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

Longer-Term Effects of Remote Patient Management Following Hospital Discharge After Acute Systolic Heart Failure: The Randomized E-INH Trial

Longer-Term Effects of Remote Patient Management Following Hospital Discharge After Acute Systolic Heart Failure: The Randomized E-INH Trial

Background: The randomized INH (Interdisciplinary Network Heart Failure) trial (N = 715) reported that 6 months’ remote patient management (RPM) (HeartNetCare-HF) did not reduce the primary outcome (time to all-cause death/rehospitalization) vs usual care (UC) in patients discharged after admission for acute heart failure, but suggested lower mortality and better quality of life in the RPM group.

Objectives: The Extended (E)-INH trial investigated the effects of 18 months’ HeartNetCare-HF on the same primary outcome in an expanded population (N = 1,022) and followed survivors up to 60 months (primary outcome events) or up to 120 months (mortality) after RPM termination.

Methods: Eligible patients aged ≥18 years, hospitalized for acute heart failure, and with predischarge ejection fraction ≤40% were randomized to RPM (RPM+UC; n = 509) or control (UC; n = 513). Follow-up visits were every 6 months during RPM, and then at 36, 60, and 120 months.

Results: The primary outcome did not differ between groups at 18 months (60.7% [95% CI: 56.5%-65.0%] vs 61.2% [95% CI: 57.0%-65.4%]) or 60 months (78.1% [95% CI: 74.4%-81.6%] vs 82.8% [95% CI: 79.5%-86.0%]). At 60 and 120 months, all-cause mortality was lower in patients previously undergoing RPM (41.1% [95% CI: 37.0%-45.5%] vs 47.4% [95% CI: 43.2%-51.8%]; P = 0.040 and 64.0% [95% CI: 59.8%-68.2%] vs 69.6% [95% CI: 65.6%-73.5%]; P = 0.019). At all visits, health-related quality of life was better in patients exposed to HeartNetCare-HF vs UC.

Conclusions: Although 18 months’ HeartNetCare-HF did not significantly reduce the primary outcome of death or rehospitalization at 60 months, lower 120-month mortality in patients previously undergoing HeartNetCare-HF suggested beneficial longer-term effects, although the possibility of a chance finding remains.

January 11th, 2023|

Alliance for Connected Care Executive Director Featured in The Hill

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Krista Drobac, executive director of the Alliance for Connected Care, was featured in The Hill.

See below for an excerpt:

Clock is still ticking on virtual mental health prescribing

Congress acted last month to extend important telehealth flexibilities that will ensure millions of Americans and their providers will continue to have access to telehealth when the COVID-19 public health emergency is officially over. The importance of these policy extensions can’t be overstated. However, there is one remaining critical action item: prescribing for mental health and substance abuse treatment.

Read the full article here.

For more information about the Alliance’s advocacy in this area, see here.

January 6th, 2023|

Top Accomplishments 2022

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Building off of the transformation of telehealth access since 2020, the Alliance has continued to drive the advocacy steps needed for permanent telehealth expansion. We are excited to successfully hold on to important expansions and continue progress in 2023.

Alliance Top Accomplishments

1 A temporary two-year extension of all Medicare telehealth in the fiscal year (FY) 2023 Omnibus Appropriations bill was a major Alliance accomplishment. The Alliance has been calling for a two-year extension since 2021 – citing the need to create for predictability for patients and clinicians while we continue to work toward permanent telehealth authorization.

  • The Alliance lobbied heavily for this expansion, led numerous advocacy letters with hundreds of signers, and most importantly – built the evidence base needed to support policy action.
  • Notably, this expansion also includes a two-year delay of patient-harming in-person requirements on mental health in Medicare.
  • On top of all this – it was the second legislative extension this year, expanding upon the short-term extension we secured in the spring of 2022.

2 A crucial two-year extension of commercial market telehealth flexibilities for individuals and families with high deductible health plans coupled with a health savings accounts (HDHP-HSA) allowing employers and health plans have to provide pre-deductible coverage of telehealth services. This policy is a game changer for the 32 million Americans who would otherwise have to think twice about out-of-pocket costs in accessing care.

  • The Alliance led other groups on numerous comment letters, supported Congressional member advocacy letters, and continued to build the evidence base for how these important provisions impact individuals and families.
  • Progress in this space is particularly notable because major wins in spring 2022 and December 2022 reversed a failure to extend this policy in December 2021.

