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The Drug Enforcement Administration (DEA) announced proposed permanent rules

for the prescribing of controlled medications through telemedicine with new appropriate safeguards.

These rules — developed with the U.S. Department of Health and Human Services and the U.S. Department of Verterans Affairs —  are expanding patient access to critical therapies beyond the scheduled end of the 

In specific, doctors would be recquired to evaluate patients in person before writing prescriptions for some controlled medications and meeting them through a telemedicine consultation.

For these types of consultations, the proposed telemedicine rules would allow medical practitioners to prescribe a 30-day supply of Schedule III-V non-narcotic controlled medication and a 30-day supply of buprenorphine for the treatment of opioid use disorder without an in-person evaluation or referral from a medical practitioner that has conducted an in-person evaluation, as long as the prescription is otherwise consistent with any applicable Federal and State laws. 

The public has 30 days to review and comment on the proposals, which DEA will then consider before drafting final regulations.

DEA Administrator Anne Milgram said in a release, the permanent expansion of telemedicine flexibilities would continue greater access to care for patients across the country, while ensuring the safety of patients. 

"DEA is committed to the expansion of telemedicine with guardrails that prevent the online overprescribing of controlled medications that can cause harm," Milgram added.

The proposed telemedicine rules also further DEA’s goal of expanding access to medication for opioid use disorder to anyone in the country who needs it, the DEA release said.

“Medication for opioid use disorder helps those who are fighting to overcome substance use disorder by helping people achieve and sustain recovery, and also prevent drug poisonings,” said Milgram. “The telemedicine regulations would continue to expand access to buprenorphine for patients with opioid use disorder.”

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The Drug Enforcement Administration (DEA) announced proposed permanent rules for the prescribing of controlled medications through telemedicine with new appropriate safeguards.

In-Person Visits For Some Drug Prescriptions Are Required Over Telehealth Prescriptions

The American Cancer Society has introduced the American Cancer Society Center for Diversity in Cancer Research Training to address the lack of diversity in research environments.

The Cancer Society recently announced the new center will enhance the traditional academic journey, focusing on meeting potential researchers where they are and helping them overcome barriers to future success. 

Initial programming will support underrepresented high school, college and post-baccalaureate students and include exposure to oncology and cancer research as a career. Mentorship, hands-on research experiences and career development will also be included. 

The aim is to increase efforts to recruit and nurture individuals from diverse backgrounds within scientific and clinical training environments, according to a release by the Cancer Society.

"The center is a perfect way to build upon the Diversity in Cancer Research internship program we launched in 2021," said 

, MPH, senior vice president of the center," in the release. "Its success caused us to think about the support we could provide more broadly. Inequities impact cancer outcomes in tangible and intangible ways. Working to remove the academic barriers people of color face allows us to grow a pipeline of well-qualified researchers who have a unique connection to the communities we need to impact."

Today, the racial and ethnic communities that bear a disproportionate burden of cancer unfortunately continue to be underrepresented in the cancer research workforce. For example, while the number of biomedical scientists in the U.S. has grown since the 1990s, the percentage of African Americans and Hispanics in biomedical careers is lowest among any ethnic group, the release said.

In addition, funding rates for the National Institute of Health's R01 grant program, which serves as a catalyzing milestone in the academic careers of many research scientists, remains lowest for African American applicants at 16.6% compared to 27.8% for White applicants. 

Lastly, people of color represent 20% of first-year college students pursuing degrees in science and engineering. The numbers decrease as these students move through their education with 17% receiving a bachelor's degree and only 10% completing advanced degrees in these disciplines.

, CEO of the American Cancer Society said the new initiative will help further enhance diversity in cancer research and cancer care and "expand the expert breadth of voices and innovative strategies to accelerate progress against cancer."

The American Cancer Society has introduced the American Cancer Society Center for Diversity in Cancer Research Training to address the lack of diversity in research environments. The new center will enhance the traditional academic journey, focusing on meeting potential researchers where they are and helping them overcome barriers to future success. 

American Cancer Society is Tackling Diversity in Cancer Research With New Training Program


Compared with medications and medical devices, digital therapeutics are newcomers to the sometimes complex and often arcane ways of the FDA approval process. Rather than cooking up a new process from scratch for digital therapeutics, the federal government’s regulatory agency has decided to review and approve digital therapeutics in the same way it reviews and approves medical devices.

And, for now, that suits the digital therapeutics industry just fine

“With FDA, we do say, OK, at least this works,” says 

, CEO of the Digital Therapeutics Alliance, the six-year-old trade association for the budding digital therapeutics industry. In contrast, Molnar notes, Centers for Medicare and Medicaid Services (CMS) and, more specifically, the Medicare program, have no process that the digital therapeutic companies can use to gain Medicare reimbursement. The association is lobbying to Congress to pass legislation that would open up Medicare reimbursement for prescription digital therapeutics.

