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.
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
Methods
Findings
Interpretation
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.
The first multicenter, randomized, controlled trial of home telemonitoring for Japanese patients with heart failure: home telemonitoring study for patients with heart failure (HOMES-HF)
The first multicenter, randomized, controlled trial of home telemonitoring for Japanese patients with heart failure: home telemonitoring study for patients with heart failure (HOMES-HF)
Abstract
Home telemonitoring is becoming more important to home medical care for patients with heart failure. Since there are no data on home telemonitoring for Japanese patients with heart failure, we investigated its effect on cardiovascular outcomes. The HOMES-HF study was the first multicenter, open-label, randomized, controlled trial (RCT) to elucidate the effectiveness of home telemonitoring of physiological data, such as body weight, blood pressure, and pulse rate, for Japanese patients with heart failure (UMIN Clinical Trials Registry 000006839). The primary end-point was a composite of all-cause death or rehospitalization due to worsening heart failure. We analyzed 181 recently hospitalized patients with heart failure who were randomly assigned to a telemonitoring group (n = 90) or a usual care group (n = 91). The mean follow-up period was 15 (range 0-31) months. There was no statistically significant difference in the primary end-point between groups [hazard ratio (HR), 0.95; 95% confidence interval (CI), 0.548-1.648; p = 0.572]. Home telemonitoring for Japanese patients with heart failure was feasible; however, beneficial effects in addition to those of usual care were not demonstrated. Further investigation of more patients with severe heart failure, participation of home medical care providers, and use of a more integrated home telemonitoring system emphasizing communication as well as monitoring of symptoms and physiological data are required.
Summary of Proposed Telemedicine Policy Changes in Medicare
This is the first of two blogs about the telemedicine provisions in the draft CY2019 Medicare Physician Fee Schedule published last week by the Centers for Medicare & Medicaid Services (CMS). I’ve summarized below what CMS is proposing, and I will follow up with some thoughts about the implications for telehealth coverage and adoption.
Each year, the Physician Fee Schedule addresses telemedicine. The annual rulemaking process is the mechanism by which CMS adds codes to the list of “telehealth services” allowed in Medicare, and also determines what is allowable for remote care.
But this year’s rule was different. It went beyond routine coding changes and clearly showed that CMS is committed to bringing virtual care to seniors. CMS used incredible creativity to get around some very restrictive statutory provisions. CMS Administrator Seema Verma expressed her commitment to telehealth early in her tenure, and this rule shows she was serious.
Telemedicine is generally divided into three modalities: real-time (live video or phone); remote patient monitoring (asynchronous monitoring); and store-and-forward (sending images via secure messaging). All are regulated differently, and this proposed rule addressed all three.
Physician-Patient Telehealth in Medicare
The CMS proposal getting the most attention is the addition of a new code for a “brief communications technology-based service,” or a virtual check-in (real-time) conducted by a physician or other qualified health care professional for 5-10 minutes of medical discussion. It’s meant to allow the provider “to assess whether the patient’s condition necessitates an office visit.” It can’t originate from a provider service offered within the previous seven days nor lead to a service or procedure within the next 24 hours or soonest available appointment. If either of those things is linked to the virtual visit, the virtual check-in gets bundled into the office visit and is not separately billable.
CMS is proposing to price this service at a rate lower than existing E/M in-person visits ($14 for the new service, compared to $92 for an in-person E/M visit) to reflect the “low work time and intensity.” This service could only be furnished to established patients.
The way the Medicare statute is written necessitated the creation of this new code because rural and site limitations apply to primary care and behavioral health codes that would be useful in treating Medicare patients remotely. By creating a new code, CMS got around the statutory limitation. They did as much as they can without Congressional action, but even with their clever approach we need Congress to change the law to fully allow real-time telehealth to take hold in Medicare (as will be discussed in more detail in my second post).
