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Tuesday, March 1, 2022

Medicare Cuts Threaten Specialty Practices Nationwide

 The COVID-19 pandemic has brought to the forefront inequities and vulnerabilities that have always existed in our healthcare system. Yet, as the pandemic persists, policies that further limit access to care for underserved populations continue to be pushed forward.

For about a year now, providers have been ringing alarm bells about devastating cuts to Medicare funding for specialty care services directed by CMS. The 2022 Medicare Physician Fee Schedule final rule issued in November proposes reimbursement cuts of 20% that will harm a large variety of office-based specialists treating cancer, vascular and heart disease, dialysis patients, and more. The cuts will force free-standing medical clinics to close their doors, reducing treatment options for patients and, in many cases, leaving hospital-based care as the only option, despite the already existing strain on hospital resources.

Some claim the clinical labor pricing updates in the 2022 Physician Fee Schedule will help address workforce shortages among nurses and other clinical staff. However, this is based on the false assertion that staff won't get pay raises in 2022 if clinical labor pricing isn't updated. Salary data from the last 20 years shows that Medicare's clinical labor pricing doesn't dictate what doctors actually pay staff.

Further, proponents of the clinical labor cuts acknowledge that Medicare's budget neutrality requirements will lead to payment reductions for many procedures, but they don't address how the specialty practices performing those procedures will make up for lost revenue. By ignoring the dire consequences for specialty practices, they're leaving an essential sector of the healthcare system out of the equation. With the clinical labor pricing in effect, specialty clinical staff won't be getting raises -- they'll be losing their jobs as centers inevitably close.

With hospitals across the country overwhelmed, this is a particularly grim time to force the closures of specialty practices that provide a measure of relief to both the patient as well as these overburdened hospitals. Patients who are grappling with serious illness will have to face the added health risk of seeking treatment in a hospital setting.

In the long-term, these slashes in funding will accelerate the consolidation of our healthcare system, which limits patient choice and drives up costs for everyone. Large hospital systems are already devouring physician networks and office-based specialists in an effort to grab a larger portion of the pie. The CMS-directed cuts will only serve to help these organizations gain more market share and further drive down competition, which will lead to increased healthcare costs. Small, office-based healthcare providers cannot stay in business without reasonable reimbursement rates from the federal government.

Many of the illnesses treated by specialty clinics disproportionally affect underserved populations already struggling to access care. To be clear, these funding cuts will likely lead to worse health outcomes for Black, Hispanic, and Native Americans -- exacerbating existing inequities. Easily accessible outpatient care centers in underserved communities could be shuttered permanently.

Fortunately, Congress has the opportunity to prevent these serious adverse outcomes by reversing the cuts in the upcoming omnibus appropriations legislation. Many lawmakers are sounding the alarms right alongside healthcare providers and patient advocates. In a 2021 letter to CMS, 75 lawmakers in the House of Representatives -- led by Reps. Bobby Rush (D-Ill.) and Gus Bilirakis (R-Fla.) -- highlighted the troubling impacts that the cuts would have on the U.S. healthcare system.

Patient access to appropriate care, hard-earned progress toward health equity, and even our capacity to fight the pandemic are at risk. There is only one ethical course of action: I respectfully encourage our representatives in Congress to act to prevent the weakening of our already strained healthcare system by providing relief for office-based specialty care and working on fundamental reform of the Physician Fee Schedule.

Mark Garcia, MD, is CMO for American Vascular Associates and the Health Policy Advisor for United Specialists for Patient Access.

https://www.medpagetoday.com/opinion/second-opinions/97414

White House Plans to Add to Mental Health Workforce, Better Enforce Parity Laws

 Increasing the mental health workforce and improving parity in mental health coverage are among the mental health issues President Biden plans to address in Tuesday night's State of the Union speech.

"Our country faces an unprecedented mental health crisis for people of all ages, one which COVID has exacerbated but which predates the current challenges," a senior administration official said on a Tuesday morning phone call with reporters. "Two out of five adults today report symptoms of anxiety or depression and children face especially acute challenges as COVID has disrupted routines and relationships ... The president will announce a mental health strategy that marks a major transformation in how mental health is understood, perceived, accessed, treated, and integrated in and out of healthcare settings."

