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Objective: To characterize the relationship between office-based laboratory (OBL) use and Medicare payments for peripheral vascular interventions (PVI)., Methods: Using the Centers for Medicare and Medicaid Services Provider Utilization and Payment Data Public Use Files from 2014 to 2017, we identified providers who performed percutaneous transluminal angioplasty, stent placement, and atherectomy. Procedures were aggregated at the provider and hospital referral region (HRR) level., Results: Between 2014 and 2017, 2641 providers performed 308,247 procedures. The mean payment for OBL stent placement in 2017 was $4383.39, and mean payment for OBL atherectomy was $13,079.63. The change in the mean payment amount varied significantly, from a decrease of $16.97 in HRR 146 to an increase of $43.77 per beneficiary over the study period in HRR 11. The change in the rate of PVI also varied substantially, and moderately correlated with change in payment across HRRs (R 2  = 0.40; P < .001). The majority of HRRs experienced an increase in rate of PVI within OBLs, which strongly correlated with changes in payments (R 2  = 0.85; P < .001). Furthermore, 85% of the variance in change in payment was explained by increases in OBL atherectomy (P < .001)., Conclusions: A rapid shift into the office setting for PVIs occurred within some HRRs, which was highly geographically variable and was strongly correlated with payments. Policymakers should revisit the current payment structure for OBL use and, in particular atherectomy, to better align the policy with its intended goals., (Copyright © 2021 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

The Emergency Medical Treatment and Active Labor Act (EMTALA) protects patient access to emergency medical treatment regardless of insurance or socioeconomic status. A significant result of the COVID-19 pandemic has been the rapid acceleration in the adoption of telemedicine services across many facets of healthcare. However, very little literature exists regarding the use of telemedicine in the context of EMTALA. This work aimed to evaluate the potential to expand the usage of telemedicine services for neurotrauma to reduce transfer rates, minimize movement of patients across borders, and alleviate the burden on tertiary care hospitals involved in the care of patients with COVID-19 during a global pandemic. In this paper, the authors outline EMTALA provisions, provide examples of EMTALA violations involving neurosurgical care, and propose guidelines for the creation of telemedicine protocols between referring and consulting institutions.

Background and Purpose- Industry payments to physicians raise concerns regarding conflicts of interest that could impact patient care. We explored nonresearch and nonownership payments from industry to vascular neurologists to identify trends in compensation. Methods- Using Centers for Medicare and Medicaid Services and American Board of Psychiatry and Neurology data, we explored financial relationships between industry and US vascular neurologists from 2013 to 2018. We analyzed payment characteristics, including payment categories, payment distribution among physicians, regional trends, and biomedical manufacturers. Furthermore, we analyzed the top 1% (by compensation) of vascular neurologists with detailed payment categories, their position, and their contribution to stroke guidelines. Results- The number of board certified vascular neurologist increased from 1169 in 2013 to 1746 in 2018. The total payments to vascular neurologist increased from $99 749 in 2013 to $1 032 302 in 2018. During the study period, 16% to 17% of vascular neurologists received industry payments. Total payments from industry and mean physician payments increased yearly over this period, with consulting fee (31.1%) and compensation for services other than consulting (30.7%) being the highest paid categories. The top 10 manufacturers made the majority of the payments, and the top 10 products changed from drug or biological products to devices. Physicians from south region of the United States received the highest total payment (38.72%), which steadily increased. Payments to top 1% vascular neurologists increased from 64% to 79% over the period as payments became less evenly distributed. Among the top 1%, 42% specialized in neuro intervention, 11% contributed to American Heart Association/American Stroke Association guidelines, and around 75% were key leaders in the field. Conclusions- A small proportion of US vascular neurologists consistently received the majority of industry payments, the value of which grew over the study period. Only 11% of the top 1% receiving industry payments have authored American Heart Association/American Stroke Association guidelines, but ≈75% seem to be key leaders in the field. Whether this influences clinical practice and behavior requires further investigation.

