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Let's Go: Time to Write Legislators and Press for the Payment Cut Fix
Lawmakers are back. A bill has been introduced that could offset the cuts. It's time to make this happen.
Bipartisan legislation is in the U.S. House of Representatives that would prevent cuts to the 2022 Medicare Physician Fee Schedule, and another bill in the House would address the PTA payment differential set to begin in January. Now that Congress is back in session, we're calling on the entire profession, patients, and supporters to use the APTA Patient Action Center to send a message to lawmakers that they can't ignore.
Click here to read more. |
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New Cures 2.0 Bill Extends Key Telehealth Flexibilities, Hastens CMS Approval of Medical Devices
Fierce Healthcare | Nov 16, 2021
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.
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Payment Due for Deferred Payroll Taxes
The Internal Revenue Service is reminding employers they need to pay off part of the deferral of payroll taxes permitted last year under the Coronavirus, Aid, Relief and Economic Security (CARES) Act. The CARES Act allowed employers to defer the deposit and payment of the employer's share of Social Security taxes during the "payroll tax deferral period" that began on March 27, 2020 and ended December 31, 2020. Fifty percent of the deferred payments must now be deposited by December 31, 2021, to be treated as timely and avoid a failure to deposit penalty. The IRS website provides more information on how to pay the CARES Act deferral amount. |
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Merck's COVID-19 pill significantly less effective in new analysis
By Manas Mishra and Michael Erman, Reuters
WASHINGTON — Merck & Co said on Friday updated data from its study of its experimental COVID-19 pill showed the drug was significantly less effective in cutting hospitalizations and deaths than previously reported.
The drugmaker said its pill showed a 30% reduction in hospitalizations and deaths, based on data from 1,433 patients. In October, its data showed a roughly 50% efficacy, based on data from 775 patients. The drug, molnupiravir, was developed with partner Ridgeback Biotherapeutics.
The lower efficacy of Merck's drug could have big implications in terms of whether countries continue to buy the pill. Interim data from 1,200 participants in Pfizer Inc's trial for its experimental pill, Paxlovid, showed an 89% reduction in hospitalizations and deaths.
Merck's shares fell 3.5% to $79.39 in morning trading.
Merck released the data before the U.S Food and Drug Administration published a set of documents on Friday intended to brief a panel of outside experts who will meet on Tuesday to discuss whether to recommend authorizing the pill.
The agency's staff did not make their own recommendation as to whether the pill should be authorized.
FDA staff asked the panel to discuss whether the benefits of the drug outweigh the risks and whether the population for whom the drug should be authorized should be limited.
They also asked the committee to weigh in on concerns over whether the drug could encourage the virus to mutate, and how those concerns could be mitigated.
Pills like molnupiravir and Paxlovid could be promising new weapons in the fight against the pandemic, as they can be taken as early at-home treatments to help prevent COVID-19 hospitalizations and deaths. They could also become important tools in countries and areas with limited access to vaccines or low inoculation rates…
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7 policies in Biden’s spending plan aimed at health equity
STAT News / Rachel Cohrs
WASHINGTON — Democrats have made big promises to tackle racial inequities across society, including in health care, since protests for racial justice swept the nation in 2020.
Until recently, it wasn’t clear how either lawmakers or the Biden administration would deliver on those goals — but some of the first concrete steps are now taking shape in the new spending plan Democrats are moving.
Embedded in the nearly $2 trillion plan are billions of dollars to help make health care services more accessible and affordable for Americans who slipped through the cracks of existing safety-net policies.
The health equity programs span the beginning of life, aiming to make birth safer for Black mothers, to the end, offering incentives to boost pay for home care services disproportionately provided by Black and Hispanic women. The package would also provide cheaper coverage options for low-income adults in states that haven’t expanded Medicaid under the Affordable Care Act — a population that is 60% people of color — and provide stable funding for coverage programs for children and people in the U.S. territories.
The package, dubbed the Build Back Better Act, has passed the House, but still has to clear the Senate without a single Democratic defection, and then will likely have to go to another vote in the House before proceeding to the president’s desk.
“This is historic legislation, and an incredible investment in health equity. There’s a lot of important provisions, and we need to get this across the finish line,” said Frederick Isasi, executive director of the consumer advocacy group Families USA.
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