, the group’s director of U.S. government affairs, were recently interviewedby 

Digital Therapeutics Alliance Has Doubled in Size

Technically, the FDA does not “approve” medical devices and digital therapeutics, Molnar and Elalamy noted. Approval is reserved for drugs. The agency “clears” or “authorizes” devices and digital therapeutics. “When I saw ‘approval,’ everybody corrects me,” Elalamy says.

For FDA clearance and authorization purposes, devices and digital therapeutics arere grouped into 

. Class one devices are those that pose little if any risk of causing harm, such as tongue depressors and toothbrushes. Class two devices, which the FDA deems as posing an intermediate or medium risk of resulting harm, include CT scanners and infusion pumps. Molnar says the FDA views almost all digital therapeutics as class two devices. Class three devices are seen as posing the greatest potential risk and include implantable devices such as pacemakers.

“I’ve heard of a few companies that are going for class three (approval), but I have not heard that have gotten through the process yet,” says Molnar. Those digital therapeutics likely work in some way with devices that are implanted.

Like devices, digital therapeutics may also be evaluated in the “510(K)” process, which means that the maker shows that the digital therapeutic is “substantially equivalent” to one that already has received an FDA OK. 

Molnar says digital therapeutics must indicate on their FDA application whether the product is prescription or not. “You can’t be silent on it. You have to say during the application whether or not its prescription or nonprescription.”But he says that the FDA says most of the class two digital therapeutic products should be prescription.

The prescription versus nonprescription distinction may become especially important when it comes to Medicare coverage because the legislation that the Digital Therapeutics Alliance is currently lobbying for would limit coverage to prescription digital therapeutics, Molnar and Elalamy explain.

Supporting evidence from a clinical trial has been an important criterion for products that the alliance views as digital therapeutics in contrast to the thousands of health and wellness apps.

But Molnar there is a growing demand for the digital therapeutics to have real-world evidence behind them.

“We do love to see publications about how it functions in the real world. And it is not just coming from us as a trade organization. It’s coming from provider, payers, professional associations that really want to make sure that when you take these (digital therapeutics) out of controlled trial that they still function in the way you say they will.”

“It is incredibly important,” Molnar continues, “particularly when engagement is one of the most important drivers for an effective outcome when it comes to digital health.”

Although putting digital therapeutics into the existing the pathways for FDA clearance and authorization of device has worked out for the digital therapeutics industry, Molnar says both the FDA and the industry are grappling with issues that are still taking shaping.

“I think AI (artificial intelligence) is probably one of important things. How do you treat AI?” Molnar says.

Many other unanswered questions are looming, in Molnar’s telling. The initial OK for a digital therapeutic might be the easiest part, conceptually, he says.

Digital therapeutics are regulated like devices by the FDA. Andy Molnar, the  CEO of the industry’s trade organization, the Digital Therapeutics Alliance,  says the FDA clearance and authorization process for digital therapeutics “works.” 

For Digital Therapeutics, Many Issues. But FDA Process Is Not One of Them.

Data collected from more than 40,000 practitioners revealed the top healthcare trends that will have the biggest impact on physicians and medical offices in 2023.

The aggregated, anonymous user data was collected from the practitioners spanning from 13,000 medical practices who subscribe to 

  practice management, EHR and patient engagement solutions.

AdvancedMD is a provider of cloud healthcare software for independent medical, mental health, and physical therapy practices. 

Data compiled the top six healthcare trends that will have the biggest impact this year.

“Our industry has witnessed extraordinary growth over the last few years that has brought about entirely new models for delivering healthcare services with tremendous productivity gains,” said Amanda Hansen, president of AdvancedMD, in a release. “From the way patient records are maintained and shared to integrative healthcare offerings, patient engagement tactics, and billing processes, healthcare providers are becoming more effective and more efficient across the board. These advancements are not only driving more successful business practices for medical offices but creating significantly improved patient outcomes.”

The top trends according to AdvancedMD are:

Medical offices will adopt a broader selection of patient-centric payment capabilities.

 
As expectations rise among younger, digitally-native patients, medical offices and healthcare providers will seek more patient-centric payment models that make it easier to distribute billing information and receive electronic payments from patients.

Mental healthcare will become an integral component of the healthcare experience.

 
Physicians and healthcare providers will lean more heavily into building integrative practices that include behavioral and mental health offerings, delivering a more holistic patient experience.

3. There will be a resurgence of independent practices with more physicians choosing to take full ownership over their offerings and administrative processes.


With massive advancements across the healthtech space that streamline workflow and enable more efficient billing, patient engagement and EHR processes, staff physicians will seek to “be their own boss,” launching autonomous independent practices that remove the barriers of corporate-owned healthcare practices.

