Authority of Medicare to Limit Coverage of FDA-Approved Products: Legal and Policy Considerations.

Importance: When the US Food and Drug Administration (FDA) approves a drug or medical device on the basis of limited clinical evidence, the Centers for Medicare & Medicaid Services (CMS) must decide whether the therapy is "reasonable and necessary" for coverage among Medicare beneficiaries. However, the legal underpinnings of CMS's authority to shape coverage of FDA-regulated products under Medicare Part B are controversial. To clarify this area, we reviewed relevant legal precedents on CMS's approaches to limit coverage and recent decisions Medicare has issued affecting coverage for FDA-regulated products. Observations: The CMS continues to exercise considerable legal discretion to limit coverage of FDA-authorized products to only uses it determines are reasonable and necessary for patients with Medicare. Courts have upheld this discretion repeatedly, emphasizing the difference between Medicare's coverage criteria and the FDA's review standards. As more new drugs and devices come to market without solid evidence of efficacy on clinical outcomes, or have narrow benefit-risk considerations, CMS may increasingly rely on forms of limited or conditional coverage, including coverage with evidence development (CED), which provides reimbursement only in the context of a clinical trial or registry. Conclusions and Relevance: The ability of CMS to condition or limit coverage of FDA-approved products is a commonsense necessity for this crucial taxpayer-funded program. Although courts have thus far deferred to the authority of CMS to make such decisions on the basis of its clear statutory discretion and public health expertise, Congress may want to act to reaffirm statutory language giving CMS sufficient flexibility to craft coverage determinations that reflect the evidence for a product's use.

The Effect of the Affordable Care Act on Women's Postpartum Insurance and Depression in 5 States That Did Not Expand Medicaid, 2012-2015.

BACKGROUND: Before the Affordable Care Act (ACA), most women who gained pregnancy-related Medicaid were not eligible for Medicaid as parents postpartum. The ACA aimed to expand health insurance coverage, in part, by expanding Medicaid; introducing mandates; reforming regulations; and establishing exchanges with federal subsidies. Federal subsidies offer a means to coverage for individuals with income at 100%-400% of the federal poverty level who do not qualify for Medicaid. OBJECTIVE: The objective of this study was to identify the effects of the ACA's non-Medicaid provisions on women's postpartum insurance coverage and depressive symptoms in nonexpansion states with low parental Medicaid thresholds. PARTICIPANTS: Women with incomes at 100%-400% of the federal poverty level who had prenatal insurance and completed the Pregnancy Risk Assessment Monitoring System (2012-2015). SETTING: Five non-Medicaid expansion states with Medicaid parental eligibility thresholds below the federal poverty level. DESIGN: Interrupted time-series analyses were conducted to examine changes between pre-ACA (January 2012-November 2013) and post-ACA (December 2013-December 2015) trends for self-reported loss of postpartum insurance and symptoms of postpartum depression. RESULTS: The sample included 9,472 women. Results showed significant post-ACA improvements where the: (1) trend for loss of postpartum insurance reversed (change of -0.26 percentage points per month, P=0.047) and (2) level of postpartum depressive symptoms decreased (change of -3.5 percentage points, P=0.042). CONCLUSIONS: In these 5 states, the ACA's non-Medicaid provisions were associated with large increases in retention of postpartum insurance and reductions in postpartum depressive symptoms, although depressive symptoms findings are sensitive to model specification.

Trends in Use of Next-Generation Sequencing in Patients With Solid Tumors by Race and Ethnicity After Implementation of the Medicare National Coverage Determination.