3 Major progress in advancing cross-state licensure for telehealth and the need to reform outdated licensure laws that impose barriers in access to care for patients. The Alliance continues to be regularly consulted as an authority on these challenges and opportunities to advance them.

  • The Alliance helped drive forward a new Model Telehealth Law with the Uniform Law Commission telehealth working group, which published its Uniform Telehealth Act in July 2022.
  • The Alliance actively supported a number of state legislative initiatives and made headway on related areas, such as ensuring clinical trials are able to be managed across state lines – which is now recognized as an important access exception by the Federation of State Medical Boards. We are looking forward to significant new wins in 2023.

See here or below for the Alliance’s top accomplishments in 2022.

The Alliance’s expertise was quoted on average of

1.3

times per week

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January 3rd, 2023|

Heart Failure Drug Treatment-Inertia, Titration, and Discontinuation: A Multinational Observational Study (EVOLUTION HF)

Heart Failure Drug Treatment-Inertia, Titration, and Discontinuation: A Multinational Observational Study (EVOLUTION HF)

Background: Guidelines recommend early initiation of multiple guideline-directed medical therapies (GDMTs) to reduce mortality/rehospitalization in patients with heart failure and reduced ejection fraction. Understanding GDMT use is critical to improving clinical practice.

Objectives: This study sought to describe GDMT use in Japan, Sweden, and the United States in contemporary real-world settings.

Methods: EVOLUTION HF (Utilization of Dapagliflozin and Other Guideline Directed Medical Therapies in Heart Failure Patients: A Multinational Observational Study Based on Secondary Data) is an observational cohort study using routine-care databases. Patients initiating any GDMT within 12 months of a hospitalization for heart failure (hHF) discharge were included. Dapagliflozin (the only sodium-glucose cotransporter-2 inhibitor approved at study onset), sacubitril/valsartan, angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), beta-blockers, and mineralocorticoid receptor antagonists (MRAs) were considered separately. Doses and discontinuation were assessed in the 12 months following initiation. Target dose was defined as ≥100% of the guideline-recommended dose.

Results: Overall, 266,589 patients were included. Mean times from hHF to GDMT initiation were longer for novel GDMTs (dapagliflozin or sacubitril/valsartan) than for other GDMTs: 39 and 44 vs 12 to 13 days (Japan), 44 and 33 vs 22 to 31 days (Sweden), and 33 and 19 vs 18 to 24 days (United States). Pooled across countries, proportions of patients who discontinued therapy (not including switches from ACE inhibitor or ARB to sacubitril/valsartan) within 12 months were 23.5% (dapagliflozin), 26.4% (sacubitril/valsartan), 38.4% (ACE inhibitors), 33.4% (ARBs), 25.2% (beta-blockers), and 42.2% (MRAs). Corresponding target dose achievements were 75.7%, 28.2%, 20.1%, 6.7%, 7.2%, and 5.1%, respectively.

Conclusions: Initiation of novel GDMTs is delayed compared with other GDMTs. Few patients received target doses of GDMTs requiring uptitration. Persistence was higher for dapagliflozin than other GDMTs.

January 1st, 2023|

Alliance Applauds Inclusion of Major Telehealth Provisions in FY2023 Omnibus Appropriations Bill

The inclusion of a two-year extension of Medicare telehealth and commercial market telehealth flexibilities will make a huge difference to so many Americans. The Alliance for Connected Care has been calling for predictability for patients and clinicians while continuing to work toward permanent telehealth authorization. This gives us both.

The package includes a two-year extension of widely supported Medicare telehealth services that Congress enacted at the start of the pandemic. This extension will provide certainty to beneficiaries and health care providers, along with continued access to these critical virtual care services, while ensuring sufficient time is taken to analyze the impact of telehealth on patient care throughout the pandemic and beyond.  With the data currently pouring in, we are confident Congress will have the evidence needed to make telehealth permanent in Medicare two years from now.

The package also includes a two-year extension of the flexibility employers and health plans have to provide pre-deductible coverage of telehealth services for individuals and families with high deductible health plans coupled with a health savings accounts (HDHP-HSA). This policy is a game changer for the 32 million Americans who would otherwise have to think twice about out of pocket costs in accessing care.

Overall, a big win for America’s patients and caregivers. Bravo Congress.

