Although CMS has earned praise for responding to errors identified by Plan Finder users, some people may have signed up for plans before the mistakes were caught.

This story was published December 6, 2019, by Kaiser Health News.

By Susan Jaffe

Saturday is the deadline for most people with Medicare coverage to sign up for private drug and medical plans for next year. But members of Congress, health care advocates and insurance agents worry that enrollment decisions based on bad information from the government's revamped, error-prone Plan Finder website will bring unwelcome surprises.

Beneficiaries could be stuck in plans that cost too much and don't meet their medical needs—with no way out until 2021.

On Wednesday, the Centers for Medicare & Medicaid Services told Kaiser Health News that beneficiaries would be able to change plans next year because of Plan Finder misinformation, although officials provided few details. And the Medicare.gov website and representatives at Medicare's call center had no information about that option.

The overhauled Plan Finder debuted at the end of August, and 2020 plan information was added in October. Over the past three months, Plan Finder problems reported to CMS by the National Association of Insurance Commissioners, the National Association of Health Underwriters, and state and national consumer advocates included inaccurate details about prices, covered drugs and dosages, and difficulty sorting and saving search results, among other things.

CMS made almost daily corrections and fixes to the website, which is the only tool that can compare dozens of private drug and medical plans―each with different pharmacy networks, covered drugs and drug prices. The website provides information for more than 60 million people with Medicare and their families, as well as state Medicare counselors and the representatives who answer the 800-MEDICARE help line.

In an unsigned blog article published on a Medicare website last week, officials said they're "not done improving the Plan Finder." And they promised "in the coming months we'll be scoping out additional improvements that we can implement based on lessons we learn this year."

Related: Medicare Plan Finder Tool Revamped to Make Comparison Shopping Easier

Although CMS has earned praise for responding to errors identified by Plan Finder users, some people may have signed up for plans before the mistakes were caught―mistakes they may not notice until their coverage kicks in next year.

"Seniors should be able to choose the plans that work best for them," said Sen. Susan Collins (R-Maine), chairwoman of the Senate Special Committee on Aging. "Issues with Medicare's new Plan Finder website, however, have reportedly created confusion among beneficiaries as well as those assisting them." She added that she was concerned "this problem even occurred."

Medicare's response, Collins said, "must be vigorous with extensive outreach to inform seniors of special enrollment periods."

Sen. Bob Casey of Pennsylvania, the senior Democrat on that committee, also said Medicare needs to reach out so people know they can request a "special enrollment period" if they discover next year they made a wrong choice due to inaccurate Plan Finder information.

"People with Medicare must be aware that this reprieve exists and should not have to jump through hoops to qualify," he said. The administration should "use all means necessary" to let beneficiaries know about their options for a special enrollment period.

In the statement to KHN Wednesday, CMS said it provides special enrollment periods for a number of reasons. It added that beneficiaries can get a special enrollment period related to Plan Finder issues anytime next year.

They can "call 1-800-MEDICARE and explain to our call center representatives that they have an issue with their plan choice. It is not CMS's expectation that beneficiaries will have documentation or screenshots," the statement said. The call center representatives "are trained and ready to help the beneficiary through the rest of the process."

CMS officials refused to be identified but would not give a reason.

Information about Plan Finder special enrollment periods will be available on the Medicare.gov website and at the call center, a CMS spokesman said.

However, nothing was posted on the website Thursday, and when Kaiser Health News called Medicare twice Thursday, both representatives said it would not be possible to switch plans next year because of inaccurate information from the Plan Finder.

Applying for a special enrollment period could be tricky. In the blog post, Medicare officials said the information on the Plan Finder is "the most current and accurate information on premiums, deductibles and cost sharing that Medicare Advantage and Prescription Drug Plans provide." They noted that the "information changes frequently because plans regularly update drug formularies and renegotiate drug prices."

America's Health Insurance Plans, the trade group representing health insurers, "is not aware of any systematic problems with the Plan Finder, which is operated by CMS," said spokeswoman Cathryn Donaldson.

People who enroll in a private Medicare Advantage policy, an alternative to traditional government-run Medicare that covers both drugs and medical care, already have an alternative. They have until March 31 to change plans or enroll in traditional Medicare.

