martes, 4 de agosto de 2020

Reminder: Webinar on FDA’s Regulation of Face Masks and Surgical Masks During the COVID-19 Pandemic



Join Us Today: Webinar on FDA’s Regulation of Face Masks and Surgical Masks during the COVID-19 Pandemic

Today, Tuesday, August 4, 12:00 p.m.-1:00 p.m. ET, the U.S. Food and Drug Administration (FDA) will host a webinar on the FDA’s regulation of face masks and surgical masks during the COVID-19 pandemic. This webinar will expand the scope of the respirator webinar series to discuss face masks and surgical masks.

During this webinar, representatives from the FDA will share information and answer questions related to face masks and surgical masks. The discussion will include the FDA’s Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised) and relevant emergency use authorizations (EUAs).

We encourage all interested stakeholders to join. Registration is not necessary.

To ensure you are connected, please dial in at 11:45 a.m.

U.S. Callers Dial:
  • 888-455-1392
  • Conference Number: PWXW1573188
  • Passcode: 8364649
International Callers Dial:
  • 1-773-799-3847           
  • Conference Number: PWXW1573188
  • Passcode: 8364649
To view the slide presentation during the webinar:  https://www.mymeetings.com/nc/join.php?i=PWXW1573188&p=8364649&t=c
SAVE THE DATE:
The FDA plans to hold additional webinars every two weeks to continue to share information and answer your questions on respirators and other personal protective equipment (PPE). Save the date for the next webinar:
  • August 18, 2020, from 12:00 pm-1:00 pm ET

Questions?

If you have questions, please contact the Division of Industry and Consumer Education.

CDRHNew - News and Updates | FDA

CDRHNew - News and Updates | FDA



CDRH New

August 4, 2020

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on August 3, 2020. To view listings for other dates, see CDRH New - News and Updates.

Is the FDA ready to decide whether CBD gummy bears are legal?

D.C. Diagnosis
Nicholas Florko

Coming soon: An FDA policy on CBD? 

The FDA is about to release a long-awaited enforcement policy on cannabidiol, the marijauna-adjacent compound it has struggled to regulate for years. 

The policy is going through the formal White House vetting process now, according to a White House website. And while the FDA hasn’t released virtually any specifics about the guidance beyond its title, “Cannabidiol Enforcement Policy; Draft Guidance for Industry,” it’s already getting outsized attention.

The CBD industry wants clear rules of the road for how to sell its products, as do its congressional allies. But the FDA, which still considers CBD products illegal, has been incredibly skittish about setting any such policies. It’s even vehemently denied that it currently uses a policy of “enforcement discretion” and only going after companies flagrantly violating the law, despite the fact that the FDA has essentially used that policy for more than a year.

That lack of clarity has led some industry lawyers to insist that even a formal codification of FDA’s existing policy would be a major step forward for industry.

“The FDA has adopted a de facto enforcement policy without actually adopting an enforcement policy,” said Jonathan Havens, a partner at Saul Ewing Arnstein & Lehr.

Havens insisted that FDA formalizing the policy would show investors and retailers that the FDA feels so confident that it can safely use enforcement discretion that it was able to release a formal policy on the topic that was vetted by the White House.

In the past weeks, the White House held a series of meetings with industry groups like the National Industrial Hemp Council and Ziese Farms.

Jonathan Miller, the general counsel for the U.S. Hemp Roundtable, which represents a number of the top CBD-makers in Washington and which also sent representatives, told STAT he pitched the White House on the importance of the FDA creating a formal enforcement discretion policy or a kind of safe harbor that would allow the CBD industry to sell their products legally.

The White House is set to meet with the American Herbal Products Association and the law firm WassermanRowe later this week. 