Remote Patient Monitoring
Remote patient monitoring, or the transmission of biometric information from patient to a medical provider asynchronously, is not considered “telehealth” under the Medicare statute. Therefore, it is not restricted by the same limitation applied to real-time telehealth visits. The newly created CPT codes related to remote patient monitoring – 990X0, 990X1, 93XX1 and 994X9 – were deemed by CMS to be “inherently non face-to-face” and therefore not telehealth services. So, these codes will simply be adopted as part of regular Medicare services under Part B in addition to CPT code 99091 which was unbundled from chronic care management (CCM) codes last year This is excellent news for patients with chronic illness who can benefit from a medical provider monitoring their disease state.
Remote Evaluation of Pre-Recorded Patient Information (“Store and Forward”)
Currently, store and forward, sending pre-recorded video or image technology to another provider for evaluation, is not permitted beyond Alaska and Hawaii. Like the virtual check-ins, CMS intends for store and forward information to be used to determine whether or not an office visit is warranted. It is mostly used in dermatology, radiology, pathology and ophthalmology.
CMS proposes to create a new code that would be separately billable as long as the review of a patient-submitted image or video does not result in an in-person office visit with the same physician, or originate from a service provided within the previous seven days by the same physician. In those cases, payment would be considered bundled into the in-person office visit.
CMS is seeking comment as to whether store and forward services should be limited to established patients, or whether there are certain cases where it might be appropriate for a new patient to receive these services.
Payment for Phone/Internet “Interprofessional Consultation”
CMS proposes to make a separate payment for interprofessional consultations undertaken “for the benefit of treating a patient that will contribute to payment accuracy for primary care and care management services.”
Interprofessional 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.”
Eventual Cuts to Base Rate to Achieve Budget Neutrality
CMS estimates that the usage of these new services will result in fewer than 1 million visits in the first year but will eventually result in more than 19 million visits per year, ultimately increasing payments under the PFS by about 0.2 percent. In order to maintain budget neutrality in setting proposed rates for CY19, CMS assumed the number of services that would result in a 0.2 percent reduction in the proposed base rate conversion factor.
Stay tuned for the second part of this series next week.
CMS Telemedicine Expansion Could Lead to Cuts in Medicare Base Rate
Politico | July 16, 2018
Excerpt:
The rule won’t open the floodgates for telemedicine reimbursement by Medicare. It requires doctors to have a prior relationship with the patient, a limitation criticized by Krista Drobac, executive director of the Alliance for Connected Care. She noted that all states — and the AMA — allow relationships to be established via telemedicine.
“An established relationship with a provider will limit access for people who don’t have a usual source of care, or whose usual medical provider does not offer telemedicine,” Drobac said.
Telehealth Advocates Respond to CMS ‘Virtual Visit’ Proposal
Healthcare Informatics | July 16, 2018
Excerpt:
The CMS proposal brought a mix of enthusiasm and concerns from groups advocating for greater usage of telehealth. “What they have done is creative and brilliant, and it goes further than CMS has ever gone previously to ensure that seniors have services everyone else in the marketplace has,” said Krista Drobac, executive director of the Alliance for Connected Care. On the other hand, she expressed concern that CMS paying for brief e-visits is going to create an environment where providers are going to weigh whether it is worth it to invest in telehealth systems. “What they will probably find is that the reimbursement is not enough to transform their practice and make telehealth part of their work flow,” she said.
Drobac believes CMS has gone as far as it can go within the existing law. She said Congress needs to give the Secretary the authority to waive the telehealth restrictions on all provider codes.
Medical Therapy for Heart Failure With Reduced Ejection Fraction: The CHAMP-HF Registry
Medical Therapy for Heart Failure With Reduced Ejection Fraction: The CHAMP-HF Registry
Background:
Guidelines strongly recommend patients with heart failure with reduced ejection fraction (HFrEF) be treated with multiple medications proven to improve clinical outcomes, as tolerated. The degree to which gaps in medication use and dosing persist in contemporary outpatient practice is unclear.
Objectives:
This study sought to characterize patterns and factors associated with use and dose of HFrEF medications in current practice.
