Welcome to the National Council’s Health Reform Implementation Tracker. Here, you’ll find all the information you need to know about upcoming changes under the law as well as those that have already gone into effect.
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The following updates are organized by the title and section where they can be found in the Affordable Care Act. Please use the “Ctrl+F” function to find a specific topic.
- PHSA 2711, 2712, 2719A (Section 1001) – No Lifetime or Annual Limits, Rescissions, Patient Protections – On April 4, CMS published a Paperwork Reduction Act Notice (reinstatement with change of a previously approved information collection) relative to the requirement for health plans to provide advance notices of the potential for coverage rescission, as well as patient protection notifications that inform enrollees of their right to select a primary care provider or pediatrician or use OG/GYN services without obtaining prior approval. The Notice also indicates the discontinuation of the requirement for plans and issuers to provide an enrollment opportunity notice to individuals whose coverage ended because they reached a lifetime limit, saying this was a “one-time” requirement.
- PHSA 2711, 2715A (Section 1001); PHSA 2706, 2709 (Section 1201); Section 1311 – No Lifetime or Annual Limits, Provision of Additional Information, Non-Discrimination in Health Care, Coverage for Individuals Participating in Approved Clinical Trials, Affordable Choices of Health Benefit Plans, respectively – On April 29, DOL, Treasury and HHS issued FAQs clarifying that waivers from the annual limit requirements will expire on the approved expiration date, notwithstanding any modifications that plans may make to their plan or policy years. The FAQs also clarify that the ACA’s provider non-discrimination and clinical trial coverage provisions are self-implementing and that no regulations are expected “in the near future.” The Departments note that the Qualified Health Plan transparency reporting requirements under section 1311(e)(3) will take effect “only after QHPs have been certified as QHPs for one benefit year,” adding that outside-the-Exchange reporting requirements under PHSA 2715A will not take effect sooner than this.
- PHSA 2715 (Section 1001) – Summary of Benefits and Coverage (SBC) – On April 23-24, DOL, HHS and Treasury released FAQs on the SBC requirements including links to templates (PDF; Word) authorized for the second year of applicability (i.e., regarding coverage starting on or after January 1, 2014, and before January 1, 2015). Also see sample completed SBCs (PDF; Word). The Departments note that the only changes from the prior year relate to denoting whether the plan provides minimum essential coverage and meets minimum value requirements under the ACA. Additionally, the FAQ provides an extension of enforcement relief through the end of 2014 for certain requirements, delineated in previous FAQs.
- PHSA 2718 (Section 1001) – Medical Loss Ratio (MLR) – On April 5, CCIIO posted technical guidance presenting Q&As on MLR reporting and rebate issues, including ACA fees, aggregation of data and closed blocks of business.
- Section 1101 – Immediate Access to Insurance for Uninsured Individuals with Pre-Existing Condition – On April 4, via a Paperwork Reduction Act Notice, CMS requested clearance from the Office of Management and Budget for an information collection package involving a HIPAA Authorization Form to be utilized by applicants or enrollees of the Pre-Existing Condition Insurance Plan (PCIP); the form would enable a designee to “communicate with PCIP about their protected health information (PHI).” On April 19, CCIIO posted a link to updated state-by-state enrollment data in the PCIP.
- Section 1104 – Administrative Simplification – On April 8, CMS updated FAQs on HIPAA administrative simplification, some of which relate to the ACA (e.g., health plan certification of compliance with HIPAA operating rules and standards).
- Sections 1251,1312; PHSA 2701, 2702 (Section 1201) – Preservation of Right to Maintain Existing Coverage, Consumer Choice, Fair Health Insurance Premiums, Guaranteed Availability – In an April 26 Q&A on health insurance market reforms, CCIIO addresses the withdrawal of non-grandfathered business; States’ maintenance of “alternative mechanisms” for HIPAA eligible individuals in light of 2014 guaranteed availability; geographic rating areas; issues associated with the definition of association coverage; and premium adjustment when coverage becomes secondary to Medicare.
- Section 1251 – Preservation of Right to Maintain Existing Coverage – On April 4, CMS posted a Paperwork Reduction Act Notice regarding grandfathered plans’ recordkeeping and disclosure requirements.
- Section 1253 – Annual Report on Self-Insured Plans – On April 1, DOL released its third annual report (accompanying: Appendix A; Appendix B) on self-insured employee health benefit plans, as required by the ACA. Also see a press release in which DOL notes that this year, it used a revised algorithm to distinguish self-funded plans from those that are fully insured or use mixed-funding arrangements.