Collins and Casey are not the only members of Congress raising the issue. Sen. Sherrod Brown (D-Ohio) wants CMS to provide a special enrollment period in these cases and clearly communicate the details, a spokesman said.

Rep. Richard Neal (D-Mass.), who chairs the House Ways and Means Committee, believes Saturday's deadline should be extended, a committee aide said. The committee has heard about the Plan Finder's problems from numerous seniors' advocates and counselors from state health insurance assistance programs, as well as the insurance companies that sell coverage.

Since enrollment for 2020 coverage began Oct. 1, the National Association of Health Underwriters, which represents 100,000 insurance agents, has sent CMS officials 54 Plan Finder problems and is still receiving reports from agents, said John Greene, the vice president for congressional affairs.

The Medicare counselors at Nebraska's Senior Health Insurance Information Program flagged more than 100 issues as of mid-November, said Alicia Jones, the program's administrator.

After receiving complaints about the Plan Finder, Delaware's insurance commissioner, Trinidad Navarro, issued a consumer alert last week.

Tatiana Fassieux, education and training specialist at California Health Advocates, said her organization wants CMS to offer a blanket, nationwide special enrollment period instead of granting it case by case. The group helps train Medicare counselors for California's Health Insurance Counseling and Advocacy Program, known as HICAP.

Leslie Fried has been an elder law attorney in Washington, D.C., since 1985, so imagine her surprise when she was stumped last weekend helping her mother pick a policy through the Plan Finder.

Fried, who is also senior director of the Center for Benefits Access at the National Council on Aging, did the same search three times for the least expensive plans that cover her mother's drugs and came up with a different result each time.

"Beneficiaries should be able to have confidence in the Plan Finder after a single search," she said.

For assistance reviewing drug and medical plans, call your state's Senior Health Insurance Information Program at 877-839-2675 or the Medicare Rights Center at 800-333-4114.

Physicians say the law's constraints on what insurers now pay has given the companies an unfair advantage in negotiations with doctors, which is leading to major changes in the industry that may affect patients.

This article was published December 5, 2019, by Kaiser Health News.

By Michelle Andrews

More than two years after California's surprise-billing law took effect, there's one thing on which consumer advocates, doctors and insurers all agree: The law has been effective at protecting many people from bills they might have been saddled with from doctors who aren't in their insurance network.

But the consensus stops there.

"In general, the law is working as intended," said Anthony Wright, executive director of Health Access California, a patient advocacy group that pushed for the measure, AB-72. "Patients are protected and the providers are getting paid."

Physicians beg to differ. They say the law's constraints on what insurers now pay has given the companies an unfair advantage in negotiations with doctors, which is leading to major changes in the industry that may affect patients.

Recent analyses by some researchers, however, cast doubt on some of the doctors' dire warnings.

"The problem is that AB-72 is creating imbalances in the health care marketplace that are decreasing access to care," said Dr. Antonio Hernandez Conte, an anesthesiologist whose specialty is among those most affected by the law.

The California law, which took effect in July 2017, protects consumers who use an in-network hospital or other facility from being hit with surprise bills when cared for by a doctor who has not contracted with their insurer. If that happens, consumers are responsible only for the copayment or other cost sharing that they would have owed if they had been seen by an in-network doctor.

Federal lawmakers are eyeing the California law as a possible model as they debate legislative proposals that would address surprise billing at the national level.

The California law applies to nonemergency services, since most state consumers were already protected for emergency care through an earlier court ruling.

It's not unusual for patients who visit a hospital or ambulatory surgical center that is covered by their insurance to encounter specialists who aren't, even in nonemergency situations.

For example, someone who has knee replacement surgery with an in-network surgeon at an in-network hospital may not realize that the anesthesiologist and assistant surgeon also scrubbing in on the operation are not.

Or a couple may be surprised to learn that the neonatologist caring for their baby in intensive care is outside their insurance network, even though the hospital where they gave birth is inside it. Diagnostic specialists like radiologists and pathologists whom patients rarely see may be out-of-network at an in-network hospital as well.

Under the California law, the doctor's payment from an insurer in those situations is based on either the average contracted rate for similar services in the area or 125% of what Medicare would have paid, whichever is greater.