Importance: In March 2018, Medicare issued a national coverage determination (NCD) for next-generation sequencing (NGS) to facilitate access to NGS testing among Medicare beneficiaries. It is unknown whether the NCD affected health equity issues for Medicare beneficiaries and the overall population. Objective: To examine the association between the Medicare NCD and NGS use by insurance types and race and ethnicity. Design, Setting, and Participants: A retrospective cohort analysis was conducted using electronic health record data derived from a real-world database. Data originated from approximately 280 cancer clinics (approximately 800 sites of care) in the US. Patients with advanced non-small cell lung cancer (aNSCLC), metastatic colorectal cancer (mCRC), metastatic breast cancer (mBC), or advanced melanoma diagnosed from January 1, 2011, through March 31, 2020, were included. Exposure: Pre- vs post-NCD period. Main Outcomes and Measures: Patients were classified by insurance type and race and ethnicity to examine patterns in NGS testing less than or equal to 60 days after diagnosis. Difference-in-differences models examined changes in average NGS testing in the pre- and post-NCD periods by race and ethnicity, and interrupted time-series analysis examined whether trends over time varied by insurance type and race and ethnicity. Results: Among 92 687 patients with aNSCLC, mCRC, mBC, or advanced melanoma, mean (SD) age was 66.6 (11.2) years, 51 582 (55.7%) were women, and 63 864 (68.9%) were Medicare beneficiaries. The largest racial and ethnic categories according to the database used and further classification were Black or African American (8605 [9.3%]) and non-Hispanic White (59 806 [64.5%]). Compared with Medicare beneficiaries, changes in pre- to post-NCD NGS testing trends were similar in commercially insured patients (odds ratio [OR], 1.03; 95% CI, 0.98-1.08; P = .25). Pre- to post-NCD NGS testing trends increased at a slower rate among patients in assistance programs (OR, 0.93; 95% CI, 0.87-0.99; P = .03) compared with Medicare beneficiaries. The rate of increase for patients receiving Medicaid was not statistically significantly different compared with those receiving Medicare (OR, 0.92; 95% CI, 0.84-1.01; P = .07). The NCD was not associated with statistically significant changes in NGS use trends by racial and ethnic groups within Medicare beneficiaries alone or across all insurance types. Compared with non-Hispanic White individuals, increases in average NGS use from the pre-NCD to post-NCD period were 14% lower (OR, 0.86; 95% CI, 0.74-0.99; P = .04) among African American and 23% lower (OR, 0.77; 95% CI, 0.62-0.96; P = .02) among Hispanic/Latino individuals; increases among Asian individuals and those with other races and ethnicities were similar. Conclusions and Relevance: The findings of this study suggest that expansion of Medicare-covered benefits may not occur equally across insurance types, thereby further widening or maintaining disparities in NGS testing. Additional efforts beyond coverage policies are needed to ensure equitable access to the benefits of precision medicine.

Association of Surprise-Billing Legislation with Prices Paid to In-Network and Out-of-Network Anesthesiologists in California, Florida, and New York: An Economic Analysis.

Importance: Several states have passed surprise-billing legislation to protect patients from unanticipated out-of-network medical bills, yet little is known about how state laws influence out-of-network prices and whether spillovers exist to in-network prices. Objective: To identify any changes in prices paid to out-of-network anesthesiologists at in-network facilities and to in-network anesthesiologists before and after states passed surprise-billing legislation. Design, Setting, and Participants: This retrospective economic analysis used difference-in-differences methods to compare price changes before and after the passage of legislation in California, Florida, and New York, which passed comprehensive surprise-billing legislation between January 1, 2014, and December 31, 2017, to 45 states that did not. Commercial claims data from the Health Care Cost Institute were used to identify prices paid to anesthesiologists in hospital outpatient departments and ambulatory surgery centers. The final analytic sample comprised 2 713 913 anesthesia claims across the 3 treated states and the 45 control states. Exposures: Temporal and state-level variation in exposure to surprise-billing legislation. Main Outcomes and Measures: The unit price (allowed amounts standardized per unit of service) paid to out-of-network anesthesiologists at in-network facilities and to in-network anesthesiologists. Results: This retrospective economic analysis of 2 713 913 anesthesia claims found that after surprise-billing laws were passed in 3 states, the unit price paid to out-of-network anesthesiologists at in-network facilities decreased significantly in 2 of them: California, -$12.71 (95% CI, -$25.70 to -$0.27; P = .05) and Florida, -$35.67 (95% CI, -$46.27 to -$25.07; P < .001). In New York, a decline in the overall out-of-network price was not statistically significant (-$7.91; 95% CI, -$17.48 to -$1.68; P = .10); however, by the fourth quarter of 2017, the decline was -$41.28 (95% CI, -$70.24 to -$12.33; P = .01). In-network prices decreased in California by -$10.68 (95% CI, -$12.70 to -$8.66; P < .001); in Florida, -$3.18 (95% CI, -$5.17 to -$1.19; P = .002); and in New York, -$8.05 (95% CI, -$11.46 to -$4.64; P < .001). Conclusions and Relevance: This retrospective study found that prices paid to in-network and out-of-network anesthesiologists in hospital outpatient departments and ambulatory surgery centers decreased after the introduction of surprise-billing legislation, providing early insights into how prices may change under the federal No Surprises Act and in states that have recently passed their own legislation.

