Local Coverage Determinations Research Articles

Navigating obstacles impacting the sustainability of Medicare-funded wound care pricing.

With more effective oversight, Medicare costs can be reduced, while stabilising a portion of its trust fund, disincentivising non-compliance and improving outcomes for the growing population of US beneficiaries with hard-to-heal wounds.

Time From Authorization by the US Food and Drug Administration to Medicare Coverage for Novel Technologies

A wide variety of novel medical diagnostics and devices are determined safe and effective by the US Food and Drug Administration (FDA) each year, but to our knowledge the literature lacks evidence documenting how long it takes to establish new Medicare coverage for these technologies. To measure time from FDA authorization to at least nominal Medicare coverage for technologies requiring a new reimbursement pathway. In this cross-sectional study, public databases were used to associate each technology to billing codes, determine the effective date of each code and Medicare coverage decisions, and stratify by the maturity of the Medicare coverage. At least nominal coverage was defined as achievement of explicit coverage milestones through a national coverage determination, local coverage determinations by Medicare administrative contractors, or by implicit coverage aligned to a new billing code. Characterization by product type (acute treatment, chronic or ongoing treatment, diagnostic assay, and diagnostic device), manufacturer size, and evidence level were assessed for association with coverage achievement. The study included new product applications authorized by the FDA through the premarket approval pathway, the de novo pathway, or with breakthrough designation in the 510(k) pathway from January 1, 2016, to December 31, 2019. Data analysis took place between May 1, 2022, and December 31, 2022. Time from FDA authorization to the first coverage milestone. Among 281 identified technologies in the total sample, 64 (23%) were deemed novel technologies based on the absence of coverage determinations and/or the use of temporary or miscellaneous billing codes. Twenty-eight of 64 technologies (44%) successfully achieved explicit or implicit coverage following FDA authorization. The median time to at least nominal coverage for the analysis cohort was 5.7 years (90% CI, 4.4-NA years). Analysis of time-to-coverage data highlighted company size (log-rank P<.001) and product type (log-rank P = .01) as significant covariates associated with coverage achievement. No association was observed for technologies with level 1 evidence at FDA authorization and subsequent coverage milestone achievement (log-rank P = .40). In this cross-sectional study of 64 novel technologies, only 28 (44%) achieved coverage milestones over the study timeline. The several-year period observed to establish at least nominal coverage suggests existing coverage processes may affect timely reimbursement of new technologies.

Private Payer and Medicare Coverage Policies for Use of Circulating Tumor DNA Tests in Cancer Diagnostics and Treatment.

Circulating tumor DNA (ctDNA) is used to select initial targeted therapy, identify mechanisms of therapeutic resistance, and measure minimal residual disease (MRD) after treatment. Our objective was to review private and Medicare coverage policies for ctDNA testing. Policy Reporter was used to identify coverage policies (as of February 2022) from private payers and Medicare Local Coverage Determinations (LCDs) for ctDNA tests. We abstracted data regarding policy existence, ctDNA test coverage, cancer types covered, and clinical indications. Descriptive analyses were performed by payer, clinical indication, and cancer type. A total of 71 of 1,066 total policies met study inclusion criteria, of which 57 were private policies and 14 were Medicare LCDs; 70% of private policies and 100% of Medicare LCDs covered at least one indication. Among 57 private policies, 89% specified a policy for at least 1 clinical indication, with coverage for ctDNA for initial treatment selection most common (69%). Of 40 policies addressing progression, coverage was provided 28% of the time, and of 20 policies addressing MRD, coverage was provided 65% of the time. Non-small cell lung cancer (NSCLC) was the cancer type most frequently covered for initial treatment (47%) and progression (60%). Among policies with ctDNA coverage, coverage was restricted to patients without available tissue or in whom biopsy was contraindicated in 91% of policies. MRD was commonly covered for hematologic malignancies (30%) and NSCLC (25%). Of the 14 Medicare LCD policies, 64% provided coverage for initial treatment selection and progression, and 36% for MRD. Some private payers and Medicare LCDs provide coverage for ctDNA testing. Private payers frequently cover testing for initial treatment, especially for NSCLC, when tissue is insufficient or biopsy is contraindicated. Coverage remains variable across payers, clinical indications, and cancer types despite inclusion in clinical guidelines, which could impact delivery of effective cancer care.

