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The existing coverage criteria for noninvasive ventilation (NIV) do not recognize the benefits of early initiation of NIV for those with thoracic restrictive disorders and do not address the unique needs for daytime support as the patients progress to ventilator dependence. This document summarizes the work of the thoracic restrictive disorder Technical Expert Panel working group. The most pressing current coverage barriers identified were: (1) delays in implementing NIV treatment; (2) lack of coverage for many nonprogressive neuromuscular diseases; and (3) lack of clear policy indications for home mechanical ventilation (HMV) support in thoracic restrictive disorders. To best address these issues, we make the following key recommendations: (1) given the need to encourage early initiation of NIV with bilevel positive airway pressure devices, we recommend that symptoms be considered as a reason to initiate therapy even at mildly reduced FVCs; (2) broaden CO2 measurements to include surrogates such as transcutaneous, end-tidal, or venous blood gas; (3) expand the diagnostic category to include phrenic nerve injuries and disorders of central drive; (4) allow a bilevel positive airway pressure device to be advanced to an HMV when the vital capacity is < 30% or to address severe daytime respiratory symptoms; and (5) provide additional HMV when the patient is ventilator dependent with use > 18 h per day. Adoption of these proposed recommendations would result in the right device, at the right time, for the right type of patients with thoracic restrictive disorders.

The existing coverage criteria for home noninvasive ventilation (NIV) do not recognize the diversity of hypoventilation syndromes and advances in technologies. This document summarizes the work of the hypoventilation syndromes Technical Expert Panel working group. The most pressing current coverage barriers identified were: (1) overreliance on arterial blood gases (particularly during sleep); (2) need to perform testing on prescribed oxygen; (3) requiring a sleep study to rule out OSA as the cause of sustained hypoxemia; (4) need for spirometry; (5) need to show bilevel positive airway pressure (BPAP) without a backup rate failure to qualify for BPAP spontaneous/timed; and (6) qualifying hospitalized patients for home NIV therapy at the time of discharge. Critical evidence support for changes to current policies includes randomized controlled trial evidence and clinical practice guidelines. To decrease morbidity and mortality by achieving timely access to NIV for patients with hypoventilation, particularly those with obesity hypoventilation syndrome, we make the following key suggestions: (1) given the significant technological advances, we advise acceptance of surrogate noninvasive end-tidal and transcutaneous Pco2 and venous blood gases in lieu of arterial blood gases; (2) not requiring Pco2 measures while on prescribed oxygen; (3) not requiring a sleep study to avoid delays in care in patients being discharged from the hospital; (4) remove spirometry as a requirement; and (5) not requiring BPAP without a backup rate failure to approve BPAP spontaneous/timed. The overarching goal of the Technical Expert Panel is to establish pathways that improve clinicians' management capability to provide Medicare beneficiaries access to appropriate home NIV therapy. Adoption of these proposed suggestions would result in the right device, for the right type of patient with hypoventilation syndromes, at the right time.

This document summarizes suggestions of the central sleep apnea (CSA) Technical Expert Panel working group. This paper shares our vision for bringing the right device to the right patient at the right time. For patients with CSA, current coverage criteria do not align with guideline treatment recommendations. For example, CPAP and oxygen therapy are recommended but not covered for CSA. On the other hand, bilevel positive airway pressure (BPAP) without a backup rate may be a covered therapy for OSA, but it may worsen CSA. Narrow coverage criteria that require near elimination of obstructive breathing events on CPAP or BPAP in the spontaneous mode, even if at poorly tolerated pressure levels, may preclude therapy with BPAP with backup rate or adaptive servoventilation, even when those devices provide demonstrably better therapy. CSA is a dynamic disorder that may require different treatments over time, sometimes switching from one device to another; an example is switching from BPAP with backup rate to an adaptive servoventilation with automatic end-expiratory pressure adjustments, which may not be covered. To address these challenges, we suggest several changes to the coverage determinations, including: (1) a single simplified initial and continuing coverage definition of CSA that aligns with OSA; (2) removal of hypoventilation terminology from coverage criteria for CSA; (3) all effective therapies for CSA should be covered, including oxygen and all PAP devices with or without backup rates or servo-mechanisms; and (4) patients shown to have a suboptimal response to one PAP device should be allowed to add oxygen or change to another PAP device with different capabilities if shown to be effective with testing.

