New Cures 2.0 bill extends key telehealth flexibilities, hastens CMS approval of medical devices

Fierce Healthcare
Nov 16, 2021 12:51pm
 
New major legislation would require Medicare to cover breakthrough medical devices faster and make permanent key flexibilities to telehealth reimbursement for providers.
 
Lawmakers introduced on Tuesday Cures 2.0 bipartisan legislation that builds on the 21st Century Cures Act of 2016. The legislation includes major investments in medical research including the creation of a new agency to research difficult diseases such as Alzheimer’s, but also contains several reforms to Medicare reimbursement and coverage.
 
The legislation would permanently remove Medicare’s geographic and originating site requirements that require a patient to live in a rural area and be in a doctor’s office to qualify for telehealth services.
 
The use of telehealth has exploded since the pandemic when patients were afraid of going to the doctor’s office. The Centers for Medicare & Medicaid Services also granted greater flexibility for providers to get reimbursement from Medicare for telehealth services.
 
But those flexibilities are expected to be removed at the end of the COVID-19 public health emergency, which will now sunset early next year.
 
The legislation would make some of those flexibilities permanent.
 
Another key provision is to codify a rule that would let Medicare automatically cover products approved or cleared by the Food and Drug Administration under the breakthrough therapy pathway, which grants advanced approval to devices that treat unmet medical needs.
 
The bill would allow CMS to temporarily cover breakthrough products approved by FDA for four years. The agency will have to make a permanent coverage determination in those four years. It also calls for the Government Accountability Office to offer recommendations on how to enhance Medicare coverage and reimbursement of innovative health technologies.
 
But the decision comes a few days after CMS issued a final rule that got rid of a Trump-era regulation that requires CMS to approve breakthrough medical devices under the same type of pathway as in the Cures 2.0 bill.
 
CMS said that it was concerned the clinical data necessary for the FDA breakthrough therapy approval may not meet Medicare’s guidelines for a coverage determination.
 
The insurance industry has fought the Trump-era rule, arguing that it could lead to premature coverage of medical devices.
 
The legislation now heads to the House Energy & Commerce Committee. The lawmakers behind the legislation—Democratic Rep. Dianne Degette of Colorado and Republican Rep. Fred Upton of Michigan—spearheaded the 2016 law.
 
“The federal government has shown, time and time again, that when it’s given the resources needed to accomplish the impossible, there’s not much it cannot do,” the lawmakers said in a statement.

Hospice Quality Reporting Program (HQRP) October Forum Materials Available Now

On Tuesday, October 19, the Centers for Medicare & Medicaid Services (CMS) hosted the October 2021 HQRP Forum to provide information on the new Quality Measure (QM) Specifications User’s Manual v1.00 and the two new claims-based measures included in the Manual. Materials from this HQRP Forum, including a recording of the presentation, are now available in the Downloads section of the Provider and Stakeholder Engagement page at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting/Hospice-QRP-Provider-Engagement-Opportunities.

"Don't wait": WHO urges U.S. to pay attention as surging COVID cases flood Europe's hospitals again

London — The coronavirus has been resurging across Europe, including in some places where it was thought to be well under control. A top world health official tells CBS News the trend shows that success today does not necessarily mean success tomorrow, and the United States should pay close attention.

Europe has seen a jump of more than 50% in new coronavirus cases over the last month, and the World Health Organization has warned the continent could see another half of a million deaths by February. CBS News senior foreign correspondent Charlie D'Agata spoke with the top official ringing those alarm bells, who told him there's "grave concern" as Europe is once again under siege by COVID-19.

"If you look at the last four weeks, the hospitalizations have doubled," Dr. Hans Kluge, the World Health Organization's Regional Director for Europe, told CBS News.

He said vaccination uptake has plateaued in some parts of Europe and, "at the same time, there's a relaxation of the public health and social measures, which is a cocktail for what we see: a fourth wave."

Kluge called Europe "the epicenter" of a new global COVID-19 outbreak, fuelled by the highly transmissible Delta variant of the virus.

While case rates are up across the continent, European countries with higher vaccination uptake appear to be staving off a major new wave of severe COVID-19 illness, but in some Eastern European nations, the daily mortality rate is surging.

Portugal has one of the highest vaccination rates in the world, for instance, whereas Romania has one of the lowest in Europe — and one the highest death rates on the globe.

On Monday, Germany's daily infection rate hit its highest recorded level since the pandemic began.

"Vaccines are a game changer," said Kluge. But alone, they are "not enough."