Evaluation of Insurance Coverage and Cancer Stage at Diagnosis Among Low-Income Adults With Renal Cell Carcinoma After Passage of the Patient Protection and Affordable Care Act.

Importance: The association of the Patient Protection and Affordable Care Act (ACA) with insurance status and cancer stage at diagnosis among patients with renal cell carcinoma (RCC) is unknown. Objective: To test the hypothesis that the ACA may be associated with increased access to care through expansion of insurance, which may vary based on income. Design, Setting, and Participants: This retrospective cohort analysis included patients diagnosed with RCC from January 1, 2010, to December 31, 2016, in the National Cancer Database. Data were analyzed from July 1 to December 31, 2020. The periods from 2010 to 2013 and from 2014 to 2016 were defined as pre- and post-ACA implementation, respectively. Patients were categorized as living in a Medicaid expansion state or not. Exposures: Implementation of the ACA. Main Outcomes and Measures: The absolute percentage change (APC) of insurance coverage was calculated before and after ACA implementation in expansion and nonexpansion states. Secondary outcomes included change in stage at diagnosis, difference in the rate of insurance change, and change in localized disease between expansion and nonexpansion states. Adjusted difference-in-difference modeling was performed. Results: The cohort included 78 099 patients (64.7% male and 35.3% female; mean [SD] age, 54.66 [6.46] years), of whom 21.2% had low, 46.2% had middle, and 32.6% had high incomes. After ACA implementation, expansion states had a lower proportion of uninsured patients (adjusted difference-in-difference, -1.14% [95% CI, -1.98% to -1.41%]; P = .005). This occurred to the greatest degree among low-income patients through the acquisition of Medicaid (APC, 11.0% [95% CI, 8.6%-13.3%]; P < .001). Implementation of the ACA was also associated with an increase in detection of stage I and II disease (APC, 4.0% [95% CI, 1.6%-6.3%]; P = .001) among low-income patients in expansion states. Conclusions and Relevance: Among patients with RCC, ACA implementation was associated with an increase in insurance coverage status in both expansion and nonexpansion states for all income groups, but to a greater degree in expansion states. The proportion of patients with localized disease increased among low-income patients in both states. These data suggest that ACA implementation is associated with earlier RCC detection among lower-income patients.

Cervical testing beyond the screening target age - A register-based cohort study from Finland.

OBJECTIVE: It has been proposed that cervical cancer screening should be continued in women with previous abnormal results or irregular attendance. We examined the coverage and factors that might influence cervical testing beyond the age range of the organized cervical screening programme in Finland. The national programme invites women in every five years least until the age of 60. After the stopping age, only opportunistic service is available. METHODS: Data on cervical testing were collected from the Mass Screening Registry and providers of opportunistic Pap/HPV-testing and were linked with information on socio-economic variables. The study included 373,353 women who had at least one invitation to the national screening programme between ages 50-60 years, and who were aged 65-74 years in the follow-up period 2006-2016. Multivariable binomial regression models were conducted to determine associations. RESULTS: Altogether 33% of the study population had been tested at least once at ages 65-74 years. Previous regular screening attendance (adjRR 1.70; 95% CI 1.67-1.73) and earlier abnormal results (adjRR 2.08; 95% CI 2.04-2.12) were most clearly related to higher testing adherence at older age. Other factors related to higher testing adherence were urban area of residence, domestic mother tongue, high education level, and high socio-economic status. CONCLUSION: Testing at older age was frequent with normal results, whereas only a small proportion of women with earlier abnormal results or irregular attendance were tested. The upper age limit of the national programme should be raised to 65 years, and the invitations thereafter should be targeted to selected high-risk groups.