- Sections 1311, 1321 – Affordable Choices of Health Benefits Plans, State Flexibility in Operation and Enforcement of Exchanges and Related Requirements – On April 5, CCIIO released a final letter to issuers providing Qualified Health Plans (QHP) in Federally Facilitated Marketplaces and Federally Facilitated SHOPs, including State Partnership Exchanges, with operational and technical guidance in areas such as QHP certification standards and QHP performance and oversight. This followed a draft letter on March 1. Additional developments include:
o On April 12, CCIIO posted the companion guide for the enrollment (834) transaction that Federally Facilitated Marketplaces will use, including detailed technical and operational specifications.
o On April 22, CCIIO released a fact sheet detailing progress toward implementing Federally Facilitated Marketplaces. CCIIO also released a Marketplace timeline charting implementation steps culminating in October 1 open enrollment, as well as a narrative description of the timeline.
o On April 24, CCIIO Director Gary Cohen testified before the House Energy and Commerce Oversight and Investigations Subcommittee, saying the agency is on track with Marketplace implementation and noting milestones including the on-time opening of the submission window for health insurance issuers to submit QHP applications for Federally Facilitated Marketplaces, as well as a successful test for the Federal Data Hub that will facilitate verification of certain eligibility-related data.
- Section 1311 – Affordable Choices of Health Benefits Plans – CCIIO opened the application submission window for Qualified Health Plan certification in Federally Facilitated Marketplaces on April 1, and it was slated to continue through April 30 but was extended until May 3 in an FAQ available on the agency’s Registration for Technical Assistance Portal (registration required), where various other operational guidance also is being posted. Additional developments include:
o On April 4, CCIIO posted a chart indicating the systems (HIOS, SERFF and/or State system) that QHP issuers should use to file QHP applications. CCIIO also posted other QHP application resources on its QHP page.
o Also on April 4, CMS requested clearance for 2 surveys (individual and SHOP) to “aid in understanding levels of consumer awareness and customer service needs” involving the Health Insurance Marketplaces.
o On April 5, CMS published a proposed rule outlining standards for Navigators in Health Insurance Marketplaces. The rule proposes standards for Navigators and Non-Navigator Assistance Personnel, including conflict-of-interest and training and certification standards, among other provisions. Comments are due on May 6. Also see a concurrently published Paperwork Reduction Act statement regarding disclosure-related reporting associated with various Navigator standards.
o On April 8, CCIIO posted an interactive map of Exchange establishment grants.
o On April 9, CMS released a Funding Opportunity Announcement (FOA) under which the agency intends to provide up to $54 million to support the establishment of Navigators in Federally Facilitated and State Partnership Marketplaces. Applications are due by June 7. Also see CCIIO’s FAQs on the Navigator FOA, as well as an overview of the application process and a concurrently released Paperwork Reduction Act Notice regarding reporting requirements under these cooperative agreements.
o On April 11, CMS posted to REGTAP (see above; registration required) a list of insurers that, based on data reported separately for MLR purposes, would be subject to the “tying” provision between participation in the Federally Facilitated individual and SHOP markets for those with small group market share of over 20 percent.
o On April 18, CCIIO posted a fact sheet on Marketplace consumer assistance summarizing the roles of Navigators, in-person assistance personnel, certified application counselors and agents/brokers, as well as their availability by Marketplace type (Federally Facilitated, Partnership or State Based), funding mechanisms and training requirements.
o On April 23, CCIIO released FAQs regarding the use of funds under 1311(a) for marketing activities in a Federally Facilitated or Plan Management State Partnership Marketplace.
- Section 1331 – Basic Health Plan (BHP) Program – On April 18, Sen. Maria Cantwell (D-WA) released a timeline that was provided to her in a letter from HHS on April 12 outlining the agency’s plan for implementing the BHP. HHS’s steps include convening a collaborative of States interested in pursuing the BHP option in May, followed by the issuance of proposed regulations in September and a final rule in March 2014.
- Section 1322 – CO-OPs – On April 4, CCIIO posted a Q&A on the CO-OP Contingency Fund; the American Taxpayer Relief Act (ATRA) of 2012 rescinded 90 percent of unobligated CO-OP funding and transferred 10 percent to this Fund to facilitate assistance and oversight of CO-OPs already funded through ACA loans and grants before the ATRA.
