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Home » Topics » Regulatory » CMS

CMS
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Drugs-insulin2

Manufacturers to foot much of the bill for Medicare insulin savings

May 26, 2020
By Mari Serebrov
Unpredictable and unaffordable copays for insulin could be a thing of the past for millions of people enrolled in certain Medicare Part D prescription drug plans.
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2-24-Viz-AI.png

Medicare NTAP no tap dance for some new technologies, pricing models

May 18, 2020
By Mari Serebrov
Except for breakthrough devices and qualifying infectious disease drugs, the footwork for getting Medicare's new technology add-on payment (NTAP) can be more challenging than that needed to win FDA approval. It could be even tougher for products that use artificial intelligence (AI) or that follow a subscription model for pricing.
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Laptop, stethoscope, medical icons, health professional

CMS, ONC offer enforcement discretion for EHR rules

April 24, 2020
By Mark McCarty
The U.S. Centers for Medicare and Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) said that they will offer enforcement discretion for their respective final rules for electronic health records (EHRs), a nod to the COVID-19 pandemic.
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Laptop, stethoscope, medical icons, health professional

CMS, ONC offer enforcement discretion for EHR rules

April 23, 2020
By Mark McCarty
The U.S. Centers for Medicare and Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) said that they will offer enforcement discretion for their respective final rules for electronic health records (EHRs), a nod to the COVID-19 pandemic. The term of the delays of compliance for several of these rules is not uniform, ranging from “late 2020” to “spring 2021,” and vendors thus will have to be vigilant to ensure they do not cross any compliance tripwires.
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U.S. FDA headquarters

FDA gives Labcorp the nod for Pixel home collection swab, but access limited for now

April 21, 2020
By Mark McCarty
The U.S. FDA reported that it has expanded the emergency use authorization for the Labcorp polymerase chain reaction (PCR) test for SARS-CoV-2 to include the company’s Pixel self-collection kit, a development that may presage a wider testing paradigm that is needed to restore the U.S. economy to normalcy.
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Coronavirus vs U.S. wrecking balls

Administration’s outpatient-first policy should aid cardiovascular, orthopedic implants

April 21, 2020
By Mark McCarty
The Trump administration has proposed a policy to gradually reopen the U.S. for business, part of which is to allow a resumption of elective procedures and treatments in outpatient settings. While patients with urgent medical needs presumably are being treated already, the policy would seem to promise a boost in volumes for certain devices, such as coronary artery stents, knee implants and transcatheter aortic valve replacement (TAVR) devices, all of which enjoy at least limited Medicare coverage for outpatient use.
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FDA icons

FDA adds to EUAs for COVID-19 as Congress presses agency on serological testing

April 13, 2020
By Mark McCarty
The U.S. FDA’s routine guidance agenda may be badly disrupted by the COVID-19 outbreak, but the agency continues to pump out guidances and emergency use authorizations (EUAs) directed to the pandemic. While the FDA has included only one serological test under the diagnostic EUA paradigm, Rep. Diana DeGette penned a letter inquiring into when the agency intends to move more decisively on serological tests, arguing that the absence of action on this front endangers the nation’s economic health as well as the public’s health.
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Coronavirus-lungs-test-tube
Swabs among next rate-limiting factors on testing

Test makers say testing volume ramping up quickly despite concerns over reagents

March 19, 2020
By Mark McCarty
The U.S. capacity for SARS-CoV-2 testing is limited by several items, including the swabs used to collect patient specimens, but the supply of reagents has been front and center recently. Despite those concerns, several private test makers said they are quickly ramping up production, including Thermo Fisher Scientific Inc., of Waltham, Mass., which said it has enough supplies of all types on hand to provide 2 million reactions per week, a volume that should increase to 5 million per week in April.
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Tablet, health professional, EHR/medical icons
Digital health developers, telehealth among the winners

CMS, ONC rules for electronic health records largely mirror both drafts

March 10, 2020
By Mark McCarty
The Office of the National Coordinator (ONC) and CMS both posted their final rules for electronic health records (EHRs), and analysts with Cowen Washington Research Group said both rules essentially replicate the draft versions. The provisions dealing with data blocking and interoperability are expected to benefit developers of HER systems in the near term, and telehealth should also benefit, albeit over a longer scale of time.
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U.S. flag and money

Senate passes COVID-19 spending bill 96-1, awaits POTUS sign-off

March 5, 2020
By Mark McCarty
The Senate passed by a vote of 96-1 the spending bill for the outbreak of the new coronavirus (COVID-19), which will be on President Donald Trump’s desk by week’s end. The bill provides $7.8 billion in new funds to tackle the outbreak and another $490 million in existing funds for telehealth, all with the aim of speeding the response to the pathogen.
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