Frequent Marijuana Use May Raise Risk of Heart Attack

A new study analyzed several years of surveys on increases in marijuana and cannabis consumption.People who frequently smoke marijuana have a higher risk of heart attack and stroke, according to a study published on Wednesday.The article, published in The Journal of the American Heart Association, is an analysis of responses to the U.S. government’s annual survey on behavioral risk from 2016 to 2020.The respondents answered health questions, including reporting their own health problems related to heart disease.About 4 percent of the respondents reported daily marijuana use, which the researchers suggested raised the chance of a heart attack by 25 percent and of a stroke by 42 percent. Among those who never smoked tobacco, daily use was tied to a 49 percent higher risk of heart attack and a more than doubled risk of stroke, the study indicated.About three-quarters of the respondents said that smoking was their main method of using weed. The other quarter consumed it by vaping, through edibles or drinking it.“Cannabis smoke releases the same toxins and particulate matter that tobacco does,” said the study’s first author, Abra M. Jeffers, a data analyst at Massachusetts General Hospital in Boston. She conducted the analysis during her post-doctoral fellowship at the University of California, San Francisco.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe.

Read more →

A Fading Weapon in the H.I.V. Fight: Condoms

A Fading Weapon in the H.I.V. Fight: CondomsSome H.I.V. experts worry that the public health focus on prevention medication has accelerated a decline in condom use.Feb. 27, 2024Gay and bisexual men are using condoms less than ever, and the decline has been particularly steep among those who are young or Hispanic, according to a new study. The worrisome trend points to an urgent need for better prevention strategies as the nation struggles to beat the H.I.V. epidemic, researchers said.Over the past decade, prevention medication known as PrEP has helped fuel a moderate drop in H.I.V. rates. And yet, despite persistent public health campaigns promoting the drugs, they have not been adopted in substantial numbers by Black and Hispanic men who are gay or bisexual.The use of condoms, which prevent H.I.V. as well as other sexually transmitted infections, has been declining across the board in recent years, not just among gay men, contributing to a rise in sexually transmitted infections.Researchers said that, with so much focus on PrEP, public health officials have overlooked condoms, contributing to the drop-off in their use.“The goal of promoting PrEP is a valuable one, but it has overshadowed other prevention strategies like condoms,” said Steven Goodreau, an H.I.V. expert at the University of Washington. He led the new study and co-wrote a related editorial.A spokesman for the Centers for Disease Control and Prevention acknowledged declining condom use, but he said the agency continues to promote them. Local health departments that receive federal money for H.I.V. prevention must include condom distribution in their strategies, for example.

figcaption[data-testid=”photoviewer-children-caption”] {
margin: 12px auto 0 auto;
padding-right: 13px;
text-align: center;
}
/* TOP AD CODE BELOW */
#top-wrapper, sponsor-wrapper { display: none; }
We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe.

Read more →

H.I.V. Groups Warn of Privacy Risks in How C.D.C. Tracks Virus Samples

Since 2018, the agency has mandated tracking the genetic signatures of viruses collected from people with H.I.V., a practice known as molecular surveillance.The Centers for Disease Control and Prevention on Friday revised its guidelines for tracking the genetic signatures of viruses collected from people newly diagnosed with H.I.V., a controversial practice used by state and local health departments to curb infections.The updated policy encouraged health officials to be more transparent with their communities about the tracking, one of many changes sought by H.I.V. advocacy organizations concerned about how so-called molecular surveillance could violate patients’ privacy and civil rights.But the agency stopped short of adopting more significant changes that some advocates had pushed for, such as allowing health agencies to opt out in states where people can be prosecuted for transmitting H.I.V.“We’re in a period in which health data is increasingly used in criminal prosecutions, as seen in prosecutions of people seeking abortion care or who have perhaps miscarried,” said Carmel Shachar, a professor at Harvard Law School who specializes in health care. The revised policy did not go far enough, she said, to protect people with H.I.V.Dr. Alexandra Oster, who leads the C.D.C.’s molecular surveillance team, said the benefits of the program far exceed the risks. “We need to do it well,” she said. “But we need to keep doing it.”H.I.V. has a distinctive genetic signature in each person that helps doctors decide which drugs are likely to thwart it. But the information can also be used to track its spread through a population — including identifying clusters of people who carry closely related viruses.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe.

