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Covered Outpatient Drugs (CMS-2345-F)
PENDING AT OMB FOR APPROVAL
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Received at OMB: 8/4/2015
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This final rule revises requirements pertaining to Medicaid reimbursement for covered outpatient drugs to implement provisions of ACA. This final rule also revises other requirements related to covered outpatient drugs, including key aspects of Medicaid coverage, payment, and the drug rebate program.
On April 2, 2012, tribal organizations made the following recommendations on the proposed version of this rule:
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Tribal Consultation: CMS should consider in its decisions regarding the final rule all comments received during tribal consultation, although the agency would not have received these comments until after the April 2, 2012, deadline.
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Payment Methodologies: Proposed § 447.518 requires the State plan to describe the payment methodology for prescription drugs, including those dispensed by I/T/U pharmacies, provided that the allowable methodologies include reimbursement on the same basis as retail pharmacies and the OMB encounter rate already approved by CMS in a number of State plans; CMS should retain this provision in the final rule but provide clarification regarding allowable methodologies to ensure that states do not mistakenly believe that current reimbursement models, such as encounter rates, are not permitted.
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Dispensing Fee Calculations: CMS should retain in the final rule the proposed requirement that dispensing fee calculations take into account special circumstances of I/T/U pharmacies.
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9/3/2015: Not yet released by OMB / CMS.
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Full Roster
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CMS-10398
AGENCY: CMS
PRA Request for Comment
http://www.gpo.gov/fdsys/pkg/FR-2015-09-04/pdf/2015-22020.pdf
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Released: 9/14/2015
Due date: 10/14/2015
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Type of Information Collection Request: Revision of a currently approved collection; Title: Demonstration Programs to Improve Community Mental Health Services; Use: CMS, SAMHSA, and the HHS Assistant Secretary of Planning and Evaluation (ASPE) intend to collect information from states selected to participate in the Section 223 Demonstration Programs to Improve Community Mental Health Services. Completed annually by each certified community behavioral health clinic (CCBHC), CMS would use the information collection cost report to determine the prospective payment system (PPS) rate, effective January 1, 2017, for payment of demonstration services for each CCBHC. The cost report would facilitate rate determinations for both PPS-1 and PPS-2 (the two methodologies allowed by CMS and specified in CCBHC PPS guidance previously issued by CMS). The cost report would assist states in meeting the requirement for annual reporting of CCBHC cost to CMS in a manner consistent with cost reporting and documentation requirements in the guidance.
Review/approval of information collections under this control number occurs under the generic OMB process. As such, they usually do not undergo formal public review and comment. In this instance, however, CMS seeks public input and is posting the cost report, cost report instructions, and Supporting Statement on its Web site for public review.
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9/15/2015: Paperwork Reduction Act Notice. No comments recommended.
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Reform of Requirements for Long-Term Care Facilities
CMS-3260-P
AGENCY: CMS
Medicare and Medicaid Programs; Reform of Requirements for Long-Term Care Facilities
http://www.gpo.gov/fdsys/pkg/FR-2015-07-16/pdf/2015-17207.pdf
http://www.gpo.gov/fdsys/pkg/FR-2015-09-15/pdf/2015-23110.pdf
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Released: 7/16/2015
Due date: 9/14/2015
10/15/2015
Reopening of comment period:
9/15/2015
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This proposed rule would revise the requirements that long-term care facilities must meet to participate in the Medicare and Medicaid programs. These proposed changes are necessary to reflect the substantial advances made over the past several years in the theory and practice of service delivery and safety. These proposals also serve as an integral part of CMS efforts to achieve broad-based improvements both in the quality of health care furnished through federal programs, and in patient safety, while at the same time reducing procedural burdens on providers.
Reopening of comment period (9/15/2015): This document (CMS-3260-N) reopens the comment period for the July 16, 2015, proposed rule titled “Reform of Requirements for Long-Term Care Facilities.” This document reopens the comment period for the proposed rule, which ended on September 14, 2015, for 30 days.
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Hospital and Hospital Health Care Complex Cost Report
CMS-2552-10
AGENCY: CMS
PRA Request for Comment
http://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23462.pdf
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Released: 9/18/2015
Due date: 10/19/2015
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Type of Information Collection Request: Revision of a currently approved collection; Title: Hospital and Hospital Health Care Complex Cost Report; Use: Providers of services participating in the Medicare program must, under sections 1815(a) and 1861(v)(1)(A) of the Social Security Act, submit annual information to achieve settlement of costs for health care services rendered to Medicare beneficiaries. In addition, regulations at 42 CFR 413.20 and 413.24 require adequate cost data and cost reports from providers on an annual basis.