The current national coverage determinations (NCDs) for noninvasive ventilation for patients with thoracic restrictive disorders, COPD, and hypoventilation syndromes were formulated in 1998. New original research, updated formal practice guidelines, and current consensus expert opinion have accrued that are in conflict with the existing NCDs. Some inconsistencies in the NCDs have been noted, and the diagnostic and therapeutic technology has also advanced in the last quarter century. Thus, these and related NCDs relevant to bilevel positive airway pressure for the treatment of OSA and central sleep apnea need to be updated to ensure the optimal health of patients with these disorders. To that end, the American College of Chest Physicians organized a multisociety (American Thoracic Society, American Academy of Sleep Medicine, and American Association for Respiratory Care) effort to engage experts in the field to: (1) identify current barriers to optimal care; (2) highlight compelling scientific evidence that would justify changes from current policies incorporating best evidence and practice; and (3) propose suggestions that would form the basis for a revised NCD in each of these 5 areas (thoracic restrictive disorders, COPD, hypoventilation syndromes, OSA, and central sleep apnea). The expert panel met during a 2-day virtual summit in October 2020 and subsequently crafted written documents designed to achieve provision of "the right device to the right patient at the right time." These documents have been endorsed by the participating societies following peer review and publication in CHEST and will be used to inform efforts to revise the current NCDs.

This document summarizes the work of the CPAP and bilevel PAP therapy for OSA Technical Expert Panel working group. For positive airway pressure (PAP) therapy, the most pressing current coverage barriers identified were: an insufficient symptom list describing all potential symptoms in patients with mild OSA; the 4 h per night of PAP usage requirement to keep the device; the additional sleep studies requirement to re-qualify for PAP or supplemental oxygen; and the inability to use telehealth visits for follow-up visits. Critical evidence supports changes to current policies and includes: symptom list inadequate to cover all scenarios based on updated clinical practice guidelines; published evidence that 2 h per night of PAP use can result in benefit to quality of life and other metrics; the costs of another sleep study not justified for all nonadherent patients or for supplemental oxygen due to other types of assessment currently available; and the remarkable success and acceptance of telehealth visits. To achieve optimal access for patients on PAP therapy, we make the following key suggestions: removing symptom criteria for mild OSA; reduce continued coverage criteria to > 2 h per night; eliminate the need for a sleep study to re-qualify if nonadherent or for new Centers for Medicare & Medicaid Services beneficiaries already on and adherent to PAP therapy; allow telehealth visits for documenting benefit and adherence; and allow PAP reports and domiciliary oximetry to qualify for supplemental oxygen with PAP if needed. This paper shares our best vision for bringing the right device to the right patient at the right time.

This document summarizes the work of the COPD Technical Expert Panel working group. For patients with COPD, the most pressing current coverage barriers identified were onerous diagnostic requirements focused on oxygenation (rather than ventilation) and difficulty obtaining bilevel devices with backup rate capabilities. Because of these difficulties, many patients with COPD were instead sometimes prescribed home mechanical ventilators. Critical evidence supports changes to current policies, including randomized controlled trial evidence suggesting a mortality benefit from bilevel positive airway pressure with backup rate and updated clinical practice guidelines from the American Thoracic Society as well as the European Respiratory Society. To achieve optimal access to noninvasive ventilation for patients with COPD, we make the following key recommendations: (1) removal of the need for overnight oximetry testing; (2) the ability to initiate therapy using bilevel devices with backup rate capability; and (3) increased duration of time to meet adherence criteria (ie, a second 90-day trial period) in those patients actively engaged in their care. Clear guidelines based on medical necessity are also included for patients who require initiation of or switch to a home mechanical ventilator. Adoption of these proposed recommendations would result in the right device, for the right type of patient with COPD, at the right time. Finally, we emphasize the need for adequate clinical support during initiation and maintenance of home noninvasive ventilation in such patients.

