DOJ employees ask for expanded benefits to protect abortion access

 A group of Justice Department employees sent a list of demands to Attorney General Merrick Garland and Vice President Kamala Harris on Thursday, asking for the administration to expand health care coverage to include abortion-related benefits like paid leave to travel out of state and reimbursement for travel expenses.

The group, the Department of Justice Gender Equality Network, told administration officials they have not done enough to support federal workers since the Supreme Court overturned Roe v. Wade in late June.

"[T]he federal government has chosen not to follow countless employers in the private sector that support their employees affected by restrictive state laws," states the letter from DOJ GEN, a 1,200-member organization comprised of Justice Department employees who pursue gender equity in the federal workforce. "Failing to act quickly to address this issue could hinder the Administration's work to advance diversity, equity, inclusion, and accessibility in the federal workforce, and harm the Administration's efforts to recruit and retain talented employees."

In the weeks since Roe was overturned, several large companies, including Amazon, Bank of America and Target, have promised to cover certain expenses for employees who need to travel for abortion services.

The employees are asking the administration to approve paid leave and coverage of travel expenses for federal employees who travel out of state for abortion care; allow federal workers to decline work travel to states that ban abortion; pledge to shield employees who are prosecuted for abortion-related crimes from being penalized in the federal workforce; promise to fight the Hyde Amendment; and to add federal employees to newly formed reproductive rights task forces.

"These are meaningful steps the administration should take right now to protect abortion access for the nation's 2 million federal public servants and their dependents in states that have already banned abortion, or likely will soon," said Stacey Young, President of the Gender Equality Network.

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CNN has reached out to the Justice Department and the White House for comment.

President Joe Biden and Garland have both repeatedly pledged to protect abortion rights. On Wednesday, the President issued his second executive order designed to ensure access to abortion care this summer. Wednesday's order would pave the way for Medicaid to pay for certain abortion services for people forced to travel outside their state, though questions loom whether this would violate the Hyde Amendment which prohibits the use of federal funds to perform abortions.

The Justice Department on Tuesday filed its first lawsuit related to abortion rights against the state of Idaho, asking a federal court to block the state's abortion ban set to go into effect August 25.

DOJ GEN sent a similar letter to administration officials in May after the leak of a draft opinion that signaled the Supreme Court was set to overturn Roe. Then, however, the group only asked the administration to allow time off for employees who needed to travel to get an abortion. This latest letter, more than a month after the court issued the decision, asks for much greater protections and benefits for federal workers.

Justice Department employees are asking the administration not only to provide paid leave -- arguing that a recent Office of Personnel Management fact sheet reminding workers they can use sick leave for travel does not go far enough -- but also to pay for the expenses associated with travel to get an abortion.

The group argues that "covering travel expenses would not run afoul of the Hyde Amendment, which restricts only the use of federal funding for most abortion procedures themselves -- not ancillary benefits."

Additionally, the group wants the administration to allow federal employees to opt out of work travel to states that ban abortion or relocate entirely if they are based in such a state.

Biden and Garland this week have referenced the uncertainty, and often danger, women and doctors have confronted in the wake of Roe being overturned.

"Emergency medical care being denied to women experiencing miscarriages, doctors uncertain about what they can do to provide for their patients, pharmacists unsure whether they can fill prescriptions that they've always filled before, a tragic case of rape survivors, including a 10-year-old girl forced to travel to another state for care," Biden said before signing his second executive order on the issue Wednesday.

https://www.cnn.com/2022/08/04/politics/justice-department-employees-abortion-access/index.html

Medicare policy still failing home infusion therapy patients

 Over the last several years, the COVID-19 pandemic has accelerated trends that encourage the utilization of home-based health care. For example, commercial payers across the country are increasingly employing “site of care optimization” to lower costs associated with infused or injected drugs by encouraging the use of clinically appropriate and convenient settings. However, almost four years into the creation of a new Medicare benefit designed to promote access to home infusion, this vital health program is failing to keep up with the needs of America’s seniors.  

Nearly four years ago, I penned an op-ed in The Hill that lamented the flawed rollout of Medicare’s new home infusion benefit. As an original supporter of the legislation that created this benefit, I was disappointed that the Centers for Medicare and Medicaid Services’ (CMS) implementation fell short by providing insufficient reimbursement for home-infusion professional services, therefore jeopardizing Medicare beneficiaries’ access. 

