Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and analyses; and other health policy news.
Week in Review Highlight of the Week:
This week, CMS finalized its fiscal year (FY) 2025 payment rules for inpatient hospitals, inpatient psychiatric facilities, inpatient rehabilitation facilities, skilled nursing facilities, and hospice providers.
I. Regulations, Notices & Guidance
- On July 29, 2024, the Food and Drug Administration (FDA) released a notice entitled, Advisory Committee; Pharmacy Compounding Advisory Committee; Renewal. FDA is announcing the renewal of the Pharmacy Compounding Advisory Committee by the Commissioner of Food and Drugs. The Commissioner has determined that it is in the public interest to renew the Pharmacy Compounding Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until April 25, 2026.
- On July 30, 2024, FDA released a notice entitled, Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2025. FDA is announcing the fee rates and payment procedures for fiscal year (FY) 2025 animal drug user fees. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Animal Drug User Fee Amendments of 2023 (ADUFA V), authorizes FDA to collect user fees for certain animal drug applications and supplemental animal drug applications, for certain animal drug products, for certain establishments where such products are made, and for certain sponsors of such animal drug applications and/or investigational animal drug submissions. This notice establishes the fee rates for FY 2025.
- On July 30, 2024, FDA released a notice entitled, Animal Generic Drug User Fee Program Rates and Payment Procedures for Fiscal Year 2025. FDA is announcing the fee rates and payment procedures for FY 2025 generic new animal drug program user fees. The FD&C Act, as amended by the Animal Generic Drug User Fee Amendments of 2023 (AGDUFA IV), authorizes FDA to collect user fees for certain abbreviated applications for generic new animal drugs, for certain generic new animal drug products, for certain sponsors of such abbreviated applications for generic new animal drugs and/or investigational submissions for generic new animal drugs (JINAD’s), and for certain submissions related to JINAD files. This notice establishes the fee rates for FY 2025.
- On July 30, 2024, FDA released a notice entitled, Biosimilar User Fee Rates for Fiscal Year 2025. FDA is announcing the rates for biosimilar user fees for FY 2025. The FD&C Act, as amended by the Biosimilar User Fee Amendments of 2022 (BsUFA III), authorizes FDA to assess and collect user fees for certain activities in connection with biosimilar biological product development; review of certain applications for approval of biosimilar biological products; and each biosimilar biological product approved in a biosimilar biological product application. BsUFA III directs FDA to establish, before the beginning of each fiscal year, the amount of initial and annual biosimilar biological product development (BPD) fees, the reactivation fee, and the biosimilar biological product application and program fees for such year. These fees apply to the period from October 1, 2024, through September 30, 2025.
- On July 30, 2024, FDA released a notice entitled, Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2025. FDA is announcing the FY 2025 fee rates for certain domestic and foreign facility reinspections, failures to comply with a recall order, and importer reinspections that are authorized by the FD&C Act, as amended by the FDA Food Safety Modernization Act (FSMA).
- On July 30, 2024, FDA released a notice entitled, Food Safety Modernization Act Third-Party Certification Program User Fee Rate for Fiscal Year 2025. FDA is announcing the FY 2025 annual fee rate for recognized accreditation bodies and accredited certification bodies, and the initial and renewal fee rate for accreditation bodies applying to be recognized in the third-party certification program that is authorized by the FD&C Act, as amended by the FSMA. FDA is also announcing the fee rate for certification bodies that are applying to be directly accredited by FDA.
- On July 30, 2024, FDA released a notice entitled, Food Safety Modernization Act Voluntary Qualified Importer Program User Fee Rate for Fiscal Year 2025. FDA is announcing the FY 2025 annual fee rate for importers approved to participate in the Voluntary Qualified Importer Program (VQIP) that is authorized by the FD&C Act, as amended by the FSMA. This fee is effective from August 1, 2024, through September 30, 2025.
