Proponents of direct primary care say it can provide a safety net for those with limited treatment options and is particularly helpful in states that have not expanded Medicaid access.

This article first appeared October 03, 2017 on Kaiser Health News.

By Charlotte Huff

JARRELL, Texas — Darrell Kenyon had been punting for years on various medical issues — fatigue, headaches, mood swings. The 43-year-old uninsured carpenter was particularly worried about his blood pressure, which ran high when he checked it at the grocery store. Then he heard about a different type of physician practice, one that provided regular primary care for a monthly fee.

“Insurance for the self-employed is through the roof,” Kenyon told Dr. Loy Graham, as she examined him one morning in August. Two years ago, Graham had hung out her shingle in this central Texas town of nearly 1,400, about 40 miles north of Austin.

Under the practice model, called direct primary care, patients are charged monthly — typically $20 to $75, depending on age, in Graham’s practice — for basic, office-based medical care and frequently cell phone and other after-hours physician access. Proponents of the model, which is also supported as a practice option by the American Academy of Family Physicians, say it can provide a safety net for those with limited treatment options, including the uninsured and people in the country illegally. The alternative is particularly helpful in states like Texas that haven’t expanded Medicaid access, the advocates add.

But there’s a sizable catch: Direct primary care is not insurance.

Carolyn Engelhard worries that strapped individuals will decide the easier access to primary care is “good enough” and won’t investigate insurance options. “It can be a false security,” said Engelhard, who directs the health policy program at the University of Virginia School of Medicine in Charlottesville. “There’s sort of the illusion that it’s kind of like insurance.”

Lower-income Texans would be better off with coverage on the Affordable Care Act’s insurance exchange, where they could get a subsidy to reduce the cost of their premiums, Engelhard said. The policy would have a deductible, “which they might feel that they can’t afford,” she said. “But they would be protected if they got cancer or if they had an automobile accident.”

Graham estimates that at least three-quarters of her roughly 450 patients lack insurance, even though she advises them to carry some kind of catastrophic coverage for major health expenses. But the cost for such policies can be daunting. Like Kenyon, some of Graham’s patients are self-employed with fluctuating incomes or work for businesses that don’t offer coverage. Even if their employer offers affordable coverage for the employee, premiums for dependents might make coverage financially out of reach. Roughly 1 in 5 of her patients speak primarily Spanish. Some are undocumented, working in construction and other labor-intensive jobs in the region.

Despite her concerns, Engelhard said, such flat-fee practices might offer “one of the few viable options” for those living here under the radar, given they’re not eligible for ACA-related coverage. “So they are completely dependent on paying out-of-pocket for medical care,” she said.

‘Better Than Nothing’?

Nationally, direct primary care is relatively new and very much a niche option. Nearly 3 percent of family physicians practice it, according to a 2017 survey by the American Academy of Family Physicians. Some critics have questioned whether the model’s growth is already stalling, after one of its earliest providers, Seattle-based Qliance, closed its clinics this year.

Graham, who practiced traditional medicine in Central Texas for decades, said she was drawn to the option after growing weary of packing too many patients into each day. She was considering leaving medicine and had started developing a lavender farm as an alternative source of income when she heard about direct primary care.

In 2015, she opened her practice in a small strip mall in Jarrell, figuring that nearby residents — with limited access to primary care — might take a chance on the different style of medicine.

Dr. John Bender, an academy board member who is part of a larger practice that’s transitioning to direct primary care, said that the low monthly fees are attracting patients who view insurance as out of reach. “I think something [in terms of medical care] is better than nothing,” said the Fort Collins, Colo., family physician, who estimates that roughly half of the practice’s 800-plus direct primary care patients are uninsured.

“I can spare them quite a few urgent care and emergency room bills,” Bender said, noting that his office handles anything from strep throat to stitches for minor gashes. Moreover, the cost is within reach of people on tight budgets, he said. “In fact, a carton of cigarettes runs $49, which just happens to be the price of my monthly subscription fee [for adults].”

In Texas, 16.6 percent of the state’s residents were uninsured as of 2016, the highest rate nationally, according to the most recent Census Bureau data. The Lone Star State didn’t expand Medicaid access and has one of the nation’s lowest income-eligibility cutoffs. A single mother with two children can’t earn more than $3,781 annually to qualify for coverage herself, according to a 2017 Medicaid report by the Center for Public Policy Priorities, an Austin-based nonprofit research and advocacy organization.