The Long-Term Oxygen Treatment Trial demonstrated that long-term supplemental oxygen did not reduce time to hospital admission or death for patients who have stable chronic obstructive pulmonary disease and resting and/or exercise-induced moderate oxyhemoglobin desaturation, nor did it provide benefit for any other outcome measured in the trial. Nine months after initiation of patient screening, after randomization of 34 patients to treatment, a trial design amendment broadened the eligible population, expanded the primary outcome, and reduced the goal sample size. Within a few years, the protocol underwent minor modifications, and a second trial design amendment lowered the required sample size because of lower than expected treatment group crossover rates. After 5.5 years of recruitment, the trial met its amended sample size goal, and 1 year later, it achieved its follow-up goal. The process of publishing the trial results brought renewed scrutiny of the study design and the amendments. This article expands on the previously published design and methods information, provides the rationale for the amendments, and gives insight into the investigators' decisions about trial conduct. The story of the Long-Term Oxygen Treatment Trial may assist investigators in future trials, especially those that seek to assess the efficacy and safety of long-term oxygen therapy. Clinical trial registered with clinicaltrials.gov (NCT00692198).

Vocal fold paralysis in adduction can result in dyspnea. The authors have previously described an original vocal fold lateralization technique performed exclusively through an endoscopic approach. In this work, we studied long and short-term results of this procedure on dyspnea, phonation, and swallowing. Retrospective cohort study through data from medical records and operative notes. Patients with unilateral or bilateral vocal fold paralysis in adduction who underwent transoral lateralization were included. In all patients, under laryngosuspension, a supraglottic laryngotomy was performed with CO 2 laser and a lateralization suture was passed through the thyroid cartilage to the vocal process of the vocal fold with the desired tension allowing lateralization of the arytenoid and corresponding vocal fold. We studied evolution of breathing, phonation, and swallowing in all patients who underwent lateralization suture. We tried to correlate symptoms to preoperative and postoperative glottic area, inter-arytenoid distance, and anterior glottic angle. Eighteen patients were included in the study. Three patients were tracheostomy-dependent and were successfully decannulated. All other cases presented short and long-term significant improvement of their dyspnea index score (P < 0.001) in correlation with glottic area enlargement (P < 0.001). There was no statistical difference between preoperative and postoperative voice and swallowing parameters. Our transoral lateralization technique allows enlargement of the glottic aperture in case of laryngeal dyspnea secondary to vocal fold paralysis in adduction. This technique optimally preserves laryngeal structures, especially the mucosa. It is reproducible and reliable for all laryngologists experienced in reconstructive transoral laser microsurgery. [ABSTRACT FROM AUTHOR]

BACKGROUND: Readmission following a hospitalization for COPD is associated with significant health-care expenditure. METHODS: A multicomponent COPD post-discharge integrated disease management program was implemented at the Cleveland Clinic to improve the care of patients with COPD and reduce readmissions. This retrospective study reports our experience with the program. Groups of subjects who were exposed to different components of the program were compared regarding their readmission rates. Multivariate logistic regression analysis was performed to build predictive models for 30- and 90-d readmission. RESULTS: One hundred sixty subjects completed a 90-d follow-up, of which, 67 attended the exacerbation clinic, 16 subjects received care coordination, 51 subjects completed both, and 26 subjects did not participate in any component despite referral. Thirty- and 90-d readmission rates for the entire group were 18.1 and 46.2%, respectively. Thirty- and 90-d readmission rates for the individual groups were: exacerbation clinic, 11.9 and 35.8%; care coordination, 25.0 and 50.0%; both, 19.6 and 41.2%; and neither, 26.9 and 80.8%, respectively. The model with the best predictive ability for 30-d readmission risk included the number of hospitalizations within the previous year and use of noninvasive ventilation (C statistic of 0.84). The model for 90-d readmission risk included receiving any component of the post-discharge integrated disease management program, the number of hospitalizations, and primary care physician visits within the previous year (C statistic of 0.87). CONCLUSIONS: Receiving any component of a post-discharge integrated disease management program was associated with reduced 90-d readmission rate. Previous health-care utilization and lung function impairment were strong predictors of readmission. [ABSTRACT FROM AUTHOR]