In a California Medical Association online survey released last month ― in which 855 physician practices responded ― nearly 90% of the doctors said that the law allowed insurers to shrink physician networks, thus limiting patients' access to in-network doctors. Physicians blame the new law's reimbursement rates for surprise out-of-network care. The payment standard made insurers less inclined to negotiate payments and reduced doctors' bargaining power, the physicians say.

Those surveyed said they faced insurer payment rate cuts, refusal to renew their contracts and contract termination, among other problems.

This has led some physicians to try to gain leverage by consolidating practices, a move that can drive up health care costs significantly, the doctors warn.

The medical association did not respond to calls for comment on the survey.

Hernandez Conte, who chairs the legislative and practice affairs division of the California Society of Anesthesiologists, also pointed to data from the California Department of Managed Health Care showing that consumer complaints about access to care have risen from 415 in 2016 to 614 in 2018, a 48% jump.

Those complaints represent a minuscule number of consumers in the context of the more than 30 million Californians covered by commercial insurance or Medi-Cal, said Loren Adler, associate director at the University of Southern California-Brookings Schaeffer Initiative for Health Policy. Adler noted that there's no way to know if the complaints had anything to do with the surprise-billing law.

Hernandez Conte also pointed to a study published in August by the research firm Rand Corp. that he said showed the law is eroding doctors' leverage with insurers.

But that study ― a series of 28 interviews with doctors and others about their experiences in the first year after the law took effect ― wasn't definitive, said author Erin Duffy, an adjunct policy researcher at Rand and postdoctoral fellow at the Schaeffer Center for Health Policy and Economics at USC.

"It's more a reflection of what are some of the potential things we should look at down the road," she said.

Aside from individual examples of contracting problems cited by the physician group, researchers cite little evidence that patients are losing access to doctors who accept their insurance because of dwindling insurance networks.

The opposite appears to be true. USC-Brookings researchers published an analysis in September examining more than 17 million specialty claims by California physicians affected by the law. They found the share of services that specialty physicians delivered out-of-network at hospitals and ambulatory surgical centers declined by 17% after the law took effect.

When the law went into effect, there was a "precipitous" movement by affected physicians into insurance networks, said Adler, a co-author of the study.

Similarly, when the trade group America's Health Insurance Plans surveyed 11 large California health insurers about in-network providers during the two years after the law took effect, it found that the numbers grew or remained flat across specialties. There was a 16% increase in the number of in-network physicians overall, including a 26% rise in diagnostic radiologists and an 18% bump in anesthesiologists.

The plight of consumers who go to an in-network facility and, unbeknownst to them, receive treatment from out-of-network doctors has garnered plenty of attention in recent months.

In a typical scenario, the doctor charges the insurance company for services, then turns around and bills the patient for whatever amount the insurance company doesn't pay, a practice called balance billing. With no contract between the insurer and the doctor to set payment rates, the amounts billed by physicians are often higher than market rates, and the balance bills that patients face are many times higher than the regular copayment they would owe for in-network care.

Federal lawmakers are debating a number of measures that would address the issues at the federal level. The leading House and Senate bills would set minimum payment standards based on insurers' median in-network rate for a service for applicable out-of-network care, similar to the California law.

A federal law is key to broadening the surprise-billing protections provided by California's law, Wright said.

More than half of states now provide some level of consumer protection against surprise bills, and the efforts vary. But state surprise-billing laws protect only people insured by state-regulated plans. In California, that means 5.5 million consumers whose employers self-fund workers' health claims directly, rather than through an insurance plan, aren't covered by the law.

Since AB-72 was implemented, the Department of Managed Health Care hasn't taken any enforcement actions against physicians for balance-billing patients in nonemergency situations, according to agency spokeswoman Rachel Arrezola. It has pursued a handful of cases against doctors for out-of-network balance billing in emergency situations, however.

As doctors and patient advocates wrangle over AB-72, lawmakers are pressing new protections for consumers. A state law recently barred balance billing by air ambulance services.

Starting in January, California consumers who are airlifted by an out-of-network air ambulance won't be responsible for any more than their regular cost sharing for in-network providers.

For nearly two decades, malfunctions and injuries linked to more than 100 medical devices were funneled into an FDA database that few patients, doctors or even FDA officials knew existed.