- On July 30, 2024, FDA released a notice entitled, Generic Drug User Fee Rates for Fiscal Year 2025. The FD&C Act, as amended by the Generic Drug User Fee Amendments of 2022 (GDUFA III), authorizes FDA to assess and collect fees for abbreviated new drug applications (ANDAs); drug master files (DMFs); generic drug active pharmaceutical ingredient (API) facilities, finished dosage form (FDF) facilities, and contract manufacturing organization (CMO) facilities; and generic drug applicant program user fees. In this document, FDA is announcing FY 2025 rates for GDUFA III fees. These fees are effective from October 1, 2024, through September 30, 2025.
- On July 30, 2024, FDA released a notice entitled, Medical Device User Fee Rates for Fiscal Year 2025. FDA is announcing the fee rates and payment procedures for medical device user fees for FY 2025. The FD&C Act, as amended by the Medical Device User Fee Amendments of 2022 (MDUFA V), authorizes FDA to collect user fees for certain medical device submissions and annual fees both for certain periodic reports and for establishments subject to registration. This notice establishes the fee rates for FY 2025, which apply from October 1, 2024, through September 30, 2025, and provides information on how the fees for FY 2025 were determined, the payment procedures to follow, and how to qualify for reduced small business fees.
- On July 30, 2024, FDA released a notice entitled, Outsourcing Facility Fee Rates for Fiscal Year 2025. FDA is announcing the FY 2025 rates for the establishment and reinspection fees related to entities that compound human drugs and elect to register as outsourcing facilities under the FD&C Act. The FD&C Act authorizes FDA to assess and collect an annual establishment fee from outsourcing facilities, as well as a reinspection fee for each reinspection of an outsourcing facility. This document establishes the FY 2025 rates for the small business establishment fee ($6,488), the non-small business establishment fee ($21,534), and the reinspection fee ($19,465) for outsourcing facilities; provides information on how the fees for FY 2025 were determined; and describes the payment procedures outsourcing facilities should follow.
- On July 30, 2024, FDA released a notice entitled, Over-the-Counter Monograph Drug User Fee Program--OTC Monograph Order Request Fee Rates for Fiscal Year 2025. FDA is announcing the over-the-counter (OTC) monograph order request (OMOR) fee rates under the OTC monograph drug user fee program (OMUFA) for FY 2025. The FD&C Act authorizes FDA to assess and collect user fees from qualifying manufacturers of OTC monograph drugs and submitters of OMORs. This notice publishes the OMOR fee rates under OMUFA for FY 2025. FDA plans to publish the FY 2025 OMUFA facility fee rates, i.e., monograph drug facility (MDF) and CMO facility fee rates, in a subsequent Federal Register notice (and anticipates its issuance will generally align with the timing of OMUFA facility fee rate publication for prior fiscal years).
- On July 30, 2024, FDA released a notice entitled, Prescription Drug User Fee Rates for Fiscal Year 2025. FDA is announcing the rates for prescription drug user fees for FY 2025. The FD&C Act, as amended by the Prescription Drug User Fee Amendments of 2022 (PDUFA VII), authorizes FDA to collect application fees for certain applications for the review of human drug and biological products and prescription drug program fees for certain approved products. This notice establishes the fee rates for FY 2025.
- On July 31, 2024, the Agency for Healthcare Research and Quality (AHRQ) released a notice entitled, Supplemental Evidence and Data Request on Blood-based Tests for Multiple Cancer Screening: A Systematic Review. AHRQ is seeking scientific information submissions from the public. Scientific information is being solicited to inform AHRQ review on Blood-based Tests for Multiple Cancer Screening: A Systematic Review, which is currently being conducted by the AHRQ’s Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.
- On July 31, 2024, the Substance Abuse and Mental Health Services Administration (SAMHSA) released a notice entitled, Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards to Engage in Urine and Oral Fluid Drug Testing for Federal Agencies. The Department of Health and Human Services (HHS) notified federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITFs) that are currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine and the laboratories currently certified to meet the standards of the Mandatory Guidelines using Oral Fluid.