Read more →

Statin May Lower Heart Disease Risk for H.I.V. Patients

A recent study showed that a statin drug significantly lowered the risk of heart attacks and strokes among middle-aged and older people with the virus.Americans with H.I.V. are achieving the once unthinkable: a steady march into older age. But beginning around age 50, many people living with the virus face a host of health problems, from heart disease and diabetes to social isolation and cognitive decline.And so the medical research community, which some three decades ago developed lifesaving drugs to keep the virus at bay, is now hunting for new ways to keep people with H.I.V. healthier in their later years.A recent study, for example, showed that a statin drug significantly lowered the risk of heart attacks and strokes among middle-aged and older adults with H.I.V., and may reveal biological insights into why this group tends to age faster than others. And a crop of academic hospitals have established specialized clinics for older people with the virus, offering medical experts as well as social workers, substance abuse counselors, psychologists and nutritionists.“I have been unbelievably impressed at how care for the older H.I.V. population has really exploded,” said Dr. Nathan Goldstein, who heads one such clinic at Mount Sinai in New York City. “I get emails every day about new models, new grant funding. People are paying so much attention to this.” More than two dozen H.I.V. and aging experts also expressed optimism, in contrast to the more grim perspective many held a decade ago.Researchers have often referred to a looming “silver tsunami” of older people with H.I.V. needing better care. In 2021, there were 572,000 Americans aged 50 and older diagnosed with H.I.V., up 73 percent from 2011.Today, two-thirds of deaths in the H.I.V. population are from causes other than the virus. This aging group faces an increased risk of diabetes, liver and kidney disease, osteoporosis, cognitive decline and various cancers.But perhaps their most pressing health concern is a doubled risk of cardiovascular disease compared with people who do not carry the virus. Researchers in the Netherlands estimated that by 2030, more than three-quarters of that country’s H.I.V. population will have cardiovascular disease, including high blood pressure, high cholesterol, heart attacks or strokes.Seeking a bulwark against this mounting threat, the National Institutes of Health invested $100 million in a randomized controlled trial, called Reprieve, that tested a statin medication against a placebo among 7,769 people with H.I.V. 40 to 75 years old. The volunteers were relatively healthy and on stable antiretroviral treatment, so they typically would not have been recommended a statin. But the results of that trial, published in The New England Journal of Medicine, showed that the drug lowered the volunteers’ risk of major cardiovascular events by more than one-third.“This is really an important study,” said Dr. Anthony S. Fauci, who as the former director of the National Institute of Allergy and Infectious Diseases — he retired in December — was among the N.I.H.’s leaders who approved Reprieve’s mammoth budget. “The results, in some respects — they’re even better than I would have expected.”Donté Smith, a health consultant from Kansas City, Mo., is 37 but began taking a statin earlier this year. Mx. Smith, who is genderqueer and uses gender-neutral pronouns, said they were motivated to take the medication because, in addition to H.I.V., they had a family history of cardiovascular disease and diabetes and had smoked on and off.Donté Smith of Kansas City. “A lot of us don’t make it,” they said. “The best revenge for me is being an elder and being able to share and exist and to still be here.”Arin Yoon for The New York TimesMx. Smith also noted that the virus took an extra toll on Black and L.G.B.T.Q. people. Of the nearly 1.1 million Americans diagnosed with H.I.V., 63 percent are gay and bisexual men, and 40 percent are Black.“A lot of us don’t make it,” Mx. Smith said. “It’s important to buck that trend. The best revenge for me is being an elder and being able to share and exist and to still be here.”Heart disease and other conditions occur disproportionately among H.I.V.-positive people in part because of environmental risk factors that are more common among this group.“People aging with H.I.V. are more likely to continue to smoke cigarettes, consume unhealthy amounts of alcohol and use cocaine than people aging without H.I.V.,” said Dr. Amy Justice, a clinical epidemiologist at Yale School of Medicine who studies this population. “Each of these behaviors adds to the excess risk of cardiovascular disease.”Even without those risk factors, aging is accelerated in people with H.I.V. Researchers have long believed the reason to be chronic inflammation and immune dysregulation spawned by the virus, even when it is controlled by antiretroviral drugs.Dr. Steven Grinspoon, Reprieve’s lead author and a professor at Harvard Medical School, said that the clinical trial also measured many chemical markers of inflammation in the volunteers’ blood and scanned their coronary arteries. The researchers are now looking at whether these data can help explain why the statin lowered cardiovascular events. The researchers will present their findings at a meeting in November.Dr. Fauci suspected that this analysis will likely reveal that the statin tamped down the volunteers’ chronic inflammation, and in turn prevented the plaque buildup in the arteries that can precipitate a heart attack or stroke.But experts said that the long-term care of people with H.I.V. will depend on much more than prescription drugs. An array of social problems are especially prevalent among older people with H.I.V. and can exacerbate the perils of aging, including poverty, loneliness, addiction, mental illness, stigma and housing insecurity.Paul Aguilar, 60, was given five years to live when he was diagnosed with H.I.V. in 1988. He has survived, but not without struggle. The fat has drained from his face, a side effect of the toxic early generation of antiretroviral drugs. And he has weathered waves of lost peers in San Francisco: first from AIDS and more recently from other illnesses.Last year, he began going to the “Golden Compass” program for aging H.I.V. patients at the University of California, San Francisco, which provides a panoply of services, including cardiology, exercise classes and dental, vision and mental health care. He said that the psychological counseling and support he received there helped him cope with his closest friend’s death by suicide and his own subsequent mental health crisis.The university’s program is “really a godsend,” Mr. Aguilar said, noting that he has no out-of-pocket costs, thanks to his coverage from Medicare and Medicaid.But the vast majority of older people with the virus still lack the type of high-quality care that has helped Mr. Aguilar thrive, experts said. Such programs are often prohibitively expensive and pose staffing and space demands that many clinics, especially in resource-poor areas, cannot hope to meet.“Patients are falling through the cracks,” said Jules Levin, 73, a leading activist holding the bullhorn on behalf of H.I.V.-positive seniors such as himself.After learning about the Reprieve study’s findings, Mr. Aguilar asked his doctor about starting a statin.“I’m going to be crotchety and telling kids to get off my lawn,” he quipped.