Background: Availability of nursing home care has declined and national efforts have been initiated to improve the quality of nursing home care in the U.S. Yet, data are limited on whether there are geographic variations in declines of availability and quality of nursing home care, and whether variations persist over time. We sought to assess geographic variation in availability and quality of nursing home care., Methods: Retrospective study using Medicaid/Medicare-certified nursing home data from the Centers for Medicare & Medicaid Services, 1996-2016. Outcomes were 1) availability of all nursing home care (1996-2016), measured by the number of Medicaid/Medicare-certified beds for a given county per 100,000 population aged ≥65 years, regardless of nursing home star rating; 2) availability of 5-star nursing home care, measured by the number of Medicaid/Medicare-certified beds provided by 5-star nursing homes; and 3) utilization of nursing home beds, defined as the rate of occupied Medicaid/Medicare-certified beds among the total Medicaid/Medicare-certified beds., Results: From 1999 to 2016, availability of all nursing home care declined from 4882 (standard deviation: 931) to 3480 (912) beds, per 100,000 population aged ≥65 years. Persistent geographic variation in availability of nursing home care was observed; the correlation coefficient of county-specific availabilities from 1996 to 2016 was 0.78 (95% CI 0.77-0.79). From 2011 to 2016, availability of 5-star nursing home beds increased from 658 (303) to 895 (661) per 100,000 population aged ≥65 years. The correlation coefficient for county-specific availabilities from 2011 to 2016 was 0.54 (95% CI 0.51-0.56). Availability and quality of nursing home care were not highly correlated. In 2016, the correlation coefficient for county-specific availabilities between all nursing home and 5-star nursing home beds was 0.33 (95% CI 0.30-0.36). From 1996 to 2016, the utilization of certified beds declined from 78.5 to 72.2%. This decline was consistent across all census divisions, but most pronounced in the Mountain division and less in the South-Atlantic division., Conclusion: We observed persistent geographic variations in availability and quality of nursing home care. Availability of all nursing home care declined but availability of 5-star nursing home care increased. Availability and quality of nursing home care were not highly correlated.

Background: Regulatory approval of novel therapies by the FDA does not guarantee insurance coverage requisite for most clinical use. In the United States, the largest health insurance payer is the Centers for Medicare & Medicaid Services (CMS), which provides Part D prescription drug benefits to over 43 million Americans. While the FDA and CMS have implemented policies to improve the availability of novel therapies to patients, the time required to secure Medicare prescription drug benefit coverage-and accompanying restrictions-has not been previously described., Objective: To characterize Medicare prescription drug plan coverage of novel therapeutic agents approved by the FDA between 2006 and 2012., Methods: This is a cross-sectional study of drug coverage using Medicare Part D prescription drug benefit plan data from 2007 to 2015. Drug coverage was defined as inclusion of a drug on a plan formulary, evaluated at 1 and 3 years after FDA approval. For covered drugs, coverage was categorized as unrestrictive or restrictive, which was defined as requiring step therapy or prior authorization. Median coverage was estimated at 1 and 3 years after FDA approval, overall, and compared with a number of drug characteristics, including year of approval, CMS-protected class status, biologics versus small molecules, therapeutic area, orphan drug status, FDA priority review, and FDA-accelerated approval., Results: Among 144 novel therapeutic agents approved by the FDA between 2006 and 2012, 14% (20 of 144) were biologics; 40% (57 of 144) were included in a CMS-protected class; 31% (45 of 144) were approved under an orphan drug designation; 42% (60 of 144) received priority review; and 11% (16 of 144) received accelerated approval. The proportion of novel therapeutics covered by at least 1 Medicare prescription drug plan was 90% (129 of 144) and 97% (140 of 144) at 1 year and 3 years after approval, respectively. At 3 years after approval, 28% (40 of 144) of novel therapeutics were covered by all plans. Novel therapeutic agents were covered by a median of 61% (interquartile range [IQR] = 39%-90%) of plans at 1 year and 79% (IQR = 57%-100%) at 3 years (P < 0.001). When novel therapeutics were covered, many plans restricted coverage through prior authorization or step therapy requirements. The median proportion of unrestrictive coverage was 29% (IQR = 13%-54%) at 3 years. Several drug characteristics, including therapeutic area, FDA priority review, FDA-accelerated approval, and CMS-protected drug class, were associated with higher rates of coverage, whereas year of approval, drug type, and orphan drug status were not., Conclusions: Most Medicare prescription drug plans covered the majority of novel therapeutics in the year following FDA approval, although access was often restricted through prior authorization or step therapy and was dependent on plan choice., Disclosures: Funding for this study was contributed by a student research grant awarded to Shaw and provided by the Yale School of Medicine Office of Student Research under National Institutes of Health training grant award T35DK104689. Ross reports research grants to Yale University from the U.S. Food and Drug Administration (U01FD005938, U01FD004585), Medtronic, Johnson & Johnson, Centers for Medicare & Medicaid Services (HHSM-500-2013-13018I), Blue Cross-Blue Shield Association, Laura and John Arnold Foundation, Agency for Healthcare Research and Quality (R01HS022882), and National Institutes of Health (R01HS025164), unrelated to this study. Dhruva has nothing to disclose. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Background: Post-market surveillance is needed to evaluate the real-world clinical effectiveness and safety of U.S. Food and Drug Administration-approved devices., Objectives: The authors examined the commercial experience with transcatheter mitral valve repair for the treatment of mitral regurgitation., Methods: Data from the Society of Thoracic Surgery/American College of Cardiology Transcatheter Valve Therapy Registry on patients commercially treated with transcatheter mitral valve repair were analyzed. The study population consisted of 2,952 patients treated at 145 hospitals between November 2013 and September 2015. In 1,867 patients, data were linked to patient-specific Centers for Medicare and Medicaid Services administrative claims for analyses., Results: The median age was 82 years (55.8% men), with a median Society of Thoracic Surgery predicted risk of mortality of 6.1% (interquartile range: 3.7% to 9.9%) and 9.2% (interquartile range: 6.0% to 14.1%) for mitral repair and replacement, respectively. Overall, in-hospital mortality was 2.7%. Acute procedure success occurred in 91.8%. Among the patients with Centers for Medicare and Medicaid Services linkage data, the mortality at 30 days and at 1 year was 5.2% and 25.8%, respectively, and repeat hospitalization for heart failure at 1 year occurred in 20.2%. Variables associated with mortality or rehospitalization for heart failure after multivariate adjustment were increasing age, lower baseline left ventricular ejection fraction, worse post-procedural mitral regurgitation, moderate or severe lung disease, dialysis, and severe tricuspid regurgitation., Conclusions: Our findings demonstrate that commercial transcatheter mitral valve repair is being performed in the United States with acute effectiveness and safety. Our findings may help determine which patients have favorable long-term outcomes with this therapy., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: In 2001, the Center for Medicare and Medicaid Services issued a rule permitting states to "opt-out" of federal regulations requiring physician supervision of nurse anesthetists. We examined the extent to which this rule increased access to anesthesia care for urgent cases., Methods: Using data from a national sample of inpatient discharges, we examined whether opt-out was associated with an increase in the percentage of patients receiving a therapeutic procedure among patients admitted for appendicitis, bowel obstruction, choledocholithiasis, or hip fracture. We chose these 4 diagnoses because they represent instances where urgent access to a procedure requiring anesthesia is often indicated. In addition, we examined whether opt-out was associated with a reduction in the number of appendicitis patients who presented with a ruptured appendix. In addition to controlling for patient morbidities and demographics, our analysis incorporated a difference-in-differences approach, with additional controls for state-year trends, to reduce confounding., Results: Across all 4 diagnoses, opt-out was not associated with a statistically significant change in the percentage of patients who received a procedure (0.0315 percentage point increase, 95% confidence interval [CI] -0.843 to 0.906 percentage point increase). When broken down by diagnosis, opt-out was also not associated with statistically significant changes in the percentage of patients who received a procedure for bowel obstruction (0.511 percentage point decrease, 95% CI -2.28 to 1.26), choledocholithiasis (2.78 percentage point decrease, 95% CI -6.12 to 0.565), and hip fracture (0.291 percentage point increase, 95% CI -1.76 to 2.94). Opt-out was associated with a small but statistically significant increase in the percentage of appendicitis patients receiving an appendectomy (0.876 percentage point increase, 95% CI 0.194 to 1.56); however, there was no significant change in the percentage of patients presenting with a ruptured appendix (-0.914 percentage point decrease, 95% CI -2.41 to 0.582). Subanalyses showed that the effects of opt-out did not differ in rural versus urban areas., Conclusions: Based on 2 measures of access, opt-out does not appear to have significantly increased access to anesthesia for urgent inpatient conditions.