- On July 31, 2024, the Centers for Medicare & Medicaid Services (CMS) issued a rule entitled, Medicare Program; FY 2025 Hospice Wage Index and Payment Rate Update, Hospice Conditions of Participation Updates, and Hospice Quality Reporting Program Requirements. This final rule updates the hospice wage index, payment rates, and aggregate cap amount for FY 2025. This rule also adopts the most recent Office of Management and Budget (OMB) statistical area delineations, which will impact the hospice wage index. This rule clarifies current policy related to the “election statement” and the “notice of election”, as well as adds clarifying language regarding hospice certification and includes a technical regulation text change to the Conditions of Participation (CoPs). This rule finalizes changes to the Hospice Quality Reporting Program. Finally, this rule summarizes comments received regarding potential implementation of a separate payment mechanism to account for high intensity palliative care services.
- On July 31, 2024, CMS issued a final rule entitled, Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Updates to the Quality Reporting Program and Value-Based Purchasing Program for Federal Fiscal Year 2025. This final rule finalizes changes and updates to the policies and payment rates used under the Skilled Nursing Facility (SNF) Prospective Payment System (PPS) for FY 2025. First, CMS is rebasing and revising the SNF market basket to reflect a 2022 base year. Next, CMS is updating the wage index used under the SNF PPS to reflect data collected during the most recent decennial census. Additionally, CMS is finalizing several technical revisions to the code mappings used to classify patients under the Patient Driven Payment Model (PDPM) to improve payment and coding accuracy. This final rule also updates the requirements for the SNF Quality Reporting Program and the SNF Value-Based Purchasing Program. Finally, CMS is also revising its enforcement authority for imposing civil money penalties (CMPs) and including revisions to strengthen nursing home enforcement regulations.
- On July 31, 2024, CMS issued a final action entitled, Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2025 and Updates to the IRF Quality Reporting Program. This final action updates the prospective payment rates for inpatient rehabilitation facilities (IRFs) for FY 2025. As required by statute, this final action includes the classification and weighting factors for the IRF prospective payment system’s casemix groups and a description of the methodologies and data used in computing the prospective payment rates for FY 2025. CMS is updating the OMB market area delineations for the IRF PPS wage index and applying a 3-year phase-out of the rural adjustment. This rule also includes updates for the IRF Quality Reporting Program (QRP).
- On July 31, 2024, CMS issued a final action entitled, Medicare Program; FY 2025 Inpatient Psychiatric Facilities Prospective Payment System – Rate Update. This final action updates the prospective payment rates, the outlier threshold, and the wage index for Medicare inpatient hospital services provided by Inpatient Psychiatric Facilities (IPF), which include psychiatric hospitals and excluded psychiatric units of an acute care hospital or critical access hospital. This final action also revises the patient-level adjustment factors, the Emergency Department adjustment, and the payment amount for electroconvulsive therapy. These changes will be effective for IPF discharges occurring during the FY beginning October 1, 2024, through FY 2025. In addition, this final action finalizes the adoption of a new quality measure. It does not finalize modifications to the reporting requirements under the IPF Quality Reporting Program beginning with the FY 2027 payment determination. Furthermore, this final action summarizes comments received through a Requests for Information (RFI) regarding potential future revisions to the IPF PPS facility-level adjustments and regarding the development of a standardized IPF Patient Assessment Instrument.
- On August 1, 2024, the National Institutes of Health (NIH) released a notice entitled, Collaboration Opportunity for Combination of Vaccine with Adoptive Cell Therapies made at NCI for the Treatment of Solid Cancers. The Surgery Branch (SB) at the National Cancer Institute (NCI), is seeking a partner in the private sector to provide Good Manufacturing Practice-grade vaccine directed against cancer neo-antigens with the goal of conducting a Phase-I human clinical trial for solid cancers.