Read more →

Antibiotic Shortage Could Fuel Rise in Syphilis Rates

The primary drug used to treat the sexually transmitted infection could be scarce into next year, Pfizer warns.A new shortage of a type of penicillin crucial to the fight against syphilis is alarming infectious disease experts, who warn that a protracted scarcity of the drug could worsen the U.S. epidemic of the sexually transmitted infection.The shortage, announced by the drugmaker Pfizer in a letter last month, involves Bicillin L-A, a long-acting injectable antibiotic also known as penicillin G benzathine. The company cited significant increases in demand because of the rising rate of syphilis infections, as well as Bicillin’s recent use as an alternative to amoxicillin, another antibiotic that has periodically been scarce and is prescribed for more general infections like strep throat.Steven Danehy, a spokesman for Pfizer, said it would likely take about a year for the company to ramp up production by 50 percent at its plant in Rochester, Mich., and ultimately manufacture enough Bicillin to meet demand and shore up reserves.Syphilis has been on the rise in the United States since 2000, reaching 176,713 cases in 2021, which was an increase of nearly 75 percent since 2017, according to the Centers for Disease Control and Prevention.Congenital syphilis tripled during that four-year period, to 2,855 cases, including 220 stillbirths or infant deaths. Rates are highest among the infants of Native American, Native Hawaiian, Pacific Islander and Black mothers.Bicillin is the only recommended treatment for pregnant women who are infected, and is very effective at preventing transmission to the fetus if provided early enough. Congenital syphilis has a high fatality rate, and can otherwise cause preterm birth and severe birth defects.“It worries me that these moms may not have access to lifesaving medication,” Dr. Anita Henderson, a pediatrician in Hattiesburg, Miss., said. The state had seen large increases in the rate of congenital syphilis over the last five years, she said.Among adult syphilis cases, nearly one-fourth are in women; just under a third are in men who have sex only with men; and about one-fifth are in men who only have sex with women.The infection can cause sores and a rash and, if left untreated, can seriously damage the internal organs, nervous system, eyes and ears, and can be fatal.Pfizer also warned that its supply of a rarely used pediatric version of Bicillin would soon run out because the company had begun using that drug’s production line to increase the adult formula. Doctors turned to it in the last year in lieu of amoxicillin during an increase in the number of strep throat cases.Bicillin is also used to manage rheumatic heart disease and rheumatic fever, which are particular health risks, albeit uncommon, for children. Multiple antibiotic alternatives are available for these conditions, according to Dr. Meg Doherty, director of global H.I.V., hepatitis and sexually transmitted infections programs at the World Health Organization.Treponema pallidum, the bacteria that causes syphilis.NIAIDTo ward off bacterial infections, military recruits receive Bicillin during boot camp, where the drug is known as the “peanut butter shot” because of its color and consistency. According to Dr. Ryan C. Maves, a professor of infectious diseases at Wake Forest University School of Medicine, recruits otherwise face a high risk of invasive streptococcal infection.Alternatives to Bicillin for pregnant women are under development and review but are years away from becoming available to them, said Dr. Jeffrey Klausner, an infectious disease expert at the University of Southern California. He urged the Biden administration to pay Pfizer for some 500,000 doses to encourage production.The Bicillin shortfall is but one element of a widespread drug-shortage crisis that has left doctors and pharmacists scrambling for vital therapeutic staples and forced them to ration treatments like chemotherapy. A recent Senate report also characterized the supply problems as a threat to national security.Most drug companies have not been particularly keen on developing antibiotics, in part because the profit margin for this class of drugs is typically far lower than the next blockbuster drug that could be worth billions of dollars.A bipartisan group in Congress recently reintroduced the $6 billion Pasteur Act, a Netflix-like subscription model that would act as a financial incentive for research and development by pharmaceutical companies.While the legislation could address drug shortages, its main goal is to combat the global threat of drug-resistant pathogens.David Harvey, executive director of the National Coalition of S.T.D. Directors, a trade association for public health associations, said rates of syphilis, chlamydia and gonorrhea are all surging “in part due to a public health landscape that is stretched dangerously thin, resulting in a lack of S.T.I. prevention, testing, and treatment.”He and others criticized Pfizer for inadequate production of the drug given the decades-long rising trajectory of syphilis infections. But Pfizer’s spokesman, Mr. Danehy, said the company had invested $38 million in its Michigan plant to improve manufacturing after a previous shortage of Bicillin in 2017.Mr. Harvey also denounced the Biden administration for agreeing in the debt ceiling deal to slash $400 million from the C.D.C.’s budget for S.T.I. prevention.To stretch the Bicillin supply, the C.D.C. recommends that doctors give preference to pregnant patients and infected or exposed infants. Other patients should instead be prescribed doxycycline for two to four weeks, depending on the disease stage. But experts expressed worry that such individuals, including the partners of pregnant women, might have trouble sticking to the twice-daily pill regimen, potentially compromising its effectiveness.Eric Tichy, division chair of supply chain management at Mayo Clinic in Rochester, Minn., said Pfizer likely stands alone in producing Bicillin for the U.S. market because of the considerable complexity and expense of manufacturing the drug.But other experts objected to Pfizer’s pricing practices. “Here’s a prime example of why leaving public health to the free market can be disastrous,” Tim Horn, director of medication access at the National Alliance of State and Territorial AIDS Directors, an advocacy group, said in an email.“Since 2013, the price of Bicillin L-A has increased an astonishing 275 percent,” Mr. Horn said.Mr. Danehy said the list price for a 4-milliliter Bicillin L-A syringe is $470, and that the company adjusted prices to ensure proper, quality supply.While many health care organizations and clinics are able to secure discounts, some frontline independent clinics are paying top dollar for the antibiotic.Dr. Phyllis Ritchie, who runs a free S.T.I. clinic largely serving gay men in Palm Springs, Calif., said the cost of a 10-pack of shots of Bicillin had risen to $6,500 from $4,000 two years ago. With the clinic using about 15 to 20 of the 10-packs annually, its $225,000 yearly budget can no longer withstand the financial strain, she said.When she first began practicing medicine in the mid-1990s, Dr. Ritchie recalled, a 10-pack cost under $300.“It’s a crisis,” she said.