The problem lies with CMS’s unnecessary requirement that a skilled professional (such as a nurse) be physically present in the patient’s home on the day of administration for Medicare reimbursement to occur. This fundamentally defeats the purpose of home infusion, which is to give patients the freedom to receive and administer their infusions at home without a health care professional. No other payer, including commercial plans, Medicare Advantage Plans, and others, have such requirements.   

Four years later, the results are clear: CMS’ policy is failing Medicare’s home infusion patients. Despite the creation of a dedicated home infusion benefit, CMS’ own data confirms that less than 1,300 Medicare beneficiaries accessed the benefit each calendar quarter between the first quarter of 2019 and the first quarter of 2021 — an anomaly compared to the estimated 3.2 million patients served annually by home infusion pharmacies. Moreover, utilization of the benefit within the Medicare program has gone down during the public health emergency, despite increases in uptake among commercial and other government payers. 

Without access to home infusion, Medicare beneficiaries are instead being directed to institutional settings — increasing costs to both patients and federal taxpayers while unnecessarily inconveniencing patients that don’t otherwise need to be in facilities to receive their care. For some patients in southeastern Georgia, this could mean driving several hours a day to the closest facility to receive their daily IV infusion. For others, this could mean being admitted to a nursing facility or other long-term care setting for an extended period instead of easily receiving these infusions in the comfort of their own homes.  

To address the shortcomings of Medicare’s home infusion benefit, it is vital that reimbursement reflects all services necessary to administer IV drugs safely and effectively at home — including the extensive pharmacy services that are essential to ensure patients are safely and effectively administering their infused medications. One key piece of legislation pending before Congress, the Preserving Patient Access to Home Infusion Act (H.R. 5067), would do just that by providing coverage for infusion services every day a drug is infused, rather than just on days when a skilled professional is physically present. 

Medicare is the only major payer of health care services in the United States that lacks straight-forward coverage for administering IV drugs at home, despite an overwhelming need for patients to remain at home during the pandemic and the significant potential for cost savings. It is time for Medicare to recognize the value of home infusion and expand this benefit to ensure access for all of America’s seniors. 

Rep. Earl L. “Buddy” Carter, a Republican, represents Georgia’s 1st District. He is one of just two pharmacists currently serving in Congress.

https://thehill.com/opinion/congress-blog/3589834-four-years-later-medicare-policy-is-still-failing-home-infusion-therapy-patients/

Senate Dems skipping COVID testing to push spending bill vote

 That’s sick!

Senate Democrats are embracing a “Don’t Test, Don’t Tell” policy this weekend as they try to ram a $764 billion spending bill through the 50-50 chamber — knowing that even one COVID-19 positive could blow up their plans.

Senate Majority Leader Chuck Schumer (D-NY) has set a Saturday test vote for the so-called Inflation Reduction Act, which needs all 50 Democrats on board so Vice President Kamala Harris can cast a tiebreaking vote in its favor.

“They’re not going to delay it if a member has gotten COVID,” a senior Senate aide told Puck News. “Counterparts are saying they’re not going to test anymore. It’s not an official mandate but we all know we’re not letting COVID get in the way. The deal is happening. Less testing, just wear masks and get it done.” 

Another source told the outlet that even if a senator did catch the virus, “you can bring your ventilator and still vote.” 

Unlike the House, the Senate does not allow proxy voting, meaning members who cannot make it to the floor due to illness are out of luck.

Earlier in the week – before moderate Sen. Kyrsten Sinema (D-Ariz.) got on board with Schumer and Sen. Joe Manchin’s (D-WV) climate and energy plan – the Democratic leader insisted his party was “going to stay healthy” ahead of a potential vote.

“We’re not talking about a plan B,” Schumer said at the time.

Concerns about having all 50 Democrats and Democrat-voting Independents present on the Senate floor have grown in recent weeks, as several senators have tested positive for COVID or been absent for other health reasons. 

In late June, Senate President Pro Tempore Patrick Leahy (D-Vt.) fell in his Virginia home and broke his hip – keeping him out of Washington until this week. He ultimately underwent two surgeries. 