Here comes the rebate rule food fight, part deux

The Campaign for Sustainable Rx Pricing, a coalition that includes the major lobbies for insurers, hospitals and middlemen, announced Tuesday a new advertising campaign criticizing the Trump administration's renewed push to end the system of drug rebates negotiated by drug makers and middlemen.
The ads come on the heels of a similar campaign launched last week by the Pharmaceutical Care Management Association. Both sets of ads, which direct viewers to call the White House, are the clearest sign yet that defenders of drug rebates are putting serious muscle behind efforts to make Trump’s stance a liability going into the November election.
“President Trump wants to reward big pharma’s price hikes,” the ad from CSRxP states. “Tell President Trump to stop the rebate rule now."
“The Trump administration just announced a plan to raise Medicare premiums and out of pocket costs for seniors, during a pandemic, just before an election,” the PCMA ad states. 
CSRxP is planning a “significant six-figure campaign,” according to a spokesperson. The ad will run in Washington DC and in the battleground states of Arizona, Colorado, Florida, Iowa, Maine, Michigan, North Carolina, and Wisconsin through the GOP convention. PCMA didn’t detail its buy.

It’s official: Drug makers owe the government lots of missing data 

The federal government is now warning pharmaceutical companies, device makers and universities that they have to publish missing clinical trials data “as soon as possible” — a major win for transparency advocates. It comes after a federal court ruled in February that the agency has to collect the missing data; the federal government declined to appeal that decision. For more, check out my colleague Lev Facher’s story, here

Is Gilead sitting on a potentially more effective, albeit less lucrative, Covid-19 drug?

Yes, according to a pair of researchers at MD Anderson and the advocacy group Public Citizen. The groups are out with a new open letter attempting to pressure Gilead into studying another compound in the company’s portfolio, GS-441524, that they believe might be effective in treating coronavirus — and potentially more effective and easier to manufacture than the company’s approved product, remdesivir. 
The authors claim that lab tests show the compound, is “similar or superior" to remdesivir and more easily synthesized. They also imply that that the company is uninterested in commercializing the drug because it has a shorter patent life than remdesivir. 
“It is unclear why Gilead and federal scientists have not been pursuing GS-441524 as aggressively as remdesivir, but we cannot help but note that there are significant financial incentives tied to Gilead’s current patent holdings,” the letter states. “Gilead’s monopoly power over remdesivir may have at least five additional years of enforceability beyond that of GS-441524.”
For more, STAT’s Ed Silverman has the details here.

Are drug costs going up? It depends 

Despite widespread anger over rising drug prices, consumers with insurance are being asked to pay less and less at the pharmacy counter, according to a new study from the group IQVIA. The average consumer with insurance is shelling out just $8.90 per prescription, down from the $10.83 they paid per prescription in 2015, Ed Silverman reports
The situation is much different, however, for those paying cash: The uninsured are now spending an average of $50.78 per month per prescription, which is up from $36.77 in 2015. 
The study underscores how much more complex  drug pricing policy is than a simple soundbite can convey, and it shows that consumers’ exposure to high drug prices is largely dependent on the quality of their insurance. More here from Ed.

Are drug costs going up? It depends 

Despite widespread anger over rising drug prices, consumers with insurance are being asked to pay less and less at the pharmacy counter, according to a new study from the group IQVIA. The average consumer with insurance is shelling out just $8.90 per prescription, down from the $10.83 they paid per prescription in 2015, Ed Silverman reports
The situation is much different, however, for those paying cash: The uninsured are now spending an average of $50.78 per month per prescription, which is up from $36.77 in 2015. 
The study underscores how much more complex  drug pricing policy is than a simple soundbite can convey, and it shows that consumers’ exposure to high drug prices is largely dependent on the quality of their insurance. More here from Ed.