Read more →

California’s Plan for Cheaper Insulin Collides With Big Pharma’s Price Cuts

The state awarded a $50 million contract to produce less costly treatments, but moves by major suppliers might undercut the initiative before any new product emerges.California is moving ahead with its plan to produce state-sponsored insulin, but its goal of offering cheaper medicine than brand-name companies may be much harder to achieve now that those major drug makers have decided to significantly drop sticker prices on some products.So while some experts welcomed the news last weekend that the state had awarded a $50 million contract to Civica, a nonprofit organization, to manufacture low-cost insulin, others wondered if the initiative remained viable given the changing marketplace. Civica’s planned products would still need federal approval, which means it could take at least two years before they become available for sale.For years, the high costs associated with insulin for people with diabetes have forced some to ration their medicines, jeopardizing their health.For the estimated eight million Americans with diabetes who need insulin, including about one million Californians, the average price has more than quadrupled in 20 years. There have been wild variations in pricing, however, with Eli Lilly raising the sticker price of its most popular product, Humalog, more than tenfold.Many people with private health insurance pay nothing or no more than a $20 to $35 co-payment for a monthly insulin supply. And since January, the Inflation Reduction Act has imposed a $35 price cap for the nearly four million insulin users with Medicare Part D.But those with high-deductible health plans or the uninsured — an estimated 12 percent and 7 percent, respectively, of California’s insulin users — often face much higher costs, costing them hundreds of dollars per month.“This is a space where seemingly everybody seems to be making a quick buck,” Gov. Gavin Newsom said at a Saturday news conference announcing the new pharmaceutical contract in Downey, Calif., before a backdrop of insulin-stocked refrigerators. “Time for disruption.”Mr. Newsom, who was on a four-day state tour to promote his policies, also announced plans for California to develop its own naloxone, which reverses opioid overdose.The insulin contract is the outcome of the state Legislature’s appropriation last year of $100 million for the program, called the CalRx Biosimilar Insulin Initiative. (Competitor versions of so-called biologic treatments like insulin are known as biosimilars.) Under the 10-year deal, Civica said it planned to develop and produce these products at a new plant in Petersburg, Va., and would begin filing applications for approval of the biosimilar products with the Food and Drug Administration next year. Half of the $100 million budget would go toward establishing a California plant for further production.The biosimilar versions are expected to be comparable to Eli Lilly’s Humalog, Novo Nordisk’s NovoLog and Sanofi’s Lantus. These three companies control about 90 percent of the insulin market.Gov. Gavin Newsom of California announced the state’s partnership with Civica Rx during a visit to a Kaiser Permanente warehouse in Downey, Calif., last week.Damian Dovarganes/Associated PressEli Lilly, Sanofi and Novo Nordisk have announced sticker-price cuts, mostly in the 70 percent range, and some caps on out-of-pocket costs for certain insulin products. The lower prices should begin late this year into next year, depending on the company.President Biden and Democratic lawmakers have taken credit for the drug makers’ moves, but the companies had fewer financial incentives to keep prices high on their older insulin products, and they now rely more on newer drugs for diabetes and obesity. The drug makers also were facing penalties that would have forced them to pay Medicaid back for raising their prices faster than inflation.Civica was founded in 2018 by a collective of health systems seeking to mitigate chronic drug shortages. Ned McCoy, chief executive of Civica, said the company announced its pricing a year ago “with the goal of forcing the market to respond.”While many academic experts in insulin pricing expressed optimism about California’s move, some remained skeptical that its plans and others in early stages in Maine, Michigan and Washington could live up to their hype.Andrew Mulcahy, a senior policy researcher at the RAND Corporation whose 2020 study found the average U.S. list price for insulin was 10 times that of other nations, was measured in his assessment.