- Section 1102 – Reinsurance for Early Retirees – On April 23, CMS published a Notice in the Federal Register noting the January 1, 2014, sunset of the Early Retiree Reinsurance Program (ERRP) and delineating corresponding terminations of operational processes associated with the ERRP.
- Sections 1401, 1513 – Refundable Tax Credit Providing Premium Assistance for Coverage under a Qualified Health Plan, Shared Responsibility for Employers – On April 30, the IRS released a proposed rule regarding the minimum value (MV) of eligible employer-sponsored plans and other issues related to the health insurance premium tax credit. The rule addresses several considerations relating to calculating MV and assessing affordability of employer-sponsored coverage, as factors related to employees’ eligibility to access subsidies in the Exchange, including such issues as wellness program incentives and HRA contributions.
- Section 1402, 1412 – Reduced Cost-Sharing for Individuals Enrolling in Qualified Health Plans (QHPs), Advance Determination and Payment of Premium Tax Credits and Cost-Sharing Reductions – On April 12, CMS issued an information collection regarding processes whereby QHPs would report to HHS on the reconciliation reporting option – pertaining to advance payments of cost-sharing reductions they have received from the agency – that they have selected for a benefit year.
- Section 1413 – Streamlining of Procedures for Enrollment through an Exchange and State Medicaid, CHIP and Health Subsidy Programs – On April 30, HHS released revised – and shortened – versions of the single, streamlined health insurance application for individuals and families seeking financial assistance via Qualified Health Plans in Health Insurance Marketplaces, including any applicable advance premium tax credits, as well as Medicaid and CHIP. HHS also posted an application form for individuals not seeking financial assistance.
- Sections 2001 and 10201(i) of the Senate Manager’s Amendment – (Broader Provisions Potentially Implicated by Medicaid Premium Assistance for States Contemplating Exchange-Based Medicaid Expansion) – On March 29, CMS issued a FAQ document providing guidance on using Medicaid funding to enable beneficiaries to purchase Qualified Health Plans (QHPs) in the Exchange. In sum, the document suggests that while states likely have flexibility to quantify savings in an array of potential areas – as Arkansas already has taken steps to project – the federal government will not otherwise foot the bill for the delta between Medicaid and private coverage for individuals below 100% of the Federal Poverty Level under these arrangements. At the same time, CMS implies that more federal funding may be available for those above 100% FPL, because they otherwise would qualify for premium tax credits through Exchange coverage. This document also addresses related provisions regarding individual market premium assistance demonstrations per the existing section 1115 waiver authority.
- Section 2101 – Additional Federal Financial Participation – CMS recently issued a FAQ that seeks to provide additional guidance to states regarding CHIP coverage for children who lose Medicaid eligibility due to the elimination of income disregards as a result of states’ transition to Modified Adjusted Gross Income (MAGI) income eligibility guidelines.
- Sections 2201 and 10201(i) of the Senate Manager’s Amendment – Enrollment Simplification and Coordination with State Health Insurance Exchanges; Section 1115 Waiver Amendments – On April 25, CMS issued a subsequent round of FAQs to address ongoing questions regarding ACA implementation, including those pertaining to: (1) the availability of the 75% federal match for maintenance and operations; (2) systems issues regarding communication between the Federally-Facilitated Marketplace (FFEs) and Medicaid/CHIP; and (3) further policy guidance regarding the use of section 1115 demonstrations. Also, with respect to the former provision (section 2201) – see also section 1413 (above) – on April 30, CCIIO released a single, simplified application for use by individuals beginning on October 1, 2013 to apply for health coverage under the Exchange (including premium subsidies), Medicaid, and CHIP. The individual short form is available here; the family form, here; and the individual without financial assistance form, here. A CMS press release on the shortened, streamline forms is available here.
- Section 2502 – Elimination of Exclusion of Coverage of Certain Drugs – Note that the final FY 2014 Medicare Advantage (MA) rate notice, which was released on April 1, addresses this provision. Specifically, the MA notice indicates that, “despite the removal of the restrictions on barbiturates coverage, we do not believe that there are many more barbiturates that currently would meet the definition of a Part D drug. A preliminary review has identified only a few potential additional products likely to qualify as Part D drugs in 2014, the most notable being FDA-approved butalbital-containing products used for the treatment of headaches.”
- Section 2602 – Providing Federal Coverage and Payment Coordination for Dual Eligible Beneficiaries – CMS recently posted a FY 2012 report to Congress detailing recent developments of the Medicare-Medicaid Coordination Office pursuant to the ACA. See also new information during April from the State Data Resource Center to assist state Medicaid agencies obtain and use Medicare data for care coordination of the dual-eligibles. CMS also posted an update on the Financial Alignment initiative last month – see here.
