The doctor most responsible for turning the sunshine supplement into a billion-dollar juggernaut has received hundreds of thousands of dollars from the vitamin D industry, according to government records and interviews.

This article first appeared August 20, 2018 on Kaiser Health News.

By Liz Szabo

Dr. Michael Holick's enthusiasm for vitamin D can be fairly described as extreme.

The Boston University endocrinologist, who perhaps more than anyone else is responsible for creating a billion-dollar vitamin D sales and testing juggernaut, elevates his own levels of the stuff with supplements and fortified milk. When he bikes outdoors, he won't put sunscreen on his limbs. He has written book-length odes to vitamin D, and has warned in multiple scholarly articles about a "vitamin D deficiency pandemic" that explains disease and suboptimal health across the world.

His fixation is so intense that it extends to the dinosaurs. What if the real problem with that asteroid 65 million years ago wasn't a lack of food, but the weak bones that follow a lack of sunlight? "I sometimes wonder," Holick has written, "did the dinosaurs die of rickets and osteomalacia?"

Holick's role in drafting national vitamin D guidelines, and the embrace of his message by mainstream doctors and wellness gurus alike, have helped push supplement sales to $936 million in 2017. That's a ninefold increase over the previous decade. Lab tests for vitamin D deficiency have spiked, too: Doctors ordered more than 10 million for Medicare patients in 2016, up 547 percent since 2007, at a cost of $365 million.

But few of the Americans swept up in the vitamin D craze are likely aware that the industry has sent a lot of money Holick's way. A Kaiser Health News investigation found that he has used his prominent position in the medical community to promote practices that financially benefit corporations that have given him hundreds of thousands of dollars — including drugmakers, the indoor-tanning industry and one of the country's largest commercial labs.

In an interview, Holick acknowledged he has worked as a consultant to Quest Diagnostics, which performs vitamin D tests, since 1979. Holick, 72, said that industry funding "doesn't influence me in terms of talking about the health benefits of vitamin D."

There is no question that the hormone is important. Without enough of it, bones can become thin, brittle and misshapen, causing a condition called rickets in children and osteomalacia in adults. The issue is how much vitamin D is healthy, and what level constitutes deficiency.

Holick's crucial role in shaping that debate occurred in 2011. Late the previous year, the prestigious National Academy of Medicine (then known as the Institute of Medicine), a group of independent scientific experts, issued a comprehensive, 1,132-page report on vitamin D deficiency. It concluded that the vast majority of Americans get plenty of the hormone through diet and sunlight, and advised doctors to test only patients at high risk of vitamin D-related disorders, such as osteoporosis.

A few months later, in June 2011, Holick oversaw the publication of a report that took a starkly different view. The paper, in the peer-reviewed Journal of Clinical Endocrinology & Metabolism, was on behalf of the Endocrine Society, the field's foremost professional group, whose guidelines are widely used by hospitals, physicians and commercial labs nationwide, including Quest. The society adopted Holick's position that "vitamin D deficiency is very common in all age groups" and advocated a huge expansion of vitamin D testing, targeting more than half the United States population, including those who are black, Hispanic or obese — groups that tend to have lower vitamin D levels than others.

The recommendations were a financial windfall for the vitamin D industry. By advocating such widespread testing, the Endocrine Society directed more business to Quest and other commercial labs. Vitamin D tests are now the fifth-most-common lab test covered by Medicare.

The guidelines benefited the vitamin D industry in another important way. Unlike the National Academy, which concluded that patients have sufficient vitamin D when their blood levels are at or above 20 nanograms per milliliter, the Endocrine Society said vitamin D levels need to be much higher — at least 30 nanograms per milliliter. Many commercial labs, including Quest and LabCorp, adopted the higher standard.

Yet there's no evidence that people with the higher level are any healthier than those with the lower level, said Dr. Clifford Rosen, a senior scientist at the Maine Medical Center Research Institute and co-author of the National Academy report. Using the Endocrine Society's higher standard creates the appearance of an epidemic, he said, because it labels 80 percent of Americans as having inadequate vitamin D.