By Christina Jewett

Lorraine Bonner felt as though she was the only one. The surgical staples used to seal her colon after surgery had leaked, she has alleged in a lawsuit, spurring additional surgeries and a long, difficult recovery.

And then, just over a year after the ordeal, she read a Kaiser Health News investigation that described worse cases. KHN revealed that the Food and Drug Administration had allowed stapler maker Covidien to quietly file tens of thousands of reports of stapler malfunctions into a then-hidden database.

Alarmed that others had been harmed and reports had been hidden, Bonner, a retired Oakland, Calif., doctor, decided to go forward with a lawsuit against the stapler maker.

"If the information had been out there, then maybe Covidien would have changed the design of the staplers and made them safer," she said, "and that would have obviated the problem in the first place."

Bonner's lawsuit is one example of how a vast cache of records that were released this summer are taking on a life of their own.

For almost 20 years, malfunctions and injuries linked to 108 medical devices, including dental implants and pacemaker leads, were funneled into an FDA database that few patients, doctors or even FDA officials knew existed.

In 2016, for example, Covidien reported 84 injuries or malfunctions in the public database known as MAUDE, while nearly 10,000 incidents flowed into the hidden database, KHN reported in March. A few MAUDE reports mentioned the existence of an "alternative summary reporting" program, but until this summer, the FDA made that internal data available only through the Freedom of Information process, which can take up to two years.

KHN's investigation prompted then-FDA commissioner Scott Gottlieb to pledge in a tweet to open the hidden data to the public. The agency released all 5.7 million records in June.

Since then, researchers, lawyers and the FDA's own officials have taken a closer look at the data to learn more about which devices malfunctioned, and how often.

Libbe Englander, the founder and CEO of Pharm3r, a medical data consulting firm, discovered that the devices in the hidden database were much riskier than other devices tracked by the FDA.

Her firm concluded that the hidden reports were "more likely to be associated with life-threatening devices and to contain potentially serious problems."

For example, just 10% of the devices tracked in the MAUDE database are implanted in the body. But 44% of those in the hidden data are lodged in a patient's body, including pacemakers and heart valves.

The Pharm3r report also found that the devices in the hidden data were more likely to be subject to a Class 1 recall, initiated when a device problem could cause serious injury or death. The report also underscored how vast the now-open data is ― accounting for about 40% of the total device-problem reports lodged with the FDA over the past two decades.

The once-hidden reports also figured into the ECRI Institute's annual list of health technology hazards, a list circulated to hospitals and health systems.

ECRI found that this year's No. 1 hazard was misuse of the surgical stapler ― which has been linked to 412 deaths, more than 11,000 serious injuries and nearly 100,000 malfunctions since 2011, according to the FDA.

"Most of these [stapler] reports had not previously been accessible to the public," the ECRI report notes. ECRI has advised doctors to have a backup plan in place in case a stapler malfunctions during surgery.

"If a hazard is getting a lot of attention, hospitals want to have a plan to address that," said Rob Schluth, a senior project officer with the institute.

Bonner says her long, difficult recovery after several surgeries kept her from tending to her garden for about a year. (Heidi de Marco/KHN)[/caption]

For Bonner, the problems with a surgical stapler became apparent just over a week after she had colon surgery in November 2017. Retired from a career as a hospital physician, she knew the steps to take toward recovery. But she felt nauseated all the time and could barely hold down water.

"I was trying to get up and walk," she said. "I was doing everything, but I just got worse and worse."

Doctors went in for a second surgery on Dec. 6 and found infected pus filling her abdomen. They routed her colon's contents to be collected outside her body. It took additional surgeries to restore her colon function and address hernias caused by the procedures.

Bonner's lawsuit alleges that a Covidien stapler caused her bowel leak and that the company, by not reporting malfunctions to the public database for years, "have hidden the true risks of using the device from surgeons and patients."

In court records filed in the ongoing case, Covidien denied all of Bonner's claims but did say that the FDA invited the company in 2001 to submit stapler malfunctions with quarterly "alternative summary" reports.

Medtronic spokesman John Jordan said the company does not have a comment on the pending legal case.