Sen. Kyrsten Sinema agreed to a compromise for the spending plan — likely giving Democrats 50 votes for the bill in the Senate.

AP Photo/J. Scott Applewhite, File

Just a week before, Republican Sen. Kevin Cramer of North Dakota seriously injured his hand during a yard work incident. 

In early July, Schumer and Sen. Richard Blumenthal (D-Conn.) tested positive for COVID-19, both reporting mild symptoms. Days later, Manchin and Republican Sen. Lisa Murkowski of Alaska also reported positive tests. 

Ironically, Schumer accused Senate Republicans of not taking COVID-19 seriously in the fall of 2020, when a spate of positive tests threatened to derail the confirmation of Supreme Court Justice Amy Coney Barrett.

“Every Senator and relevant staff must have negative tests on two consecutive days and have completed the appropriate quarantining period, and there should be mandatory testing every day of the [confirmation] hearing,” Schumer said in a statement on Oct. 5 of that year. “Testing must be administered by an independent entity, such as the Attending Physician of the United States Congress. Failure to implement a thorough testing approach would be intentionally reckless, and could reasonably lead some wonder if Chairman [Lindsey] Graham and Leader [Mitch] McConnell may not want to know the results.”

If the bill clears the planned Saturday test vote, a series of debates and votes on Republican amendments is expected to follow before a potential vote on final passage sometime Sunday. The legislation would then go to the House.

Sinema agreed to support the measure on Thursday after a provision taxing profits earned by hedge fund, venture capital and private equity executives known as carried interest was removed. In exchange, a 1% tax on corporate stock buybacks was added.

Despite its name, several economic experts — and even the White House — have suggested the Inflation Reduction Act would have little impact on the historic price spikes being felt across the country.

https://nypost.com/2022/08/05/senate-dems-skipping-covid-testing-to-push-spending-bill-vote-report/

'Street Underestimates Jazz Pharma's Cash-Flow'

 

• HC Wainwright tweaked the price target on Jazz Pharmaceuticals plc 
  JAZZ+1.69%+ Free Alerts
   to $204 with a reiterated Buy rating on slightly increased forward EPS estimates.
• Jazz reported a thorough 2Q22 beat, with broad product outperformance vs. consensus across neuro and oncology, plus gross margin upside and light OPEX, HC Wainwright notes.
• As per the analyst, this looked to be Jazz’s second-biggest operating cash flow quarter ever, pushing net leverage down to 3.2x, six months ahead of the targeted <3.5x by year-end. 
• Xywav is adding idiopathic hypersomnia patients slightly faster than modeled, and Rylaze adoption has ramped much faster than expected, the analyst writes.
• HC Wainwright believes the Street underestimates Jazz’s cash-flow generation through limited Xyrem AG competitive entry.
• Further, Jazz’s cash flow positions the balance sheet to move on significant accretive and diversifying M&A. 

https://www.benzinga.com/general/biotech/22/08/28379865/street-underestimates-jazz-pharmas-cash-flow-says-this-analyst

Hyaluranic acid awakens stem cells to repair damaged muscle

 A new study published in the journal Science reveals a unique form of cell communication that controls muscle repair. In damaged muscle, stem cells must work together with immune cells to complete the repair process, yet how these cells coordinate to ensure the efficient removal of dead tissue before making new muscle fibers has remained unknown. The scientists have now shown that a natural substance called hyaluronic acid, which is used in cosmetics and injections for osteoarthritis, is the key molecule that manages this fundamental interaction.

"When muscles get damaged, it is important for immune cells to quickly enter the tissue and remove the damage before stem cells begin repair," said Dr. Jeffrey Dilworth, senior scientist at The Ottawa Hospital and professor at the University of Ottawa and senior author on the study. "Our study shows that muscle stem cells are primed to start repair right away, but the immune cells maintain the stem cells in a resting state while they finish the cleanup job. After about 40 hours, once the cleanup job is finished, an internal alarm goes off in the muscle stem cells that allows them to wake up and start repair."