"We see people being tested all the time and being treated based on a lot of wishful thinking, that you can take a supplement to be healthier," Rosen said.

Patients with low vitamin D levels are often prescribed supplements and instructed to get checked again in a few months, said Dr. Alex Krist, a family physician and vice chairman of the U.S. Preventive Services Task Force, an expert panel that issues health advice. Many physicians then repeat the test once a year. For labs, "it's in their financial interest" to label patients with low vitamin D levels, Krist said.

In a 2010 book, "The Vitamin D Solution," Holick gave readers tips to encourage them to get their blood tested. For readers worried about potential out-of-pocket costs for vitamin D tests — they range from $40 to $225 — Holick listed the precise reimbursement codes that doctors should use when requesting insurance coverage. "If they use the wrong coding when submitting the claim to the insurance company, they won't get reimbursed and you will wind up having to pay for the test," Holick wrote.

Holick acknowledged financial ties with Quest and other companies in the financial disclosure statement published with the Endocrine Society guidelines. In an interview, he said that working for Quest for four decades — he is currently paid $1,000 a month — hasn't affected his medical advice. "I don't get any additional money if they sell one test or 1 billion," Holick said.

A Quest spokeswoman, Wendy Bost, said the company seeks the advice of a number of expert consultants. "We feel strongly that being able to work with the top experts in the field, whether it's vitamin D or another area, translates to better quality and better information, both for our patients and physicians," Bost said.

Since 2011, Holick's advocacy has been embraced by the wellness-industrial complex. Gwyneth Paltrow's website, Goop, cites his writing. Dr. Mehmet Oz has described vitamin D as "the No. 1 thing you need more of," telling his audience that it can help them avoid heart disease, depression, weight gain, memory loss and cancer. And Oprah Winfrey's website tells readers that "knowing your vitamin D levels might save your life." Mainstream doctors have pushed the hormone, including Dr. Walter Willett, a widely respected professor at Harvard Medical School.

Today, seven years after the dueling academic findings, the leaders of the National Academy report are struggling to be heard above the clamor for more sunshine pills.

"There isn't a 'pandemic,'" A. Catharine Ross, a professor at Penn State and chair of the committee that wrote the report, said in an interview. "There isn't a widespread problem."

Ties To Drugmakers And Tanning Salons

In "The Vitamin D Solution," Holick describes his promotion of vitamin D as a lonely crusade. "Drug companies can sell fear," he writes, "but they can't sell sunlight, so there's no promotion of the sun's health benefits."

Yet Holick also has extensive financial ties to the pharmaceutical industry. He received nearly $163,000 from 2013 to 2017 from pharmaceutical companies, according to Medicare's Open Payments database, which tracks payments from drug and device manufacturers. The companies paying him included Sanofi-Aventis, which markets vitamin D supplements; Shire, which makes drugs for hormonal disorders that are given with vitamin D; Amgen, which makes an osteoporosis treatment; and Roche Diagnostics and Quidel Corp., which both make vitamin D tests.

The database includes only payments made since 2013, but Holick's record of being compensated by drug companies started before that. In his 2010 book, he describes visiting South Africa to give "talks for a pharmaceutical company," whose president and chief executive were in the audience.

Holick's ties to the tanning industry also have drawn scrutiny. Although Holick said he doesn't advocate tanning, he has described tanning beds as a "recommended source" of vitamin D "when used in moderation."

Holick has acknowledged accepting research money from the UV Foundation — a nonprofit arm of the now-defunct Indoor Tanning Association — which gave $150,000 to Boston University from 2004 to 2006, earmarked for Holick's research. The International Agency for Research on Cancer classified tanning beds as carcinogenic in 2009.

In 2004, the tanning-industry associations led Dr. Barbara Gilchrest, who then was head of Boston University's dermatology department, to ask Holick to resign from the department. He did so, but remains a professor at the medical school's department of endocrinology, diabetes and nutrition and weight management.