HRSA Launches PLOS Special Collection Highlighting Ryan White HIV/AIDS Program’s Innovative Models of Care | HIV.gov

HRSA Launches PLOS Special Collection Highlighting Ryan White HIV/AIDS Program’s Innovative Models of Care | HIV.gov

HRSA Logo: Ryan White & Global HIV/AIDS Programs

HRSA Launches PLOS Special Collection Highlighting Ryan White HIV/AIDS Program’s Innovative Models of Care
The U.S. Department of Health and Human Services’ Health Resources and Services Administration has launched a new Special Collection of manuscripts this week in PLOS (Public Library of Science), highlighting Ryan White HIV/AIDS Program’s innovative approaches for data utilization and engagement of people with HIV who are not in care and not virally suppressed, critical components of the Administration’s Ending the HIV Epidemic: A Plan for America initiative.
LEARN MORE
 
Advancing the Ending the HIV Epidemic Initiative with a $109 Million Investment in 57 Areas of the United States
Last week, the Centers for Disease Control and Prevention awarded $109 million to 32 state and local health departments that represent the 57 jurisdictions across the United States prioritized in the federal initiative Ending the HIV Epidemic: A Plan for America.
LEARN MORE

A coronavirus vaccine won’t change the world right away - The Washington Post

A coronavirus vaccine won’t change the world right away - The Washington Post

The Readout

Damian Garde & Meghana Keshavan

More reads

  • A coronavirus vaccine won’t change the world right away. (Washington Post)
  • Prescription drugs may be more affordable than you think — unless you pay cash. (STAT Plus)
  • Kodak CEO got stock options day before news of loan sent stock soaring. (New York Times)
  • Johnson & Johnson spray approved to treat suicidal people. (Bloomberg)

Chief Vaccine Scientist Will Not Be Forced to Disclose Pharmaceutical Stocks - The New York Times

Chief Vaccine Scientist Will Not Be Forced to Disclose Pharmaceutical Stocks - The New York Times

The Readout

Damian Garde & Meghana Keshavan

Moncef Slaoui wakes up at 2:30 a.m.

That’s among the details the former GlaxoSmithKline executive divulges on his work leading Operation Warp Speed in a podcast interview with the Department of Health and Human Services’ head of public affairs.

The conversation delves into the workings of Warp Speed, a pan-agency effort to speed up the development of treatments and vaccines for Covid-19, before turning into media criticism. HHS's Michael Caputo, erstwhile food photographer and podcast host, says “I'm convinced that the reporters don't want a vaccine, sir,” and Slaoui explains that he was personally offended by a July 15 New York Times story pointing out that he is not required to make routine ethics disclosures or divest any of his stock in companies working on Covid-19, a potential conflict of interest. And then things took a turn.

“If I had the possibility, I would like someday to sit down with the journalist that wrote that, and look at that person in the face, and ask that person, ‘I know what I have been doing for now 10 weeks in this role, day and night. I know what I'm doing every day to try and help all the population, including you journalists. What have you been doing?’” Slaoui said.

I Was Wrong: We Can’t Skip Phase 3 Vaccine Trials

I Was Wrong: We Can’t Skip Phase 3 Vaccine Trials

The Readout

Damian Garde & Meghana Keshavan

Warp speed is fast enough

Yesterday, amid a Twitter tempest, we asked readers whether society should wait on the results of large clinical trials before distributing Covid-19 vaccines. The answer, for the majority, was yes, please.

About 61% of respondents said Phase 3 data are key to understanding whether a vaccine actually works, and any widespread use should come only after studies are complete. The remaining 39% embraced thinking outside the box in light of Covid-19’s disastrous effects on health and society.

This may seem fairly obvious — clinical trials determine whether medicines work — but there are some prominent proponents of cutting corners when it comes to Covid-19 vaccines. Among them was Stephen Salzberg, a professor of biomedical engineering at Johns Hopkins whose editorial urging immediate vaccination blew up on Twitter over the weekend, finding at least some defenders and many more critics. It’s worth noting that Salzberg’s follow-up piece is titled “I Was Wrong: We Can’t Skip Phase 3 Vaccine Trials.”

NIH warns drug and device companies to post missing trial data

NIH warns drug and device companies to post missing trial data

The Readout

Damian Garde & Meghana Keshavan

A victory for clinical trial transparency, with a catch

A decade’s worth of clinical data on approved drugs and devices could finally be made public thanks to new federal rules, but it’s unclear just how much pressure the government will put on industry to comply.