“It’s one important change in a time where there’s a lot in flux for insulin,” he said. “There’s potential for savings for Californians and others. But it’s not clear this is going to fundamentally change the market. It already has in some ways. There are already these cheaper alternatives that are cropping up in the market.”He noted that Walmart sells a store-brand version of NovoLog, called ReliOn, for about $73 per vial. And the list price for a vial of NovoLog, a widely used product, will drop to $72, from $289, according to Novo Nordisk’s plan.CalRx will set recommended maximum retail prices of $30 for a 10-milliliter insulin vial and $55 for a set of five prefilled 3-milliliter pens. California residents will be given priority for the supply.Whether Civica’s insulin will be that much cheaper than the big-brand names once the new price cuts are imposed is open for debate, especially as Civica’s products won’t be available anytime soon.Before the new cuts were announced, a JAMA editorial suggested that a successful launch could provide a potent model for state-driven disruption of the pharmaceutical industry.“The best-case scenario is that the CalRx plan provides some sunshine on a path forward to state interventions in curbing drug prices,” Jacob S. Sherkow, a professor of law and medicine at the University of Illinois Urbana-Champaign and the editorial’s lead author, said.“A lot of previous attempts in that area have just failed completely, either by dint of economics or through legal challenges,” Mr. Sherkow continued. “This is one way that states can get back in the business of providing public goods.”Several states’ attorneys general, including California’s, recently filed suit against the three big insulin drug makers over high prices, and also against pharmacy benefit managers — companies that negotiate discounts off sticker prices on behalf of insurers, pocketing some of the difference.Doses of insulin stored at a Kaiser warehouse in Downey, Calif.Damian Dovarganes/Associated PressCalifornia’s generic drug plan would prohibit pharmacy benefit managers from profiting off rebates, undermining what critics charge is a relationship between the companies and the drug makers that is imbued with a perverse incentive to inflate sticker prices.Reid Porter, a representative for PhRMA, the major trade group for drug companies, joined a Sanofi representative in pointing the finger at pharmacy benefit managers for, they said, not passing savings on to the consumer.Mr. Newsom, Mr. Porter said, “wants to score political points and villainize the industry responsible for making California a global leader in developing lifesaving treatments and cures and infusing more than $200 billion into the economy and supporting nearly 700,000 jobs.”Reached for comment on the California program, representatives for Eli Lilly and Novo Nordisk highlighted their plans to lower some of their insulin prices.On Saturday, Mr. Newsom said, “I think it would be spectacular if all these other companies fell even further in their price considerations and dropped well below” the state’s price points. He expressed confidence that Civica could “dynamically address” such underselling.Still, the recent changes will mean many Californians with diabetes will most likely be able to spend less on their insulin next year.Once the three pharmaceutical companies’ new discounts are in place, annual out-of-pocket costs for people who are uninsured or have high-deductible plans and who use the three products that the California program seeks to replicate would range from $420 to $1,200, according to Dr. Mariana Socal, an associate scientist at the Johns Hopkins Bloomberg School of Public Health.The state program is expected to charge those individuals $200 to $375 a year for its versions of these products. Annual costs for well-insured people would drop from about $350 to $550 currently down to $140 to $250 because of the program.Baylee Bakkila, a Yale University medical student, led a study published in Health Affairs in July finding that 14 percent of insulin users spent more than 40 percent of their disposable income on the drug.Ms. Bakkila has reservations about the California program, noting that the prices are set by the insulin vial or set of pens, not a set monthly fee. She pointed to the Medicare price cap; Eli Lilly’s similar $35 cap for a monthly insulin supply, which is typically two to three vials; and Sanofi’s plan for a comparable cap.“CalRx will provide benefits to patients spending exorbitantly on insulin,” Ms. Bakkila said of the estimated 190,000 Californians with high-deductible plans or no insurance. “But, by comparison, these programs already in place cut spending even more.”Niketa Calame-Harris, 42, is an actress, acting teacher and advocate for the American Diabetes Association whose Type 1 diabetes was diagnosed in college. A resident of Los Angeles, she is covered through an Obamacare private health plan, and she pays about $5,000 a year for Humalog insulin. She said she had had to ration her doses at times.She expected she would save about $3,000 a year under the state plan. But she could save about $3,500 a year once Eli Lilly’s cut goes into effect in the last three months of this year. And possibly more if she is eligible for its $35 cap.Anticipating the savings, Ms. Harris thought of her 2-year-old daughter and said, “That money could go toward her getting a better education.”Rebecca Robbins contributed to this article.