In "The Vitamin D Solution," Holick wrote that he was "forced" to give up his position due to his "stalwart support of sensible sun exposure." He added, "Shame on me for challenging one of the dogmas of dermatology."

Although Holick's website lists him as a member of the American Academy of Dermatology, an academy spokeswoman, Amanda Jacobs, said he was not a current member.

Dr. Christopher McCartney, chairman of the Endocrine Society's clinical guidelines subcommittee, said the society has put in place stricter policies on conflict of interest since its vitamin D guidelines were released. The society's current policies would not allow the chairman of the guideline-writing committee to have financial conflicts.

A Miracle Pill Loses Its Luster

Enthusiasm for vitamin D among medical experts has dimmed in recent years, as rigorous clinical trials have failed to confirm the benefits suggested by early, preliminary studies. A string of trials found no evidence that vitamin D reduces the risk of cancer, heart disease or falls in the elderly. And most scientists say there isn't enough evidence to know if vitamin D can prevent chronic diseases that aren't related to bones.

Although the amount of vitamin D in a typical daily supplement is generally considered safe, it is possible to take too much. In 2015, an article in the American Journal of Medicine linked blood levels as low as 50 nanograms per milliliter with an increased risk of death.

Some researchers say vitamin D may never have been the miracle pill that it appeared to be. Sick people who stay indoors tend to have low vitamin D levels; their poor health is likely the cause of their low vitamin D levels, not the other way around, said Dr. JoAnn Manson, chief of preventive medicine at Brigham and Women's Hospital in Boston. Only really rigorous studies, which randomly assign some patients to take vitamin D and others to take placebos, can provide definitive answers about vitamin D and health. Manson is leading one such study, involving 26,000 adults, expected to be published in November.

A number of insurers and health experts have begun to view widespread vitamin D testing as unnecessary and expensive. In 2014, the U.S. Preventive Services Task Force said there wasn't enough evidence to recommend for or against routine vitamin D screening. In April, the task force explicitly recommended that older adults outside of nursing homes avoid taking vitamin D supplements to prevent falls.

In 2015, Excellus BlueCross BlueShield published an analysis highlighting the overuse of vitamin D tests. In 2014, the insurer spent $33 million on 641,000 vitamin D tests. "That's an astronomical amount of money," said Dr. Richard Lockwood, Excellus' vice president and chief medical officer for utilization management. More than 40 percent of Excellus patients tested had no medical reason to be screened.

In spite of Excellus' efforts to rein in the tests, vitamin D usage has remained high, Lockwood said. "It's very hard to change habits," he said, adding: "The medical community is not much different than the rest of the world, and we get into fads."

In a campaign motivated by a muddy mix of health care and business, smaller hospitals and the medical device industry are arguing that the TAVR technique should be more widely deployed.

This article first appeared August 17, 2018 on Kaiser Health News.

By Phil Galewitz

BALTIMORE — When Medicare in 2011 agreed to pay for a revolutionary procedure to replace leaky heart valves by snaking a synthetic replacement up through blood vessels, the goal was to offer relief to the tens of thousands of patients too frail to endure open-heart surgery, the gold standard.

To help ensure good results, federal officials limited Medicare payment only to hospitals that serve large numbers of cardiac patients.

The strategy worked. In the past seven years, more than 135,000 mostly elderly patients have undergone transcatheter aortic valve replacement, known as TAVR. And TAVR's in-hospital mortality rate has dropped by two-thirds, to 1.5 percent.

Now, in a campaign motivated by a muddy mix of health care and business, smaller hospitals and the medical device industry are arguing that the technique should be more widely deployed. They note only about half of the nearly 1,100 hospitals offering surgical valve replacement can do TAVR. And they say current limitations discriminate against minorities and people in rural areas, forcing patients to undergo a riskier and significantly more invasive treatment — or miss getting a new valve altogether.

Hospitals that already have a TAVR franchise are fighting to stifle new competitors, saying programs that don't do enough procedures would not provide high-quality care.