As STAT’s Lev Facher reports, thanks to a court ruling and federal action, the government has instructed clinical trial sponsors to submit data to ClinicalTrials.gov for studies conducted between 2007 and 2017 “as soon as possible.” That’s a victory for transparency advocates, who for years have fought to recover the decade-long gap in publicly available clinical trial data.

But no one knows what the government might do to compel companies to act. The FDA and NIH have the legal right to levy penalties and withhold grant funds from companies that don’t comply with transparency rules, but neither agency has ever done so.

Read more.

Gilead pressured again to pursue remdesivir-like drug to fight Covid-19

Gilead pressured again to pursue remdesivir-like drug to fight Covid-19

The Readout

Damian Garde & Meghana Keshavan

Gilead has a treatment for a coronavirus. Academics want to test it against Covid-19

There’s a compound in Gilead Sciences’ vast library that is remarkably effective against a certain coronavirus in cats. Researchers say it might hold promise for Covid-19 and could even be superior to Gilead’s own remdesivir. Now they’re pressuring the company to find out.

As STAT’s Ed Silverman reports, researchers at the MD Anderson Cancer Center have joined Public Citizen to urge Gilead, the NIH, and the FDA to run a clinical trial on GS-441524, the anti-coronavirus compound. In lab tests, GS-441524 appears to work better than remdesivir against the novel coronavirus, the researchers said, with lower toxicity and an easier manufacturing process.

So far, Gilead has showed no interest in developing GS-441524. The researchers chalk that up to “financial incentives,” pointing out that a key patent for GS-441524 expires several years before the intellectual property behind remdesivir.

Read more.

The next CMS Skilled Nursing Facilities (SNF)/Long Term Care (LTC) Open Door Forum scheduled for Thursday, August 6, 2020

CMS Open Door Forum


The next CMS Skilled Nursing Facilities (SNF)/Long Term Care (LTC) Open Door Forum scheduled for:  
Date:  Thursday, August 6, 2020
Start Time:  2:00 PM – 3:00 PM Eastern Time (ET);
Please dial-in at least 15 minutes before call start time.
Conference Leaders: Todd Smith & Jill Darling
**This Agenda is Subject to Change**

  1. Opening Remarks
Chair – Todd Smith (Center for Medicare)
Moderator – Jill Darling (Office of Communications)
       2. Announcements & Updates
III. Open Q&A
**DATE IS SUBJECT TO CHANGE**
Next ODF: TBD
---------------------------------------------------------------------
This Open Door Forum is open to everyone, but if you are a member of the Press, you may listen in but please refrain from asking questions during the Q & A portion of the call. If you have inquiries, please contact CMS at Press@cms.hhs.gov. Thank you.
Open Door Participation Instructions:
This call will be Conference Call Only.
To participate by phone:
Dial: 1-888-455-1397 & Conference Passcode: 9375124
Persons participating by phone do not need to RSVP. TTY Communications Relay Services are available for the Hearing Impaired.  For TTY services dial 7-1-1 or 1-800-855-2880. A Relay Communications Assistant will help.
Instant Replay: 1-800-925-4415; Conference Passcode: No Passcode Needed
Instant Replay is an audio recording of this call that can be accessed by dialing 1-800-925-4415. Instant Replay begins 1 hour after the call has ended. The recording expires August 10, 2020, 11:59 PM ET
For ODF schedule updates and E-Mailing List registration, visit our website at http://www.cms.gov/OpenDoorForums/.
Were you unable to attend the recent Skilled Nursing Facilities (SNF)/Long Term Care (LTC) ODF call? We encourage you to visit our CMS Podcasts and Transcript webpage where you can listen and view the most recent Skilled Nursing Facilities (SNF)/Long Term Care (LTC) ODF call. Please allow up to three weeks to get both the audio and transcript posted to: https://www.cms.gov/Outreach-and-Education/Outreach/OpenDoorForums/PodcastAndTranscripts.html. Thank you.
CMS provides free auxiliary aids and services including information in accessible formats. Click here for more information. This will point partners to our CMS.gov version of the “Accessibility & Nondiscrimination notice” page.