Summary of Key Telehealth Provisions:

See here for bill text, press release, and Labor-HHS summary and explanatory statement. Below is a quick analysis of what was included in this package:

  • Sec. 4113: Advancing Telehealth Beyond COVID-19 (pg. 3714) – This section provides a two-year extension of the following Medicare telehealth flexibilities through December 31, 2024:
    • Removing Geographic Requirements and Expanding Originating Sites for Telehealth Services
    • Expanding Practitioners Eligible to Furnish Telehealth Services
    • Expanding Telehealth Services for Federally Qualified Health Centers and Rural Health Clinics
    • Delaying the In-Person Requirements Under Medicare for Mental Health Services Furnished Through Telehealth and Telecommunications Technology
    • Allowing for the Furnishing of Audio-Only Telehealth Services
    • Use of Telehealth to Conduct Face-to-Face Encounter Prior to Recertification of Eligibility for Hospice Care During Emergency Period
    • Study on Telehealth and Medicare Program Integrity
  • Sec. 4151: Extension of Safe Harbor for Absence of Deductible For Telehealth (pg. 3805) – This section provides a two-year extension of the flexibility allowing employers/plans to provide coverage for telehealth services pre-deductible for individuals with a high-deductible health plan coupled with a health savings account (HDHP-HSA) through December 31, 2024.

For a full summary of telehealth and related provisions in the FY2023 Omnibus package, click here or see below:

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December 19th, 2022|

Alliance Supports Members of Congress in Letter Pushing for Extension of HDHP Telehealth

On December 12, 2022, Reps. Schneider (D-IL), Steel (R-CA) and Lee (D-NV) led a bipartisan group of 30 House Members in a letter asking House leadership to extend critical commercial market telehealth flexibilities in the year-end appropriations package. The Alliance for Connected Care worked closely with the Congressional offices on this advocacy effort. 

The letter called on Congress to include the extension of the flexibility that allowed health plans and employers to provide pre-deductible coverage of telehealth services for individuals with a high deductible health plan coupled with a health savings account (HDHP-HSA). This provision was included in both the Primary and Virtual Care Affordability Act (H.R. 5541) and the Telehealth Expansion Act (H.R. 5981).

The Alliance has been a leading voice in advocating for the continued extension of this flexibility over the past several years. This policy has meaningfully expanded access to virtual care for a range of critical health services for the 32 million individuals with these plans. Without action by Congress, this flexibility will expire on December 31, 2022.

To read the letter, see below or click here.

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December 12th, 2022|

Diabetes Technology: Standards of Care in Diabetes—2023

Diabetes Technology: Standards of Care in Diabetes—2023

The American Diabetes Association (ADA) “Standards of Care in Diabetes” includes the ADA’s current clinical practice recommendations and is intended to provide the components of diabetes care, general treatment goals and guidelines, and tools to evaluate quality of care. Members of the ADA Professional Practice Committee, a multidisciplinary expert committee, are responsible for updating the Standards of Care annually, or more frequently as warranted.

December 12th, 2022|

Safety, tolerability and efficacy of up-titration of guideline-directed medical therapies for acute heart failure (STRONG-HF): a multinational, open-label, randomised, trial

Safety, tolerability and efficacy of up-titration of guideline-directed medical therapies for acute heart failure (STRONG-HF): a multinational, open-label, randomised, trial

Background: There is a paucity of evidence for dose and pace of up-titration of guideline-directed medical therapies after admission to hospital for acute heart failure.

Methods: In this multinational, open-label, randomised, parallel-group trial (STRONG-HF), patients aged 18-85 years admitted to hospital with acute heart failure, not treated with full doses of guideline-directed drug treatment, were recruited from 87 hospitals in 14 countries. Before discharge, eligible patients were randomly assigned (1:1), stratified by left ventricular ejection fraction (≤40% vs >40%) and country, with blocks of size 30 within strata and randomly ordered sub-blocks of 2, 4, and 6, to either usual care or high-intensity care. Usual care followed usual local practice, and high-intensity care involved the up-titration of treatments to 100% of recommended doses within 2 weeks of discharge and four scheduled outpatient visits over the 2 months after discharge that closely monitored clinical status, laboratory values, and N-terminal pro-B-type natriuretic peptide (NT-proBNP) concentrations. The primary endpoint was 180-day readmission to hospital due to heart failure or all-cause death. Efficacy and safety were assessed in the intention-to-treat (ITT) population (ie, all patients validly randomly assigned to treatment). The primary endpoint was assessed in all patients enrolled at hospitals that followed up patients to day 180. Because of a protocol amendment to the primary endpoint, the results of patients enrolled on or before this amendment were down-weighted. This study is registered with ClinicalTrials.gov, NCT03412201, and is now complete.

