [pages 252-253]
Certified EHR Technology (CEHRT) Requirements:
a. Consolidating Reporting: The proposed rule seeks to (1) avoid redundant or duplicative reporting and align certain aspects of the reporting clinical quality measures (CQMs) component of MU under the Medicare EHR Incentive Program and Physician Quality Reporting System (PQRS) for EPs and (2) avoid redundant or duplicative reporting of CQM reporting requirements for the Medicare and Medicaid EHR Incentive Program for eligible hospitals and CAHs in the inpatient prospective payment system (IPPS); CMS should retain these provisions in the final rule.
Response: Accepted. CMS retained these provisions.
b. Electronic Reporting of CQMs: For 2018 and subsequent years, the proposed rule would require providers participating in Medicare to report CQMs electronically, where feasible, and remove the option of attestation to CQMs, except in circumstances where electronic reporting is not feasible; for I/T/Us in Indian Country where electronic reporting is not feasible, CMS should allow an alternative process.
Response: Not accepted. CMS did not address the specific concerns of I/T/Us.
c. HITECH Act Exemption: The HITECH Act requires reductions in payments to EPs, eligible hospitals, and CAHs that do not meet MU requirements, but the HHS secretary has the authority to exempt an affected EP if this reduction would result in a significant hardship; CMS should grant I/T/Us in Indian Country a permanent exemption.
Response: Not accepted. CMS did not address the specific concerns of I/T/Us.
10/7/2015: See analysis to the left on the final rule / open rules, Tribal recommendations, and responses to Tribal recommendations.