Dr. Felicia Macik, who launched her direct care practice in 2014 in Waco, estimates that 10 to 15 percent of her patients are uninsured, including some who drop coverage because they can’t afford the premiums. “I’m frightened for them,” she said. “It could decimate a family if something happened and they didn’t have any coverage.”

But Macik pointed out that getting regular primary care, rather than avoiding the doctor entirely due to lack of insurance, might avert costlier complications like an asthma attack or a diabetic crisis.

Uninsured individuals who sign up for these practices are rolling the dice, said Dr. Mohan Nadkarni, an internist who co-founded the Charlottesville (Va.) Free Clinic, which treats lower-income individuals. “For routine regular care, it may work out,” he said. “But it’s gambling that you’re not going to get sicker and need further care.”

For instance, a patient can develop severe heartburn and require further tests and referrals to specialists to look for the underlying cause — potentially anything from an ulcer to esophageal cancer — that could quickly run up a hefty bill, Nadkarni said. Another patient with chest pain might need a similarly costly work-up to rule out heart problems, including a potentially life-threatening blockage, he said.

Graham said that her monthly fees cover anything that she can handle in the office. During Kenyon’s visit, she froze a small growth off one ear. Shortly afterward, she gave a steroid injection to an older woman with a painful, swollen wrist.

She has negotiated low fees with a local laboratory; the battery of blood tests and urinalysis she ordered for Kenyon cost him just under $40. “This is concierge medicine for normal people,” said the 61-year-old family physician.

Physician enthusiasts maintain that jettisoning the paperwork and other overhead costs associated with insurance enables them to take on fewer patients — roughly 600 to 800 for direct care practices compared with 2,000 to 2,500 typically, according to the family physicians academy — and thus spend more time with each one.

As A Safety Net, It’s A Stretch

Erika Miller first came to see Graham two years ago for severe headaches. The 30-year-old mother of three, who is working on her college degree and has a full-time job, doesn’t have insurance.

Graham diagnosed high blood pressure. Getting that under control helped alleviate her headaches, Miller said. She also has shed 50 pounds under Graham’s guidance.

But Graham can’t handle everything for her patients. Last year, Miller went to the emergency room at Scott & White Medical Center in nearby Temple with severe abdominal pain. It was her appendix, which had to be removed. The safety-net hospital started Miller on a payment plan based on her income, totaling roughly $500.

“If the question is: `Is [direct primary care] better than nothing?’ Then I would say, ‘Yes,’” Engelhard said. But along with leaving uninsured patients financially vulnerable to a medical curveball, she said, these smaller practices — by seeing fewer patients per doctor — risk aggravating the nation’s primary care shortage if they become more common.

Graham countered that she nearly left medicine, but these days — as she continues to build her practice — she’s reaching some patients who had previously fallen through the health system’s cracks. On that summer morning, Kenyon left Graham’s office with a prescription for a blood pressure medication and an appointment to return in several weeks to discuss his lab results.

Kenyon and his wife, Denise, later described how they had signed up last year for a family policy through the Affordable Care Act. But the monthly premium was $750 and the deductibles were $3,500 per person, Denise Kenyon said.

She called around and couldn’t find a family doctor who would take the coverage. After several months, they stopped paying the premiums, figuring that the money they saved would pay for a lot of medical care.

Both are now patients of Graham’s; their combined monthly bill totals $125, which they can budget for, Darrell Kenyon said. “I do have good months and bad months, as far as pay is concerned,” he said. “If I have a bad month, it’s still affordable.”

The Health and Human Services Office of Inspector General, in a report released Monday, found that nearly 73,000 people on Medicare had one of the seven devices replaced because of recalls, premature failures, medically necessary upgrades or infections.

This article first appeared October 02, 2017 on Kaiser Health News.

By Fred Schulte and Christina Jewett

Medicare paid at least $1.5 billion over a decade to replace seven types of defective heart devices, a government watchdog says. The devices apparently failed for thousands of senior patients.

The Health and Human Services Office of Inspector General, in a report released Monday, said officials need to do a better job tracking these costly product failures to protect patients from harm. More detailed reporting could lead to earlier recognition of serious problems with medical devices and faster recalls of all types of “poorly performing” ones, the IG’s office said.

The report marks the first effort by anyone in government to assess the losses to taxpayers and patients 65 and older from medical gear that proves faulty.