CMS Finalizes New Medicare Advantage Prior Authorization Rule

CMS Finalizes New Medicare Advantage Prior Authorization Rule

Cervical medial branch block progression to radiofrequency neurotomy: A retrospective clinical audit

BackgroundChronic axial neck pain (CANP) due to zygapophysial joint arthropathy is best diagnosed via cervical medial branch block (MBB). However, the paradigm by which MBB is used to select patients for cervical radiofrequency neurotomy (RFN) is contested. Dual diagnostic cervical MBB with a minimum of ≥80% pain relief to diagnose cervical zygapophysial joint pain has been accepted by some Medicare Local Coverage Determinations as the method for selecting patients for cervical RFN. There are some who would argue that the utility of the dual diagnostic MBB and the ≥80% pain relief cut off lacks utility in clinical practice. The suspicion being those who progress from MBB1 to MBB2 will then flow from MBB2 to RFN without fail. Does clinical practice using dual diagnostic MBBs and using an ≥80% pain relief cut off reduce patient eligibility for cervical RFN after both MBB1 and MBB2? MethodsA retrospective clinical audit was carried out at an academic institution spine center from January 1st to December 31st, 2019. Charts were selected based on Current Procedural Terminology codes for MBB, then included if the cervical medial branches were targeted. Charts were then reviewed for procedural progression. Results21/51 (24%, 95% Confidence Interval 12-35%) patients progressed from MBB1 to MBB2. Of those 21 patients, 13 patients progressed from MBB2 to RFN (62%, 95% CI 41-83%). In total, 13/51 (14%, 95% CI 14-37%) patients who were initially suspected to have CANP due to zygapophysial joint pain progressed to RFN. Both MBB1 and MBB2 hindered the progression of 30/51 patients (59%, 95% CI 45-72%) and 8/21 patients (38%, 95% CI 17-59%), respectively. ConclusionBoth MBB1 and MBB2 served to filter patients from progression to RFN using dual MBBs with an ≥80% pain relief cutoff.

Coverage Denials for Medical Necessity Rules in Medicare

Research ObjectiveCoverage policy may be an important tool to reduce spending while discouraging low‐value medical services. Government and private insurers may also differ in their scope of coverage restrictions for suspected low‐value services. However, basic facts about coverage denials are unknown because denials are not identifiable in standard research datasets. In this study, we characterized fundamental features of coverage denials for medical necessity using data on all claims denied by a large Medicare Advantage health insurer.Study DesignWe analyzed medical benefit claims for Medicare Advantage beneficiaries. We detected all claims that were denied for failing to meet medical necessity rules. Some rules were made by the government (i.e. national or local coverage determinations) and other rules were made by the private insurer. We measured the frequency of denials, associated spending, affected service types and provider specialties, the reasons for denials, and temporal trends in denials. We also quantified differences between denials due to government coverage rules and denials due to private insurer coverage rules.Population StudiedWe analyzed 2014–2019 claims for all Medicare Advantage beneficiaries enrolled with the health insurer Aetna. Our sample included 2.9 million unique beneficiaries (mean age = 73, 56% female, 5% Medicaid dual eligible).Principal FindingsThere were 0.84 denials per beneficiary per year (95% CI 0.83–0.84), corresponding to 1.45% of claims (95% CI 1.44–0.46), with 31.8% of beneficiaries affected each year (95% CI 31.8–31.9). Denied claims accounted for $64 per beneficiary per year (95% CI 63–65), or 0.73% of medical spending (95% CI 0.71–0.76). Denial rates increased over time, from 0.59% of spending in 2014 to 0.85% of spending in 2019 (p &lt; 0.01). Government coverage rules accounted for 83% of denied claims, but only 60% of denied spending, and private insurer coverage rules accounted for the remaining denials. Most services denied under private insurer coverage rules were categorized as experimental/investigational (49%), not a treatment for disease (20%), or without proven efficacy (16%); denials for services categorized as cosmetic were rare (1%). A large majority of claims denied under Medicare coverage rules were for laboratory tests (75%), most of which were for chemistry studies. Denials under private insurer coverage rules were more widely distributed across service types; home care and chemotherapy accounted for the greatest shares of denied spending (14% and 11%). The provider types with the greatest share of denied spending were hospital outpatient departments (34%) and laboratories (19%).ConclusionsFor a large Medicare Advantage insurer, denials under medical necessity rules accounted for a small but growing fraction of annual spending. While most spending was denied under government coverage rules, additional private insurer rules targeted different types of services and accounted for additional denied spending.Implications for Policy or PracticeTo the authors' knowledge, this study presents the first comprehensive evidence on how often medical services are denied for failing to meet medical necessity criteria. In Medicare Advantage, coverage denials appear to contribute to modest savings, derived from both government‐produced and private insurer‐produced coverage criteria.Primary Funding SourceNIH, CVS Health, Phyllis &amp; Jerome Rappaport Foundation.