Eligibility for cervical cancer screening exit: Comparison of a national and safety net cohort.

OBJECTIVE: To determine eligibility for discontinuation of cervical cancer screening. METHODS: Women aged 64 with employer-sponsored insurance enrolled in a national database between 2016 and 2018, and those aged 64-66 receiving primary care at a safety net health center in 2019 were included. Patients were evaluated for screening exit eligibility by current guidelines: no evidence of cervical cancer or HIV-positive status and no evidence of cervical precancer in the past 25 years, and had evidence of either hysterectomy with removal of the cervix or evidence of fulfilling screening exit criteria, defined as two HPV screening tests or HPV plus Pap co-tests or three Pap tests within the past 10 years without evidence of an abnormal result. RESULTS: Of the 590,901 women in the national claims database, 131,059 (22.2%) were eligible to exit due to hysterectomy (1.6%) or negative screening (20.6%). Of the 1544 women from the safety net health center, 528 (34.2%) were eligible to exit due to hysterectomy (9.3%) or negative screening (24.9%). Most women did not have sufficient data available to fulfill exit criteria: 382,509 (64.7%) in the national database and 875 (56.7%) in the safety net hospital system. Even among women with 10 years of insurance claims data, only 41.5% qualified to discontinue screening. CONCLUSIONS: Examining insurance claims in a national database and electronic medical records at a safety net institution led to remarkably similar findings: two thirds of women fail to qualify for screening exit. Additional steps to ensure eligibility prior to screening exit may be necessary to decrease preventable cervical cancers among women aged >65. CLINICAL TRIAL REGISTRATION: N/A.

Regulation of provider networks in response to COVID-19.

In public health insurance programs, federal and state regulators use network adequacy standards to ensure that health plans provide enrollees with adequate access to care. These standards are based on provider availability, anticipated enrollment, and patterns of care delivery. We anticipate that the coronavirus disease 2019 pandemic will have 3 main effects on provider networks and their regulation: enrollment changes, changes to the provider landscape, and changes to care delivery. Regulators will need to ensure that plans adjust their network size should there be increased enrollment or increased utilization caused by forgone care. Regulators will also require updated monitoring data and plan network data that reflect postpandemic provider availability. Telehealth will have a larger role in care delivery than in the prepandemic period, and regulators will need to adapt network standards to accommodate in-person and virtual care delivery.

Coverage of the hospital-based cancer registries and the designated cancer care hospitals in Japan.

BACKGROUND: Hospital-based cancer registries were developed to describe and improve clinical care for cancer patients. We described the hospital-based cancer registry coverage as a reference for the users, including researchers, policymakers and clinicians. METHODS: The hospital-based cancer registry coverage was defined as the proportion of new cases registered in the hospital-based cancer registry to the National Cancer Registry as the denominator. To examine the coverage of respective cancer types, age groups and prefecture in the hospital-based cancer registry, cases were grouped based on the 10th International Statistical Classification of Diseases and Related Health Problems and were compared with the published report of the National Cancer Registry in 2017. RESULTS: The overall hospital-based cancer registries coverage was 71.7%, and 52.5% of patients were treated at designated cancer care hospitals. The hospital-based cancer registries coverage and treatment rates at designated cancer care hospitals varied per cancer type, age group, and prefecture. The hospital-based cancer registries covered over 80% of the patients with cancers of the larynx, uterus, oesophagus, lip, oral cavity, pharynx and skin, whereas patients' coverage with thyroid cancer was relatively low. The hospital-based cancer registry coverage of young patients (<15 years) was >80%, whereas that for elderly patients (≥85 years) was <55%. The range of coverage in each prefecture was from 43.0 to 89.7%. Over 70% of the patients with cancers of the larynx, lip, oral cavity and pharynx were treated at designated cancer care hospitals. CONCLUSIONS: The hospital-based cancer registry coverage is ~70% of all cancers. Because the coverage differed across cancers and age groups, the respective target groups' analysis should consider this factor.

State Standards for Insurance Access to Oncologists.