Dr. Dilworth and his team identified hyaluronic acid as the key ingredient in this internal alarm clock that tells muscle stem cells when to wake up. When muscle damage occurs, stem cells start producing and coating themselves with hyaluronic acid. Once the coating gets thick enough, it blocks the sleep signal from the immune cells and causes the muscle stem cells to wake up.

Using mouse and human tissues, Dr. Dilworth and his team also discovered how muscle stem cells control the production of hyaluronic acid using epigenetic marks on the Has2 gene.

"Interestingly, aging is associated with chronic inflammation, muscle weakness and a reduced ability of muscle stem cells to wake up and repair damage," said lead author Dr. Kiran Nakka, a research associate with Dr. Dilworth who conducted this research as part of his postdoctoral studies. "If we could find a way to enhance hyaluronic acid production in the muscle stem cells of older people it might help with muscle repair."

The authors note that the regenerative effect of hyaluronic acid seems to depend on it being produced by the muscle stem cells. The team is currently examining if drugs that modify the epigenetics of muscle stem cells could be used to increase their production of hyaluronic acid.

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Explore further

Lab grown, self-sustainable muscle cells repair injury and disease, mouse study shows

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More information: Kiran Nakka et al, JMJD3 activated hyaluronan synthesis drives muscle regeneration in an inflammatory environment, Science (2022). DOI: 10.1126/science.abm9735. www.science.org/doi/10.1126/science.abm9735

https://medicalxpress.com/news/2022-08-hyaluranic-acid-naturally-compound-awakens.html

Trial of smoking cessation drugs for reduced alcohol intake yields unexpected finding

 A clinical trial to test whether three proven smoking cessation treatments could also reduce alcohol intake found no differences between the medications, but the rates of behavior change for alcohol consumption and smoking were high in all treatment groups. Results suggest these medications could play an important role to reduce alcohol use and smoking at the same time. Unexpectedly, nicotine replacement therapy performed as well as the prescription drugs varenicline and cytisine.

The study, published Aug. 5 in JAMA Network Open, involved 400 people living with HIV in Russia and was designed by researchers from Vanderbilt University Medical Center (VUMC), Boston University School of Medicine, Boston Medical Center and First Pavlov State Medical University of St. Petersburg, Russia. The investigators, who included addiction specialists and HIV researchers, recruited volunteers who self-identified as engaging in risky drinking and daily smoking. Participants were followed up to 12 months after enrollment in the clinical trial. Medications were placebo-controlled, so participants and investigators did not know who was assigned to which medication.

The study showed that after three months, alcohol consumption decreased regardless of whether participants were given nicotine replacement therapy, varenicline or cytisine. The main outcome was number of heavy drinking days in the past month at three months, and secondary outcomes included abstinence from alcohol at three months, and abstinence from smoking at six months.

"A single medication to treat both risky drinking and smoking could improve health efficiently and significantly. Risky drinking and smoking frequently co-occur, and they both threaten health by increasing risk of cardiovascular disease, cancer and other important health outcomes," said the study's lead author, Hilary Tindle, MD, MPH, the William Anderson Spickard, Jr., MD, Professor of Medicine, and associate professor of Medicine at VUMC. "

Researchers are increasingly focusing on comorbidities among people living with HIV, such as cardiovascular disease and cancer, to improve their longevity because there are now effective treatments for the virus.

"It was gratifying to see high-risk research participants being included in NIH-funded research," said. Matthew Freiberg, MD, MSc, a study principal investigator, Dorothy and Laurence Grossman Chair in Cardiology and professor of Medicine at VUMC. "They are not only living with HIV, but also have a high burden of hepatitis, multi-substance use and mental health issues. Such participants are often excluded from drug trials. If a medication as simple as nicotine replacement could help them, that would be a win."

Freiberg noted that when investigators had designed the study, they envisioned the nicotine replacement as the "control" arm for alcohol consumption. Nicotine replacement therapy has been available in the United States to treat tobacco addiction since the early 1980s and is not used for reduction of alcohol consumption.

The study enrolled participants who engaged in five or more heavy drinking days in the past month (defined as five or more drinks in one day for a man or four or more drinks in one day for a woman) and who smoked five or more cigarettes a day.