The senior administration official outlined the administration's three-pronged strategy to improve Americans' mental health -- a strategy the president will discuss in the State of the Union speech:

  • Increase the mental health workforce. "We do not have enough providers or system capacity to meet Americans' needs," the official said. "One-third of Americans live in areas without adequate behavioral health providers, and our crisis response infrastructure is frayed. We must begin with a major new investment in building our mental health and substance use disorder workforce." According to a White House fact sheet, Biden's fiscal year 2023 budget proposal "will invest $700 million in programs – like the National Health Service Corps, the Behavioral Health Workforce Education and Training Program, and the Minority Fellowship Program – that provide training, access to scholarships, and loan repayment to mental health and substance use disorder clinicians committed to practicing in rural and other underserved communities." The official said that the budget "will also propose a transformational expansion of certified community behavioral health centers and community mental health centers to build new capacity." In addition, the new "988" mental health hotline also will launch this summer, giving Americans an easier way to connect to support and resources, the official noted.
  • Improve access to care. "Fewer than half of Americans with mental health needs receive treatment," the official said. "Costs and stigma are too often a barrier and care can be inconvenient or confusing to access." The administration is taking steps to more diligently enforce the Mental Health Parity and Addiction Equity Act of 2008, signed into law by President George W. Bush, which requires insurers to offer mental health benefits that are on a par with their physical health benefits. "That standard is too often ignored and this administration is taking important steps to enforce the law," the official said. Biden also will ask Congress to modernize mental health laws "so that all insurance plans are required ... to provide an adequate network of providers for those services." The president also will ask Congress to expand telehealth access and allow for telehealth delivery across state lines, and the Department of Health and Human Services (HHS) "will also build new, easy-to-access, user-friendly online Treatment Locator tools," the official said.
  • Foster more supportive environments. This includes social media content aimed at children, the official said. "The president will call for action to address social media's mental health harms, especially for young people ... And we must strengthen privacy and advertising protections for kids on the Internet." To help set up students for success, "the president will call on Americans nationwide to take on roles as tutors and mentors to help our students recover."
  • Regarding the parity provisions, the official said in response to a question from MedPage Today that the Biden administration hopes to both enforce existing law and to write new rules. The official noted that the departments of Labor, Treasury, and HHS recently issued a report that found "widespread failures by plans to comply with requirements related to documenting how they are setting their mental health coverage limits, and restrictive coverage that is oftentimes in violation of the law. The departments are committed to continuing those vigorous enforcement activities, and pursuing companies and plans that are not adequately covering the services" to make sure they comply.

The departments also are planning to begin rulemaking around parity later this year, the official added. And "moving beyond the existing parity requirements, we believe that all types of insurance coverage, including employer health plans, should be required to cover a robust package of behavioral health services ... and that part of that package of services should include access to three behavioral health visits with with no cost-sharing, so people have a way to walk in the front door of the behavioral health system without costs serving as a barrier." The new rules also should include network adequacy requirements, the official said.

https://www.medpagetoday.com/publichealthpolicy/healthpolicy/97442

Insulin Supplement in Preterm Babies' Milk Bolstered Feedings

 Adding recombinant human (rh) insulin to human milk and formula helped preterm infants reach full enteral feeding faster, the randomized FIT-04 study found.

Among 303 infants with a gestational age of 26 to 32 weeks, those receiving either low-dose rh insulin (400 μIU/mL milk) or high-dose rh insulin (2,000 μIU/mL milk) for 28 days were able to achieve an enteral intake of ≥150 mL/kg per day for 3 consecutive days more quickly than infants on placebo, reported Johannes B. van Goudoever, MD, PhD, of Amsterdam University Medical Centers in the Netherlands, and colleagues in JAMA Pediatrics.