Officials said the $1.5 billion lost from the seven devices from 2005 through 2014 was a “conservative estimate.” Patients also paid $140 million in out-of-pocket costs for this care, the report noted.

The report found that nearly 73,000 people on Medicare had one of the seven devices replaced because of recalls, premature failures, medically necessary upgrades or infections. It didn’t outline specific injuries patients suffered as a result.

The inspector general did not identify the manufacturers of the seven devices, but officials said they included implanted cardio defibrillators and a pacemaker that either had been recalled because of flaws or had “prematurely failed.” Pacemakers and implantable defibrillators are small devices placed under the skin to help treat irregular heartbeats.

How best to identify these defects and cut Medicare spending associated with fixing them has been under consideration at various times since 2007, according to the report. But it remains a contentious issue.

The inspector general recommended that hospitals and doctors be required to submit detailed information identifying failed devices, such as serial and batch numbers, during the billing process.

“This could help reduce Medicare costs by identifying poorly performing devices more quickly which could also protect beneficiaries from unnecessary costs and improve their chances of receiving appropriate follow-up care more quickly,” the report states.

David Lamir, an official in the inspector general’s Boston office, said the $1.5 billion figure represented a “drop in the bucket” of the true costs to Medicare from medical products that malfunction. He said device failures not only waste money, but also can expose patients to a “high risk of illness,” including needless surgeries.

The report said medical device recalls nearly doubled from 2003 through 2012 and noted they have likely cost Medicare billions of dollars. In the past five to six years, more than 200 cardiac devices have been recalled, according to the OIG. In most cases, manufacturers withdraw their products voluntarily after reports surface of injuries or malfunctions. Device makers are required to report problems they learn of, often from doctors and hospitals, to a database run by the Food and Drug Administration.

Diana Zuckerman, president of the National Center for Health Research who has testified before Congress on device safety, said her organization supports making hospitals report malfunctioning devices when they seek Medicare payments to cover an implant surgery. She said the change would help officials pinpoint faulty devices before issuing a recall for tens of thousands of products buried in patients’ bodies.

“It would be much more obvious much more quickly which implanted devices were causing problems,” she said.

Zuckerman noted that the IG report didn’t touch on many high-profile device failures, like metal-on-metal hip implants or vaginal mesh.

Medical device companies and some doctors have opposed tighter reporting saying it would be costly and difficult to integrate with existing payment claim forms and might not yield useful information.

“It is abundantly clear that data collected in electronic health records (EHR) is a far superior and more cost-effective method for monitoring the performance of medical devices,” said Mark Leahey, who heads the Medical Device Manufacturers Association. The trade group represents nearly 300 device companies.

Leahey said that the electronic health record “captures the full clinical history of the patient, their changing health status and detailed information on their medical treatments,” including any surgically implanted devices.

A Centers for Medicare & Medicaid Services spokesman said the agency had not seen the report and would have no comment.

But in written remarks included in the report, CMS Administrator Seema Verma said the tighter reporting requirement is “under consideration” and that the agency will “carefully evaluate the potential that this policy would impose a burden on physicians unnecessarily.”

CMS appears to have switched positions on whether to compel hospitals to report more details about these incidents during the Obama administration.

In a February 2015 letter to Sen. Elizabeth Warren, D-Mass., then-CMS administrator Marilyn Tavenner argued that more reporting would “entail significant technological challenges, costs and risks to normal claims processing for Medicare.”

Yet CMS and FDA supported doing so in a July 13, 2016, letter to the committee that sets standards for electronic claim forms used for medical billing.

Andy Slavitt, who succeeded Tavenner in the top CMS post and signed the July 2016 letter, called the inspector general’s report “important work” that “appears to make yet another strong case” for more complete reporting of device failures.

These policies “are important for our safety and they are clearly prudent things to do. While it requires effort from many in health care to get there, this effort is in our public interest," Slavitt wrote in an email to Kaiser Health News.

Rita Redberg, a UC-San Francisco professor and cardiologist who advises Medicare, said unique identifiers on devices could be scanned into a patient’s medical record. Earlier recognition of trouble-prone devices also might help Medicare recoup some money wasted as a result.

“Medicare is spending a lot of money on something that doesn’t seem to be their problem,” Redberg said, adding, “Most places, if something is defective, the manufacturer is responsible for replacing it, not the store where you bought it.”

"The anxiety level is increasing on almost a daily basis," says Dan Hawkins, senior vice president of the National Association of Community Health Centers.