Read more →

Emailing Your Doctor May Carry a Fee

More hospitals and medical practices have begun charging for doctors’ responses to patient queries, depending on the level of medical advice.To Nina McCollum, Cleveland Clinic’s decision to begin billing for some email correspondence between patients and doctors “was a slap in the face.”She has relied on electronic communications to help care for her ailing 80-year-old mother, Penny Cooke, who is in need of specialized psychiatric treatment from the clinic. “Every 15 or 20 dollars matters, because her money is running out,” she said.Electronic health communications and telemedicine have exploded in recent years, fueled by the coronavirus pandemic and relaxed federal rules on billing for these types of care. In turn, a growing number of health care organizations, including some of the nation’s major hospital systems like Cleveland Clinic, doctors’ practices and other groups, have begun charging fees for some responses to more time-intensive patient queries via secure electronic portals like MyChart.Cleveland Clinic said that its email volume had doubled since 2019. But it added that since the billing program began in November, fees had been charged for responses to less than 1 percent of the roughly 110,000 emails a week its providers received.“Billing a patient’s health insurance supports the necessary decision-making and time commitment of our physicians and other advanced professional providers,” said Angela Smith, a spokeswoman for the clinic.But a new study shows that the fees, which some institutions say range from a co-payment of as little as $3 to a charge of $35 to $100, may be discouraging at least a small percentage of patients from getting medical advice via email. Some doctors say they are caught in the middle of the debate over the fees, and others raised concerns about the effects that the charges might have on health equity and access to care.Dr. Eve Rittenberg, an internist in women’s health at Brigham and Women’s Hospital in Boston, examined the effects of medical correspondence with patients in a study that found that female practitioners shouldered a greater communications burden.“The volume of messaging combined with the expectation of quick turnaround is very stressful,” Dr. Rittenberg said. She recalled one day when she took her teenage daughter to the doctor but was distracted by responding to patient messages on her phone. She recently reduced her clinic schedule — and took a commensurate pay cut — to free up a few hours outside of office visits to cope with other tasks like patient messages.The U.S. Centers for Medicare and Medicaid Services first introduced Medicare billing codes in 2019 that allowed providers to seek reimbursement for writing messages through secure portals. The pandemic prompted the agency to broaden coverage for telemedicine and hospitals significantly expanded its overall use.The federal rules state that a billable message must be in response to a patient inquiry and require at least five minutes of time, effectively making it a virtual visit. Private insurers have widely followed Medicare’s lead, reimbursing health care practices for physicians’ emails, and may charge patients a co-pay. For several major hospital systems across the country, the increase in email fees has opened up a new revenue stream.More on the Coronavirus PandemicAnnual Boosters: The Food and Drug Administration proposed that most Americans be offered a single dose of a Covid vaccine each fall, much as they are given flu shots.A Better Covid Winter: Some of the worst days of Covid in the United States have come as winters have settled in. But a surge in hospitalizations has yet to materialize this season.New Subvariant: A highly contagious version of the Omicron variant — known officially as XBB.1.5 or by its subvariant nickname, Kraken — is quickly spreading in the United States.Pfizer’s Boosters: Federal officials said that fears that the Covid booster shots made by Pfizer may increase the risk of strokes in people aged 65 and older were not borne out by an intensive scientific investigation.Blue Cross Blue Shield said some of its state and regional plans reimburse for doctor emails. But David Merritt, a senior vice president for policy and advocacy for the insurer, expressed concern that the ability “to charge patients for what often should be routine email follow-up could easily be viewed and abused as a new revenue stream.”According to the Cleveland Clinic, Medicaid patients are not charged. Medicare beneficiaries without a supplemental health plan would owe a co-pay between $3 and $8. The clinic’s maximum charge, hitting those with high deductibles on private insurance plans or without coverage, would be $33 to $50 for each exchange.Ms. McCollum and other clinic patients are given the option of avoiding such fees by choosing to discontinue a query or request an appointment instead. Ms. McCollum kept on emailing on behalf of her mother: “I said, ‘Yes,’ because I need to reach her doctor.” She added, “It’s maddening.”“The volume of messaging combined with the expectation of quick turnaround is very stressful,” said Dr. Eve Rittenberg, an internist at Brigham and Women’s Hospital. She recently reduced her schedule to accommodate a few hours for patient messages.Sophie Park for The New York TimesNot all patient-doctor exchanges carry fees. Emails for simpler concerns largely remain free, including for prescription refills, appointment scheduling and follow-up care. According to several hospital systems and insurers, electronic communications that could prompt a bill would address, for example, medication changes, a new medical issue or symptom or shifts in long-term health conditions. Providers may only bill a patient once a week.Nearly a dozen of the nation’s largest hospital systems said they charged fees for some of their providers’ emails to patients or have started pilot programs, in response to an informal survey by The New York Times. In addition to Cleveland Clinic, this includes Houston Methodist; NorthShore University HealthSystem, Lurie Children’s, and Northwestern Medicine in Illinois; Ohio State University; Lehigh Valley Health Network in Pennsylvania; Oregon Health & Science University; University of California, San Francisco and U.C. San Diego; and the U.S. Department of Veterans Affairs.Other major hospitals are closely watching those at the vanguard of this new billing practice, according to A Jay Holmgren, an assistant professor in the Department of Medicine at U.C.S.F.The Health Insurance Portability and Accountability Act (HIPAA) permits doctors to send unencrypted emails or texts if they caution patients about the risks of unsecure channels. But to protect patient privacy, prevent hacking and comply with other HIPAA requirements, most health care companies and organizations discourage the use of anything other than the encrypted portals like MyChart that have become ubiquitous over the past decade.Hospital officials note that while young people may be the most tech-savvy and wedded to app-based correspondence, they are usually healthier and less apt to keep in touch with their doctors.