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House lawmakers ask CMS to temporarily cover ‘breakthrough’ devices


A bipartisan group of lawmakers on Tuesday urged Centers for Medicare and Medicaid Services Administrator Chiquita Brooks-LaSure to “expeditiously” propose policies to replace a Trump-era Medicare coverage policy for “breakthrough” devices that the agency repealed this month.

In the meantime, CMS should provide “immediate or near-immediate” temporary coverage of breakthrough devices, the lawmakers said.

“We write to express our disappointment in your decision to repeal the Medicare Coverage for Innovative Technology (MCIT) rule which would have provided access to innovative and life-saving medical devices for Medicare beneficiaries,” reads a letter led by Brett Guthrie (R-Ky.), Anna Eshoo (D-Calif.), Devin Nunes (R-Calif.) and Suzan DelBene (D-Wash.) and signed by more than 60 representatives.

The lawmakers argued that the rule would have not only made it easier for seniors to access new devices cleared by the Food and Drug Administration, but also easier for small medical devicemakers to navigate the patchwork of local coverage determinations and time-consuming adjudication process by Medicare administrative contractors to gain coverage of their devices.

“A permanent withdrawal of the MCIT rule may delay future innovative medical devices and diagnostic tools,” the letter reads. “The MCIT rule could further encourage early investors to step in to address our most critical healthcare challenges and successfully deliver life-changing treatments to patients.”

The now-repealed Medicare rule, which had been finalized in the waning days of the Trump administration, would have allowed Medicare to cover devices designated as “breakthrough technology” by the FDA for up to four years. The FDA’s breakthrough device program, which was established as part of the 21st Century Cures Act, prioritizes development of innovative devices for certain life-threatening or debilitating diseases.

Medicare beneficiaries can currently get coverage for such devices through other methods, like a national coverage determination, but the MCIT rule would have created an expedited pathway.

The Biden administration’s CMS on Nov. 12 issued a final rule to repeal the MCIT rule—after delaying the rule’s implementation multiple times—citing concerns that the policy would have led to coverage of devices without sufficient evidence. CMS in its Nov. 12 rule noted that Medicare beneficiaries aren’t required to be included in clinical studies before FDA market authorization.

CMS at the time said it planned to continue considering ways to improve access to breakthrough technologies, possibly through existing pathways or future rulemaking.

“[W]e want to reassure stakeholders that CMS does not intend to maintain the status quo,” CMS wrote in its Nov. 12 rule. “We remain committed to our goal of establishing an alternative expedited coverage pathway that better achieve the goals of timely and predictable Medicare coverage of devices while ensuring that Medicare covers items and services on the basis of scientifically sound clinical evidence and with appropriate safeguards.”



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