Unsafe Discharges: Ethics, Risk Reduction, and Obligations, Part 2

Unsafe Discharges: Ethics, Risk Reduction, and Obligations, Part 2

Private Payer and Medicare Coverage for Circulating Tumor DNA Testing: A Historical Analysis of Coverage Policies From 2015 to 2019.

Clinical adoption of the sequencing of circulating tumor DNA (ctDNA) for cancer has rapidly increased in recent years. This sequencing is used to select targeted therapy and monitor nonresponding or progressive tumors to identify mechanisms of therapeutic resistance. Our study objective was to review available coverage policies for cancer ctDNA-based testing panels to examine trends from 2015 to 2019. We analyzed publicly available private payer policies and Medicare national coverage determinations and local coverage determinations (LCDs) for ctDNA-based panel tests for cancer. We coded variables for each year representing policy existence, covered clinical scenario, and specific ctDNA test covered. Descriptive analyses were performed. We found that 38% of private payer coverage policies provided coverage of ctDNA-based panel testing as of July 2019. Most private payer policy coverage was highly specific: 87% for non-small cell lung cancer, 47% for EGFR gene testing, and 79% for specific brand-name tests. There were 8 final, 2 draft, and 2 future effective final LCDs (February 3 and March 15, 2020) that covered non-FDA-approved ctDNA-based tests. The draft and future effective LCDs were the first policies to cover pan-cancer use. Coverage of ctDNA-based panel testing for cancer indications increased from 2015 to 2019. The trend in private payer and Medicare coverage is an increasing number of coverage policies, number of positive policies, and scope of coverage. We found that Medicare coverage policies are evolving to pan-cancer uses, signifying a significant shift in coverage frameworks. Given that genomic medicine is rapidly changing, payers and policymakers (eg, guideline developers) will need to continue to evolve policies to keep pace with emerging science and standards in clinical care.

Immunohistochemistry utilization in the diagnosis of melanoma.

The use of immunohistochemical (IHC) stains in dermatopathology is commonplace; however, little is known regarding utilization trends in melanoma diagnosis. Current Medicare local coverage determinations (LCDs) state that most pigmented lesions, including melanoma, can be diagnosed using H&E alone. Histopathology reports for all biopsy-proven melanomas excised between January 1, 2017 and June 30, 2018, at a single dermatology clinic, were identified with the following parameters abstracted: laboratory/dermatopathologist rendering the diagnosis, whether IHC was performed, type/number of stains utilized, presence/depth of invasion, and melanoma subtype. The association of characteristics with IHC utilization was evaluated using χ2 test for categorical variables. Three hundred and fifty six eligible melanomas were identified. IHC was employed in 228 (64%) of the diagnoses. Invasive melanoma was diagnosed in 199 cases (55.9%) while 157 (44.1%) were identified as melanoma in situ (MIS). Of the 228 that utilized IHC, 117 were performed on invasive melanoma (58.8%) and 111 were performed on MIS (70.7%). Our findings suggest a higher IHC usage for the diagnosis of melanoma than previously reported. Existing LCDs regarding IHC utilization in melanoma do not reflect the current state of practice. Further investigation regarding IHC utilization and the development of appropriate-use criteria for melanoma IHC is necessary.

Current CPT Coding and Payment Policy Implications for Immunohistology Services.