“In my own experience, most messages come from individuals in their 50s and 60s, likely because they are sufficiently familiar with technology to learn how to use messaging and are starting to have increasing needs, whether screening or illness-related,” said Dr. Daniel R. Murphy, an internist and chief quality officer at Baylor Medicine in Houston, which does not currently bill for emails.Before the pandemic, Dr. Murphy found in his research that primary care doctors spent about an hour a day managing their inbox. But a recent study led by Dr. Holmgren of data from Epic, a dominant electronic health records company, showed that the rate of patient emails to providers had increased by more than 50 percent in the last three years.“We’re at an inflection point with messaging,” Dr. Holmgren said. “How are we going to deliver care in the future as we continuously move away from all care being a discrete visit?”Many doctors and their assistants have little time during work hours for replying to patients. Doctors find themselves attending to such demands during “pajama time” before bed, according to Dr. Anthony Cheng, an associate professor of family medicine at Oregon Health & Science.“We know that this is a contributor to burnout,” Dr. Rittenberg said. “Burnout and resulting attrition in physicians’ work is becoming a crisis in our medical system.”Dr. Rittenberg teamed up with her husband, Jeffrey B. Liebman, an economist at the Harvard Kennedy School, to study electronic health record responsibilities among primary care doctors at Brigham. In an article published in the Journal of General Internal Medicine in January 2022, they reported that female doctors spent more time responding to messages and received more messages from both patients and staff members than their male colleagues. This difference, they surmised, could help explain greater burnout rates among women in medicine.Some doctors have reported examples of patients who communicate too frequently or insistently through the online portal.“People now have the expectation that these communications are like texts and that they should get a response right away,” Dr. Rittenberg said. But, she said she empathized with what might be driving such patients’ insistent inquiries: pandemic-era malaise.“People are very anxious and worried and isolated, and the doctor offers a connection,” she said.Attaching a monetary fee to doctor-patient emails may be a step toward recognition of the value of this particular practice. But the addition of another bill has primed simmering resentments among some Americans, who are experiencing “pandemic fatigue” and have strained household budgets because of inflation, including higher health care costs.Ms. McCollum, a marketing writer, has been trying to raise extra cash to help cover her mother’s care by selling some of Ms. Cooke’s belongings online.“It’s been a tough year and I don’t need the clinic making it any worse,” she added.Dr. Kedar Mate, chief executive at the Institute for Healthcare Improvement, a nonprofit in Boston, said charging for providers’ emails amounted to “a very complicated and slippery slope” and that it could exacerbate health inequities.“Increasing levels of communication and interactions with patients is a good thing,” Dr. Mate said. “And I worry about disincentivizing that by creating a financial barrier.”“Increasing levels of communication and interactions with patients is a good thing,” said Kedar Mate, chief executive at the Institute for Healthcare Improvement.Carlos Bernate for The New York TimesCaitlin Donovan, senior director of the Patient Advocate Foundation, said that even a small co-pay could prove alienating to people living paycheck to paycheck.“We write a lot of $5 checks in this organization,” she said, referring to subsidies for co-pays and other out-of-pocket medical expenses.Others pointed out that when a severe physician shortage left patients waiting months to see a specialist, exchanging messages was a time-efficient way to bridge those gaps.“It’s really been a win-win for our physicians and our patients,” said LeTesha Montgomery, senior vice president for system patient access at Houston Methodist, which rolled out a full billing plan beginning in September. “So, it actually helped us increase access for our patients,” she said.Some patients view billing for a provider’s time and expertise as only fair and a good use of their own time, as well.Kacie Lewis, 29, is among those who manage their health concerns electronically. Until recently, her Aetna insurance coverage had a high deductible, through her work as a product manager at a health care company. And since late 2021, she said, she had been billed $32 for each of three email threads, seeking treatments for psoriasis, eczema and a yeast infection from providers at Novant Health in Charlotte, N.C.“Time is money,” Ms. Lewis said. “And to be able to submit something super simple and communicate with your doctor over email is much better than driving 20 minutes one way, 20 minutes back the other way and potentially sitting in the waiting room.”In a paper published on Jan. 6 in JAMA, Dr. Holmgren and his colleagues reported that after U.C.S.F. Health started its email billing in November 2021, there was a slight drop in the number of patient emails to providers. The researchers suggested that might have been the result of patients’ reluctance to be charged a fee.In the first year, U.C.S.F. billed for 13,000 message threads, or about 1.5 percent of 900,000 threads and more than three million messages, according to the study. (Other hospitals told The Times they billed for no greater than 2 percent of threads.) From about $20 from Medicare and Medicaid and $75 from commercial insurers per bill, the email fees generated $470,000, compared with the system’s $5.6 billion in 2021 revenues.“This will hopefully be revenue-neutral,” Dr. Holmgren said. “We are not intending to make this a profitable enterprise.”Critics argue that billing for a small fraction of emails is not likely to reduce physician burnout substantially unless hospitals also set aside workday hours for patient queries and reward clinicians for those efforts. U.C.S.F. has begun giving “productivity points,” a metric used for compensation, for doctors’ correspondence.Jack Resneck Jr., president of the American Medical Association, said he supported insurance coverage for emailing as a way to adjust health care models to fast-changing times.“How do we reinvent the physician’s day and the care delivery system to actually recognize and support the broad array of ways that we deliver care?” Dr. Resneck asked.

