Alliance News2024-04-18T13:05:37-04:00

Comment Letter on HIPAA Modifications RFI

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February 12th, 2019|

Comment Letter on Medicaid and CHIP Managed Care Proposed Rule

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January 14th, 2019|

Letter to FCC Re: Spectrum Shortage for Wireless Medical Telemetry Services (WMTS)

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December 20th, 2018|

Comment Letter on 2019 and 2020 Medicare Advantage Proposed Rule

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December 20th, 2018|

CMS Continues Its Expansion of Telehealth in Medicare

On Thursday, Centers for Medicare & Medicaid Services (CMS) finalized the Calendar Year 2019 (CY19) Medicare Physician Fee Schedule (PFS), which lays out reimbursement rates for physicians and other health professionals who provide services to Medicare beneficiaries. This year’s rule is another exciting step forward for the telehealth world, with new services like virtual check-ins, store-and-forward, and interprofessional consultations all being reimbursed by Medicare. For the most part, CMS finalized its vision from July’s proposed rule.

Additionally, CMS included provisions related to the recently signed opioids legislation – the SUPPORT for Patients and Communities Act – which will lift cumbersome restrictions on Medicare reimbursement for substance use disorder treatment provided via telehealth.

Key Provisions:

Virtual Check-Ins
CMS finalized its proposal to allow “virtual check-ins” in Medicare, which are 5 to 10 minutes of medical discussion conducted by a provider via communications technology-based services, which include real-time phone and video chat conversations.

The service must be provided to an “established patient” who has seen the treating provider within the past three years, and it may not be related to a service provided within the past seven days nor lead to a service or procedure within the next 24 hours or soonest available appointment. In other words, CMS intends for virtual check-ins to be quick, virtual visits for one-off medical questions and condition assessments, not a follow-up or triage that leads to an office visit.

Store-and-Forward
CMS finalized a code that describes “remote evaluation of recorded video and/or images submitted by an established patient (e.g. store and forward), including interpretation with follow-up with the patient within 24 business hours.” This code has the same seven-day/twenty-four-hour limitations as the virtual check-in code.

The Agency predicts that this reimbursement will be especially useful in specialties like dermatology, wherein patients could take a picture of a skin problem, send it to their doctor, and then receive an interpretation from their doctor within a business day. The beneficiary may be on the hook for cost-sharing related to this service, so CMS is requiring verbal consent from the patient to be noted in the medical record.

Interprofessional Internet Consultations
Interprofessional internet consultations include “assessment and management services conducted through telephone, internet, or electronic health record consultations furnished when a patient’s treating physician or other qualified healthcare professional requests the opinion and/or treatment advice of a consulting physician or qualified health professional with specific specialty expertise.”

By finalizing this proposal, CMS is acknowledging the time and expertise that is required for physicians to consult other physicians and reimbursing them for it. Like the store-and-forward services, the agency is requiring verbal consent from the patient to be noted in the medical record to help avoid any unexpected cost-sharing obligations.

Remote Patient Monitoring
CMS added three new codes to the list of chronic care remote physiologic monitoring CPT codes reimbursable under Medicare. These new codes include remote monitoring of a wireless pulmonary artery sensor and physiologic parameters such as weight, blood pressure, and pulse oximetry. New codes also reimburse for initial set-up and patient education on the remote monitoring equipment provided by the health care professional.

The final rule clarifies that remote patient monitoring may be furnished by clinical staff in addition to physicians, which helps eliminate any uncertainty that a clinic or health system may have about utilizing clinical staff with lower levels of training.

Telehealth Services for Treatment of Substance Use Disorders
The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act (H.R. 6) removed the originating site geographic requirements included under section 1834(m) of the Social Security Act and adds the home of an individual as a permissible originating site for telehealth services for substance use disorder under Medicare.

In accordance with the SUPPORT Act, CMS issued an interim final rule with comment period for the new originating site rules that are set to go into effect on or after July 1, 2019.

Regulatory Impact Analysis
CMS expects the new telehealth and remote patient monitoring rules to expand access to health care in rural areas, but they estimate that “there will only be a negligible impact on PFS expenditures from these additions.” Once these new rules and codes are implemented, we look forward to using them to further build on evidence showing that outdated regulations on Medicare reimbursement for telehealth services are thwarting opportunities for quality patient care.

November 6th, 2018|

Proposed CMS Rules Will Govern How MA Plans Structure Telehealth Benefits

On Friday, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule regarding Medicare Part C and Part D benefits. The proposal is the next step in the implementation of the Bipartisan Budget Act which authorized Medicare Advantage (MA) plans to offer, as part of the basic benefit package, additional telehealth benefits beyond what is currently allowable in original Medicare.