- Section 3002 – Improvements to the Physician Quality Reporting System (PQRS) – On April 8, CMS posted the Qualified Maintenance of Certification (MOC) Program Incentive Entities for 2013 listing qualifying Boards. Also see the agency’s 2013 MOC Qualification Requirements related to eligibility for the PQRS incentive available for MOC.
- Sections 3004, 3005, 3008, 3025, 3106, 3133, 3401, and section 10322 of the Senate Manager’s Amendment – (Provisions Pertaining to IPPS and LTCH Payments, including Hospital Readmissions and Medicare DSH Adjustments) – On April 26, CMS issued a proposed rule updating FY 2014 Medicare payment policies and rates for inpatient stays at general acute care and long-term care hospitals (LTCHs). Both the Medicare Inpatient Prospective Payment System (IPPS) and LTCH proposals, following CMS’ consideration of public comments and upon finalization, take effect October 1, 2013. Under the proposed rules, CMS estimates that gross hospital payments will be $27 million higher in FY14 than they were in FY15 (which reflects the ACA Medicare DSH cuts, which are expected to result in a -0.9% cut to hospital payments). Gross LTCH payments under the proposed rule will increase by 1.1% or $62 million, with the proposed implementation of the 25% Rule costing the sector $190 million. CMS fact sheets on the rule are available here and here. Comments on the proposal are due by June 25, 2013.
- Section 3021 – CMMI – On April 12, CMMI released a document relating to the Comprehensive End-Stage Renal Disease (ESRD) Care Initiative enumerating the total Medicare FFS ESRD beneficiaries not aligned to Medicare ACOs by State.
- Section 3021, 3022 – Establishment of Center for Medicare & Medicaid Innovation (CMMI) within CMS, Medicare Shared Savings Program – On April 5, the Medicare Payment Advisory Commission (MedPAC) received an update on CMS’s current ACO initiatives. Commissioners discussed these models’ designs, as well as ACOs’ strengths, weaknesses and geographic distribution relative to Medicare Advantage plans. A summary of the session is on file with TRP.
- Section 3021 – Establishment of Center for Medicare & Medicaid Innovation within CMS – The date by which eligible states – i.e., those that have already received a design contract and signed a MOU with CMS – must apply under Round 3 of the Demonstration to Integrate Care for Dual Eligible Individuals is 3pm EST on May 29 (per the recent grants.gov modification). Details are available here and here. Also please see here for an article published in the April 2013 edition of Health Affairs by a CMS official that provides insights into the CMMI’s blueprint for rapid-cycle evaluation of new care and payment models.
- Section 3011 – National Strategy – On April 4, CMS published a new information collection delineating the agency’s intend to implement a “Hospice Experience of Care Survey,” consistent with the intent of the National Quality Strategy called for under this section of the ACA. Comments are due by June 3.
- Section 3132 – Hospice Reform – On April 29, CMS issued a proposed rule for FY14 Medicare hospice payments. Under the rule, CMS would increase hospice payments for FY14 by 1.1%, or $180 million. CMS also proposes amendments to hospice reporting requirements and the use of updated data in calculating wage index adjustments. Finally, the agency provides an update regarding its consideration of hospice reforms per the ACA but does not propose implementing any significant reforms this year. Per the requirements at section 3132 of the ACA, the approximate 1.1% increase in total payments includes the ACA mandated cut of -0.7%, among other adjustments. A CMS fact sheet is available here. Comments on the proposed rule are by due June 28.
- Sections 3201, 3202, 3301, 3506 – Medicare Advantage Payment, Application of Coding Intensity Adjustment During MA Payment Transition, Medicare Coverage Gap Discount Program, Program to Facilitate Shared Decision-making – On April 1, CMS released the Announcement of Calendar Year 2014 Medicare Advantage (MA) Capitation Rates and MA and Part D Payment Policies and Final Call Letter reflecting several ACA-driven changes to MA payment, including the application of a 4.91 percent coding intensity adjustment – which also reflects an increase by the ATRA of 2012 – as well as CMS’s use of its authority to deny MA plan bids based on changes in cost-sharing or benefits. Implementation continues of the new ACA blended benchmark and related policies, as well as of the Star rating system and Quality Bonus Demonstration. The agency indicated it may issue future guidance on shared decision-making. CMS also notes that in 2014, “plan liability in the coverage gap for non-applicable (generic) drugs increases by 7 percent.” Please see the CMS press release for more details.
