RESUMO
Under the 2022 Inflation Reduction Act, the Centers for Medicare and Medicaid Services (CMS) are able to negotiate prices for topselling drugs in the Medicare Part B and D programs. In determining initial price offers, CMS will compare the prices and clinical benefits of the drugs subject to negotiation to the prices and clinical benefits of therapeutic alternatives. Despite the central role that the selection of therapeutic alternatives will play in the price negotiations, the available guidance published by CMS provides few details about how the organization will undertake this process, which will be particularly complex for drugs approved for more than one indication. To better inform the selection process, we identified all US Food and Drug Administration-approved indications for the first 10 drugs subject to negotiation. Using 2020-2021 Medicare claims data, we identified Medicare Part D beneficiaries using each of the 10 drugs. We extracted medical claims with diagnosis codes for each of the approved indications to report the relative treated prevalence of use by indication for each drug. We reviewed published clinical guidelines to identify relevant therapeutic alternatives for each of the indications. We integrated the evidence on the relative treated prevalence of indications and clinical guidelines to propose therapeutic alternatives for each of the 10 drugs. We describe challenges that CMS may face in selecting therapeutic alternatives.
Assuntos
Medicare Part B, Medicare Part D, Idoso, Humanos, Centers for Medicare and Medicaid Services, U.S., Negociação, Estados Unidos, United States Food and Drug AdministrationRESUMO
BACKGROUND: Supervised exercise therapy (SET) is the cornerstone of medical therapy for symptomatic peripheral artery disease (PAD). Despite the efficacy of SET, initial reports following the 2017 Centers for Medicare and Medicaid Services (CMS) reimbursement decision indicate low SET uptake, referral, and completion. Vascular medicine specialists are key to the success of such programs. We examined rates of SET referral, completion, and outcomes in a health system with a robust SET program during the first 5 years of CMS reimbursement. METHODS: A retrospective chart review of patients with PAD referred to SET between October 1, 2017 and December 31, 2022 was conducted. Patient demographic and medical characteristics, SET indication, referring provider specialty, SET participation (e.g., exercise modality, number of sessions, treadmill prescription), and outcomes were abstracted. Descriptive statistics, t-tests, and multiple linear regression were used to examine the sample, evaluate outcomes, and explore outcomes by relevant covariates (i.e., age, sex, referring provider specialty). RESULTS: Of 5320 patients with PAD, N = 773 were referred to SET; N = 415 enrolled and were included in the present study. Vascular medicine and vascular surgery specialists were the two primary sources of referrals (30.6% and 51.6%, respectively). A total of 207 patients (49.9%) completed SET. Statistically significant and clinically meaningful improvements were observed in all outcomes. CONCLUSION: SET referral and completion rates are low in the 5 years following CMS reimbursement, despite the advocacy of vascular medicine specialists. SET is effective in improving patient functional capacity and quality of life. Additional efforts are needed to increase both SET availability and referrals as part of comprehensive treatment of PAD.
Assuntos
Claudicação Intermitente, Doença Arterial Periférica, Humanos, Idoso, Estados Unidos, Centers for Medicare and Medicaid Services, U.S., Qualidade de Vida, Estudos Retrospectivos, Medicare, Doença Arterial Periférica/diagnóstico, Doença Arterial Periférica/terapia, Terapia por Exercício, Atenção à Saúde, CaminhadaRESUMO
Hospice care facilities are required to provide prescription drugs related to a hospice patient's terminal illness. From October 2010 to present, the Center for Medicare and Medicaid Services (CMS) has issued a series of communications regarding Medicare paying for hospice patients' prescription drugs under Part D that should be covered under the hospice Medicare Part A benefit. On April 4, 2011, CMS issued specific policy guidance to providers aimed at preventing inappropriate billing. While CMS has documented Part D prescription decreases in hospice patients, no research exists that connects these decreases and the policy guidance. This study aims to evaluate the effect of the April 4, 2011, policy guidance on hospice patients' Part D prescriptions. This study employed generalized estimating equations to assess (1) total monthly average prescriptions of all medications and (2) four categories of commonly prescribed hospice medications in pre-and-post policy guidance. This research used the Medicare claims of 113,260 Part D-enrolled Medicare male patients aged 66 and older between April 2009 and March 2013, including 110,547 non-hospice patients and 2713 hospice patients. Hospice patients' monthly average total Part D prescriptions decreased from 7.3 pre-policy guidance to 6.5 medications following the issuing of the guidance, while the four categories of hospice-specific medications decreased from .57 to .49. The findings of this study show that CMS's guidance issued to providers to prevent the inappropriate billing of hospice patients' prescriptions to the Part D benefit may lead to Part D prescription decreases as observed in this sample.
