To become an fqhc lookalike, your organization has to comply with all 19 hrsa health center program requirements see hrsa s fqhc compliance manual html or pdf. Health center program compliance manual august 2017 hrsa. These tools can be used to help organizations prepare for site visits. The health center must request prior approval from hrsa for a change in the key. The svp is designed to provide hrsa the information necessary to perform its oversight responsibilities using a standard and transparent methodology that aligns with the health center program compliance manual compliance manual. Health center program compliance manual from hrsa updated august 2017. The health center must request and receive approval from hrsa to contract for substantive programmatic. Telehealth pal now available 12720 pdf 223 kb health center program compliance manual. Site visit guide may soon be replaced by the program requirements. Part b of the ryan white hivaids treatment extension act of 2009 public law 11187 provides grants to u. Hrsas most recent protocol clarifies the documentation requirements and assessment methodologies used by hrsa to verify compliance during both onsite. This manual was created to provide fqhcs a central resource for all of the relevant information and policies to assist them with managing their 340b program to ensure compliance with the federal requirements.
Compliance manual, hrsa will withdraw support through termination of the award. Health center program compliance manual introduction. The compliance manual also addresses hrsa s approach to determining eligibility for and exercising oversight over the. The nhsc site reference guide supplements the information contained in the online. Applications created in the hrsa electronic handbook ehb after the release of the revised instructions must follow the revised instructions, however, the compliance manual is effective immediately.
See hrsa s library of standard awardlookalike designation conditions. Department of health and human services health resources and. Health center program requirements bureau of primary. See the site visit protocol and other tools hrsa uses for conducting site visits of health centers, primary care associations pcas, and health center controlled networks hccns. The substance of the relationship is more important than the form of the agreement. The aids drug assistance program adap is a state and territoryadministered program authorized under part b that provides fdaapproved medications to lowincome people living with hiv who have limited or no health coverage from private. Overview the health resources and services administrations hrsa bureau of primary health care bphc is responsible for effective and efficient oversight of the health center program. Correspondence request health center ehbs instructions. Staytuned to reglanterns blog for the most uptodate guidance. Also in august 2018, hrsa released the newly revised operational site visit protocol, which aligns with the compliance manual. Federal register request for public comment on draft. The compliance manual is the principal resource to assist health centers in understanding and demonstrating compliance with health center program requirements. Conditions are applied when a health center does not demonstrate compliance with health center program requirements and include clear descriptions of the specific actions needed to remove the conditions.
The compliance manual does not provide guidance on requirements in areas beyond health center program requirements or outside hrsa s oversight authority. Opas website provides information on all areas of the 340b program. Summary of comments and hrsa responses on the draft health center program compliance manual. Preparation for your hrsa operational site visit bkd. The health resources and services administrations hrsa health center program has continued to thrive. Getting started with 340b compliance an information guide for.
Health center boards and leaders are responsible for ensuring they comply with all the. It is a compliance application whereby you are demonstrating compliance with all 19 requirements which must be in place at the time of application. Health center program requirements bureau of primary health. In august 2018 hrsa released the newly revised health center program compliance manual, which aligns with the federal tort claims ftca deeming application and process. Covered entities which carve in must have their npi number listed on the hrsa medicaid. Quick maps interact with a variety of predefined maps. The materials do not constitute, and should not be treated as, professional ad. Resources cover registration and implementation, requirements compliance, program integrity, and more. The hrsa program guidelines within the w compliance manual and how they apply to dental the rationale and format of an operational site visit a deeper dive into the sliding fee schedule discount the winwin of preparing dental for an osv. Compliance resolution opportunity cro for osv structured. Health center program site visit protocol bureau of. Getting started with 340b compliance an information guide.
The information presented in this manual is intended to provide the reader with guidance on compliance issues related to the 340b program. Written comments were accepted through november 22, 2016. Notice of availability of final policy document federal register. Evaluation of a comprehensive oral health services program in schoolbased health centers. The compliance manual is the principal resource to assist health centers in. The health center program compliance manual compliance. Subrecipient monitoring manual for maternal, infant, and early childhood home visiting miechv award recipients august 2018. Covered entities are required to ensure program integrity and maintain accurate records documenting compliance. Hrsa intends for the manual to provide a 22 aug 2018 hrsa recently released its revised health center program compliance manual compliance manual and site. Health center program compliance manual bureau of primary. The hrsa site visit protocol states clinical staffing, element c. Read pdf hrsa 340b user guide hrsa 340b user guide when somebody should go to the books stores, search introduction by shop, shelf by shelf, it is really problematic. If you do not submit the required compliance achievement plan within 120 days of receipt of the sac noa, hrsa will withdraw support through termination of the award unless the recipient has made a demonstration of good cause as to why it has not submitted its compliance achievement plan. The compliance manual outlines the health center program requirements which form.
Process to monitor ongoing compliance with this program requirement. Application resources, as well as forms instructions and samples, and a frequently. Federally qualified health centers 101 indiana council of. This compliance manual is intended to apply, where applicable, toall relationships between sprenger and other health care providers and. Manual provides additional details regarding laboratories and laboratory tests not subject to clia requirements. However, the compliance manual also allows health centers to. Approximately 619,400 americans with an aids diagnosis have died, and many others are living with hivrelated illness and.