VUMC researchers worked with Jeffrey Samet, MD, MA, MPH, the John Noble, MD, Professor in General Internal Medicine and professor of Community Health Science at Boston University Schools of Medicine and Public Health, and colleague on the study. Samet's research focuses on substance abuse and HIV infection.

"Another important observation in our post-hoc analysis was that rates of alcohol consumption were lower, and rates of alcohol abstinence were higher, among the people who quit smoking as compared to those who continued to smoke. These results need further study to understand if findings were due to the medications directly, quitting smoking or both," said Samet, the senior author on the study.

Tindle added that there is much to be learned about how the study drugs—termed nicotinic acetylcholine receptor agonists—may work to reduce voluntary alcohol intake. Studies in animal models show that stimulation of a very specific receptor type containing the alpha four subunit is required. Importantly, all three of the study medications target these very receptors.

The investigators concluded that the results of the study, which was conducted from July 2017 to December 2020, extends prior work in several ways. Notably, this is the largest trial to study nicotinic acetylcholine receptor partial agonists to target alcohol consumption and the first to examine cytisine to treat both alcohol and tobacco. Cytisine is not yet approved by the U.S. Food and Drug Administration to treat tobacco use but it has been used widely in Eastern Europe for decades and is under active study globally.

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Explore further

Cytisine may prove a safe and effective smoking cessation therapy

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More information: Effectiveness of Varenicline and Cytisine for Alcohol Use Reduction Among People With HIV and Substance Use, JAMA Network Open (2022).

https://medicalxpress.com/news/2022-08-cessation-drugs-alcohol-intake-yields.html

Adult at Illinois day care tests positive for monkeypox, children potentially exposed

 An adult at an Illinois day care center has tested positive for monkeypox, and a number of children may have been exposed to the virus, health officials in Illinois announced on Friday.

At this time, officials did not disclose the number of children that may have been exposed to the virus. Screening of children and staff from the day care, which is located in the Rantoul area of Illinois, near Champaign, is currently underway, and no additional cases have been discovered as of yet.

"All available state, local and federal resources are being deployed to assist families," state officials said during a press conference on Friday afternoon. "Pediatricians are on site, as we speak, to screen children for cases and they're mobile testing and vaccines for their families. Health officials will continue to stay in contact with families and provide information and resources in the coming days."

The day care has been cleaned, and it is still open, officials said.

"The people who have been exposed, potentially, do not need to be in quarantine, so they are being screened and assessed. Anyone with even a tiny little suspicion, we will put them in isolation pending any type of results, but they have the guidance for cleaning and they have done that probably a lot more than is even necessary," officials said.

The individual with monkeypox "also works in a home health care," and health officials have been in contact with the one client who has been impacted.

"The person with monkeypox is in isolation, is being medically monitored, and is doing well," officials added.

The disease is typically spread through prolonged skin-to-skin contact with infected people's lesions or bodily fluids, according to the Centers for Disease Control and Prevention. In addition to lesions, which can appear like pimples or blisters, the most common symptoms associated with monkeypox are swollen lymph nodes, fever, headache, fatigue and muscle aches.

Officials reported that Illinois Gov. J.B. Pritzker had been in touch with the White House, and at the state's request, "the Food and Drug Administration has authorized use of the vaccine for anyone under 18, without jumping through the normal hoops in this process."

That means that anyone with their guardian's approval will be vaccinated today," officials said.

ABC News has reached out to the FDA and the White House for clarity on whether a formal authorization has been made for children to receive the JYNNEOS vaccine.

On Tuesday, the FDA confirmed to ABC News that "numerous" children have been granted access through a special permission process that operates on a case-by-case basis.

If a doctor decides a person under 18 was exposed to monkeypox and the benefit of the vaccine is greater than any potential risk, they can submit a request to the FDA. In a statement, the FDA said numerous such requests have been granted, but did not say exactly how many.

At this time, the majority of monkeypox cases confirmed domestically and globally in the current outbreak have been detected in gay, bisexual or other men who have sex with men. However, health officials have repeatedly stressed that the virus does not discriminate, and anyone exposed to monkeypox can contract the virus.

At least five children in the U.S. have now positive for monkeypox, according to state and local officials from across the country.

https://abcnews.go.com/Health/adult-illinois-day-care-tests-positive-monkeypox-children/story?id=88012064