4. Medical practice owners will lean more heavily into workflow and process automation improvements that enable informed decision-making capabilities based on highly-accurate data – significantly boosting the practice’s financial performance.


Automation technology has proven to be a key component of an effective practice management strategy, delivering measurable productivity gains and improved patient outcomes. For example, by automating telehealth workflows, the practice's primary schedule is updated to reflect accurate online schedules for patients, appointment reminders are automatically triggered with full appointment access details, and payments can be easily collected. Also, because automation substantially boosts data accuracy – resulting in more informed decision-making capabilities – the industry will see a noticeable lift in physicians and practice owners automating daily patient information workflow processes.

5. Remote patient monitoring solutions will gain popularity, vastly improving patient outcomes and care management.


Serving as an extension of telehealth services, remote patient monitoring (RPM) – the ability for physicians to monitor patient health data in real time – will become ubiquitous across the healthcare landscape, improving outcomes for patients suffering from chronic illnesses, including diabetes, heart conditions, and hypertension. The ability to integrate RPM data directly into patient charts within EHR systems will bolster physician productivity and quality of care.

6. Medical offices will offer comprehensive self-service capabilities that give patients more control over their healthcare experience.


To improve patient engagement, healthcare providers will implement more self-service patient tools, offering digital patient portals that allow patients to complete intake and accurate health histories, access healthcare records, pay invoices, schedule appointments, and receive telehealth services. These self-service platforms will provide an integrated patient experience, with ambulatory care providers, in-patient hospital services, and other medical providers all able to connect on a single patient portal.

Data collected from more than 40,000 practitioners revealed the top healthcare trends that will have the biggest impact on physicians and medical offices in 2023. Among them were patient-centric care, remote patient monitoring and mental healthcare.

Healthcare Trends That Could Make an Impact on Medical Practices in 2023 

, the developer of a game-based treatment for attention-deficit/hyperactivity disorder (ADHD), has moved to lay off 46 employees, or about 30% of its workforce.

CEO and co-founder Eddie Martucci, Ph.D., sent an email to employees announcing the layoffs last week, and the text of the 

Th 8K notice that the Boston-based company filed with the Securities and Exchange Commission says severance and other costs associated with layoffs will be between $1.5 and $2.5 million and that expects to record the charges in the first quarter of 2023.

Akili’s ADHD product is called EndeavorRx, and the company bills it as the “first-and-only FDA-authorized treatment delivered through a video game experience” and says it is working to develop a “a new category of medicine – medicine that is validated through clinical trials like a drug or medical device but experienced like entertainment.”

In his email to employees, which was addressed to “Aklilians,” Martucci said the company is pulling back on pipeline and growth initiatives that are not necessary to near-term growth. He mentioned a focus “EndeavorRx traction” and “key adoption, coverage, and engagement (A.C.E.) initiatives.”

Akili’s stock was trading at about $1.50 a share this morning. For most of last year, it was trading at about $10 a share before it started to dramatically slide in August.

On Jan. 5, the company announced positive results from a trial of EndeavorRx in adolescents with ADHD that it said will be used to apply for an expanded label for the treatment. According to the announcement, the results for “attention improvement” from the open-label study involving 162 adolescents, ages 13-17, were three times larger than those seen in the trial that led to FDA authorization for EndeavorRx for children, ages 8 to 12.



Developer of EndeavorRx, a game-based treatment for ADHD, is pulling back from the pipeline and focusing on near-term growth, the CEO said in an email to employees.

Akili Laying Off 30% of Workforce

Pear Therapeutics announced today that its reSET and reSET-O prescription digital therapeutics have been added to Florida’s Medicaid preferred drug list.

“Pear applauds Florida leadership for bringing reSET and reSET-O to its millions of Medicaid members in its persistent efforts to tackle the addiction crisis and bring innovative treatment options to those seeking recovery,” Julia Strandberg, MBA, Chief Commercial Officer of Pear Therapeutics.

The announcement about inclusion on Florida’s Medicaid preferred drug lists comes on the heels of a company announcement about a California Medicaid pilot program for treatment of stimulant use disorder that involves use of Pear’s services.

California Medi-Cal Contracts With Pear to Treat Stimulant Use Disorder

ReSET is used as a monotherapy for patients 18 years of age or older with substance use disorder related to alcohol, cannabis, cocaine, and methamphetamine. ReSET-O is used in combination with buprenorphine-based medication- assisted treatment for patients 18 years of age or older with opioid use disorder.

According to Pear, the Florida Medicaid program has an enrollment of approximately five million, the third highest in the country.

Pear also recently announced a deal with California's Medicaid program that involves supporting a pilot project to help people with stimulant use disorder.