As the market for health insurance plans expands, each state is responsible for setting standards to ensure that plans contain adequate coverage for cancer care. Little is currently known about what criteria states use for network adequacy of insurance plans. We contacted representatives of the Department of Insurance (or equivalent) for 50 states and the District of Columbia, as well as searched official state websites to compile data on network adequacy standards for cancer care nationwide. The standards of 16 (31.4%) states contained only qualitative elements for access to an oncologist (eg, "reasonable access"), 7 (13.7%) states included only quantitative elements (eg, travel distance and time restrictions), and 24 (47.1%) states included standards with both qualitative and quantitative elements. Standards from 4 states were not available. States should make certain that robust, transparent protections exist to ensure that patients are able to access high-quality cancer care without experiencing the financial toxicity associated with out-of-network billing.

Receipt of and Spending on Cessation Medication Among US Adults With Employer-Sponsored Health Insurance, 2010 and 2017.

OBJECTIVE: Studies examining the use of smoking cessation treatment and related spending among enrollees with employer-sponsored health insurance are dated and limited in scope. We assessed changes in annual receipt of and spending on cessation medications approved by the US Food and Drug Administration (FDA) among tobacco users with employer-sponsored health insurance from 2010 to 2017. METHODS: We analyzed data on 439 865 adult tobacco users in 2010 and 344 567 adult tobacco users in 2017 from the IBM MarketScan Commercial Database. We used a negative binomial regression to estimate changes in receipt of cessation medication (number of fills and refills and days of supply). We used a generalized linear model to estimate spending (total, employers', and out of pocket). In both models, covariates included year, age, sex, residence, and type of health insurance plan. RESULTS: From 2010 to 2017, the percentage of adult tobacco users with employer-sponsored health insurance who received any cessation medication increased by 2.4%, from 15.7% to 16.1% (P < .001). Annual average number of fills and refills per user increased by 15.1%, from 2.5 to 2.9 (P < .001) and days of supply increased by 26.4%, from 81.9 to 103.5 (P < .001). The total annual average spending per user increased by 53.6%, from $286.40 to $440.00 (P < .001). Annual average out-of-pocket spending per user decreased by 70.9%, from $70.80 to $20.60 (P < .001). CONCLUSIONS: Use of smoking cessation medications is low among smokers covered by employer-sponsored health insurance. Opportunities exist to further increase the use of cessation medications by promoting the use of evidence-based cessation treatments and reducing barriers to coverage, including out-of-pocket costs.

[COVID-19 as an occupational disease or work-related accident: Considerations regarding insurance cover and reporting obligation in the statutory accident insurance]. / COVID-19 als Berufskrankheit oder Arbeitsunfall: Überlegungen zu Versicherungsschutz und Meldepflicht in der gesetzlichen Unfallversicherung.

The COVID-19 illness can occur as an occupational disease or work-related accident. According to the German list of occupational diseases, recognition as an occupational disease 3101 requires occupational exposure of an insured person who has been exposed to an increased risk of infection compared to the general population as a result of their occupational activity in one of the four areas: (1) health service or (2) social welfare sector, (3) laboratory or (4) during activities with increased risk of infection comparable to (1) to (3). The insurance cover covers employees, self-employed people - if not exempted from insurance cover - and honorary workers. The COVID-19 disease is subject to legal notification, mostly in conjunction with a contemporary SARS-CoV-2 virus detection. Regarding insured people who are not included within the aforementioned areas (1) to (4), the COVID-19 illness can be acknowledged as an occupational accident if the intense and direct contact with infected people - not intended as in the case of occupational disease 3101 - but otherwise situationally results from the insured activity itself.

Stabilizing and Strengthening the Affordable Care Act: Opportunities for a New Administration.

For the past decade, the Affordable Care Act (ACA) has successfully reduced uninsurance and improved access to and affordability of health care services for millions of Americans. But the law was weakened when the Trump administration shortened the open enrollment period in the federal Marketplace, reduced outreach and enrollment funding, and revised the public charge rule, among other actions. The Biden administration will have the chance to reverse some of these changes and further strengthen the law to improve health care access and affordability. In this article, the author explores options for expanding access to affordable coverage and care for those who do not qualify for Medicaid or marketplace financial assistance and further discusses opportunities for increasing enrollment among those who are already eligible. The author also examines opportunities for expanding access to specific services, including reproductive health care, among those with insurance. Any attempts to modify or build on the ACA will likely be complicated by the ongoing coronavirus pandemic as well as slim Democratic majorities in the House and Senate, but regulatory solutions will likely be easier to achieve than those that require changes to federal law or state policy.