BACKGROUND: Neuralgic amyotrophy is an inflammatory peripheral nerve disorder in which phrenic nerve involvement can lead to diaphragm paralysis. The prevalence, magnitude, and time course of diaphragm recovery are uncertain. METHODS: This study modeled the course of recovery of lung function in 16 subjects with diaphragm impairment from neuralgic amyotrophy. The first and last available vital capacity, sitting-to-supine decline in vital capacity, and maximal inspiratory pressures were compared. RESULTS: An asymptotic regression model analysis in 11 subjects with at least partial recovery provided estimates of the vital capacity at onset (47%, 95% CI 25-68%), the final vital capacity (81%, 95% CI 62-101%), and the half-time to recovery (22 months, 95% CI 15-43 months). In those subjects, there was a significant improvement between the first and last measured FVC (median 44-66%, P = .004) and maximal inspiratory pressure (mean 34-51%, P = .004). Five subjects (31%) with complete recovery had a final sitting-to-supine drop of vital capacity of 16% and a maximal predicted inspiratory pressure of 63%. CONCLUSIONS: Sixty-nine percent of subjects with diaphragm impairment from neuralgic amyotrophy experience recovery of lung function and diaphragm strength, but recovery is slow and may be incomplete. [ABSTRACT FROM AUTHOR]

BACKGROUND: Positive airway pressure (PAP) in subjects with both obstructive sleep apnea and COPD reduces the risk of pulmonary hypertension, death, and hospitalizations from COPD exacerbations, but adherence to the intervention is low, similar to the experience with noninvasive ventilation in stable COPD. We sought to assess whether hyperinflation on chest radiographs contributes to low adherence to PAP therapy in the overlap syndrome. METHODS: Records of patients with a listed diagnosis of COPD at the time of polysomnography were reviewed. Overlap syndrome was diagnosed when COPD was clinically confirmed with spirometry showing a fixed airway obstruction and when the apnea-hypopnea index was ≥5. Hyperinflation was evaluated by a review of the right diaphragm height on a lateral chest radiograph. Adherence was assessed clinically or through device download at a 3-month follow-up, and later adherence was assessed by telephone interviews. A receiver operating curve was used to determine whether diaphragm height was associated with adherence. RESULTS: Twenty-one of 41 subjects (51%) were considered adherent to PAP therapy at the 3-month visit. Adherent subjects were more overweight compared with non-adherent subjects (body mass index of 36.0 ± 5.7 vs 32.0 ± 5.7 kg/m2, P = .03), sleepier at the onset (Epworth sleepiness scale score of 13.0 ± 5.8 vs 9.4 ± 5.4, P < .05), and less likely to have hyperinflation as defined by a right diaphragm height ≤ 2.45 cm (33% vs 65%, P = .04). The body mass index and initial sleepiness no longer predicted adherence beyond 3 months, but 35% of subjects with a right diaphragm height ≤ 2.45 cm were adherent beyond 3 months compared with 75%of those with a right diaphragm height > 2.45cm (P = .04 by Fisher exact test). CONCLUSIONS: Hyperinflation is associated with decreased adherence to PAP therapy in the overlap syndrome. [ABSTRACT FROM AUTHOR]

The article offers information on the study related to the management of the respiratory support in patients with amyotrophic lateral sclerosis (ALS). It states that the challenges remain in the application of noninvasive ventilation (NIV) in patients with ALS, including the timing of initiation, whether or not it favorably alters the course of diaphragm impairment and underutilization.

Summary: Screening studies reveal a much larger number of individuals expected to have alpha-1 antitrypsin deficiency than is clinically recognized, with estimates that only about 2–10% of such individuals have been diagnosed. In the context that recognition of alpha-1 antitrypsin may prompt specific interventions (e.g., smoking avoidance, testing of family members, genetic counseling, and consideration of augmentation therapy), diagnosis is important, inviting much attention for efforts to identify affected individuals. Strategies to identify affected individuals include both population-based screening and targeted detection, and available studies have employed both approaches, though large-scale population-based screening is challenging. As reviewed in this paper, targeted-detection studies have generally produced a higher rate of detecting disease, and tend to be more successful with easier sampling techniques. Strategies to enhance detection in targeted studies have included awareness campaigns, easy testing techniques (such as evaluation of dried blood spots and home, confidential testing), and inclusive criteria for testing which span the full spectrum of clinical manifestations of alpha-1 antitrypsin deficiency. [Copyright &y& Elsevier]