CMS seeks OMB review and approval of this revision to form CMS-2552-10, Hospital and Hospital Health Care Complex Cost Report. Hospitals participating in the Medicare program file these cost reports annually to determine the reasonable costs incurred to provide medical services to patients. The revisions made to the hospital cost report comport with the statutory requirement for hospice payment reform in § 3132 of ACA and the statutory requirement establishing a prospective payment system for Federally Qualified Health Centers in § 10501(i)(3)(A) of ACA, codified in section 1834(o) of the Social Security Act.
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9/18/2015: Paperwork Reduction Act Notice. No comments recommended.
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Part C Medicare Advantage Reporting Requirements
CMS-10261
AGENCY: CMS
PRA Request for Comment
http://www.gpo.gov/fdsys/pkg/FR-2015-08-24/pdf/2015-20787.pdf
http://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23482.pdf
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Released: 8/24/2015
Due date: 9/23/2015
10/19/2015
Correction and partial withdrawal:
9/18/2015
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2. Type of Information Collection Request: Revision of a currently approved collection; Title: Part C Medicare Advantage Reporting Requirements and Supporting Regulations; Use: Central and regional CMS office staff use Part C reporting data to monitor health plans and hold them accountable for their performance, and researchers and other government agencies, such as GAO, also use this information. Health plans can use this information to measure and benchmark their performance.
Correction and partial withdrawal (9/18/2015): Based on internal review, this notice withdraws a portion of a prior notice (dated August 24, 2015) concerning the same subject matter and corrects that notice by adding a new requirement inadvertently omitted from that notice. Specifically, CMS proposes to add a new Payments to Providers reporting section to capture data related to value-based payments by MA organizations. Upon OMB approval, the Payments to Providers section would add 10 data elements.
HHS has developed four categories of value based payment: (1) Fee-for-service with no link to quality; (2) fee-for-service with a link to quality; (30 alternative payment models built on fee-for-service architecture; and (4) population-based payment. To compliment this action, CMS seeks to collect data from MA organizations about the proportion of their payments to providers made based on these four categories. The collected information would help CMS understand the extent and use of alternate payment models in the MA industry.
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8/24/2015: Paperwork Reduction Act notice. No comments recommended.
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Applications for Medicare Prescription Drug Plan 2017 Contracts
CMS-10137
AGENCY: CMS
PRA Request for Comment
http://www.gpo.gov/fdsys/pkg/FR-2015-09-24/pdf/2015-24262.pdf
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Released: 9/24/2015
Due date: 10/26/2015
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1. Type of Information Collection Request: Revision of a currently approved collection; Title: Solicitation for Applications for Medicare Prescription Drug Plan 2017 Contracts; Use: CMS will collect the information under the solicitation of proposals from prescription drug plans, Medicare Advantage (MA) plans that offer integrated prescription drug and health care coverage (MA-PD) plans, Cost Plan, PACE, and Employer Group Waiver Plan applicants. CMS will use the information to (1) ensure that applicants meet agency requirements and (2) support the determination of contract awards. Participation in the Part D program is voluntary. Only organizations interested in participating in the program will respond to the solicitation. The MA-PDs that voluntarily participate in the Part C program must submit a Part D application and successful bid.
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9/24/2015: Paperwork Reduction Act notice. No comments recommended.
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Part C--Medicare Advantage and 1876 Cost Plan Expansion Application
CMS-10237
AGENCY: CMS
PRA Request for Comment
http://www.gpo.gov/fdsys/pkg/FR-2015-09-24/pdf/2015-24262.pdf
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Released: 9/24/2015
Due date: 10/26/2015
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2. Type of Information Collection Request: Revision of a currently approved collection; Title: Part C--Medicare Advantage and 1876 Cost Plan Expansion Application; Use: CMS will collect the information under the solicitation of Part C applications from Medicare Advantage, Employer Group Waiver Plan, and Cost Plan applicants. CMS will use the information to (1) ensure that applicants meet agency requirements and (2) to support the determination of contract awards. Participation is voluntary, whereby only organizations interested in participating in the program will respond to the solicitation. Medicare Advantage (MA) organizations that offer integrated prescription drug and health care products (MA-PD plans) and participate in the Part C program must submit a Part D application and successful bid.