After years of trying to convince CMS that telehealth services should not be considered separate clinical services, and that telehealth will not drive unnecessary utilization, the rule contains major progress for the telehealth community. However, in addition to these wins, there are a couple of areas we hope that CMS will consider modifications.

Telehealth Wins

Win 1: The biggest win is more of an existential one. For years, telehealth stakeholders have been bringing evidence to CMS to demonstrate that the use of telehealth will produce savings for Medicare. This evidence included avoided care in higher cost settings during acute situations, as well as use of telehealth for secondary prevention of chronic disease including post-acute care and medication management.

On Friday, CMS finally formally acknowledged this evidence. The CMS impact analysis of the proposed rule “assumes replacement of some face-to-face provider visits, and no additional increase in overall provider visits.” They also said that “increased coverage of the additional telehealth benefits will generally result in an aggregate reduction in use of emergency room visits and inpatient admissions because the relative increased ease of receiving healthcare services should improve health outcomes and reduce avoidable utilization that results in untreated conditions exacerbating illness.” They even acknowledged the value of telehealth in reducing patient travel time to the tune of $60-100 million.

Win 2: CMS’s proposal to allow MA plans to build their telehealth benefits “in a manner consistent with professionally recognized standards of health care” is consistent with the way MA plans treat other services. By declining to set up a prescriptive system to determine what is “clinically appropriate,” CMS implicitly recognized that telehealth is simply health care delivery by another modality. It’s not a separate service, and doesn’t need to be treated separately.

Win 3: CMS currently allows MA plans to engage in differential cost sharing for original Medicare benefits. This flexibility would be extended to additional telehealth benefits, meaning that MA plans could offer telehealth services for free should they so choose. This flexibility is crucial for enrollees and plans alike. Making telehealth services available with little or no co-pay facilitates it’s use.

Win 4: The proposed rule notes that CMS recognizes “the potential for additional telehealth benefits to support coordinated health care and increase access to care in both rural and urban areas.” This is exciting because in the past some have posited that telehealth may make care more disjointed. CMS sees the value that telehealth can bring to coordinating care.

Issues to Watch

Issue to Watch 1: MA plans want to offer telehealth services to increase access to care. CMS acknowledges this will happen. However, we need to ensure that telehealth services can be offered alongside in-person care without having to be classified as supplemental to in-person visits. In other words, we shouldn’t have exactly the same number of in-person providers as telehealth providers after network adequacy standards are met. MA plans should be able to add as many telehealth providers as they want after they have met their network adequacy standards.

Issue to Watch 2: The definition of technology in the rule is very broad. It’s good to have flexibility to allow for future technology innovation, but just like in the proposed Physician Fee Schedule rule, allowing secure messaging and phone to count as telehealth may simply mean paying for services that doctors already provide. We should have the same definition for telehealth in both original Medicare and fee-for-service for consistency. The fee-for-service definition is sufficiently broad to allow for technological innovation.

Overall, this proposed rule represents major progress for telehealth in Medicare, and will surely give seniors more access to care through technology.

October 30th, 2018|

Efficacy of telemedical interventional management in patients with heart failure (TIM-HF2): a randomised, controlled, parallel-group, unmasked trial

Efficacy of telemedical interventional management in patients with heart failure (TIM-HF2): a randomised, controlled, parallel-group, unmasked trial

Background

Remote patient management in patients with heart failure might help to detect early signs and symptoms of cardiac decompensation, thus enabling a prompt initiation of the appropriate treatment and care before a full manifestation of a heart failure decompensation. We aimed to investigate the efficacy of our remote patient management intervention on mortality and morbidity in a well defined heart failure population.

Methods

The Telemedical Interventional Management in Heart Failure II (TIM-HF2) trial was a prospective, randomised, controlled, parallel-group, unmasked (with randomisation concealment), multicentre trial with pragmatic elements introduced for data collection. The trial was done in Germany, and patients were recruited from hospitals and cardiology practices. Eligible patients had heart failure, were in New York Heart Association class II or III, had been admitted to hospital for heart failure within 12 months before randomisation, and had a left ventricular ejection fraction (LVEF) of 45% or lower (or if higher than 45%, oral diuretics were being prescribed). Patients with major depression were excluded. Patients were randomly assigned (1:1) using a secure web-based system to either remote patient management plus usual care or to usual care only and were followed up for a maximum of 393 days. The primary outcome was percentage of days lost due to unplanned cardiovascular hospital admissions or all-cause death, analysed in the full analysis set. Key secondary outcomes were all-cause and cardiovascular mortality. This study is registered with ClinicalTrials.gov, number NCT01878630, and has now been completed.