- General Update – In a related event, on April 1, HRSA posted a notice announcing revisions to certain performance measures under the Bureau of Health Professions Performance Data Collection pursuant to the ACA’s workforce provisions. Also, please see the new HRSA webpage dedicated to ACA provisions, which was published earlier this month. Toward that end, HRSA held a webcast on the potential impact of the ACA on safety net providers on April 3. To view an archive of the webcast, see here (slides available here).
- Section 4002 – On April 17, the House Energy and Commerce Committee advanced—by a vote of 27 to 20—H.R. 1549, legislation to transfer approximately $4 billion from the Prevention and Public Health Fund to Pre-Existing Condition Insurance Plan (PCIP) in order to provide insurance coverage for individuals with pre-existing conditions through 2014. This legislation would also eliminate the requirement that individuals go uninsured for six months as a condition of eligibility for PCIP.
- Section 4003 – Clinical and Community Preventive Services – On a related note, on April 17, AHRQ posted a notice in which it solicits nominations of individuals qualified to serve as members of the U.S. Preventive Services Task Force (USPSTF). As the notice points out, all nominations must be received by May 15, 2013 to be considered for appointment to begin January 1, 2014.
- Section 4103 – Medicare Coverage of Annual Wellness Visit Providing a Personalized Prevention Plan – On April 11, CMS issued a transmittal in which it outlined instructions to Medicare contractors regarding recovery of Annual Wellness Visit (AWV) overpayments that have been made.
- Sections 4108 and 4202 – (Provisions Pertaining to Chronic Conditions) – In a related event, on March 29, CMS released a Medicare Chronic Conditions Dashboard – accessible here – that provides researchers, physicians, public health professionals and policymakers with access to current national, state and Hospital Referral Region data on the prevalence of chronic conditions, as well as Medicare costs and utilization measures for beneficiaries with chronic conditions. The dashboard is part of HHS’s Initiative on Multiple Chronic Conditions, launched in 2009, and is intended to facilitate finding, analyzing and applying de-identified summary data from CMS’s Chronic Conditions Data Warehouse.
- Section 4203 – Removing Barriers and Improving Access to Wellness for Individuals with Disabilities – On April 23, the Architectural and Transportation Barriers Compliance Board announced a meeting of its Medical Diagnostic Equipment Accessibility Standards Advisory Committee to be convened on May 7-8. A preliminary agenda and further details are available here.
- Section 4302 – Understanding Health Disparities; Data Collection and Analysis – In a related note, on April 24, HHS released new standards intended to help reduce health disparities via the publication of the National Standards for Culturally and Linguistically Appropriate Services (CLAS) in Health and Health Care, a blueprint intended to assist organizations in implementing culturally and linguistically appropriate services. Additional details are available here.
- Section 5207 and sections 10501(a) and 10503 of the Senate Manager’s Amendment – (Provisions Pertaining to the National Health Service Corps (NHSC)) – In a related event, on April 23, HHS posted a notice titled, “Notice of Interest Rate on Overdue Debts,” in which HHS indicates that the current rate of 10 1/8% is certified for the quarter ended March 31, 2013. According to HHS, “This rate is based on the Interest Rates for Specific Legislation, “National Health Services Corps Scholarship Program,” among other programs, and is the interest rate that will be applied to overdue debt until further notice/revision. Also, as previously noted, the deadline by which to submit applications under the 2013 NHSC Loan Repayment Program was April 16 (see here).
- Section 5309 – Nurse Education, Practice, and Retention Grants – On April 29, HRSA announced a new grant opportunity, supported in part by ACA section 5309 funding, to help veterans translate their military health skills into nursing careers. The details of the Nurse Education, Practice, Quality and Retention Veteran’s Bachelor of Science Degree in Nursing Program (VBSN) are also available here. A HHS press release is available here. Applications are due June 7.
- Section 5509 – Graduate Nurse Education Demonstration – On April 4, CMS issued an information collection in which it sought comment on an upcoming evaluation of the Graduate Nurse Education Demonstration Program. Comments are due June 3.
- Section 6002 – Transparency Reports and Reporting of Physician Ownership or Investment Interests – As a follow-up to CMS’ final rule on the National Physician Payment Transparency Program, or the “Physician Payment Sunshine Rule,” which the agency released on February 1, CMS on April 11 released a variety of fact sheets clarifying aspects of this policy. The Physician Sunshine Act was enacted under section 6002 of the Affordable Care Act. To view these fact sheets, click here under the “Downloads” section of CMS’ Open Payments (Sunshine) Website.