Read more →

California Sues Companies Over Insulin Prices, Joining Other States

The state is taking action against three major drug companies and the big pharmacy benefit managers in an effort to temper costs for people with diabetes.Many Americans with diabetes still struggle to pay for their insulin, even though Medicare placed a cap on co-payments this month.With a population of 39 million, California has now become the largest state to sue the major companies on the insulin market, accusing them of illegally inflating the price of the treatment and spawning a financial and public health crisis.Rob Bonta, the state’s attorney general, said in announcing the lawsuit late last week that the companies had engaged in “unlawful, unfair and deceptive practices” in violation of California’s laws on competition.Characterizing the U.S. insulin market as “an oligopoly,” Mr. Bonta took aim in the state’s lawsuit at three pharmaceutical companies, Eli Lilly, Novo Nordisk and Sanofi, which control 90 percent of the global insulin supply, and the pharmacy benefit managers, CVS Health, Express Scripts and OptumRx, which manage 80 percent of the U.S. insulin market.Nearly 38 million Americans have diabetes, roughly 11 percent of the U.S. population. And about eight million people — including all of those with Type 1 diabetes and many with Type 2 — need insulin treatments. Well-insured patients owe nothing or a co-pay of $20 to $35 a month for insulin, while those without insurance or high deductible plans can be charged hundreds of dollars a month.President Joe Biden in August signed the Inflation Reduction Act, which now caps insulin’s monthly cost at $35 for the more than three million insulin users with Medicare Part D drug plans. Nearly half this population is expected to benefit from the cap, according to a study published Friday in JAMA Network Open. Researchers found that 45 percent of those with a Part D plan covering insulin paid at least $35 monthly for it between 2013 and 2019, up from 22 percent in 2006. The higher cost meant this group was 61 percent less likely to take their insulin doses as prescribed.But people under 65 will not benefit from the new caps, although lawmakers and public health experts have expressed hope that the Medicare pricing rules will put pressure on the industry overall.Insulin was discovered a century ago. In the wake of this medical advancement, researchers sold the patent to the University of Toronto for $1 in hopes of fostering affordable access in perpetuity.History, and the pharmaceutical industry, had other ideas. Explaining recent soaring prices for a drug long off patent, critics said that between them, the three major pharmaceutical players have stifled competition. They also point to a host of patent law maneuvers, including companies tweaking aspects of insulin’s formulation or how it is administered, such as through injector pens, to expand lucrative patent protection on branded insulin products.“The companies have been able to raise prices whenever they want, as a functional oligopoly with no major competitors in spite of patent expiration,” said Dr. Jeremy Greene, a professor of medicine at Johns Hopkins University. “They are locked into secret agreements with P.B.M.s — also an oligopoly with three major players — in which neither party will disclose what the true price of insulin products actually is.”Some of the companies that are targets of the California lawsuit contend that costs for many consumers were already lowering. And some experts have pointed to the entry of generics and biosimilars as helping to drive down costs.Daphne Dorsey, a spokesperson for Eli Lilly, said that the California lawsuit “ignores that anyone is eligible to purchase their monthly prescription of Lilly insulin for $35 or less. And the average monthly out-of-pocket cost for Lilly insulin is $21.80, a 44 percent decrease over the last five years.”California Attorney General Rob Bonta, center, announcing California’s lawsuit on Thursday.Adam Beam/Associated PressBoth the Eli Lilly and Novo Nordisk representatives highlighted company programs that provide financial assistance to those struggling to afford insulin.Representatives for both CVS Health and Optum Rx, pharmacy benefit managers that work on behalf of insurers and negotiate rebates off the list prices set by drug companies, rejected the state’s contention that the P.B.M.’s role fueled higher prices.Other states that have sued some drug companies over insulin costs include Arkansas, Kansas, Kentucky, Minnesota and Mississippi.A recent analysis by GoodRx of U.S. pharmacy and insurer data reported that the average insulin retail price rose 54 percent between 2014 and 2019, but noted a slight dip in the last few years. A RAND Corporation study in 2020 led by Andrew Mulcahy, a senior policy researcher, found that the average U.S. insulin list price — which he said had reached nearly $200 per vial, with higher prices for pre-filled pens — was 10 times that of other nations. Insulin users typically require two to three vials a month.According to the American Diabetes Association, 22 states and Washington D.C. have imposed insulin co-pay caps ranging from $25 to $100 for 30-day supplies, which some would like to expand nationwide. The association and others are also lobbying for Congress to consider bipartisan legislation called the Insulin Act, which would encourage insulin manufacturers to lower list prices and cap the monthly insulin costs for insured diabetics at $35.Dr. Kasia Lipska, an associate professor of medicine at the Yale School of Medicine, published a study in July finding that one in seven U.S. insulin users experienced “catastrophic spending” on the drug, meaning that more than 40 percent of their disposable income went toward their treatment. A survey study published in November found that 17 percent of insulin users reported rationing the drug to save money.People who require insulin but do not take it as prescribed are at substantial risk of heart attack, kidney failure, amputation, blindness and death.High insulin prices, the California lawsuit stated, also disproportionately affected Hispanic and Black people, who have higher Type 2 diabetes rates than whites and are at greater risk of dying from the disease.Larry Levitt, executive vice president for health policy at Kaiser Family Foundation, said the interaction between drug companies, pharmacy benefit managers and insurers “results in fairly modest costs for insurance companies, but has served to inflate the prices for patients who have to pay out of their own pockets,” including those with high deductibles and the uninsured.He and others hoped the lawsuits would help expose what they characterized as murky pricing schemes for insulin. But Mr. Bonta, a Democrat, disputed the idea that there was much mystery about the business relationships outlined in the lawsuit.“The broad strokes we know,” he said in an interview. “The P.B.M.s are a middle person that helps set the pricing and prepare the formulary for the insurance companies.” That industry’s symbiotic business relationship with pharmaceutical companies, he said, gives drug companies the incentives “to forever raise the price” of insulin.“It’s just pure profit padding,” Mr. Bonta said.The Federal Trade Commission in June announced an unrelated inquiry into the impact of pharmacy benefit managers on drug affordability and access.Isaac Sorensen, a spokesman for OptumRx, a subsidiary of UnitedHealth Group, said the California lawsuit mischaracterized the function of pharmacy benefit managers. He said such companies “are the only participants in the prescription drug supply chain whose role is to reduce drug costs.” OptumRx, he added, has eliminated out-of-pocket costs for insulin.“Pharmaceutical companies alone set the list price for their products,” Phil Blando, a spokesman for CVS Health, said. “Allegations that we play any role in determining the prices charged by manufacturers are false.”A University of Southern California research paper found that the rebate negotiation process among the industry’s players was a factor fueling rising drug costs and that reducing or eliminating rebates could lower list prices and out-of-pocket costs for some people.Los Angeles resident Sammi Lappin, 33, reported that living with Type 1 diabetes and depending on expensive insulin to live since she was 20 years old has narrowed her options in life.“I have had to move my career away from arts and education, where my passion lies, toward more corporate opportunities that specifically provide health insurance that covers insulin,” said Ms. Lappin, who works in talent acquisition in the medical aesthetics industry.

Read more →