- On August 1, 2024, FDA issued guidance entitled, M12 Drug Interaction Studies; M12 Drug Interaction Studies: Questions and Answers; International Council for Harmonisation; Guidances for Industry; Availability. FDA is announcing the availability of the final guidance for industry entitled “M12 Drug Interaction Studies” and the supplemental document entitled “M12 Drug Interaction Studies: Questions and Answers.” The guidance and supplemental questions and answers document were prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The guidance provides general recommendations on evaluating the enzyme and transporter-mediated pharmacokinetic drug-drug interaction potential for investigational drugs. The supplemental questions and answers document provides clarity to some concepts related to evaluation of drug interactions covered in the guidance. The guidance is intended to harmonize the regional recommendations for designing, conducting, and interpreting in vitro and clinical evaluations of drug-drug interactions while developing investigational drugs. The guidance replaces the draft guidance “M12 Drug Interaction Studies” issued on August 29, 2022.
- On August 1, 2024, FDA released a notice entitled, Advisory Committee; Psychopharmacologic Drugs Advisory Committee; Renewal. FDA is announcing the renewal of the Psychopharmacologic Drugs Advisory Committee by the Commissioner of Food and Drugs. The Commissioner has determined that it is in the public interest to renew the Psychopharmacologic Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until June 4, 2026.
- On August 1, 2024, CMS released a final rule entitled, Medicare and Medicaid Programs and the Children’s Health Insurance Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2025 Rates; Quality Programs Requirements; and Other Policy Changes. This final rule revises the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals; makes changes relating to Medicare graduate medical education (GME) for teaching hospitals; updates the payment policies and the annual payment rates for the Medicare PPS for inpatient hospital services provided by long-term care hospitals (LTCHs); and makes other policy-related changes.
- On August 2, 2024, FDA released a notice entitled, Advisory Committee; Anesthetic and Analgesic Drug Products Advisory Committee; Renewal. FDA is announcing the renewal of the Anesthetic and Analgesic Drug Products Advisory Committee by the Commissioner of Food and Drugs. The Commissioner has determined that it is in the public interest to renew the Anesthetic and Analgesic Drug Products Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until May 1, 2026.
- On August 2, 2024, FDA released a notice entitled, Advisory Committee; Drug Safety and Risk Management Advisory Committee; Renewal. FDA is announcing the renewal of the Drug Safety and Risk Management Advisory Committee by the Commissioner of Food and Drugs. The Commissioner has determined that it is in the public interest to renew the Drug Safety and Risk Management Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until May 31, 2026.
Event Notices
August 5, 2024: HHS announced a meeting of the Advisory Council on Alzheimer’s Research, Care, and Services. This is a hybrid meeting open to the public.
August 6, 2024: FDA announced a workshop entitled, Artificial Intelligence (AI) in Drug & Biological Product Development. This is a hybrid workshop open to the public.
August 7-8, 2024: CDC announced a meeting of the Advisory Board on Radiation and Worker Health. This is a virtual meeting open to the public.
August 22, 2024: The Health Resources and Services Administration (HRSA) announced a meeting of the Advisory Council on Blood Stem Cell Transplantation. This is a virtual meeting open to the public.
August 22, 2024: CDC announced a meeting of the Board of Scientific Counselors, National Institute for Occupational Safety and Health. This is a hybrid meeting open to the public.
August 22, 2024: CDC announced a meeting of the Healthcare Infection Control Practices Advisory Committee. This is a virtual meeting open to the public.
August 26-27, 2024: CMS announced a meeting of the Advisory Panel on Hospital Outpatient Payment. This is a virtual meeting open to the public.
August 27, 2024: SAMHSA announced a meeting of the Center for Substance Abuse Prevention National Advisory Council. This is a hybrid meeting open to the public.
August 28, 2024: SAMHSA announced a joint meeting of the SAMHSA National Advisory Council (NAC), the Center for Mental Health Services NAC, the Center for Substance Abuse Prevention NAC, the Center for Substance Abuse Treatment NAC; and the two SAMHSA advisory committees: Advisory Committee for Women’s Services (ACWS) and the Tribal Technical Advisory Committee (TTAC). This is a virtual meeting open to the public.
August 28-29, 2024: HHS announced a meeting of the Presidential Advisory Council on HIV/AIDS. This is a virtual meeting open to the public.