Between the Waves: Building Power for a Public Option.

Given the close division of power in Washington, DC, how might health reformers pursue their bolder aims? In particular, how might they pursue the robust public option that was a centerpiece of Joe Biden's health plan during the campaign? This new iteration of the public option-far more ambitious than anything seriously considered during the debate over the ACA-is not in the cards right now. But instead of giving up on it, advocates should recast it in an inspiring vision that can structure immediate initiatives designed to make its achievement more feasible. This strategy, which might be called "building power through policy," would involve using the openings for policy change that are likely to exist in the near term to reshape the political landscape for the long term. Three interim steps in particular could advance the public option's prospects: (1) pursuing immediate improvements in the ACA that are tangible and traceable yet do not work against the eventual creation of a public option, (2) building the necessary foundations for a public option within Medicare while encouraging progressive states to experiment with state public plan models, and (3) seeding and strengthening movements to press for more fundamental reform.

Medicare Advantage Chart Reviews Are Associated With Billions in Additional Payments for Some Plans.

BACKGROUND: In the Medicare Advantage (MA) program, private plans receive capitated payments that are adjusted based on their enrollees' number and type of clinical conditions. Plans have the ability to review charts to identify additional conditions that are not present in claims data, thereby increasing risk-adjusted payments. Recently the Government Accountability Office released a report raising concerns about the use of these chart reviews as a potential tool for upcoding. OBJECTIVES: To measure the extent to which plans receive additional payments for chart reviews, and the variation in chart reviews across plans. RESEARCH DESIGN: In this cross-sectional study we use 2015 MA Encounter data to calculate how many additional diagnoses codes were added for each enrollee using chart reviews. We then calculate how these additional diagnosis codes translate to additional reimbursements across plans. SUBJECTS: A total of 14,021,692 beneficiaries enrolled in 510 MA contracts in 2015. MEASURES: Individual and contract level hierarchical condition category codes, total plan reimbursement. RESULTS: Chart reviews were associated with a $2.3 billion increase in payments to plans, a 3.7% increase in Medicare spending to MA plans. Just 10% of plans accounted for 42% of the $2.3 billion in additional spending attributed to chart review. Among these plans, the relative increase in risk score from chart review was 17.2%. For-profit plans engaged in chart reviews substantially more frequently than nonprofit plans. CONCLUSIONS: Given the substantial and highly variable increase in payments attributable to chart review, further investigation of the validity of this practice and its implications for Medicare spending is needed.

Impact of the affordable care act's medicaid expansion on burn outcomes and disposition.

BACKGROUND: We aimed to analyze the impact of the Affordable Care Act's Medicaid Expansion on clinical outcomes and patient disposition after burn injury. We hypothesized that increased insurance coverage results in improved outcomes and higher rates of discharge to inpatient rehabilitation. METHODS: We reviewed the University of Washington Regional Burn Center registry data for patients admitted from 2011 to 2018. Patients were grouped into two categories: before (2011-2013) and after (2015-2018) Medicaid expansion; we excluded 2014 data to serve as a washout period. Outcomes assessed included length of hospital stay, patient disposition, and mortality. Multivariable logistic and linear regression models with covariates for sex, age, burn size, ethnicity ethnicity, distance from burn center, etiology of burn, and presence of inhalation injury were used to determine the impact of Medicaid expansion on outcomes. RESULTS: Rates of uninsured patients decreased while Medicaid coverage increased. Despite increased median burn size after Medicaid expansion, inpatient mortality rates did not change, but average acute care length of stay increased. More patients were discharged to rehabilitation centers. CONCLUSIONS: Our study corroborates prior findings of increased insurance coverage since Medicaid expansion. Increased insurance coverage is associated with higher rates of discharge to inpatient rehabilitation programs after burn injury.