Other devices are under scrutiny. The once-hidden data showed more than 2 million problems with dental implants.

During an October FDA webinar on dental devices, an FDA official said her office was "taking a deeper dive and trying to identify lessons learned" from dental implant incidents.

Dr. Malvina Eydelman, of the Division of Dental Devices in the agency's device branch, acknowledged that the number of events was "very high" and said her team was trying to develop a plan to share information with the public.

Also under scrutiny are the textured breast implants made by Allergan. The company's Biocell implants, recalled in July, have been linked to 12 deaths and 481 of the 573 worldwide cases of "breast implant-associated" lymphoma, according to the FDA. Breast implant injuries and malfunctions accounted for nearly half a million reports in the hidden database, including implants that leaked, deflated or migrated.

Patients in Missouri, California, New York and Illinois have filed federal class action lawsuits against Allergan in recent weeks, each decrying the company's heavy use of the "alternative summary reporting" program to file injury reports ― which were analyzed by the International Consortium of Investigative Journalists.

A class action case filed in Florida notes FDA rules say that alternative summary reports cannot include severe or unexpected events, "yet it is believed that these incidents were kept hidden in ASRs," including at least one lymphoma case.

An ongoing federal securities lawsuit also alleges that Allergan used "inappropriately nonpublic" alternative summary reports, disregarding the "risk that some [lymphoma] cases would go undetected by the FDA."

Allergan has not yet responded to the class action cases or to calls for comment. It denied the "threadbare" allegation in the securities lawsuit, citing the KHN article, which "makes clear that the filing of ASRs was permissible and even encouraged by the FDA to reduce 'redundant paperwork.'"

While the FDA has ended the alternative summary reporting program, it opened the door for makers of more than 5,000 device types to file quarterly summaries of reported malfunctions. In each case, the device maker must file a public report to the MAUDE database noting how many reports were filed directly with the agency.

An FDA spokeswoman said the agency has stopped accepting summary reports of injuries cited in pelvic mesh lawsuits. The agency does continue to accept hundreds of death report summaries under a special exemption for devices tracked in a "registry" held by a specialty medical society.

"We are in the process of reviewing the effects of these changes and will continue working to improve the usability and transparency of information in the MAUDE database — whether that information was submitted as a summary or individual report," FDA spokeswoman Stephanie Caccomo said in an email.

The release has not been as informative as Madris Tomes had hoped, she said, given that the FDA did not disclose data on how the devices harmed patients. Tomes is a former FDA manager who runs the company Device Events, which analyzes FDA data.

For instance, she said a breast implant injury report might say there was a "biocompatibility" problem, but it's unclear what happened to the patient.

"Did it result in lymphoma or the patient needing a device replacement?" asked Tomes. "Without that outcome, we're still a little bit in the dark on what this data means."

The outages are likely to be a long-term problem. Hospitals and clinics must be prepared for this new reality. And so must patients.

This story was published by Kaiser Health News on November 27, 2019.

By Mark Kreidler

We all know that when the power goes out, refrigerators, heaters and air conditioners stop running. Homes go dark, and desktop computers shut down.

But those are mere inconveniences. If you need regular dialysis or chemotherapy at a clinic, or you have an infant in a neonatal intensive care unit or a loved one on a hospital ventilator, a loss of power carries far more dire implications.

California's recurrent power outages this year by Pacific Gas & Electric Co. and Southern California Edison, in response to wildfire threats up and down the state, have forced patients to think about how they get care when the power is cut at hospitals and clinics.

Hospitals that provide critical care are required by state and federal law to have backup generators on-site. In California, hospitals, outpatient clinics and treatment centers have long-standing disaster plans in place, which cover the possibility of temporary power outages.

"But continuous power shut-offs, sometimes lasting for days and then happening again within a week or two, were never what those plans were intended for," said Jan Emerson-Shea, vice president for external affairs at the California Hospital Association. "This is all very new to everybody."

Communities in Northern and Southern California have been subjected this year to numerous outages, often with no assurance of when their power would be restored. The utilities' estimates sometimes miss the mark. The outages are likely to be a long-term problem, given PG&E's 10-year timetable for fixing power transmission risks.