At stake is the care of thousands of patients. Half of the more than 250,000 Americans estimated each year to develop severe aortic valve stenosis — narrowing of the valve that regulates the flow of blood from the heart to the largest artery of the body — die within two years. Getting an artificial heart valve lowers that death rate to as low as 17 percent, studies show.

Also at stake is the $45,000 Medicare pays hospitals for each TAVR case — excluding the doctor's fee. While hospitals typically make only a small profit on the procedure — partly because the device costs more than $30,000 — they benefit because each TAVR patient typically needs other cardiac services and tests that can boost the hospital's bottom line.

In addition, offering TAVR carries a cachet that helps recruit and retain top specialists, who bring in more patients.

At a Medicare advisory committee hearing in Baltimore on July 25, both sides of the debate emphasized how they were seeking to help patients. But the economics of TAVR was ever-present given the horde of medical device and hospital officials and industry analysts in the audience.

The committee split on the issue, although a majority of members backed the continued use of volume requirements. The Centers for Medicare & Medicaid Services is expected to decide later this year whether to change its patient volume minimum for TAVR.

Dr. Jason Felger, a heart surgeon who wants his community hospital in San Angelo, Texas, to offer the procedure, said behind the fight over TAVR is protecting profit and revenue. He refers patients to hospitals more than three hours away for the procedure or, if they aren't willing to travel, they risk their lives to undergo the conventional operation.

Hospitals that offer TAVR, he said, aren't willing to give up the referrals they now rely on from other hospitals.

"It's all about the money," he said.

Improving A Hospital's Reputation

Unlike open-heart surgery, in which the chest is cracked open to remove the unhealthy valve, TAVR involves threading a catheter tipped with a replacement valve through a blood vessel to the heart. Doctors then implant the new valve. The old valve remains but is pushed aside, and the new one takes over its work.

With this less invasive valve procedure, people can get out of the hospital within two or three days and get back to daily activities much sooner than with open-heart surgery, which typically has a six-week recovery time.

TAVR has been approved by the Food and Drug Administration for people who cannot have open-heart surgery or for whom it would be risky. These include the elderly and frail and people with complications such as kidney and lung disease. But TAVR use has expanded among younger, and less sick, patients in recent years. Within the next year, the FDA is likely to approve the procedure for all patients needing a new aortic valve, industry analysts say.

TAVR does carry risks, including stroke. Patients may also need a pacemaker after the procedure to regulate heart rhythm.

TAVR involves threading a catheter tipped with a replacement valve through a blood vessel to the heart. Doctors then implant the new valve.

The large majority of patients getting TAVR are 65 and over. The importance of Medicare's blessing goes beyond its payments, since private insurers typically follow Medicare standards. Physicians seeking to expand use of TAVR point out that Medicare has no volume requirements for other major cardiac procedures.

The two largest TAVR medical device companies are divided on the issue. Edwards Lifesciences Corp. of Irvine, Calif., supports eliminating the minimum-patient requirements, while Minneapolis-based Medtronic favors keeping the status quo. The Advanced Medical Technology Association, or AdvaMed, an industry trade group, also supports the change.

About 50,000 patients are expected to have TAVR this year, and those numbers are forecast to double by 2020, according to American College of Cardiology and other major heart groups.

When Michael Vigil, 50, needed TAVR in May, he drove more than three hours from his home in eastern Wyoming to a hospital in Denver. Before the procedure, the oil-drilling contractor was constantly tired and out of breath — even after mundane chores at home. Vigil's aortic valve had been damaged from radiation treatments for non-Hodgkin lymphoma decades before.

Vigil was sent home a day after the TAVR procedure. He was back at work the following week.

He said he felt more energized almost immediately after having the procedure.

"It's worked so well, my wife wishes they dialed it back a little," Vigil said.

Donnette Smith, president of the patient advocacy group Mended Hearts, said many patients don't have good access to the procedure.

"Patients do not know of this option unless they walk through the right door of the right hospital," said Smith of Huntsville, Ala. She had heart valve surgery in 1988.

Mended Hearts receives funding from device makers.