Immunohistology is essential to the practice of modern surgical and cytopathology. There are 3 major types of immunohistologic services provided in clinical practice: traditional immunohistochemistry, morphometric analysis of tumor immunohistochemistry, and immunofluorescence. Proper Current Procedural Terminology coding for these services has been updated to reflect current medical practice. Subsequent to changes in the Current Procedural Terminology coding structure for these services, the valuation of these services have been reviewed by the American Medical Association/Specialty Society Relative Value Update Committee and new valuations instituted by the Centers for Medicare and Medicaid Services. Although valuations for services may be established, the circumstances of payment may be affected by Medicare Contractor's Local Coverage Determinations or service limits imposed by the National Correct Coding Initiative.

The Ever-Changing Medicare Local Coverage Determinations

The Ever-Changing Medicare Local Coverage Determinations

Should I Unplug the Phones Again: Understanding Government Hospice Audits and “Pre-Tecting” Your Organization Through Robust Provider Documentation (TH303)

•Describe 3 common legal avenues federal and state investigators and Medicare contractors use to target hospice organizations.•Discuss commonly encountered barriers to adequate nursing documentation in hospice care.•Demonstrate 4 evidence-based tools useful for supporting prognosis in patients near the end of life. Since the inception of the Medicare Hospice Benefit, hospice has grown to serve over 1.6 million people per year at an annual cost of over $15.8 billion dollars. This high price tag has led to increased scrutiny by federal and state regulators over the past decade. Documentation by bedside and interdisciplinary team clinicians represents the vast majority of data in these inquiries. Unfortunately, nurses, nurse practitioners, and physicians have been trained to document clinically relevant information without always understanding the impact that this documentation will have during payer audits sometimes years later. How can hospice clinicians further not only their clinical information needs but also protect the organization should an audit occur in the future? In this concurrent session, a healthcare law attorney with 25 years of healthcare and hospice experience will partner with a hospice's nurse manager and 2 HPM physicians who have reviewed hundreds of thousands of pages of hospice records under government audit to share strategies to support effective documentation of eligibility. The False Claims Act and hospice-focused program integrity initiatives will be examined and the role of recovery audit contractors (RAC) and zone program integrity contractors (ZPIC) will be presented. Our nursing leader will address barriers to effective nursing documentation, which constitutes the vast majority of clinical information, including difficulties with technical Local Coverage Determinations, struggles around complex prognostication, and limitations inherent to hospice electronic medical record systems. During the second half of the interdisciplinary presentation, the physician team will present 4 evidence-based tools and articles that cut across disease states that will inform prognostic abilities of physicians completing Certification of Terminal Illness (CTI) documentation and support their prognostic claims. They will use examples from real cases showing well- and poorly written face-to-face and CTI notes, reworking those with opportunities for improvement using the presented tools to reinforce audience learning.

IMRT Use for the Treatment of Early Stage Breast Cancer in the United States

In 2013, ASTRO issued a Choosing Wisely recommendation (CWr) to “not routinely use intensity modulated radiotherapy (IMRT) to deliver whole breast radiotherapy as part of breast conservation therapy.” A previous study reported that 11.2% of women, age ≥66, with breast cancer received IMRT in 2005. Since Choosing Wisely addresses common treatments that are unnecessary, we hypothesized that IMRT use for breast cancer was variable among regions in United States immediately preceding the CWr. SEER records for women, age ≥66, with first primary diagnosis of Stage I/II breast cancer (2007-2012) were linked with Medicare claims (2007-2013). All women had coverage for at least 12 months before and after cancer diagnosis (or until death), lumpectomy 1 month before to 6 months after diagnosis, and RT within 6 months of lumpectomy. We evaluated receipt of IMRT versus conventional or conformal therapy within 1 year of diagnosis overall and by SEER registry (12 sites). Medicare coverage was defined as favorable when Carrier or Fiscal Intermediary Local Coverage Determinations explicitly allowed breast IMRT, neutral when IMRT was not mentioned, or unfavorable when breast IMRT was explicitly forbidden or only allowed in unusual situations. We used logistic regression to estimate the adjusted associations between demographic (age, race) or tumor characteristics (grade, laterality, diagnosis year) and receipt of IMRT. Age and diagnosis year were incorporated as continuous variables, and the remaining as categorical variables. Among 13,037 women meeting inclusion criteria, mean age was 74.4, 89% were white, 50.5% had left-sided breast cancer, and 19.8% received IMRT. Table 1 shows the proportions receiving IMRT, varying from 0% in Hawaii to 52% in Detroit. Only left-sided cancer (OR=1.62, p<0.001) was associated with receipt of IMRT. The rate of IMRT did not significantly change during 2008-2012. In analyses of individual SEER sites, IMRT use was independently associated with left-side cancer in several registries (CA, GA, IA, KY, NJ, SE, UT), and significantly decreased over time in three regions (CT, GA, SE). IMRT use for women with early stage breast cancer and Medicare fee for service coverage was 19.8% across SEER registries in 2008-2012. However, the overall usage rate remained stable preceding publication of the CWr. In GA and CT, where Medicare coverage policies changed from favorable or neutral to unfavorable, there was a rapid decrease in use. Left-sided cancer was strongly associated with IMRT—suggesting that concerns about cardiac exposure and/or specific coverage policies may drive use. Our findings suggest the need for national dialogue to align practice with the CWr and reduce the considerable variation in practice between regions.Abstract 2946; Table 1% IMRTRegistryOverallLeftRightAll202416California (CA)161913Connecticut (CT)141712Detroit (DT)525846Georgia (GA)263023Hawaii (HI)000Iowa (IA)360.5New Jersey (NJ)253119Seattle (SE)693 Open table in a new tab

