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HRSA Issues Proposed Guidance for 340B Drug Pricing Program

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The Health Resources and Services Administration (HRSA) has released “mega guidance” for its proposed 340B Drug Pricing Program. The guidance is included in a notice with a 60-day comment period. In the guidance, HRSA provides clarification on the areas of covered entity eligibility, patient definition, group purchasing organization prohibition, contract pharmacy, duplicate discounts and covered entity audits. It also includes enhanced program integrity requirements for pharmaceutical manufacturers participating in the program. CHA is reviewing the proposed guidance and will seek member input on the anticipated hospital impact. Comments are due Oct. 26.

Registration for Call on CCJR Bundled Payment Model Closes Tomorrow

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CHA reminds members to register by noon tomorrow, Aug. 13, for a member call on the proposed rule for the Comprehensive Care for Joint Replacement (CCJR) bundled payment model. Scheduled for Aug. 14 from 11 a.m. – noon (PT), the call will provide an overview of the proposed rule and solicit member input for CHA’s comments, which are due Sept. 8. CHA encourages all hospitals currently providing lower extremity joint replacement services to participate. While CMS is currently proposing this mandatory model in randomly selected metropolitan statistical areas (MSAs) across the country — including three in California — the MSAs have the potential to change between now and release of the final rule. The policy’s effective date is currently scheduled for Jan. 1, 2016.

To register for the call, visit www.surveymonkey.com/r/ccjrproposed. Members are encouraged to send questions in advance. A dial-in number and materials will be sent to registered attendees on Aug. 13 and posted to the CHA website. Additional information about the proposed rule is available at www.calhospital.org/cha-news-article/cha-issues-summary-ccjr-payment-model-proposed-rule. 

CHA DataSuite Releases Analysis of CCJR Payment Model

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CHA DataSuite has released a report analyzing the 2015 Comprehensive Care for Joint Replacement (CCJR) model, a new Medicare Part A and B payment model. The proposed rule implementing CCJR would require acute care hospitals in certain selected geographic areas, including three in California, to participate in the model and receive bundled payments for episodes of care where the diagnosis at discharge included lower extremity joint replacement or attachment of a lower extremity that was furnished by the hospital. The DataSuite analysis provides hospitals with a first look at Medicare spending for episodes of care specific to their own patients. The report uses only 2013 data and is not an estimate of the program’s impact, although an impact analysis will be produced when 2014 data becomes available from the Centers for Medicare & Medicaid Services.

CHA Issues Summary of CCJR Payment Model Proposed Rule

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CHA has released the attached summary, prepared by Health Policy Alternatives, Inc., detailing the Centers for Medicare & Medicaid Services (CMS) proposed rule implementing the Comprehensive Care for Joint Replacement (CCJR) model, a new Medicare Part A and B payment model. The proposed rule would require acute care hospitals in certain selected geographic areas, including three in California, to participate in the CCJR model and receive bundled payments for episodes of care where the diagnoses at discharge included lower extremity joint replacement or attachment of a lower extremity that was furnished by the hospital. The summary details provisions of the proposed rule, including the definition of the episode initiator; methodology for setting episode prices and payment for model participants; and the use of quality measures and data sharing.

CMS to Host Webinars on its New Joint Replacement Model

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As reported in CHA News last week, the Centers for Medicare & Medicaid Services (CMS) has issued a proposed rule that creates a new model in which acute care hospitals in certain selected geographic areas will receive retrospective bundled payments for episodes of care for hip and knee replacements beginning Jan. 1, 2016. This week, the CMS Innovation Center will host two webinars for providers to discuss the new model: July 15 from 10 – 11 a.m. (PT) and July 16 from 11 a.m. – noon.

CMS Proposes Bundled Payment Model for Joint Replacements to Begin in January

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The Centers for Medicare & Medicaid Services (CMS) yesterday issued the attached proposed rule that creates a new model in which acute care hospitals in certain selected geographic areas, including three in California, will receive retrospective bundled payments for episodes of care for hip and knee replacements beginning Jan. 1, 2016 through Dec. 31, 2020. The Comprehensive Care for Joint Replacement (CCJR) model would hold participant hospitals financially accountable for the quality and cost of a  90-day episode of care and is intended to incentivize increased coordination of care among hospitals, physicians and post-acute care providers.

Participation in the model would be required by hospitals paid under the inpatient prospective payment system (IPPS) in 75 geographic areas defined by metropolitan statistical areas (MSAs). CMS has proposed participation for three California MSAs, including Los Angeles-Long Beach-Anaheim (Orange County and Los Angeles County), Modesto (Stanislaus County), and San Francisco-Oakland-Hayward (Alameda County, Contra Costa County, San Francisco County, San Mateo County and Marin County).

Budget Trailer Bill Recognizes Alternative Quality Control in Clinical Laboratories

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The budget trailer bill adopted as part of the state’s final 2015-16 budget amends Section 1220 of the Business and Professions Code pertaining to clinical laboratories. Specifically, the budget trailer bill allows clinical laboratories to establish an alternative quality control program that meets federal regulations under the Clinical Laboratory Improvement Act and that may include the use of alternative quality control testing procedures already recognized by the Centers for Medicare & Medicaid Services (CMS). Until now, the California Department of Public Health has interpreted regulations in a way that did not recognize federally approved alternative quality control methods, requiring labs to perform frequent quality control tests, which are substantially more expensive than the current federally recognized equivalent quality control (EQC) procedures and the impending individualized quality control plans (IQCPs).

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