'Experience Matters'

To gain Medicare approval for TAVR programs, hospitals have to perform annually 50 open-heart valve repairs, 400 angioplasties and 1,000 cardiac catheterizations — a procedure in which medical teams use skills similar to those needed for TAVR.

Doctors at larger hospitals say procedure volume is a good predictor for success. The American College of Cardiology and the Society of Thoracic Surgeons recommend hospitals be able to do at least 50 TAVRs each year within two years of startup. More than three-quarters of the 582 hospitals authorized by Medicare for TAVR meet that standard.

"Whether it's playing the violin or performing heart surgery, experience matters," said Dr. Thoralf Sundt, chief of cardiac surgery at Massachusetts General Hospital.

Dr. Ashish Pershad, an interventional cardiologist who performs TAVR at Banner Medical Center in Phoenix, agreed that there are access issues. But he said it's not because of a lack of programs. Rather, he said, surgeons too often don't refer patients for it because they make more money from doing the open-heart surgical valve replacement.

"Patients are missing out on this procedure because they are not being referred, and primary care doctors lack knowledge about it," he said.

Expanding Treatment Options

Doctors seeking a Medicare rule to widen access say there is little evidence hospitals that perform more TAVRs have lower mortality rates. As long as they can show low mortality and complications, they believe their hospitals should be able to offer the service.

"Our intention is not to lower the quality of outcomes by expanding to 'low volume' centers; but to provide excellent care to a larger population of patients," Felger and his colleagues at Shannon Medical Center in San Angelo, Texas, wrote to the CMS advisory group.

Last year, Felger said, he sent a dozen patients to hospitals in Austin or Dallas for TAVR, while eight other patients opted for the open-heart surgery.

"I have patients tell me they would rather have the surgical procedure at their local hospital than traveling to another city," he said. "They tell me 'Let's do this; if I die, I die.'"

The healthcare sector is responsible for nearly 10% of all greenhouse gas emissions. Increasingly, though, health systems are paying attention.

This article first appeared August 08, 2018 on Kaiser Health News.

By Julie Appleby

Hospitals are energy hogs.

With their 24/7 lighting, heating and water needs, they use up to five times more energy than a fancy hotel.

Executives at some systems view their facilities like hotel managers, adding amenities, upscale new lobbies and larger parking garages in an effort to attract patients and increase revenue. But some hospitals are revamping with a different goal in mind: becoming more energy-efficient, which can also boost the bottom line.

"We're saving $1 [million] to $3 million a year in hard cash," said Jeff Thompson, the former CEO of Gundersen Health System in La Crosse, Wis., the first hospital system in the U.S. to produce more energy than it consumed back in 2014. As an added benefit, he said, "we're polluting a lot less."

The health care sector — one of the nation's largest industries — is responsible for nearly 10 percent of all greenhouse gas emissions — hundreds of millions of tons worth of carbon each year. Hospitals make up more than one-third of those emissions, according to a paper by researchers at Northeastern University and Yale.

Increasingly, though, health systems are paying attention:

• Gundersen Health System in Wisconsin employs wind, wood chips, landfill-produced methane gas — and even cow manure — to generate power, reporting more than a 95 percent drop in its emissions of carbon monoxide, particulate matter and mercury from 2008 to 2016.
   
• Boston Medical Center analyzed its hospital for duplicative and underused space, then downsized while increasing patient capacity. Among other changes, it now has a gas-fired 2-megawatt cogeneration plant that traps and reuses heat, saving money and emissions, while supplying 41 percent of the hospital's needs and acting as a backup for essential services if the municipal power grid goes out.
   
• Theda Clark Medical Center in Wisconsin is saving nearly $800,000 a year — 30 percent of its energy costs — after making changes that included retrofitting lights, insulating pipes, taking the lights out of vending machines and turning off air exchangers in parts of its building after hours.
   
• Kaiser Permanente aims to be "carbon-neutral" by 2020, mainly by incorporating solar energy at up to 100 of its hospitals and other facilities. One already in use — at its Richmond (Calif.) Medical Center — is credited with reducing electric bills by about $140,000 a year. (Kaiser Health News is not affiliated with Kaiser Permanente.)
   