Cognitive Treatment: Is It Covered?

Cognitive Treatment: Is It Covered?

Clinical Genomic Profiling of a Diverse Array of Oncology Specimens at a Large Academic Cancer Center: Identification of Targetable Variants and Experience with Reimbursement

Large cancer panels are being increasingly used in the practice of precision medicine to generate genomic profiles of tumors with the goal of identifying targetable variants and guiding eligibility for clinical trials. To facilitate identification of mutations in a broad range of solid and hematological malignancies, a 467-gene oncology panel (Columbia Combined Cancer Panel) was developed in collaboration with pathologists and oncologists and is currently available and in use for clinical diagnostics. Herein, we share our experience with this testing in an academic medical center. Of 255 submitted specimens, which encompassed a diverse range of tumor types, we were able to successfully sequence 92%. The Columbia Combined Cancer Panel assay led to the detection of a targetable variant in 48.7% of cases. However, although we show good clinical performance and diagnostic yield, third-party reimbursement has been poor. Reimbursement from government and third-party payers using the 81455 Current Procedural Terminology code was at 19.4% of billed costs, and 55% of cases were rejected on first submission. Likely contributing factors to this low level of reimbursement are the delays in valuation of the 81455 Current Procedural Terminology code and in establishing national or local coverage determinations. In the absence of additional demonstrations of clinical utility and improved patient outcomes, we expect the reimbursement environment will continue to limit the availability of this testing more broadly.

Home Nutrition Support: Ethics and Reimbursement.

Ethical dilemmas challenge providers on both sides of the hospital and clinic doors. In addition to establishing the nutrition care plan and guiding the client into the home setting with safe and effective parenteral or enteral nutrition therapy, procuring home nutrition support involves meeting documentation requirements and verifying that clients meet reimbursement criteria for home therapy based on third-party payer criteria. Providers have entered a realm for which training has been scarce and they face moral and ethical dilemmas involving serving as patient advocates, possibly stretching the truth to fit the clinical documentation to criteria vs maintaining professional integrity. Nutrition research and evidence-based practice have outpaced modifications to policies including Medicare's national and local coverage determinations, the bulk of which have not seen revisions in 32 years. This review elucidates clinical dilemmas and urges a political call to action to advocate for changes in current, outdated requirements for reimbursement. Given the current healthcare environment and trend toward expedited hospital stays, patients may be better served (and nourished) with revised guidelines.