Assuntos
Hospitais para Doentes Terminais, Medicare Part D, Medicamentos sob Prescrição, Humanos, Masculino, Idoso, Estados Unidos, Feminino, Medicaid, Centers for Medicare and Medicaid Services, U.S., Prescrições de Medicamentos, PolíticasRESUMO
BACKGROUND: In January 2021, the US Medicare program approved reimbursement of outpatient total shoulder arthroplasties (TSA), including anatomic and reverse TSAs. It remains unclear whether shifting TSAs from the inpatient to outpatient setting has affected clinical outcomes. Herein, we describe the rate of outpatient TSA growth and compare inpatient and outpatient TSA complications, readmissions, and mortality. METHODS: Medicare fee-for-service claims for 2019-2022Q1 were analyzed to identify the trends in outpatient TSAs and to compare 90-day postoperative complications, all-cause hospital readmissions, and mortality between outpatients and inpatients. Outpatient cases were defined as those discharged on the same day of the surgery. To reduce the COVID-19 pandemic's impact and selection bias, we excluded 2020Q2-Q4 data and used propensity scores to match 2021-2022Q1 outpatients with inpatients from the same period (the primary analysis) and from 2019-2020Q1 (the secondary analysis), respectively. We performed both propensity score-matched and -weighted multivariate analyses to compare outcomes between the two groups. Covariates included sociodemographics, preoperative diagnosis, comorbid conditions, the Hierarchical Condition Category risk score, prior year hospital/skilled nursing home admissions, annual surgeon volume, and hospital characteristics. RESULTS: Nationally, the proportion of outpatient TSAs increased from 3% (619) in 2019Q1 to 22% (3456) in 2021Q1 and 38% (6778) in 2022Q1. A total of 55,166 cases were identified for the primary analysis (14,540 outpatients and 40,576 inpatients). Overall, glenohumeral osteoarthritis was the most common indication for surgery (70.8%), followed by rotator cuff pathology (14.6%). The unadjusted rates of complications (1.3 vs 2.4%, P < .001), readmissions (3.7 vs 6.1%, P < .001), and mortality (0.2 vs 0.4%, P = .024) were significantly lower among outpatient TSAs than inpatient TSAs. Using 1:1 nearest matching, 12,703 patient pairs were identified. Propensity score-matched multivariate analyses showed similar rates of postoperative complications, hospital readmissions, and mortality between outpatients and inpatients. Propensity score-weighted multivariate analyses resulted in similar conclusions. The secondary analysis showed a lower hospital readmission rate in outpatients (odds ratio: 0.8, P < .001). CONCLUSIONS: There has been accelerated growth in outpatient TSAs since 2019. Outpatient and inpatient TSAs have similar rates of postoperative complication, hospital readmission, and mortality.
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Artroplastia do Ombro, Pacientes Internados, Idoso, Humanos, Estados Unidos/epidemiologia, Pacientes Ambulatoriais, Artroplastia do Ombro/efeitos adversos, Centers for Medicare and Medicaid Services, U.S., Pandemias, Medicare, Complicações Pós-Operatórias/epidemiologia, Complicações Pós-Operatórias/etiologia, Readmissão do Paciente, Estudos RetrospectivosRESUMO
When physicians admit patients to a hospital, their decisions about where-and to whose professional stewardship and services-those patients belong are influenced by federal policies, of which many clinicians are not aware. The distinction between observation and admission has clinical and ethical implications for patients and practices. The evolution of "observation status" from a clinical tool to a catchall of vague and imprecise meaning has been driven by changes to physician payment and compensation structures, particularly Current Procedural Terminology codes and Centers for Medicare and Medicaid Services regulations, and its current value to clinicians and patients is questionable. This article contextualizes clinicians' admission and observation practices and considers how metrics influence patient costs and how clinicians and organizations are compensated.