Findings: Between May 10, 2018, and Sept 23, 2022, 1641 patients were screened and 1078 were successfully randomly assigned to high-intensity care (n=542) or usual care (n=536; ITT population). Mean age was 63·0 years (SD 13·6), 416 (39%) of 1078 patients were female, 662 (61%) were male, 832 (77%) were White or Caucasian, 230 (21%) were Black, 12 (1%) were other races, one (<1%) was Native American, and one (<1%) was Pacific Islander (two [<1%] had missing data on race). The study was stopped early per the data and safety monitoring board’s recommendation because of greater than expected between-group differences. As of data cutoff (Oct 13, 2022), by day 90, a higher proportion of patients in the high-intensity care group had been up-titrated to full doses of prescribed drugs (renin-angiotensin blockers 278 [55%] of 505 vs 11 [2%] of 497; β blockers 249 [49%] vs 20 [4%]; and mineralocorticoid receptor antagonists 423 [84%] vs 231 [46%]). By day 90, blood pressure, pulse, New York Heart Association class, bodyweight, and NT-proBNP concentration had decreased more in the high-intensity care group than in the usual care group. Heart failure readmission or all-cause death up to day 180 occurred in 74 (15·2% down-weighted adjusted Kaplan-Meier estimate) of 506 patients in the high-intensity care group and 109 (23·3%) of 502 patients in the usual care group (adjusted risk difference 8·1% [95% CI 2·9-13·2]; p=0·0021; risk ratio 0·66 [95% CI 0·50-0·86]). More adverse events by 90 days occurred in the high-intensity care group (223 [41%] of 542) than in the usual care group (158 [29%] of 536) but similar incidences of serious adverse events (88 [16%] vs 92 [17%]) and fatal adverse events (25 [5%] vs 32 [6%]) were reported in each group.

Interpretation: An intensive treatment strategy of rapid up-titration of guideline-directed medication and close follow-up after an acute heart failure admission was readily accepted by patients because it reduced symptoms, improved quality of life, and reduced the risk of 180-day all-cause death or heart failure readmission compared with usual care.

December 3rd, 2022|

Alliance Statement on Pandemic Response Accountability Committee Report on Telehealth Use and Program Integrity Risks During COVID-19

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On December 1, 2022, the Pandemic Response Accountability Committee issued a report on telehealth use and program integrity risks across selected health care programs during the first year of the COVID-19 pandemic. Given the debate on Capitol Hill about the permanent flexibilities in the Medicare program, we focus here on Medicare fee-for-service and Medicare Advantage, which HHS examined from March 2020 through February 2021, and the year prior from March 2019 through February 2020.

The report shared several impressive findings:

  • 37 million individuals used telehealth services across the programs of six federal agencies – an expansion from approximately 3 million individuals using telehealth in the prior year. Pre-pandemic, the vast majority of those telehealth visits were only available to veterans.
  • In Medicare, the expansion was huge – with over 80 times the number of individuals using telehealth in 2020.

The report identifies some potential areas of program integrity concern. While there will always be program integrity risks in federal programs, we urge policymakers to keep it in perspective. There is no evidence of a need for widespread concern related to telehealth in the Medicare program. In fact, the telehealth risks appear lower than in-person care.

HHS OIG Claim: “In total, Medicare paid over $5.1 billion for telehealth services for beneficiaries enrolled in Medicare fee-for-service. HHS OIG identified more than 300 Medicare providers who billed for telehealth services at the highest, most expensive level every time, totaling approximately $5.2 million.

  • Perspective:
    • The report identified 300 Medicare providers who billed for telehealth services at the highest, most expensive level every time was 0.1 percent of total Medicare payment for telehealth services for beneficiaries enrolled in Medicare fee-for-service. For 2020, Medicare spending was $829.5 billion for total Medicare services.
    • As context, the estimated Medicare total improper payment rate in 2020 was 6.27 percent, representing $25.74 billion in improper payments. Prior to the pandemic, the Medicare improper payment rate in 2019 was 25 percent. Other government watchdogs estimated $43 billion in FY 2020 for Medicare improper payments, accounting for over one-quarter of the total amount of improper payments made government-wide in fiscal year 2019.

HHS OIG Claim: “We identified over 1,700 providers whose billing for telehealth services poses a high risk to Medicare. Although these providers represent a small proportion of the approximately 742,000 providers who billed for a telehealth service, their billing raises concern.”