And the fires are not necessarily finished for this season: The Camp Fire, the most deadly in California history, started in the second week of November last year. And the Thomas Fire, a huge blaze that ravaged swaths of Ventura and Santa Barbara counties, erupted in early December 2017 and burned well into January.

The bottom line: Hospitals and clinics must be prepared for this new reality. And so must patients. The following answers to some critical questions will help readers understand what patients' options will be the next time a vital treatment is threatened by a loss of power.

Q: We have a family member on a ventilator in the hospital. What happens to her if the power goes out?

She will likely not be affected. All California hospitals must have backup generators and enough diesel fuel on hand to run for 72 hours without electricity. The generators kick in within 10 seconds of a power shut-off, Emerson-Shea said, so all critical functions — ventilators, heart monitors, surgical procedures — can continue without interruption.

Q: Some recent outages have lasted longer than 72 hours. What happens then?

As long as the hospital has access to diesel fuel, it can run on its generators for as long as it needs to (although air quality issues arise from their prolonged use). But even with generators, hospital administrators must decide which services are absolutely critical and which ones are temporarily dispensable.

Q: What are some examples of both?

If you have elective surgery like a knee replacement scheduled, and power is expected to be cut off that day, there's a chance the hospital will reschedule the operation. The generators are intended primarily to power the critical-care functions of a hospital — operating and emergency rooms; labor centers; the monitoring of patients' heart rates, breathing and blood pressure — and officials will keep those functions going even if it means turning off the building's air conditioning or heat.

Q: I have a chemotherapy treatment scheduled on a day when a power shut-off may occur. Should I still go?

That depends on your provider. Many oncology practices are located within or next to hospitals, so they would retain access to power even in a shut-off. The situation changes, though, if your treatments are normally provided at a free-standing health clinic or private care center, where such backup may not exist. A survey by the disaster-preparedness nonprofit Direct Relief found that only 44% of California's community health centers have a backup energy source in case of electrical failure.

Q: What do clinics without backup energy do, then, if the power goes out?

Phone calls by California Healthline to several such clinics found that most of them had a similar plan: Staffers use their cellphones to contact each patient and cancel his or her session. So be aware that you may see an unfamiliar incoming number that turns out to be your provider. If someone from your treatment team doesn't call you, call them. And if your treatment is canceled, make sure it is rescheduled for immediately after power is restored. A few of the facilities noted that their doctors have privileges at local hospitals, so in cases where the treatment is indispensable, they can send patients there. Emerson-Shea said several hospitals have reported receiving patients who had been directed there by clinics.

Q: How bad is it if I miss a chemo or radiation treatment?

In many cases, a delay of a few days won't hurt you. But missing a session altogether is not good. A study published by the National Institutes of Health showed that missed chemotherapy doses correlated with worse prognoses and higher mortality rates among cancer patients. Missed radiation treatments, likewise, have been linked to a greater risk of cancer recurrence. So it's important to stay on track.

Q: What about dialysis? If my clinic has no power, can I get treatment elsewhere?

Yes. During mandatory fire-related evacuations in Sonoma County last month, some clinics with no formal affiliation functioned as ad hoc cooperatives, cross-referring their patients depending upon which facilities were up and running, said Monica Hannaman, a dialysis social worker at Fresenius Medical Care in Santa Rosa. The goal was to treat patients without having to send them to a hospital, she said, "because the hospitals are already so burdened during emergencies like that."

Also, keep in mind that if your dialysis center is part of a bigger chain, you can go to one of its other locations. Some Sonoma County dialysis patients of San Jose-based Satellite Healthcare, which has multiple locations in California, went as far as Sacramento for treatment last month, said Lanie Borja, manager of the Satellite clinic in Windsor, Calif.

Q: What else can health care providers do to ensure my well-being in the likely case of future power outages?

Hospitals may start rethinking ways to store backup energy, Emerson-Shea said, especially given the long time PG&E has said it will take before it can stop the precautionary outages. Some free-standing medical clinics in areas with high fire and wind risk are considering buying generators large enough to power their operations, despite the big expense. Hannaman said Fresenius is thinking of putting generators in its two Santa Rosa-area clinics, because "this will be happening more often, we're afraid."

This KHN story first published on California Healthline, a service of the California Health Care Foundation.