Local Coverage Determination Policy and the Use of Stereotactic Body Radiation Therapy for Prostate Cancer

IntroductionLocal coverage determinations are local decisions that regulate health care coverage. We evaluated the impact of local coverage determinations as well as patient, tumor and market characteristics on the adoption of stereotactic body radiation therapy for prostate cancer. MethodsUsing SEER-Medicare data we identified men treated with stereotactic body radiation treatment, intensity modulated radiotherapy and robotic prostatectomy. We compared demographics, clinical characteristics and market factors among these 3 treatments. Our primary exposure was local coverage determination policy. Using the Medicare Coverage Database we categorized local coverage determinations as favorable (stereotactic body radiation treatment covered), neutral (stereotactic body radiation treatment covered in the context of a clinical trial or registry), unfavorable (stereotactic body radiation treatment not covered) or absent (ie stereotactic body radiation treatment not governed by a local coverage determination at the time of treatment). We fit a multivariable multinomial logistic regression model and generated predicted probabilities to examine the relationship between local coverage determinations and stereotactic body radiation treatment. ResultsDuring this early period of stereotactic body radiation treatment adoption, intensity modulated radiotherapy was the most common of the 3 treatments, followed by robotic prostatectomy and stereotactic body radiation treatment. Stereotactic body radiation treatment use was high when governed by favorable and neutral local coverage determinations, and lowest when governed by unfavorable local coverage determinations. Compared with favorable local coverage determinations, areas where local coverage determinations were absent were associated with higher stereotactic body radiation treatment use compared with intensity modulated radiotherapy (OR 1.56, 95% CI 1.07–2.25) and robotic prostatectomy (OR 1.84, 95% CI 1.25–2.69). ConclusionsWhen present, local coverage determinations appear to regulate the early adoption of stereotactic body radiation treatment, but when absent are associated with increased stereotactic body radiation treatment use. Although stereotactic body radiation treatment use was uncommon, it varied across a wide range of patient, tumor and market characteristics.

Evaluating Prognostication Tools to Aid in Hospice Referral, Certification & Recertification Narratives of Patients Afflicted With Pulmonary Arterial Hypertension (SA545-D)

•Understand the utility of the REVEAL PAH risk calculator vs LCDs in prognostication of PAH.•Understand how prognostication tools can enhance hospice certification and recertification narratives. Pulmonary Arterial Hypertension is a progressive and fatal disease with no cure. A recent small study suggests that a majority of patients with PAH die in the hospital (67%) and most in the ICU (83%). Research suggests that patients benefit most from receiving hospice care from 2-3 months. Local Coverage Determinations (LCDs) were created to assess whether patients are likely to be in their last 6 months of life. However, these LCDs have not been updated with recent disease-specific prognostication research. We asked whether there were newer disease-specific prognostication tools that could be compared to or used with the LCDs to better predict PAH survival time. To review the literature for PAH prognostication tools, then evaluate and compare prognostication tools for PAH as relevant to hospice referral, certification, and recertification narratives. Phase 1: A review of the PAH-specific prognostication literature to identify target tools. Phase 2: A retrospective analysis of 100% sample of hospice patients with a diagnosis of PAH who received hospice services at one large nonprofit hospice and palliative care provider in the Mid-Atlantic region since 2010. Phase 1: 12 articles on prognostication of PAH were identified, of which one tool, the REVEAL, was the most highly regarded. Phase 2: A 100% sample (n=21) of charts from deceased hospice patients seen between 2010-2013 were selected for a retrospective analysis. The analysis will compare the LCDs against the REVEAL prognostication tool in predicting actual date of death and length of stay in hospice. The REVEAL risk calculator is a prognostication tool that could aid hospice and palliative care physicians in more accurately predicting survival time as well as appropriate and timely referrals to hospice.

Considering the demand for and prioritization of intravenous immunoglobulin

Considering the demand for and prioritization of intravenous immunoglobulin

What Is the Level of Evidence Substantiating the Medicare Local Coverage Determinations?

Total joint arthroplasty (TJA) accounts for large expenditures of Medicare resources. Recovery audit contractors (RACs) utilize Local Coverage Determinations (LCDs) documents to retrospectively assess the medical necessity of performed procedures. The Florida LCD requires 3months of documented unsuccessful nonoperative care prior to TJA. The purpose of our study was to evaluate the applicability and quality of the evidence cited in the Florida LCD for patients undergoing TJA. Applicability was assessed by evaluating the efficacy of nonoperative treatment in candidates for TJA. There were 23 citations, of which 11 mentioned nonoperative treatment and only 5 provided references. No citations provided Level I or II evidence substantiating the effectiveness of 3months of nonoperative treatment in patients who would otherwise be candidates for TJA.