September 10-11, 2024: CDC announced a meeting of the ICD-10 Coordination and Maintenance Committee. This is a virtual meeting open to the public.
September 11, 2024: NIH announced a meeting of the National Institute on Drug Abuse. This is a hybrid meeting open to the public.
September 13, 2024: CDC announced a meeting of the Advisory Committee on Breast Cancer in Young Women. This is a hybrid meeting open to the public. Registration is required.
September 17, 2024: NIH announced a meeting of the Scientific Advisory Committee on Alternative Toxicological Methods. This is a hybrid meeting open to the public.
September 18, 2024: FDA announced a meeting of the Pediatric Advisory Committee (PAC). This is a virtual meeting open to the public.
October 21-22, 2024: HHS announced a meeting of the CDC/HRSA Advisory Committee on HIV, Viral Hepatitis, and STD Prevention and Treatment. This is a hybrid meeting open to the public.
October 22-23, 2024: HRSA announced a meeting of the National Advisory Council on Migrant Health. This is a hybrid meeting open to the public.
II. Hearings & Markups
- On July 31, 2024, the Senate Committee on Health, Education, Labor and Pensions (HELP) held a markup entitled, S. 4776, Older Americans Act Reauthorization Act, S. 4762, Autism CARES Act, and S. 4755, Traumatic Brain Injury Program Reauthorization Act. All bills were reportedly favorably to the full Senate.
- On August 1, 2024 the Senate Committee on Appropriations held a markup entitled, Full Committee Markup of Energy and Water Development; Defense; Labor, Health, and Human Services; and Financial Services and General Government Appropriations Acts. All bills were reportedly favorably to the full Senate.
III. Reports, Studies, & Analyses
- On July 30, 2024, the Kaiser Family Foundation (KFF) released an issue brief entitled, The Landscape of Medicare and Medicaid Coverage Arrangements for Dual-Eligible Individuals Across States. Some policymakers and other stakeholders worry that coverage for dually eligible beneficiaries is fragment and advocate for a more coordinated and streamlined model of coverage. The report merged Medicaid and Medicare data from 2021 to assess how duals receive their coverage. KFF found that 94 percent of duals received their coverage through traditional, separate Medicare and Medicaid benefits. Of that, roughly 28 percent of beneficiaries were enrolled in traditional Medicare (TM) and fee-for-service (FFS) Medicaid; 24 percent were enrolled in Medicare Advantage (MA) and Medicaid managed care; 24 percent were enrolled in TM and Medicaid managed care and 19 percent were enrolled in MA and FFS Medicaid. However, these coverage combinations varied widely across states. Conversely, the report finds that only six percent of duals received their care through a single coverage arrangement, namely the Program of All-Inclusive Care for the Elderly (PACE) or a Medicare-Medicaid Plan (MMP). Utilization of single coverage arrangements also varied widely across states, with Rhode Island and Ohio having over 25 percent of their duals in PACE or a MPP, while less than 5 percent of duals were enrolled in these programs in 38 states.
- On July 31, 2024, the Bipartisan Policy Center (BPC) released a report entitled, The Future of Acute Hospital Care at Home. The Acute Hospital Care at Home (AHCAH) program, which allows hospitals to deliver inpatient-level care for Medicare and Medicaid FFS beneficiaries at their homes, is currently set to expire on December 31, 2024. BPC outlines federal policy recommendations for Congress to consider when potentially reauthorizing the AHCAH program. The report recommends that, in the short term, Congress should reauthorize the program for five years, direct CMS to provide hospitals technical support, and require the development of quality measures. BPC also outlines future policy considerations regarding the AHCAH program, including the longevity and permanency of the program, whether the program design should be modified, and how to bolster safety and program integrity as the program grows.