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Hospitalização, Medicare, Idoso, Humanos, Estados Unidos, Hospitais, Centers for Medicare and Medicaid Services, U.S., Custos e Análise de CustoRESUMO
Evaluation of new and established patients is an integral part of interventional pain management. Over the last 3 decades, there has been significant confusion over the proper documentation for evaluation and management (E/M) services in general and for interventional pain management in particular. Interventional pain physicians have learned how to evaluate patients presenting with pain on the basis of their specialty training. Although modern training programs are introducing residents and fellows to the intricacies of E/M services and federal regulations, this has not always been the case. Multiple textbooks about pain management, physiatry, and neurology, and numerous journal articles have described the evaluation of pain patients, but they have not been specific to chronic pain patients and may not meet the regulatory perspective.A multitude of these issues led to the development of guidelines in 1995 and 1997, which were highly complicated and difficult to follow. These also led to significant criticism from clinicians. Consequently, further guidance was developed to be effective January 2021.The crucial concept in the present system of coding for E/M services is medical decision making, which includes 3 elements since 2021: 1.The number and complexity of problems addressed. 2. Amount or complexity of data to be reviewed and analyzed. 3. Risk of complications and/or morbidity or mortality of patient management. In order to select a level of E/M service, 2 of the 3 elements of medical decision making (MDM) must be met or exceeded. This is in contrast to prior guidelines wherein for new patients, all 3 elements with history, physical examination and MDM , and for established patients have been met. For ease of appreciation, an algorithmic approach created by the American Medical Association (AMA), and Centers for Medicare and Medicaid Services (CMS) approved a new MDM table outlining all of the appropriate criteria.This review systematically describes the changes and provides an algorithmic approach for application in interventional pain management practices.
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Dor Crônica, Manejo da Dor, Idoso, Humanos, Estados Unidos, Medicare, Dor Crônica/diagnóstico, Dor Crônica/terapia, Documentação, Centers for Medicare and Medicaid Services, U.S.RESUMO
BACKGROUND: There are limited data on female Mohs surgeon industry relationships. OBJECTIVE: To evaluate industry payment activity between female and male Mohs surgeons. MATERIALS AND METHODS: A retrospective review of the U.S. Centers for Medicare and Medicaid Services open payments data was performed between 2015 and 2021 for Mohs surgeons in the United States. Gender, academic affiliation, practice region, annual total payment, cumulative payment, and industry payment type was collected. RESULTS: Male Mohs surgeons received higher mean total payments than female Mohs surgeons ( p = .04), which persisted when data were stratified based on industry payment type and practice region. Both genders had similar median total payments ( p = .4). Females in academic practice received higher mean total payments than those in private practice. Females experienced a significant lower mean total payment compared with males in the South ( p = .03). CONCLUSION: High total payments received by male Mohs surgeons skewed the data, which is supported by a significant mean total payment difference despite a similar median total payment distribution. Female Mohs surgeons receiving the top payments may address this mean payment difference. Females seem to have higher payments if they practice in the Northeast and are in academics. Further studies are needed to evaluate this payment gap.
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Medicare, Cirurgiões, Idoso, Humanos, Masculino, Feminino, Estados Unidos, Bases de Dados Factuais, Estudos Retrospectivos, Centers for Medicare and Medicaid Services, U.S.RESUMO
Aim: To evaluate the availability of published comparative real-world evidence (RWE) studies in Medicare patients for the ten drugs set to undergo Centers for Medicare and Medicaid Services (CMS) price negotiations in 2026. Materials & methods: A scoping review was completed in MEDLINE/PubMed to evaluate the availability of comparative RWE investigations conducted among Medicare-eligible patient populations in the US for the following drugs: apixaban, rivaroxaban, sitagliptin, ibrutinib, empagliflozin, etanercept, dapagliflozin, sacubitril/valsartan, ustekinumab and insulin aspart. Results: Of the 170 real-world comparative studies identified, 55 (32.4%) used Medicare real-world data (RWD) while 34 (20.0%) used commercial claims data in conjunction with either Medicare Advantage or Medicare Supplementary databases. The number of studies varied considerably by drug with apixaban and rivaroxaban studies accounting for the majority (i.e., 67.1%) of comparative RWE studies. Approximately a third or less of the comparative RWE studies were conducted in CMS RWD per drug. Conclusion: Our results demonstrate there is a considerable amount of comparative RWE for apixaban, rivaroxaban, and etanercept but limited comparative RWE for the other drugs set to undergo CMS price negotiations in 2026; additionally, our findings set up a number of next steps (e.g., risk of bias assessments) for further exploration of the available evidence base. Overall, CMS and manufacturers should consider proactively generating high-quality comparative RWE studies in the Medicare population to ensure that future price negotiations are based on robust evidence.
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Medicare, Rivaroxabana, Idoso, Humanos, Estados Unidos, Rivaroxabana/efeitos adversos, Negociação, Centers for Medicare and Medicaid Services, U.S., EtanercepteRESUMO
This position statement is issued by the American Society for Metabolic and Bariatric. Surgery in response to inquiries made to the Society by patients, physicians, Society members, hospitals, health insurance payors, the media, and others regarding the access and outcomes of metabolic and bariatric surgery for beneficiaries of Centers for Medicare and Medicaid Services. This position statement is based on current clinical knowledge, expert opinion, and published peer-reviewed scientific evidence available at this time. The statement is not intended to be and should not be construed as stating or establishing a local, regional, or national standard of care. This statement will be revised in the future as additional evidence becomes available.