The median time to achieve full enteral feeding -- the study's primary outcome -- was significantly reduced for both groups on insulin versus placebo:

  • Low-dose rh insulin: 10.0 days (IQR 7.0-21.8 days, P=0.03)
  • High-dose rh insulin: 10.0 days (IQR 6.0-15.0 days, P=0.001)
  • Placebo: 14.0 days (IQR 8.0-28.0 days)

Likewise, the proportion of infants who achieved full feeding in the initial days of intervention was significantly higher in both insulin groups versus the placebo group:

  • Day 6: low dose 21%, high dose 25%, placebo 9%
  • Day 8: low dose 35%, high dose 37%, placebo 22%
  • Day 10: low dose 48%, high dose 48%, placebo 32%

However, rates of weight gain did not differ between the groups. Infants across each of the three arms saw a range from a median 17.2 to 17.9 g/kg/d gain.

All study groups also saw similar head circumference gains -- 0.8 cm/week for both insulin groups and 0.7 cm/week for placebo -- as well as similar body length gains, with a median growth of 1 cm/week for all groups.

Necrotizing enterocolitis (Bell stage 2 or 3) occurred in 6% of the low-dose group, 5% of the high-dose group, and 10% of the placebo group.

None of the preterm infants in any of the study groups developed serum insulin antibodies. The rate of hypoglycemic events was also similar between the groups.

"These findings support the use of rh insulin as a supplement to human milk and preterm formula," van Goudoever's group concluded.

When discussing the background behind the study, the researchers highlighted the slew of clinical benefits of preterm infants being fed with their mother's own milk. Some of these benefits include fewer clinical symptoms of feeding intolerance and a lower risk of postnatal complications relative to preterm infants fed with formula.

However, "it has been shown that the natural insulin concentration in human milk peaks in the early postpartum period but declines to a basal level within the first 3 days postpartum," the group pointed out. "To date, insulin is absent in formula."

For this study, van Goudoever's group enrolled preterm infants with a birth weight of 500 g from 46 neonatal intensive care units throughout Europe, Israel, and the U.S. from 2016 to 2018. Exclusion criteria included major congenital malformations, suspected infections, confirmed necrotizing enterocolitis, and maternal diabetes.

The rh insulin supplement came in powdered form for enteral administration. A standard stock solution was prepared each day by either the researcher, physician, or neonatal nurse, including one insulin powder sachet per 1.8-mL solvent (i.e., mother's own milk, donor human milk, or preterm formula). A 0.04-mL dose of stock solution per planned mL of enteral feeding was also prescribed each day for all infants to obtain the target rh insulin concentration (400 μIU/mL milk for the low-dose group and 2,000 μIU/mL milk for the high-dose group).

The minimum of four administrations for each infant was to ensure intestinal rh insulin exposure throughout the day.

Although infants younger than 26 weeks' gestation were intentionally excluded, van Goudoever and colleagues said they "expect that the effect would be even more significant in infants with a lower gestational age given that time to achieve full enteral feeding is inversely related to gestational age."

This should be a topic for future research, they noted.


Disclosures

The study was supported by Nutrinia Ltd.

van Goudoever and some co-authors reported receiving grants and other fees from Nutrinia Ltd during the conduct of the study. van Goudoever also reported being founder and director of the Dutch National Human Milk Bank; being a member of the National Health Council; and serving as chair of the Committee on Nutrition and Pregnancy. One co-author reported being employed with Baxter Healthcare Corporation after the study's completion.

FDA Unveils New Cancer Trial Guidance to Back 'Moonshot' Initiative

 The FDA issued three final guidances to industry for cancer clinical trials that align with the goals set by President Biden in the relaunch of his "Cancer Moonshot" initiative, which was announced last month.

According to the White House, the goal of this revamped endeavor is to cut the age-adjusted death rate from cancer by a least 50% over the next 25 years, and improve on the experiences of people living with and surviving cancer, as well as those of their families and caregivers.

"With today's actions the FDA is recommending important principles that involve addressing inequities, targeting the right treatments to the right patients, speeding progress against the most deadly and rare cancers, and learning from the experience of all patients," said Richard Pazdur, MD, director of the FDA's Oncology Center of Excellence, in a press release. "All of these are tenets of Cancer Moonshot's mission."

The first guidance, "Inclusion of Older Adults in Cancer Clinical Trials," provides recommendations on the inclusion of older adults (65 years and older) -- with specific emphasis on including adults over the age of 75 -- in clinical trials of cancer drugs in order to ensure that this historically under-represented group is adequately studied.