Celebs tried Soon-Shiong's cancer therapy. Can it work in a clinical trial?

Celebs tried Soon-Shiong's cancer therapy. Can it work in a clinical trial?

Cancer Briefing

STAT Plus: Harry Reid and Alex Trebek tried Patrick Soon-Shiong’s experimental cancer therapy. Can their results be duplicated in a clinical trial?

By REBECCA ROBBINS AND ADAM FEUERSTEIN


PHOTO ILLUSTRATION: STAT; PHOTOS: GETTY IMAGES
Harry Reid and Alex Trebek both seem to be improving due to an experimental cancer therapy developed by physician and billionaire Patrick Soon-Shiong.

Cancer drug is first therapy to emerge from 23andMe-GSK deal - STAT

Cancer drug is first therapy to emerge from 23andMe-GSK deal - STAT

Cancer Briefing

STAT Plus: Cancer drug is the first potential therapy to emerge from 23andMe and GlaxoSmithKline collaboration

By MATTHEW HERPER


ADOBE
GlaxoSmithKline is starting human trials of the first medicine, a cancer drug, to emerge from its collaboration with consumer genetics firm 23andMe.

NIH warns drug and device companies to post missing trial data

NIH warns drug and device companies to post missing trial data

Cancer Briefing

Following court ruling, NIH warns drug and device companies to post missing trial data 

By LEV FACHER


NIH
Hundreds of drug and device companies and universities owe the public a decade’s worth of missing data from clinical trials, federal officials warned.

Dra. Marisa Aizenberg: Amplían la definición de caso sospechoso de coronavirus: se agregan cefalea, diarrea y vómitos

Dra. Marisa Aizenberg: Amplían la definición de caso sospechoso de coronavirus: se agregan cefalea, diarrea y vómitos





Posted: 03 Aug 2020 12:54 PM PDT
De esta forma, estos tres síntomas se suman a los de fiebre de 37.5 Cº o más, tos, dolor de garganta, dificultad respiratoria y falta de olfato o gusto (anosmia/disgeusia).

El Ministerio de Salud de la Nación amplió la definición de caso sospechoso de coronavirus al incorporar síntomas como diarrea, vómitos y cefalea, por lo que estos factores se suman a los que existían hasta el momento, y que deben darse al menos de a dos en forma concomitante para ser catalogado como probable Covid-19.

De esta forma, estos tres síntomas se suman a los de fiebre de 37.5 Cº o más, tos, dolor de garganta, dificultad respiratoria, falta de olfato o gusto (anosmia/disgeusia), sin otra enfermedad que explique completamente el cuadro clínico, según se informó oficialmente.

El primer criterio para definir casos sospechoso de Covid-19 vincula a la persona que tenga dos o más de esos síntomas, detalló la cartera sanitaria

A estas características, se le debe agregar el hecho de que esa persona haya estado en los últimos 14 días en contacto con casos confirmados de COVID-19; o tenga un antecedente de viaje internacional; historial de viaje o residencia en nuestro país en zonas de transmisión local, ya sea comunitaria o por conglomerados.

También se considerará caso sospechoso a toda persona que presente dos o más de los síntomas y resida o trabaje en instituciones cerradas ó de internación prolongada, es decir penitenciarias, residencias de adultos mayores, instituciones neuropsiquiátricas, hogares de niñas y niños; o sea personal esencial.

Este criterio alcanza también a personas que se desempeñan en Fuerzas de seguridad y Fuerzas Armadas, y a quienes brinden asistencia a personas mayores, o residan en barrios populares o pueblos originarios.