Map tool build your own maps featuring a variety of hrsa data layers. In august 2017, hrsa issued the final health center program compliance manual, providing a streamlined and consolidated resource to assist health centers in understanding and demonstrating compliance with the program requirements. National health service corps site reference guide u. Maternalwomens health maternal and child health bureau. Association of community health centers nachc regarding hrsa s implementation of the 340b program. The uds modernization initiative aims to reduce uds reporting burden, improve data quality, and more fully measure the impact of the health center program. Correspondence request for bphc sac and rd applicants. Hrsa is inviting public comment on the draft health center program compliance manual, hereafter referred to as the compliance manual. Check out these uds resources to learn more health center program compliance manual updated august 2018 pdf and website compliance manual faqs. The compliance manual also addresses hrsas approach to determining. Mastering the compliance manual ftlf learning center. Hrsa s office of pharmacy affairs opa is committed to educating and informing 340b drug pricing program stakeholders about the program.
Hrsa will update or amend the compliance manual as needed to provide further policy clarification with. Policies calendar year 2021 requirements for federal tort claims act ftca coverage for health centers program assistance letter 202002 pdf 514 kb this program assistance letter pal addresses the process that health centers must take in order to submit their ftca deeming and redeeming applications for calendar year 2021. This manual covers a myriad of topics related to the medicaid fqhc prospective payment system pps, which is the payment methodology that federal law requires states to use in reimbursing federally qualified health centers. Links to the hrsa bphc website including the health center program compliance manual, site visit protocol, and other resources to assist health centers in understanding and demonstrating compliance with program requirements. Hrsa site visit protocol for hrsa health center program grantees and look. Administration hrsabureau of primary health care bphc has revised the. Is not subject to federal program compliance requirements source. Requirements the health center must operate in a manner that no. Hrsa programs provide health care to people who are geographically isolated, economically or medically vulnerable. Individuals and groups submitted more than 700 comments. The purpose of the compliance manual is to provide a consolidated webbased resource to assist current and prospective health centers in understanding and. Demystifying the compliance manual ftlf learning center.
The content of this compliance improvement guide was developed by faculty and experts drawn from actual highperforming 340b covered entities that form the health resources and services administration hrsa 340b peertopeer program. Consultant enews management solutions consulting group. View timelimited monitoring changes resulting from the 2020 covid19 emergency pdf 373 k updated 462020. In addition, the compliance manual is not intended to address best or promising practices or performance improvement strategies that may support effective operations or organizational. This manual was created to provide fqhcs a central resource for all of the relevant information and policies to assist them with managing their 340b program to ensure compliance with the. Structure of the health center program compliance manual. This compliance manual formalizes sprengers commitment to compliance by establishing sprengers standards of conduct for its nursing facilities, sprenger hospice, inc. In order to obtain deemed public health service employment status under sections 224gn of the phs act 1 for themselves and for their covered individuals, 2 health center program awardees and subrecipients including those defined as subrecipients under the health.
View the complete evaluation plan pdf 598 k updated 462020. The health center program compliance manual is the principal resource to assist health centers in understanding and demonstrating compliance with health center program requirements. The manual replaces several policy information notices pins and program assistance letters pals, consolidating. Email address for comments, questions, or suggestions about the content of this guide. Nachc 340b manual for health centers, second edition 43 the recertification process requires that the a. Bureau of primary health care health center program. Ryan white hivaids program part a manualrevised 20. Pdf 791 mb of the comments for each section and chapter and hrsas. Download the health center compliance manual pdf 1.
The compliance manual also addresses hrsas approach to determining eligibility for and. Hrsa updated the compliance manual in 2018 to reflect amendments section 330 that resulted from the bipartisan budget act of 2018. Access the latest funded projects, news and information from the maternal and child health research program american board of pediatrics annual report 2017 pdf 6. The hiv epidemic has taken an enormous toll since its onset in the early 1980s. Form 5b instructions pdf 432 kb hrsa grants policies, regulations, and guidance.
In particular, the governance guide includes hyperlinks to the compliance manual, which are best utilized when reading an electronic version of this. Below are the revisions and the relevant compliance manual chapter and sections impacted. Hrsa announced the availability of the draft health center program compliance manual for public comment in august 2016. It is critical to understand that a robust internal auditing program is the foundation to a successful, compliant program. Program assistance letter 201409 pdf 103 kb this pal is intended to announce, and disseminate the clarifications and updates that will be published in the federal tort claims act ftca health center policy manual which will supersede policy information notice pin 201101. Ftca policies for health centers bureau of primary. Medicaid patients comprise about 40% of health center patients and medicaid payments comprise about 38% of all health center revenues. Quality assurance, bhpr, hrsa, was responsible for overseeing the research project. Board size governance board has at least 9 but no more than 25 members, as. This report describes a comprehensive national study of the.
Federal tort claims act health center policy manual pdf 369 kb. Fact sheet maps map hrsa grant totals at national, regional, state, county, and congressional district level. The fqhc attests to its eligibility to participate in medicare and agrees to remain in compliance with all of the fqhc requirements specified in medicare regulations at 42 cfr part 405 subpart x, and at 42 cfr part 491, with the exception of 491. Hrsa will update or amend the compliance manual as needed to provide further clarification of program policies. Health center program compliance manual revisions bureau of. This includes people living with hivaids, pregnant women, mothers and their families, and those otherwise unable to access high quality health care. Health center program compliance manual introduction bureau of. The compliance manual restates the health center programs statutory and regulatory requirements and provides guidance on how health centers would demonstrate compliance with such requirements to hrsa. Looking for information on health center program conditions. Health center program compliance manual updated august 2018 pdf and website. Health center program compliance manual updated august 2018 pdf and. Department of health and human services health resources and services administration sites must meet eligibility requirements, submit any required documentation and an application, and be approved by hrsa, before nhsc participants can earn service credit for clinical care at the site.
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