The guidance includes recommendations for trial design, recruitment strategies, data collection, and developing and reporting more discrete age groups to encourage enrollment among older adults.

The FDA noted that it is important to include older adults in clinical trials due to the many differences between this age group and younger adults, such as comorbidities and use of certain medications that could affect the study drug's efficacy or the incidence of adverse events.

The second guidance, "Expansion Cohorts: Use in First-in-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics," provides recommendations on designing and conducting trials with multiple expansion cohorts that allow for concurrent accrual of patients into different cohorts in order to assess safety, pharmacokinetics, and antitumor activity of first-in-human cancer drugs.

According to the FDA, trials with expansion cohort designs can assess many different aspects of a drug in a single clinical trial and expedite the clinical development of the drug more efficiently.

The third guidance, "Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics," directs trial sponsors on the design and conduct of clinical trials that are intended to evaluate multiple drugs, disease types, and/or patient populations in multiple substudies, with the goal of accelerating drug development.

It also advises sponsors on how they should interact with the FDA to ensure efficient review and prevent risks to patients.

"Because of the complexity of these trials and the potential regulatory impact, it's important that the FDA is providing this guidance on how to conduct well designed trials that protect patient safety and obtain quality data needed to support drug approval," the agency noted.

https://www.medpagetoday.com/publichealthpolicy/clinicaltrials/97449

Novavax Expects At Least $4 Billion In Covid Vaccine Sales This Year

 Novavax's (NVAX) highly anticipated Covid vaccine lagged sales expectations in its first quarter on the market, but NVAX stock turned around early losses Tuesday.

The vaccine won its first authorization in Indonesia on Nov. 1. Since then, the company has launched its two-shot inoculation to a number of countries abroad. But for the fourth quarter, Novavax posted $222.2 million in revenue, far below estimates for $331.8 million, according to FactSet.

Revenue fell roughly 21% year over year. The lion's share of revenue stemmed from royalties. Partner companies sell Novavax's vaccine in South Korea and Indonesia, and pay Novavax a royalty. The shot is also now shipping to Australia and the European Union.

On today's stock marketNVAX stock gained 0.4% to close at 83.74. Shares were up more than 6% at one point, reversing an early 5.2% dive.

NVAX Stock Pops Despite Sales Miss

The biotech company also reported wider-than-expected losses for the quarter. Per-share losses were $11.18, vs. NVAX stock analysts' projection for a loss of $1.80 per share.

For the year, Novavax predicts total revenue of $4 billion to $5 billion. The midpoint of the outlook came short of analysts' more bullish forecast for $4.92 billion. NVAX stock analysts expect the Covid vaccine to generate $4.6 billion of that.

But NVAX stock shrugged off the earnings and forecast disappointment on Tuesday. Shares rose to a month-high in early action.

Next up, investors are watching for updates on Novavax's omicron-specific vaccine. Novavax is now ramping manufacturing with expectations to deliver shots toward the end of the first quarter.

Officials in the U.S. are also considering the Covid shot, which would provide another alternative to the messenger RNA vaccines from Pfizer (PFE) and Moderna (MRNA). NVAX stock has struggled recently, though, amid the omicron wave.

https://www.investors.com/news/technology/nvax-stock-shrugs-off-slow-covid-vaccine-sales-guidance/

RI opens applications for safe injection sites

 

  • Rhode Island is accepting applications for safe drug consumption sites.
  • The state is rolling out a two-year pilot program to see how harm reduction centers improve public health.
  • The state experienced a 25 percent increase in drug overdoses in 2020.

Almost eight months after Rhode Island authorized safe drug injection sites to operate in the state, its Department of Health has opened up applications and is encouraging organizations to apply. 

In July, Rhode Island authorized a two-year pilot program to try to prevent drug overdoses by establishing harm reduction centers, community-based resources for health screening, disease prevention and recovery assistance where people can safely consume pre-obtained substances. 

The regulations for Rhode Island’s harm reduction centers took effect on Feb. 16, and now the Rhode Island Department of Health (RIDOH) has opened licensing applications for organizations interested in establishing harm reduction centers. 