El segundo criterio para sospecha de Covid-19 incluye a toda persona que presente dos o más de los síntomas y requiera internación, independientemente del nexo epidemiológico.

En tanto, el tercer criterio indica que debe considerarse caso sospechoso a toda persona que sea contacto estrecho de caso confirmado de coronavirus y presente uno o más de esos síntomas.

El cuarto criterio señala que debe sospecharse de Covid-19 a todo paciente que presente pérdida de olfato o gusto , de reciente aparición y sin otra etiología definida y sin otros signos o síntomas

En estos casos, ante la aparición de este único síntoma, se indicará aislamiento durante 72 horas, detalla el protocolo.

Fuente: Télam

CMS NEWS: Trump Administration Proposes to Expand Telehealth Benefits Permanently for Medicare Beneficiaries Beyond the COVID-19 Public Health Emergency and Advances Access to Care in Rural Areas

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CMS NEWS

FOR IMMEDIATE RELEASE
August 3, 2020
Contact: CMS Media Relations
(202) 690-6145 | CMS Media Inquiries

Trump Administration Proposes to Expand Telehealth Benefits Permanently for Medicare Beneficiaries Beyond the COVID-19 Public Health Emergency and Advances Access to Care in Rural Areas
Physician Fee Schedule Proposed Rule would make permanent certain telehealth and workforce flexibilities provided during the COVID-19 Public Health Emergency and improve healthcare for Americans in Rural Areas 
The Centers for Medicare & Medicaid Services (CMS) is proposing changes to expand telehealth permanently, consistent with the Executive Order on Improving Rural and Telehealth Access that President Trump signed today. The Executive Order and proposed rule advance our efforts to improve access and convenience of care for Medicare beneficiaries, particularly those living in rural areas. Additionally, the proposed rule implements a multi-year effort to reduce clinician burden under our Patients Over Paperwork initiative and to ensure appropriate reimbursement for time spent with patients. This proposed rule also takes steps to implement President Trump’s Executive Order on Protecting and Improving Medicare for our Nation’s Seniors and continues our commitment to ensure that the Medicare program is sustainable for future generations. 

Expanding Beneficiary Access to Care through Telehealth 
Over the last three years, as part of the Fostering Innovation and Rethinking Rural Health strategic initiatives CMS has been working to modernize Medicare by unleashing private sector innovations and improve beneficiary access to services furnished via telecommunications technology. Starting in 2019, Medicare began paying for virtual check-ins, meaning patients across the country can briefly connect with doctors by phone or video chat to see whether they need to come in for a visit. In response to the COVID-19 pandemic, CMS moved swiftly to significantly expand payment for telehealth services and implement other flexibilities so that Medicare beneficiaries living in all areas of the country can get convenient and high-quality care from the comfort of their home while avoiding unnecessary exposure to the virus. Before the public health emergency (PHE), only 14,000 beneficiaries received a Medicare telehealth service in a week while over 10.1 million beneficiaries have received a Medicare telehealth service during the public health emergency from mid-March through early-July. For more information on Medicare’s unprecedented increases in telemedicine and its impact on the health care delivery system, visit the CMS Health Affairs blog here.
As directed by President Trump’s Executive Order on Improving Rural and Telehealth Access, through this rule, CMS is taking steps to extend the availability of certain telemedicine services after the PHE ends, giving Medicare beneficiaries more convenient ways to access healthcare particularly in rural areas where access to healthcare providers may otherwise be limited Improving Rural and Telehealth Access.
“Telemedicine can never fully replace in-person care, but it can complement and enhance in-person care by furnishing one more powerful clinical tool to increase access and choices for Americas seniors,” said CMS Administrator Seema Verma. “The Trump Administration’s unprecedented expansion of telemedicine during the pandemic represents a revolution in healthcare delivery, one to which the healthcare system has adapted quickly and effectively. Never one merely to tinker around the edges when it comes to patient-centered care, President Trump will not let this opportunity slip through our fingers.”
During the public health emergency, CMS added 135 services such as emergency department visits, initial inpatient and nursing facility visits, and discharge day management services, that could be paid when delivered by telehealth. CMS is proposing to permanently allow some of those services to be done by telehealth including home visits for the evaluation and management of a patient (in the case where the law allows telehealth services in the patient’s home), and certain types of visits for patients with cognitive impairments. CMS is seeking public input on other services to permanently add to the telehealth list beyond the PHE in order to give clinicians and patients time as they get ready to provide in-person care again. CMS is also proposing to temporarily extend payment for other telehealth services such as emergency department visits, for a specific time period, through the calendar year in which the PHE ends. This will also give the community time to consider whether these services should be delivered permanently through telehealth outside of the PHE.