Methods:
The CHAMP-HF (Change the Management of Patients with Heart Failure) registry included outpatients in the United States with chronic HFrEF receiving at least 1 oral medication for management of HF. Patients were characterized by baseline use and dose of angiotensin-converting enzyme inhibitor (ACEI)/angiotensin II receptor blocker (ARB), angiotensin receptor neprilysin inhibitor (ARNI), beta-blocker, and mineralocorticoid receptor antagonist (MRA). Patient-level factors associated with medication use were examined.
Results:
Overall, 3,518 patients from 150 primary care and cardiology practices were included. Mean age was 66 ± 13 years, 29% were female, and mean EF was 29 ± 8%. Among eligible patients, 27%, 33%, and 67% were not prescribed ACEI/ARB/ARNI, beta-blocker, and MRA therapy, respectively. When medications were prescribed, few patients were receiving target doses of ACEI/ARB (17%), ARNI (14%), and beta-blocker (28%), whereas most patients were receiving target doses of MRA therapy (77%). Among patients eligible for all classes of medication, 1% were simultaneously receiving target doses of ACE/ARB/ARNI, beta-blocker, and MRA. In adjusted models, older age, lower blood pressure, more severe functional class, renal insufficiency, and recent HF hospitalization generally favored lower medication utilization or dose. Social and economic characteristics were not independently associated with medication use or dose.
Conclusions:
In this contemporary outpatient HFrEF registry, significant gaps in use and dose of guideline-directed medical therapy remain. Multiple clinical factors were associated with medication use and dose prescribed. Strategies to improve guideline-directed use of HFrEF medications remain urgently needed, and these findings may inform targeted approaches to optimize outpatient medical therapy.
Why Congress’s Opioid Effort is a Major Step Forward for Telehealth Reimbursement
Over the past several weeks, the House of Representatives passed 58 opioid-related bills. The Senate is in the midst of considering their own legislation. The intent of congressional leaders in both chambers is to reconcile these legislative packages and send a final bill to the President this year. This effort is key to solving a major national problem and demonstrates that Congress can come together to support people, families and communities in need.
It also happens to be a significant step for Medicare reimbursement of telehealth. Telehealth supporters have long tried to overturn outdated statutory language that requires Medicare beneficiaries who are enrolled in traditional fee-for-service (FFS) to be in specific institutional sites in rural areas for their providers to qualify for Medicare coverage. About 80 percent of Medicare beneficiaries live in 1,200 metropolitan counties that are not considered “rural” under HHS’ definition, and making people go to a clinic or hospital to receive telehealth services defeats the purpose of the technology.
Our challenge as advocates has been assumptions by the Congressional Budget Office (CBO) that increasing access to telehealth for seniors will increase utilization without a subsequent decrease in utilization of other forms of care. In other words, they think people will use telehealth and also go to the doctor in person, thereby increasing costs. Studies showing that telehealth substitutes for in-person care, reduces re-admissions and increases preventive care have not convinced them, nor have the major investments that capitated insurers have made in telehealth services.
The opioid effort in Congress has changed the course of this debate. As a result of the dire need for behavioral health services to help mitigate the crisis, both the House and Senate have moved bills to lift telehealth restrictions in Medicare to enable more mental health and substance abuse providers to see patients via telehealth, and thereby expand access to care. The eTREAT Act (S. 2901) in the Senate would entirely lift Medicare’s originating site restrictions on reimbursement for patients suffering from substance use disorder (SUD). The Access to Telehealth Services for Opioid Disorders Act (H.R. 5603) in the House would give the Secretary of HHS authority to waive telehealth restrictions for opioid abuse disorder.
These bills, led by a powerful group of bipartisan lawmakers, have cracked the CBO code. They demonstrate what telehealth advocates have been trying for years to convey – allowing telehealth coverage in Medicare will not significantly impact the federal budget. According to CBO, the House version would cost a mere $11 million over 10 years. The Senate bill, which entirely lifts the restrictions, is only $14 million. That’s out of a program that will spend as much as $10 trillion over the same time period.
The relatively small price tag and bi-partisan support of these bills sets the stage for Congress to consider future legislation that would remove even more barriers to telehealth, and could pave the way for originating site restrictions to be lifted for all patients. In the meantime, Medicare patients with substance abuse disorders will be able to access care remotely. This is a huge step forward.