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Cirurgia Bariátrica, Medicare, Idoso, Humanos, Estados Unidos, Centers for Medicare and Medicaid Services, U.S.RESUMO
This Viewpoint discusses the CMS approach to incentivize excellent care for underserved populations.
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Centers for Medicare and Medicaid Services, U.S., Equidade em Saúde, Estados UnidosRESUMO
Of people appointed to the Department of Health and Human Services between 2004 and 2020, 15 percent had been employed in private industry immediately before their appointment. At the end of their tenure, 32 percent exited to industry. The greatest net exits to industry were from the Centers for Disease Control and Prevention and the Centers for Medicare and Medicaid Services.
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Instalações de Saúde, Medicare, Idoso, Estados Unidos, Humanos, Centers for Disease Control and Prevention, U.S., Centers for Medicare and Medicaid Services, U.S.RESUMO
This cohort study examines changes in research pancreas procurement from deceased donors before and after the Centers for Medicare & Medicaid Services (CMS) updated its Final Rule in November 2020.
Assuntos
Pâncreas, Obtenção de Tecidos e Órgãos, Humanos, Centers for Medicare and Medicaid Services, U.S., Estados Unidos, Obtenção de Tecidos e Órgãos/legislação & jurisprudênciaRESUMO
BACKGROUND: The post-acute patient standardized functional items (Section GG) include non-response options such as refuse, not attempt and not applicable. We examined non-response patterns and compared four methods to address non-response functional data in Section GG at nation-wide inpatient rehabilitation facilities (IRF). METHODS: We characterized non-response patterns using 100% Medicare 2018 data. We applied four methods to generate imputed values for each non-response functional item of each patient: Monte Carlo Markov Chains multiple imputations (MCMC), Fully Conditional Specification multiple imputations (FCS), Pattern-mixture model (PMM) multiple imputations and the Centers for Medicare and Medicaid Services (CMS) approach. We compared changes of Spearman correlations and weighted kappa between Section GG and the site-specific functional items across impairments before and after applying four methods. RESULTS: One hundred fifty-nine thousand six hundred ninety-one Medicare fee-for-services beneficiaries admitted to IRFs with stroke, brain dysfunction, neurologic condition, orthopedic disorders, and debility. At discharge, 3.9% (self-care) and 61.6% (mobility) of IRF patients had at least one non-response answer in Section GG. Patients tended to have non-response data due to refused at discharge than at admission. Patients with non-response data tended to have worse function, especially in mobility; also improved less functionally compared to patients without non-response data. Overall, patients coded as 'refused' were more functionally independent in self-care and patients coded as 'not applicable' were more functionally independent in transfer and mobility, compared to other non-response answers. Four methods showed similar changes in correlations and agreements between Section GG and the site-specific functional items, but variations exist across impairments between multiple imputations and the CMS approach. CONCLUSIONS: The different reasons for non-response answers are correlated with varied functional status. The high proportion of patients with non-response data for mobility items raised a concern of biased IRF quality reporting. Our findings have potential implications for improving patient care, outcomes, quality reporting, and payment across post-acute settings.