- Section 6301 – Patient-Centered Outcomes Research – On April 2, PCORI announced the appointment of individuals to serve on PCORI’s first four advisory panels (the details of which are available here). Also, on April 23, PCORI announced two new funding opportunities totaling $68 million to conduct patient-centered comparative clinical effectiveness research (CER) via the development of a National Patient-Centered Clinical Research Network (NPCCRN). A major component of this network are Clinical Data Research Networks (CDRNs), or system based networks (such as hospital systems) that have the potential to become an ideal electronic network, without structural impediments, and Patient Powered Research Networks (PPRNs), which are groups of patients interested in forming a research network and in participating in research. The funding opportunity pertaining to support CDRN development is available here. With respect to the latter opportunity (available here), PCORI aims to support the initiation and development of up to 18 new or existing PPRNs. Required letters of intent (LOI) from applicants are due June 19 and complete applications are due September 27. Also, on April 24, PCORI announced the appointment of Bryan Luce, PhD, MBA, as PCORI’s first Chief Science Officer, overseeing the development and implementation of PCORI’s patient-centered comparative clinical effectiveness research (CER) agenda. Details here. To view AHRQ-originating PCORI opportunities, see here.
- Section 6401 – Provider Screening and Other Enrollment Requirements under Medicare, Medicaid and CHIP – On April 24, CMS issued a proposed rule increasing rewards for whistle blowers to report instances of fraud and abuse in the Medicare program. The rule would also tighten provider enrollment standards by, for example, allowing CMS to reject enrollment of providers affiliated with an entity that has unpaid Medicare debts. CMS could also deny billings from individuals with felony convictions and ban providers who have demonstrated a pattern of abusive billing practices. A sheet regarding the rule is available here. Comments are due by 5pm ET on June 28.
- Section 6403 – Elimination of Duplication between the Healthcare Integrity and Protection Data Bank and the National Practitioner Data Bank – On April 5, CMS issued a final rule which, among other things, implements this provision of the ACA that calls for the elimination of duplicative data reporting and access requirements between the Healthcare Integrity and Protection Data Bank (HIPDB) and the National Practitioner Data Bank (NPDB). The regulation also addresses the mandated transition and transfer of all data in the HIPDB to the NPDB.
- Section 6410 – Adjustments to the Medicare Durable Medical Equipment, Prosthetics, Orthotics and Supplies Competitive Acquisition Program – On April 9, CMS announced that 799 suppliers were awarded contracts as part of Round 2 of the Medicare Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding (CB) Program, which takes effect in 91 MSAs on July 1, 2013. In conjunction with the announcement, CMS indicated that 18 suppliers accepted contracts under Round 2 of the program to provide mail-order diabetic testing supplies. A CMS fact sheet is available here. A list of contract suppliers is available here.
- Section 7101, 7102 – Expanded Participation in the 340B Program, Improvements to 340B program integrity – On April 3, Sen. Charles Grassley (R-IA) issued a press release regarding his investigation of North Carolina hospitals’ participation in the 340B Drug Discount Program, the results of which were detailed in a March 27 letter to HRSA. In the letter, Sen. Grassley also poses questions to the agency relative to 340B program integrity. On April 5, HRSA updated an FAQ extending the deadline to August 7 for covered entities’ compliance with the stipulations of February 7 guidance regarding the GPO prohibition. The agency notes that participating facilities must attest that they are in compliance with all requirements, including the GPO prohibition, at the time of annual re-certification, which it says it will conduct after the August 7 deadline. On April 18, Sen. Grassley and Rep. Bill Cassidy (R-LA) wrote a letter to a Georgia hospital regarding its participation in the 340B Program. Also see a related press release.
- Section 9007 – Additional Requirements for Charitable Hospitals – On April 5, the IRS issued a proposed rule that expounds upon previous guidance pertaining to charitable 501(c)(3) hospitals on the community health needs assessment (CHNA) requirements, and related excise tax and reporting obligations pursuant to new provisions under the ACA. The proposed rule also clarifies the consequences for failing to meet these and other requirements. Comments and requests for a public hearing are due by July 5.
- Section 9014 – Limitation on Excessive Remuneration Paid by Certain Health Insurance Providers – On April 2, the IRS published a proposed rule regarding the $500,000 deduction limitation under this section. Comments are due on July 1.