Background: In October 2008, the Centers for Medicare & Medicaid Services (CMS) stopped reimbursing hospitals for the marginal cost of treating certain preventable hospital-acquired conditions., Objective: This study evaluates whether CMS's refusal to pay for hospital-acquired pulmonary embolism (PE) or deep vein thrombosis (DVT) resulted in a lower incidence of these conditions., Design: We employ difference-in-differences modeling using 2007-2009 data from the Nationwide Inpatient Sample, an all-payer database of inpatient discharges in the U.S. Discharges between 1 January 2007 and 30 September 2008 were considered "before payment reform;" discharges between 1 October 2008 and 31 December 2009 were considered "after payment reform." Hierarchical regression models were fit to account for clustering of observations within hospitals., Participants: The "before payment reform" and "after payment reform" incidences of PE or DVT among 65-69-year-old Medicare recipients were compared with three different control groups of: a) 60-64-year-old non-Medicare patients; b) 65-69-year-old non-Medicare patients; and c) 65-69-year-old privately insured patients. Hospital reimbursements for the control groups were not affected by payment reform., Intervention: CMS payment reform for hospital-based reimbursement of patients with hip and knee replacement surgeries., Main Measures: The outcome was the incidence proportion of hip and knee replacement surgery admissions that developed pulmonary embolism or deep vein thrombosis., Key Results: At baseline, pulmonary embolism or deep vein thrombosis were present in 0.81% of all hip or knee replacement surgeries for Medicare patients aged 65-69 years old. CMS payment reform resulted in a 35% lower incidence of hospital-acquired pulmonary embolism or deep vein thrombosis in these patients (p = 0.015). Results were robust to sensitivity analyses., Conclusion: CMS's refusal to pay for hospital-acquired conditions resulted in a lower incidence of hospital-acquired pulmonary embolism or deep vein thrombosis after hip or knee replacement surgery. Payment reform had the desired direction of effect.