While the environmental benefits are important, "what I've seen over the years is cost reductions are the prime motivator," said Patrick Kallerman, research manager at the Bay Area Council Economic Institute, which released a report this spring outlining ways the hospital industry can help states such as California reach environmental goals by becoming more efficient.

Some of its recommendations are simple: replacing old lighting and windows. Others are more complex: powering down heating and cooling in areas not being used and updating ventilation standards first set back in Florence Nightingale's day. Such tight standards "might not be necessary," Kallerman said. Loosening them could help save money and energy.

When Bob Biggio was hired in 2011 to oversee Boston Medical Center's facilities, hospital leaders were about to launch a broad redesign. Yet the hospital was also facing serious financial struggles. He put the move on hold while analyzing how the hospital was using its existing space, looking for unused or duplicative areas.

"My first impression with data I had gathered was our campus was about 400,000 square feet bigger than it needed to be, said Biggio. "A square foot you never have to build is most efficient of all."

The new design is smaller but more efficient, handling 20 percent higher patient volume and eliminating the need for ambulance transportation between far-flung areas of the campus. It also cut power consumption by 42 percent from a 2011 baseline.

While the hospital sunk a lot of money into the renovation, the center was able to sell off some of its land to help offset the costs, leading to about a five-year return on investment, Biggio said.

"We are a safety-net hospital with a large Medicaid population," he said. "So this is the last place people expect to see the type of investments and progress we've made."

But how to sell that in the C-suite?

The environmental argument wasn't how Thompson convinced executives at Gundersen.

"At no point did I mention climate change or polar bears," said Thompson.

Instead, he focused on the organization's mission to improve health — and the potential cost savings.

"There are multiple examples — at Gundersen and other places — where, if we're thoughtful, we can improve the local economy, lower the cost of health care and decrease the pollution that is making people sick," he said.

But hospitals' energy efficiency efforts vary, with only about 10 percent attempting changes as dramatic as those done at Gundersen, estimated Alex Thorpe, a hospital energy expert at Optum Advisory Services, a consulting firm owned by UnitedHealth Group.

"About 50 percent are in the middle," he added, perhaps because these investments are weighed against other capital needs.

"If you have a well-known doctor that wants a new cutting-edge piece of equipment, then it can be hard to make the business case [for investing in alternative energy]," said Thorpe.

Of the more than 5,000 hospitals in the country, about 1,100 are members of Practice Greenhealth, a nonprofit that promotes environmental stewardship. Fewer than 300 hospitals qualify as Energy Star facilities, an Environmental Protection Agency program that recognizes buildings that rank in the top quartile for energy conservation among their peers.

Greenhealth estimates its members average about a million dollars a year in savings, but it all depends what steps they take.

There are modest savings from such things as reducing the heating and air conditioning in operating rooms during hours they are not in use, with median annual cost savings of $45,398, a report from the group notes. Other energy reduction efforts net another median $53,599 in annual savings, while swapping older lighting for new LED bulbs in operating rooms saves another $3,329.

Individually, those savings are not even rounding errors in most hospitals' total expenses, which are measured in the millions of dollars.

Still, within facility expenses, energy use accounts for 51 percent of spending, so even modest cuts are "significant," said Kara Brooks, sustainability program manager for the American Society for Healthcare Engineering.

Ultimately, that may affect what hospitals charge insurers and patients.

"If hospitals can lower peak demand through energy efficiency efforts, that will directly impact their pricing," said Thorpe.

If fewer insurers add the CSR load to silver plans sold off the exchange, those plans may be more affordable next year than they were this year.

This article first appeared August 14, 2018 on Kaiser Health News.

By Michelle Andrews

For those who make too much money to qualify for health insurance subsidies on the individual market, there may be no Goldilocks moment when shopping for a plan. No choice is just right.

A policy with an affordable premium may come with a deductible that's too high. If the copayments for physician visits are reasonable, the plan may not include their preferred doctors.