Prioritizing Investment in Preventive Care and Chronic Disease Management
Under our Patients Over Paperwork initiative, the Trump Administration has taken steps to eliminate burdensome billing and coding requirements for Evaluation and Management (E/M) (or office/outpatient visits) that make up 20 percent of the spending under the Physician Fee Schedule. These billing and documentation requirements for E/M codes were established 20 years ago and have been subject to longstanding criticism from clinicians that they do not reflect current care practices and needs. After extensive stakeholder collaboration with the American Medical Association and others, simplified coding and billing requirements for E/M visits will go into effect January 1, 2021, saving clinicians 2.3 million hours per year in burden reduction. As a result of this change, clinicians will be able to make better use of their time and restore the doctor-patient relationship by spending less time on documenting visits and more time on treating their patients.
Additionally, last year, the Trump Administration finalized historic changes to increase payment rates for office/outpatient E/M visits beginning in 2021. The higher payment for E/M visits takes into account the changes in the practice of medicine, recognizing that additional resources are required of clinicians to take care of the Medicare patients, of which two-thirds have multiple chronic conditions. The prevalence of certain chronic conditions in the Medicare population is growing. For example, as of 2018, 68.9% of beneficiaries have 2 or more chronic conditions. In addition, between 2014 and 2018, the percent of beneficiaries with 6 or more chronic conditions has grown from 14.3% to 17.7%.
In this rule, CMS is proposing to similarly increase the value of many services that are comparable to or include office/outpatient E/M visits such as maternity care bundles, emergency department visits, end-stage renal disease capitated payment bundles, physical and occupational therapy evaluation services and others. The proposed adjustments, which implement recommendations from the American Medical Association, help to ensure that CMS is appropriately recognizing the kind of care where clinicians need to spend more face-to-face time with patients, like primary care and complex or chronic disease management.

Bolstering the Healthcare Workforce/Patients Over Paperwork
CMS is also taking steps to ensure that healthcare professionals can practice at the top of their professional training. During the COVID-19 public health emergency, CMS announced several temporary changes to expand workforce capacity and reduce clinician burden so that staffing levels remain high in response to the pandemic. As part of its Patients over Paperwork initiative to reduce regulatory burden for providers, CMS is proposing to make some of these temporary changes permanent following the PHE. Such proposed changes include nurse practitioners, clinical nurse specialists, physician assistants, and certified nurse-midwives (instead of only physicians) to supervise others performing diagnostic tests consistent with state law and licensure, providing that they maintain the required relationships with supervising/collaborating physicians as required by state law; clarifying that pharmacists can provide services as part of the professional services of a practitioner who bills Medicare; allowing physical and occupational therapy assistants (instead of only physical and occupational therapists) to provide maintenance therapy in outpatient settings; and allowing physical or occupational therapists, speech-language pathologists and other clinicians who directly bill Medicare to review and verify (sign and date), rather than re-document, information already entered by other members of the clinical team into a patient’s medical record.
Public comments on the proposed rules are due by October 5, 2020.
To view the CY 2021 Physician Fee Schedule and Quality Payment Program proposed rule, please visit: https://www.cms.gov/files/document/cms-1734-p-pdf.pdf