This article first appeared September 27, 2017 on Kaiser Health News.

By Rachel Bluth

One community health center in New York has frozen hiring. Another in Missouri can’t get a bank loan to expand.

The nation’s 1,400 community health centers are carefully watching expenses in case the financial rescue they hope Congress delivers this week doesn’t arrive. With four days left in the government’s fiscal year, Congress has not voted on reauthorizing billions of dollars now going to community health centers and other health programs for the 2018 budget year that starts Sunday.

“The anxiety level is increasing on almost a daily basis,” said Dan Hawkins, senior vice president of the National Association of Community Health Centers (NACHC) in Washington, D.C. “There is broad support and agreement in Congress that it should get done, but we are working against a ticking clock and a crowded legislative calendar.”

For the past two weeks, the GOP’s scramble to repeal the Affordable Care Act before the month ends pushed other health care matters off the congressional agenda. That effort ended Tuesday when Senate Republicans said they would not seek a vote this week because they lacked enough support to pass the bill.

It’s not clear if lawmakers’ lighter agenda will now leave room for funding health centers or deciding other issues, such as renewing the Children’s Health Insurance Program (CHIP), which also expires Saturday. At a hearing Monday, Senate Finance Committee Chairman Orrin Hatch (R-Utah) urged his colleagues to work with the Senate’s health committee to settle the matter. NACHC officials privately express optimism that a deal might come later in October if not by Sunday.

Community health centers operate in more than 9,500 locations, serving 27 million people, according to the NACHC. They are the main source of health care for many low-income Americans — and the only source of primary care in many underserved areas.

Health centers provide preventive care, counseling, dentistry and primary care to everyone, whether or not they can pay. A sliding fee scale based on income and family size is available to patients without insurance.

In 2015, nearly 1 in 6 Medicaid beneficiaries received health center services, the Kaiser Family Foundation reported this year. (Kaiser Health News is an editorially independent program of the foundation.)

“The end result is these are people who will be locked out of health care” without new funding, Hawkins said.

Community health centers gained billions of dollars in federal revenue under the ACA, which created a special trust fund to support them from 2011 through 2015. The Community Health Center Fund was extended in 2015 for two years with an additional $3.6 billion annually.

That money represents 70 percent of all federal grants to health centers and about a fifth of their annual revenue. Medicaid reimbursements account for the largest share, about 40 percent.

One beneficiary is Pamela Richardson, a 60-year-old patient of Valley Community Healthcare in North Hollywood, Calif., who suffers from an iron absorption disorder called hereditary hemochromatosis. She was unable to get health insurance before Obamacare prohibited insurers from excluding people with preexisting medical conditions. The clinic helped her sign up for coverage through the Medi-Cal expansion.

Once Richardson was covered, she received long-delayed primary care, which revealed she had “scary high” blood pressure and a lump in one breast (which proved benign). “When you don’t have insurance you don’t get breast exams. You don’t have Pap smears,” she told a KHN reporter earlier this year. “I wish people had a little more patience with Obamacare. Once you get what’s wrong with you under control, the cost would come down.”

California has by far the most federally funded health centers and they serve 6.2 million Californians, according to CaliforniaHealth+ Advocates, which represents state clinics. They have received over $1.6 billion from 2011 through 2016 from the Community Health Center Fund, more than any other state, the Congressional Research Service reported in January.

If health centers receive no new funds for 2018, the ensuing financial crunch would cost 51,000 jobs, force the centers to close 2,800 locations and cause 9 million people to lose health care services, according to a budget document that the Health and Human Services Department gave Congress in July.

Uncertainty about what Congress will do now is already causing problems. Hawkins said his members call him and his staff every day, fretting about employment contracts, lease agreements and equipment rentals that run past Oct. 1.

Neighborhood Health in Nashville, Tenn., has federal grant money that will carry it through Jan. 31, but CEO Mary Bufwack said some of her 180 staff members live paycheck to paycheck and are getting nervous about Neighborhood’s stability.

Bufwack is worried the health center won’t receive money it needs to replace a clinic, a project now being planned.

She fears that a new doctor she recruited to join Neighborhood next June will take another job before she can get his signature on an employment contract. And she doesn’t want to do that until she’s sure about her budget.

Mostly, she worries that whatever Congress gives her will be only for one year.

“We’re already worried about next Sept. 30,” Bufwack said.