Findings

Between Aug 13, 2013, and May 12, 2017, 1571 patients were randomly assigned to remote patient management (n=796) or usual care (n=775). Of these 1571 patients, 765 in the remote patient management group and 773 in the usual care group started their assigned care, and were included in the full analysis set. The percentage of days lost due to unplanned cardiovascular hospital admissions and all-cause death was 4·88% (95% CI 4·55–5·23) in the remote patient management group and 6·64% (6·19–7·13) in the usual care group (ratio 0·80, 95% CI 0·65–1·00; p=0·0460). Patients assigned to remote patient management lost a mean of 17·8 days (95% CI 16·6–19·1) per year compared with 24·2 days (22·6–26·0) per year for patients assigned to usual care. The all-cause death rate was 7·86 (95% CI 6·14–10·10) per 100 person-years of follow-up in the remote patient management group compared with 11·34 (9·21–13·95) per 100 person-years of follow-up in the usual care group (hazard ratio [HR] 0·70, 95% CI 0·50–0·96; p=0·0280). Cardiovascular mortality was not significantly different between the two groups (HR 0·671, 95% CI 0·45–1·01; p=0·0560).

Interpretation

The TIM-HF2 trial suggests that a structured remote patient management intervention, when used in a well defined heart failure population, could reduce the percentage of days lost due to unplanned cardiovascular hospital admissions and all-cause mortality.
September 22nd, 2018|

Comment Letter on CY 2019 Physician Fee Schedule Proposed Rule

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September 10th, 2018|

Long-term Outcomes of the Effects of Home Blood Pressure Telemonitoring and Pharmacist Management on Blood Pressure Among Adults With Uncontrolled Hypertension: Follow-up of a Cluster Randomized Clinical Trial

Long-term Outcomes of the Effects of Home Blood Pressure Telemonitoring and Pharmacist Management on Blood Pressure Among Adults With Uncontrolled Hypertension: Follow-up of a Cluster Randomized Clinical Trial

Importance: Hypertension is a leading cause of cardiovascular disease. The results were previously reported of a trial of home blood pressure (BP) telemonitoring and pharmacist management intervention in which the interventions stopped after 12 months. There were significantly greater reductions in systolic BP (SBP) in the intervention group than in the usual care group at 6, 12, and 18 months (-10.7, -9.7, and -6.6 mm Hg, respectively).

Objectives: To examine the durability of the intervention effect on BP through 54 months of follow-up and to compare BP measurements performed in the research clinic and in routine clinical care.

Design, setting, and participants: Follow-up of a cluster randomized clinical trial among 16 primary care clinics and 450 patients with uncontrolled hypertension in a large health system from March 2009 to November 2015.

Interventions: A home BP telemonitoring intervention with pharmacist management or usual care.

Main outcomes and measures: Change from baseline to 54 months in SBP and diastolic BP (DBP) measured as the mean of 3 measurements obtained at each research clinic visit.

Results: Among 450 patients, 228 (mean [SD] age, 62.0 [11.7] years; 54.8% male) were randomized to the telemonitoring intervention and 222 (mean [SD] age, 60.2 [12.2] years; 55.9% male) to usual care. Research clinic BP measurements were obtained from 326 of 450 (72.4%) study patients at the 54-month follow-up visit, including 162 (mean [SD] age, 62.0 [11.1] years; 54.9% male) randomized to the telemonitoring intervention and 164 (mean [SD] age, 60.0 [11.2] years; 57.3% male) to usual care. Routine clinical care BP measurements were obtained from 439 of 450 (97.6%) study patients at 6248 visits during the follow-up period. Based on research clinic measurements, baseline mean SBP was 148 mm Hg in both groups. In the intervention group, mean SBP at 6-, 12-, 18-, and 54-month follow-up was 126.7, 125.7, 126.9, and 130.6 mm Hg, respectively. In the usual care group, mean SBP at 6-, 12-, 18-, and 54-month follow-up was 136.9, 134.8, 133.0, and 132.6 mm Hg, respectively. The differential reduction by study group in SBP from baseline to 54 months was -2.5 mm Hg (95% CI, -6.3 to 1.2 mm Hg; P = .18). The DBP followed a similar pattern, with a differential reduction by study group from baseline to 54 months of -1.0 mm Hg (95% CI, -3.2 to 1.2 mm Hg; P = .37). The SBP and DBP results from routine clinical measurements suggested significantly lower BP in the intervention group for up to 24 months.

Conclusions and relevance: This intensive intervention had sustained effects for up to 24 months (12 months after the intervention ended). Long-term maintenance of BP control is likely to require continued monitoring and resumption of the intervention if BP increases.

September 7th, 2018|
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