These consumers need better options, and in early August federal officials offered a strategy to help bring down costs for them.

The guidance is from the Centers for Medicare & Medicaid Services, which oversees the insurance marketplaces set up by the Affordable Care Act. CMS is encouraging states to allow the sale of plans outside of those exchanges that don't incorporate a surcharge insurers started tacking on last year.

Many insurers added the premium surcharges last fall to plans sold on the individual market. It was a response to the Trump administration's announcement that it would no longer pay the companies for the "cost-sharing reduction" subsidies required under the health law. The subsidies help cover deductibles and other out-of-pocket costs for lower-income consumers who buy marketplace plans.

Insurers typically added the cost to silver-level plans because those are the type of plans that consumers have to buy in order to receive the cost-sharing subsidies. "Silver loading," as it's called, added an estimated 10 percent to the cost of those plans, according to the Congressional Budget Office.

People who qualified for federal premium subsidies — those with incomes up to 400 percent of the federal poverty level (about $48,000 for one person or $100,000 for a family of four) — were shielded from the surcharge because their subsidies increased to cover the cost.

But people with higher incomes faced higher premiums. The new guidance is geared to help them.

"It encourages states to encourage silver loading only on the exchange," said Aviva Aron-Dine, vice president for health policy at the Center on Budget and Policy Priorities.

But some analysts say they're unsure if the new federal policy will make a difference since states have already implemented similar strategies.

Many states moved last fall to limit silver loading to plans sold on the exchanges, while allowing or, in the case of California, requiring, very similar plans to be sold off the exchanges without the extra premium charge.

Yet CMS' endorsement of the strategy removes doubts states may have had, said David Anderson, a research associate at Duke University's Margolis Center for Health Policy who has tracked the issue.

Eighty-three percent of people who bought a plan during the open-enrollment period for 2018 qualified for premium tax credits. The average monthly premium per subsidized enrollee was $639; after accounting for premium tax credits, however, enrollees owed just $89 on average. That amount was 16 percent lower than the monthly premium the year before.

For people who don't qualify for premium tax credits, the picture is very different. The average monthly premium for 2018 was $522. That total was 28 percent higher than the previous year's total of $407, according to an analysis by the Center on Budget and Policy Priorities of CMS enrollment data.

In general, federal rules require that insurers charge the same rates for identical qualified health plans that are sold on and off the exchanges. The CMS guidance suggests that the unloaded plans could be tweaked slightly in terms of cost sharing or other variables so that they are not identical to those on the marketplaces.

Tracing what type of coverage is purchased off the exchange is difficult because there is no centralized source. Consumers can buy plans directly from insurers, or they may use a broker or an online web portal. According to one such portal, eHealth, 28 percent of unsubsidized consumers on its site bought silver plans in 2018, while 42 percent bought bronze plans, whose coverage is less generous than silver plans and typically have lower premiums. Conversely, on the exchanges nearly two-thirds of people bought silver plans in 2018 while 29 percent bought bronze plans, according to federal data.

If fewer insurers add the CSR load to silver plans sold off the exchange, those plans may be more affordable next year than they were in 2018, said Cynthia Cox, director of health reform and private insurance at the Kaiser Family Foundation. (Kaiser Health News is an editorially independent program of the foundation.)

"This makes silver plans an option for [unsubsidized] people who wanted to buy a silver plan but might have been pushed off onto a bronze plan," she said.

Consumers who want to consider off-exchange plans have to find them first. Some experts suggest checking with insurers that are selling on the marketplace in an area, because it's possible that they'll also be selling plans off the exchange.

But that's not a given. A health insurance broker can help people find and evaluate plans sold off the exchange. But experts urge consumers to stay on their toes and make sure they understand whether the plans they're considering provide comprehensive coverage.

Starting in October, insurers can offer short-term plans with limited benefits that last up to a year.

"Differentiating between the two may not be easy, and the off-exchange unsubsidized market is the target market for short-term plans," said Anderson.