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Medicare, Doenças Musculoesqueléticas, Estados Unidos, Humanos, Idoso, Centers for Medicare and Medicaid Services, U.S., Hospitalização, Cadeias de MarkovRESUMO
Policy Points The increasing number of drugs granted accelerated approval by the Food and Drug Administration (FDA) has challenged the Medicare program, which often pays for expensive therapies despite substantial uncertainty about benefits and risks to Medicare beneficiaries. We recommend several administrative and legislative approaches for improving FDA-Centers for Medicare and Medicaid Services (CMS) coordination around accelerated-approval drugs, including promoting earlier discussions among the FDA, the CMS, and drug companies; strengthening Medicare's coverage with evidence development program; linking Medicare payment to evidence generation milestones; and ensuring that the CMS has adequate staffing and resources to evaluate new therapies. These activities can help improve the integrity; transparency; and efficiency of approval, coverage, and payment processes for drugs granted accelerated approval. CONTEXT: The Food and Drug Administration (FDA)'s accelerated-approval pathway expedites patient access to promising treatments. However, increasing use of this pathway has challenged the Medicare program, which often pays for expensive therapies despite substantial uncertainty about benefits and risks to Medicare beneficiaries. We examined approaches to improve coordination between the FDA and Centers for Medicare and Medicaid Services (CMS) for drugs granted accelerated approval. METHODS: We argue that policymakers have focused on expedited pathways at the FDA without sufficient attention to complementary policies at the CMS. Although differences between the FDA and CMS decisions are to be expected given the agencies' different missions and statutory obligations, procedural improvements can ensure that Medicare beneficiaries have timely access to novel therapies that are likely to improve health outcomes. To inform policy options and recommendations, we conducted semistructured interviews with stakeholders to capture diverse perspectives on the topic. FINDINGS: We recommend ten areas for consideration: clarifying the FDA's evidentiary standards; strengthening FDA authorities; promoting earlier discussions among the FDA, the CMS, and drug companies; improving Medicare's coverage with evidence development program; tying Medicare payment for accelerated-approval drugs to evidence generation milestones; issuing CMS guidance on real-world evidence; clarifying Medicare's "reasonable and necessary" criteria; adopting lessons from international regulatory-reimbursement harmonization efforts; ensuring that the CMS has adequate staffing and expertise; and emphasizing equity. CONCLUSIONS: Better coordination between the FDA and CMS could improve the transparency and predictability of drug approval and coverage around accelerated-approval drugs, with important implications for patient outcomes, health spending, and evidence generation processes. Improved coordination will require reforms at both the FDA and CMS, with special attention to honoring the agencies' distinct authorities. It will require administrative and legislative actions, new resources, and strong leadership at both agencies.
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Aprovação de Drogas, Medicare, Idoso, Humanos, Estados Unidos, Preparações Farmacêuticas, Centers for Medicare and Medicaid Services, U.S., United States Food and Drug AdministrationRESUMO
The use of transcatheter aortic valve replacement (TAVR) in the United States has been increasing but with variability. We used a 100% sample of Medicare beneficiaries (MBs), from the Centers for Medicare and Medicaid Services database, who underwent TAVR by cardiologists between 2015 and 2019. We stratified data by geographic region, rural/urban areas, and provider's gender. We examined the average number of TAVRs performed per 100,000 MBs, the average number of TAVRs performed per individual cardiologist, and the average submitted charge (ASC) per procedure. The number of TAVR per 100,000 MBs was significantly variable among regions in all years (all P≤0.028), except in 2015 (P=0.103), with the highest rates being in the Northeast and the lowest being in the West. The number of TAVRs per cardiologist was significantly different among regions only in 2019 (P=0.04), with the Northeast showing the highest numbers and the South showing the lowest. The ASC was also significantly variable among regions in all years (all P≤0.01). The highest ASC was in the Midwest for all years, whereas the lowest was in the West in 2015 to 2016 and in the South in 2017 to 2019. In all years, the number of TAVRs per cardiologist was higher in urban areas than in rural areas (all P<0.05); however, rural cardiologists had higher ASCs (all P<0.05). The number of TAVR procedures per cardiologist was not significantly different between male and female cardiologists (all P>0.1). Female cardiologists had a significantly higher ASC only in 2015 (P=0.034). In conclusion, there are variations in TAVR use and charges for MBs according to geographic, urban, and rural regions and the performing cardiologist's gender.
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Cardiologistas, Substituição da Valva Aórtica Transcateter, Idoso, Estados Unidos/epidemiologia, Humanos, Feminino, Masculino, Medicare, Geografia, Centers for Medicare and Medicaid Services, U.S.RESUMO
Several Centers for Medicare and Medicaid Services (CMS) programs aim to transform how health care is delivered by adjusting Medicare inpatient hospital payments through a system of rewards and penalties based on performance on measures of quality. These programs are the Hospital Readmissions Reduction Program, the Hospital Value-Based Purchasing Program, and the Hospital-Acquired Condition Reduction Program. We analyzed value-based program penalty results for various groups of hospitals across these three programs and assessed the impact of patient and community health equity risk factors on hospital penalties. We found statistically significant positive relationships between hospital penalties and several factors that affect hospital performance but that hospitals cannot control-namely, medical complexity (as measured by Hierarchical Condition Categories scores), uncompensated care, and the portion of hospital catchment area populations who live alone. Moreover, these environmental conditions can be worse for hospitals that operate in areas with historically underserved populations. This suggests that the CMS programs might not adequately account for health equity factors at the community level. Refinements to these programs (including an explicit incorporation of patient and community health equity risk factors) and continued monitoring will help ensure that the programs work as intended in a fair and equitable fashion.