“Harm reduction centers in Rhode Island will be an important part of Rhode Island’s approach to the drug overdose crisis. These community-based resources allow people to safely consume pre-obtained controlled substances in a supportive environment without legal repercussions,” said Joseph Wendelken, spokesperson for RIDOH, to local media. 

Advocates urge the use of harm reduction, like the Substance Abuse and Mental Health Services Administration (SAMHSA), because it incorporates a spectrum of strategies that meet people where they are on their own terms and serves as a pathway to prevention, treatment and recovery.  

Provisional data from the Centers for Disease Control and Prevention (CDC) found that there were an estimated 100,306 drug overdose deaths in the U.S. during the 12-month period ending in April 2021, an increase of nearly 29 percent from the same period in 2020. 

Under federal law, harm reduction centers remain illegal, but states are beginning to test them out. Similar to Rhode Island, New York City approved the opening of a supervised drug consumption facility, known as an “overdose prevention center.” The city’s health department said after three weeks of operation, two overdose prevention sites, “averted at least 59 overdoses to prevent injury and death.” 

The health department also said in the first three weeks of operation, the centers were used more than 2,000 times. 

Officials in Rhode Island hope to find similar success, as the state found drug overdoses increased by 25 percent in 2020. In 2021, over 400 people died in Rhode Island by overdose, the highest number ever recorded to date in the state. 

Rhode Island’s harm reduction centers will offer naloxone, a medicine that can reverse an opioid overdose, harm reduction training and distribution of safer drug use supplies, like sterile injection, smoking supplies and fentanyl test strips. 

Free sterile needles will be available, as will the safe and secure collection of used needles. 

Connections and referrals to recovery support programs, treatment, counseling and housing, employment and legal services will also be available. 

Rhode Island’s pilot program will end on March 1, 2024, at which point lawmakers will evaluate how the harm reduction centers helped public health.

https://thehill.com/changing-america/well-being/prevention-cures/596401-rhode-island-opens-applications-for-safe

Verily taps Oncimmune tech for ‘long COVID’ study

 Alphabet’s Verily Life Science has contracted UK biotech Oncimmune to investigate autoantibodies in people who have developed long-lasting symptoms after COVID-19 infection, a condition known as ‘long COVID’.

The aim of the project is to try to find patterns of autoantibodies – antibodies that react with self antigens – that are present early on in COVID-19 infection that are associated with the development of long COVID, also known as post-acute sequelae SARS-CoV-2 (PASC) infection.

Studies have suggested that some patients with COVID-19 exhibit marked increases in autoantibody reactivities as compared to uninfected individuals, including some that seem to target immune components like cytokines, chemokines and complement proteins.

It’s still an emerging area of research, with intriguing findings from scientists working in this area, for example that autoantibody activation is more common in women after asymptomatic infection and in men after a symptomatic infection, which paint a picture of a complex syndrome.

Oncimmune will use its infectious disease panel of biomarkers to find autoantibodies that are indicators of long COVID, and see if levels remain in long COVID patients during their period to recovery.

Verily meanwhile has been active in the response to COVID-19 since early on in the pandemic, devoting some of its lab capacity to testing, developing screening tools for health systems and hospitals, and working with Janssen to explore how the coronavirus affects a person’s immune system immediately after a positive test result.

“The real impact on society of long COVID is only beginning to be understood,” said Oncimmune’s chief executive Dr Adam Hill.

The contract includes “potential for the initial discovery work in autoantibodies to progress onto the identification of intellectual property rights, and to the development of viable commercial companion diagnostic devices,” he added.

Financial terms of the contract have not been disclosed. The deal was announced as Oncimmune reported half-year revenues of £1.4 million ($1.9 million) in the first half of its financial year ended November 30, 2021, slightly down on the same period of 2020 shortly after the company launched.

It now counts five of the top 10 pharma companies as customers for its ImmunoINSIGHTS autoantibody profiling platform, and says it expects revenues for the full year to reach around £6 million.

https://pharmaphorum.com/news/verily-taps-oncimmune-for-long-covid-study/