  • Perspective: An identification of providers who pose a high risk to Medicare does not indicate the presence of fraud – only that there are practices which should be monitored.
  • This point made by HHS OIG is out of context. OIG originally mentioned these providers in this report where they noted that more than half of those high-risk providers belonged to a medical practice that posed high risk billing to Medicare in general, not just telehealth. As such, the billing practices of these providers do not pose a risk solely as it relates to telehealth – they are risks to the Medicare program broadly that CMS should address.

HHS OIG Claim: “HHS OIG identified 138 providers who repeatedly billed both Medicare fee-for-service and a Medicare Advantage plan for the same telehealth service.”

  • Perspective: There are bad actors within the Medicare program, 138 providers is a low number for such billing practices to be occurring for the 28 million Medicare beneficiaries who used telehealth services and the $5.1 billion in spending on Medicare telehealth services during the first year of the pandemic.
    • In its September 2022 report on program integrity risks in Medicare telehealth services during the first year of the pandemic, HHS OIG noted that a total of 18,034 providers billed both Medicare fee-for-service and Medicare Advantage for the same telehealth service for the same beneficiary on the same date of service at least once. However, HHS OIG only classified providers as “high risk” if they billed this way for more than 20 percent of their claims and encounters – in this case 0.7 percent of providers who billed this way.
    • While OIG claims this could be an indicator of providers intentionally submitting duplicate claims to increase their Medicare payments, there is no concrete evidence to support this claim, nor is there an indication of the circumstances surrounding these claims (i.e., potential for practitioner error).
    • In 2018, OIG found that many of the disallowed payments for telehealth services were because of practitioner errors in understanding and meeting Medicare telehealth requirements. One of their recommendations was to offer education and training sessions to practitioners on Medicare telehealth requirements. Given that this was the case for the limited number of practitioners using telehealth in 2018, we have a hard time believing there were not many similar errors in 2020.

HHS OIG Claim: “HHS OIG identified 86 providers who billed for a high average number of hours of telehealth services per visit.”

  • Perspective: This again is a low number compared to the patients served and spending that occurred, and could be related to any number of factors such as practitioner error in codes used, the nature of the service rendered, or treatment of high-need patients.
    • In the same September 2022 report mentioned above, HHS OIG identified 86 providers that billed for an average of more than two hours of telehealth services per visit, compared to the median of 21 minutes of telehealth services per visit for all providers who billed for telehealth services. However, OIG does not note the types of services rendered for these longer visits, which is a critical data point necessary to make accurate comparisons to affirm whether there is call for widespread concern.
    • A visit with a psychotherapist who is treating a patient in crisis for a mental health or substance use disorder, for example, is going to require more intensive time and care compared to a visit for acute conditions. HHS OIG notes in a previous report that, during the first year of the pandemic, “beneficiaries used telehealth for 43 percent of behavioral health services, whereas they used telehealth for 13 percent of office visits.” Given the proliferation of telehealth for mental and behavioral health services in particular during the pandemic, this merits further analysis.

It’s important to note that this report recycles past policy recommendations made by HHS OIG. These recommendations include:

  • Strengthen monitoring and targeted oversight of telehealth services;
    • The Alliance has supported additional oversight to ensure bad actors do not undermine access to telehealth in Medicare.
  • Provide additional education to providers on appropriate billing for telehealth services;
    • The Alliance strongly agrees that provider education is useful, as accidental misbilling has in the past been interpreted as fraudulent. Similarly, HHS steps to simplify telehealth billing are welcomed.
  • Improve the transparency of “incident to” services when clinical staff primarily delivered a telehealth service;
    • The Alliance recognizes the importance of accurate data for analysis. We also stress the importance maintaining “incident to” services for healthcare practitioners unable to bill the Medicare program directly.
  • Identify telehealth companies that bill Medicare;
    • If a provider, including a virtual-only provider, wants to bill Medicare directly, they must enroll in Medicare, thereby giving CMS oversight of that provider. We don’t believe there is clear justification for singling out virtual-only providers, particularly when Medicare beneficiaries are overwhelmingly seeing providers that use telehealth services in addition to maintaining brick and mortar. Given that virtual-only is a new modality, limited steps to improve CMS’s understanding and oversight of these providers seems logical, and if it helps prevent limits on beneficiary access to telehealth, then we support it.
  • Require a modifier to identify all audio-only telehealth services provided in Medicare; and
    • HHS has already acted on this recommendation, with Alliance for Connected Care support.
  • Collect data on the use of telehealth in opioid treatment programs.
    • The Alliance recognizes the importance of accurate data for analysis and supports calls for additional data to further analyze this occurrence.
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December 1st, 2022|
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