"We need to keep pressure on the virus, not surrendering on masks, the hand-washing, indoor ventilation — particularly in the schools," he told D'Agata.

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Infrastructure bill to be signed by President today. Next up, “Build Back Better”

Late Friday night, on November 5^th, the House passed the $1.2 trillion infrastructure bill that is a key piece of President Biden's agenda.

Following its passage, President Biden, who is scheduled to sign the bill today, described the legislation as a, "once-in-a-generation investment that's gonna create millions of jobs, modernize our infrastructure, our roads, our brides, our broadband, a whole range of things, to turn the climate crisis into an opportunity.” Thirteen Republicans voted to pass the infrastructure bill, while six Democrats voted against it.

The bill provides $550 billion in new spending on the nation's physical infrastructure, including roads, bridges, ports, water and rail.  It also includes $65 billion for broadband infrastructure deployment and $55 billion for clear water investments. In order to pass the bill, Democrat moderates had to assure progressives that the Party’s larger climate and social initiatives, which are found in the Build Back Better Act (BBB), would be voted on in its current form no later than this week.

If the House passes the BBB, it’s still not clear what its fate would be in the Senate, where moderates have threatened to vote against it unless they first have the opportunity to weigh its anticipated impact on the economy following scoring by the Congressional Budget Act (CBO).

• Bill text of the latest version of the BBB can be found HERE
• Bill text of the hard infrastructure package can be found HERE

Proposed spending targets for the BBB were initially around $3.5 trillion but will likely be closer to $1.75 trillion in order to secure every Senate Democrat vote, which it is anticipated will be required to pass. The legislation would impact almost every sector in the United States and contains multiple policies with direct relevance for home care and hospice.

The following is a synopsis of some of the most consequential policies included in the current version of the House BBB legislation (thank you to the National Association for Home Care & Hospice for their analysis). It should be noted that it is almost a certainty that the Senate will make additional revisions.

Medicaid Home and Community-Based Services (HCBS) found in the “Better Care Better Jobs Act”)

$150 billion to bolster Medicaid HCBS, increasing access to services and supporting direct care workers

• Provide a 6% FMAP increase for HCBS
• Require coverage of personal care services
• Require caregiver supports (e.g., respite care)
• Require payment rates that “support the recruitment and retention of the direct care workforce.”
• Require an update of payment rates at least every 3 years.
• Make spousal impoverishment protections permanent for recipients of Medicaid HCBS.
• Make the Medicaid Money Follows the Person (MFP) demonstration permanent, to  help those in institutional facilities transition back to the community.
• See the legislative language for this provision HERE

Direct Care Worker Training and Support

Billions in grant-based programs for states and territories to improve frontline caregiver access to economic and educational supports. Eligible initiatives may include wage subsidies, student loan repayment or tuition assistance, childcare, and other activities that benefit direct care workers.  Grants would also be created for use in recruiting, retaining, and advancing the direct care workforce; implementing models and strategies to make the field of direct care more attractive; and improving wages, including through training and registered apprenticeships, career pathways, or mentoring.

Hospice and Palliative Care Training Support

$90 million for investments to train, educate, and strengthen the specialty hospice and palliative care provider workforce. $25 million would go to funding for broad-based palliative care and hospice education and training, $20 million to palliative medicine physician training, $20 million to palliative care and hospice academic career awards, $20 million to hospice palliative care nursing, and $5 million to dissemination of palliative care information.

Paid Family and Medical Leave

Beginning in January 2024, all workers would be eligible for up to four weeks of paid leave as new parents, workers dealing with their own serious medical conditions, and workers who need leave to care for a loved one with a serious medical issue. Benefits would be progressive, with lower-income workers receiving higher levels of wage replacement (approximately two-thirds for the average worker).

Increases in OSHA Fine Amounts

The bill also includes provisions that would:

• Expand Medicaid coverage
• Lower prescription drug costs
• Extend ACA marketplace health plan subsidies
• Add hearing coverage to the Medicare program
• Invest tens of billions of dollars in bolstering public health infrastructure and training
• Boost funding by over $1 billion for Older Americans Act (OAA) programs that support older adults and family caregivers
• Provide $40 million in funding for programs to support family caregivers’ mental health and well-being
• Provide $500 million in new grant funding to support medical-legal partnerships (programs that integrate patient-centered legal services into health care settings to address their patient and families’ health-related social needs)

Major health and care-related provisions that were not incorporated into the House bill include:

• A separate tax credit for family caregivers
• New Medicare dental and vision benefits.