IV. Other Health Policy News
- On July 29, 2024, CMS released preliminary Medicare Part D bid information for contract year 2025 to aid Part D plan sponsors in finalizing their Part D and MA bids. The Inflation Reduction Act of 2022 (IRA) made changes to the Medicare Part D drug benefit in an effort to lower out-of-pocket (OOP) drug costs for Medicare beneficiaries. Provisions that will go into effect in 2025 include:
- Beneficiary OOP spending will be capped at $2,000;
- No beneficiary cost sharing will go above the annual OOP threshold;
- The coverage gap phase (known as the “donut hole”) will be eliminated;
- Standard Part D coverage will consist of a three-phase benefit: a deductible phase, an initial coverage phase, and a catastrophic phase.
- There will be no initial coverage limit, and the initial coverage phase will extend to the maximum annual OOP threshold, at which point the catastrophic phase will begin.
- The Coverage Gap Discount Program will sunset effective January 1, 2025, and will be replaced by the Manufacturer Discount Program;
- Under the Manufacturer Discount Program, the manufacturer will typically provide a 10 percent discount for brand-name drugs and biologics in the initial coverage phase. In the catastrophic phase, the manufacturer will typically provide a 20 percent discount for brand-name drugs and biologics.
- Additionally, CMS announced it is conducting a demonstration for the Medicare Part D program to test whether premium stabilization and revised risk corridors for stand-alone prescription drug plans (PDPs) increase the efficiency and economy of services under the Part D program. This demonstration includes three main elements: 1) a $15 reduction in the base beneficiary premium for all participating PDPs; 2) a cap on year-over-year premium increases of $35; and 3) adjusted risk corridors for greater government risk sharing for potential plan losses. This voluntary and nationwide demonstration will run for one year initially and at least two more years. PDP sponsors must commit to participate in 2025 to be eligible for subsequent years, and they must notify CMS of their participation by August 5, 2024. A fact sheet with more information, including frequently asked questions, is available here.
- On August 1, 2024, the Centers for CMS released its Fiscal Year (FY) 2025 Hospital Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital Prospective Payment System (LTCH PPS) final rule. The 2,987-page annual final rule includes key policy changes, including changes to payment rates, continuation of the low-wage index policy established in FY 2020, and a new mandatory alternative payment model. The rule finalizes a 2.9 percent increase to hospitals paid under the IPPS that participate in the Hospital Inpatient Quality Reporting program and are meaningful electronic health record (EHR) users. This reflects a projected hospital market basket percentage increase of 3.4 percent, reduced by a 0.5 percentage point productivity adjustment. The overall increase in hospital payments is $2.9 billion for FY 2025, which includes a decrease in Medicare uncompensated care payments to disproportionate share hospitals (DSH) by $200 million and an increase in payments for inpatient cases involving new medical technologies by $335.6 million, largely due to the continuation of new technology add-on payments. The final rule is available here. The press release can be found here and the fact sheet can be found here.
- On August 1, 2024, the Senate Appropriations Committee released a summary of the FY 2025 Labor, Health and Human Services, Education, and Related Agencies Appropriations Act. The bill provides approximately $231 billion in base discretionary funding, with $122.8 billion allocated to HHS. Included in the appropriations bill is a $275 million increase for mental health research through NIH, as well as a combined increase of $215 million for substance use and mental health programs through SAMHSA and HRSA. The funding would strengthen programs to address the opioid crisis, including $155 million for the Rural Communities Rural Opioid Response Program. Additionally, the bill includes funding to improve health care access and affordability and bolster the healthcare workforce, including: 1) a $25 million dollar increase for the Substance Use Disorder Treatment and Recovery (STAR) Loan Repayment Program for those working in mental health professional shortage areas; 2) $1.4 billion in funding for other health professions workforce development across public health programs; 3) $1.86 billion for Community Health Centers (CHCs); and 4) a $21.3 billion increase in funding to rural health programs to recruit healthcare providers to rural areas and support rural hospitals. In a markup the same day, the Senate Appropriations Committee approved the bill in a 25-3 vote. The House Appropriations Committee approved their bill on July 10, 2024. Timing of floor action in either chamber is uncertain at this time. The bill text is available here. The bill summary is available here. The Senate Report is available here. A recording of the markup is available here.
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