The flow of funds in the U.S. health care system is crucial both for the provision of services to patients and to encourage innovation that enables long-term improvement of health services. Rising concern about health care costs often includes concerns about inappropriate adoption of costly or unnecessary technology. Many innovations in diabetes technology may involve personal technology, which does not qualify under existing health insurance categories such as "durable medical equipment" or under a currently defined telehealth technology. In such cases, the diabetes technology industry may be developing types of technology that are so innovative they do not have clearly established payment mechanisms in the existing U.S. fee for service health care reimbursement system. This article describes key features of the U.S. health care payment system relevant to developers of new diabetes technologies., (© 2013 Diabetes Technology Society.)

The CMS has proposed paying physicians for managing patients apart from face-to-face office visits. Among the details under consideration are requiring practices to use an electronic health-record system that supports access to care, care coordination, care management and communications. "It's a step in the right direction. The devil will be in the details and, if the burden of documentation is so high, people may choose not to spend their time doing it," says Dr. Matt Handley, physician and medical director for quality at the Group Health Cooperative.

The CMS' laboratory for revamping the healthcare delivery system doesn't expect to produce policy changes for two more years. That has left lawmakers impatient for results. "Of course, we're all eager to see the results of these models, but we need to be realistic; this change is difficult," says Dr. Richard Gilfillan, left, director of the Center for Medicare & Medicaid Innovation.

The focus of palliative care is to alleviate pain and suffering for patients, potentially while they concurrently pursue life-prolonging or curative therapy. The potential breadth of palliative care is recognized by the Medicare program, but the Medicare hospice benefit is narrowly defined and limited to care that is focused on comfort and not on cure. Any organization or setting that has been accredited or certified to provide health care may provide palliative care. Home health agencies are highly attuned to patients' need for palliative care, and often provide palliative care for patients who are ineligible for hospice or have chosen not to enroll in it. Two home health-based programs have reported improved patient satisfaction, better utilization of services, and significant cost savings with palliative care. Moving the focus of care from the hospital to the home and community can be achieved with integrated care and can be facilitated by changes in government policy.

Physician spending is complex related to national health care spending, government regulations, health care reform, private insurers, physician practice, and patient utilization patterns. In determining payment rates for each service on the fee schedule, the Centers for Medicare and Medicaid Services (CMS) considers the amount of work required to provide a service, expenses related to maintaining a practice, and liability insurance costs. The value of 3 types of resources are adjusted on a yearly basis of the combined total multiplied by a standard dollar amount, called the fee schedules conversion factor, which was $33.98 in 2011, to arrive at the payment amount. This factor will stay almost the same ($34.03) unless a 27.4% cut in the sustainable growth rate (SGR) takes place or CMS enacts further reductions. With a 27.4% cut, the conversion factor will be $24.67 in 2012 after the first 2 months if Congress fails to act. Since the inception of Medicare programs in 1965, several methods have been used to determine the amounts paid to physicians for each covered service. The SGR was enacted in 1997 to determine physician payment updates under Medicare Part B with intent to reduce Medicare physician payment updates to offset the growth and utilization of physician services that exceed gross domestic product (GDP) growth. This is achieved by setting an overall target amount of spending for physicians' services and adjusting payment rates annually to reflect differences between actual spending and the spending target. Since 2002, the SGR has annually recommended reductions in Medicare reimbursements. Payments were cut in 2002 by 4.8%. Since then, Congress has intervened on 13 separate occasions to prevent additional cuts from being imposed. The Medicare physician payment rule of 2012, which is still undergoing revisions -- but considered as the final rule-- is a 1,235 page document, released in November 2011. In this manuscript, we will describe important aspects of the 2012 physician fee schedule which include potentially disvalued services under the physician fee schedule, expansion of the multiple procedure payment reduction (MPPR) policy, establishment of the value-based payment modifier, changes to direct practice expenses (PEs), electronic prescribing, the Physician Quality Reporting System (PQRS), and lab testing signatures, along with their implications. Additionally, the impact of multiple changes on interventional pain management will be described. In conclusion, interventional pain management is facing widespread challenges in the U.S. health care system. A historic reform, which has been passed by Congress and signed into law whose survivability is not quite known yet, is affecting medicine drastically in the United States. Interventional pain management, like other evolving specialties will probably most likely suffer under the new affordable health care law and regulatory burden.

After listening to the concerns and criticisms of healthcare leaders, the CMS significantly revised final ACO regulations. Dr. Mark Kelley, left, of the Henry Food Medical Group, called the rule changes a "good start," but said the health system decided even before their release that bundled payments would better serve the system's coordination efforts.