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9/24/2015: Paperwork Reduction Act notice. No comments recommended.
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Medicare Beneficiary and Family-Centered Satisfaction Survey
CMS-10393
AGENCY: CMS
PRA Request for Comment
http://www.gpo.gov/fdsys/pkg/FR-2015-09-25/pdf/2015-24471.pdf
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Released: 9/25/2015
Due date: 10/26/2015
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Type of Information Collection Request: Extension of a currently approved collection; Title: Medicare Beneficiary and Family-Centered Satisfaction Survey; Use: The data collection methodology used to determine Beneficiary Satisfaction flows from the proposed sampling approach. Based on recent literature on survey methodology and response rates by mode, CMS recommends using a data collection done primarily by mail. A mail-based methodology will achieve the goals of making the survey efficient, effective, and minimally burdensome for beneficiary respondents. CMS anticipates that a mail-based methodology could yield a response rate of approximately 60 percent. To achieve this response rate, CMS would recommend a 3-staged approach to data collection:
(1) Mailout of a covering letter, the paper survey questionnaire, and a postage-paid return envelope.
(2) Mailout of a postcard that thanks respondents and reminds the non-respondents to please return their survey.
(3) Mailout of a follow-up covering letter, the paper survey questionnaire, and a postage-paid return envelope.
Through the pilot test, CMS will determine the response rate that it can achieve using this approach. If deemed necessary, CMS can add a prenotification letter, additional mailout reminders, and a telephone non-response step to the protocol to achieve the desired response rate.
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9/24/2015: Paperwork Reduction Act notice. No comments recommended.
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Tribal Consultation on Implementation of VA Budget and Choice Improvement Act
VA (no reference number)
AGENCY: VA
Dear Tribal Leader Letter Requesting Tribal Consultation on Implementation of the VA Budget and Choice Improvement Act
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Released: 10/7/2015
Due date: 10/26/2015
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This letter requests tribal consultation regarding the inclusion of IHS and tribal health programs as part of the proposed core provider network under a new plan to consolidate and streamline VA community care, as required by the VA Budget and Choice Improvement Act enacted in July 2015. Inclusion in the core network of providers would preserve and build on existing VA relationships with IHS and tribal health programs and facilitate future collaboration to improve health care services to all eligible, enrolled veterans. Future collaborations might focus on streamlined credentialing processes and enhanced care options for veterans.
Interested parties can submit written comments to tribalgovernmentconsultation@va.gov by October 26, 2015. For addition information on this issue, please contact Marvin Rydberg at Marvin.Rydberg@va.gov or 202-904-7287. VA will seek additional tribal consultation on this issue after November 1, 2015.
A copy of the letter is embedded below.
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340B Drug Pricing Program Omnibus Guidance
HRSA (RIN 0906-AB08)
AGENCY: HRSA
340B Drug Pricing Program Omnibus Guidance - Proposed
http://www.gpo.gov/fdsys/pkg/FR-2015-08-28/pdf/2015-21246.pdf
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Released: 8/28/2015
Due date: 10/27/2015
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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.
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8/31/2015: See details on entry in Priority Roster above.
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REG-143800-14
AGENCY: IRS
Minimum Value of Eligible Employer-Sponsored Health Plans
http://www.gpo.gov/fdsys/pkg/FR-2015-09-01/pdf/2015-21427.pdf
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Released: 9/1/2015
Due Date: 11/2/2015
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This document withdraws, in part, a notice of proposed rulemaking published on May 3, 2013, relating to the health insurance premium tax credit enacted by ACA (including guidance on determining whether health coverage under an eligible employer-sponsored plan provides minimum value) and replaces the withdrawn portion with new proposed regulations providing guidance on determining whether health coverage under an eligible employer-sponsored plan provides minimum value. These proposed regulations affect participants in eligible employer-sponsored health plans and employers that sponsor these plans.
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9/3/2015: This “supplemental notice of proposed rulemaking reviews (and confirms) the requirement being imposed by the IRS to define “minimum value” of employer-sponsored coverage to include both (1) a requirement to cover at least 60 percent of the average costs of the covered services and (2) include hospitalization and physician services, effective pursuant to the dates provided in the proposed rule.
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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
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Released: 10/1/2015
Due date: 11/2/2015
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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/.
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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.
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