If a recent MedPAC proposal is adopted, some providers predict free-standing emergency facilities could become scarcer.

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

By Michelle Andrews

The woman arrived at the emergency department gasping for air, her severe emphysema causing such shortness of breath that the physician who examined her put her on a ventilator immediately to help her breathe.

The patient lived across the street from the emergency department in suburban Denver, said Dr. David Friedenson, who cared for her that day a few years ago. The facility wasn’t physically located at a hospital but was affiliated with North Suburban Medical Center several miles away.

Free-standing emergency departments have been cropping up in recent years and now number more than 500, according to the Medicare Payment Advisory Commission (MedPAC), which reports to Congress. Often touted as more convenient, less crowded alternatives to hospitals, they often attract suburban walk-in patients with good insurance whose medical problems are less acute than those who visit an emergency room located in a hospital.

If a recent MedPAC proposal is adopted, however, some providers predict that these free-standing facilities could become scarcer. Propelling the effort are concerns that MedPAC’s payment for services at these facilities is higher than it should be since the patients who visit them are sometimes not as severely injured or ill as those at on-campus facilities.

The proposal would reduce Medicare payment rates by 30 percent for some services at hospital-affiliated free-standing emergency departments that are located within 6 miles of an on-campus hospital emergency department.

“There has been a growth in free-standing emergency departments in urban areas that does not seem to be addressing any particular access need for emergency care,” said James Mathews, executive director of MedPAC. The convenience of a neighborhood emergency department may even induce demand, he said, calling it an “if you build it, they will come” effect.

Emergency care is more expensive than a visit to a primary care doctor or urgent care center, in part because emergency departments have to be on standby 24/7, with expensive equipment and personnel ready to handle serious car accidents, gunshot wounds and other trauma cases. Even though free-standing emergency departments have lower standby costs than hospital-based facilities, they typically receive the same Medicare rate for emergency services. The Medicare “facility fee” payments, which include some ancillary lab and imaging services but not reimbursement to physicians, are designed to help defray hospitals’ overhead costs.

The proposal would affect only payments for Medicare beneficiaries. But private insurers often consider Medicare payment policies when setting their rules.

According to a MedPAC analysis of five markets — Charlotte, N.C.; Cincinnati; Dallas; Denver; and Jacksonville, Fla. — 75 percent of the free-standing facilities were located within 6 miles of a hospital with an emergency department. The average drive time to the nearest hospital was 10 minutes.

Overall, the number of outpatient emergency department visits by Medicare beneficiaries increased 13.6 percent per capita from 2010 to 2015, compared with a 3.5 percent growth in physician visits, according to MedPAC. (The reported data doesn’t distinguish between conventional and free-standing emergency facility visits.)

“I think [the MedPAC proposal] is a move in the right direction,” said Dr. Renee Hsia, a professor of emergency medicine and health policy at the University of California-San Francisco who has written about free-standing emergency departments. “We have to understand there are limited resources, and the fixed costs for stand-alone EDs are lower.”

Hospital representatives say the proposal could cause some free-standing emergency departments to close their doors.

“We are deeply concerned that MedPAC’s recommendation has the potential to reduce patient access to care, particularly in vulnerable communities, following a year in which hospital EDs responded to record-setting natural disasters and flu infections,” Joanna Hiatt Kim, vice president for payment policy at the American Hospital Association, said in a statement.

Independent free-standing emergency departments that are not affiliated with a hospital would not be affected by the MedPAC proposal. These facilities, which make up about a third of all free-standing emergency facilities, aren’t clinically integrated with a hospital and can’t participate in the Medicare program.

The MedPAC proposal will be included in the group’s report to Congress in June.

Even though stand-alone emergency facilities might not routinely treat patients with serious trauma, they can provide lifesaving care, proponents say.

Friedenson said that for his emphysema patient, avoiding the 15- to 20-minute drive to the main hospital made a critical difference.

“By stopping at our emergency department, I truly think her life was saved,” he said.

Unlike delirium, postoperative cognitive dysfunction can involve subtle, difficult-to-recognize symptoms that develop days to weeks after surgery.

This article first appeared April 12, 2018 on Kaiser Health News.

By Judith Graham

Two years ago, Dr. Daniel Cole’s 85-year-old father had heart bypass surgery. He hasn’t been quite the same since.

“He forgets things and will ask you the same thing several times,” said Cole, a professor of clinical anesthesiology at UCLA and a past president of the American Society of Anesthesiologists.

“He never got back to his cognitive baseline,” Cole continued, noting that his father was sharp as a tack before the operation. “He’s more like 80 percent.”

The old man likely has postoperative cognitive dysfunction (POCD) — a little-known condition that affects a substantial number of older adults after surgery, Cole said.

Some patients with POCD experience memory problems; others have difficulty multitasking, learning new things, following multistep procedures or setting priorities.

“There is no single presentation for POCD. Different patients are affected in different ways,” said Dr. Miles Berger, a POCD specialist and assistant professor of anesthesiology at Duke University School of Medicine.

Unlike delirium — an acute, sudden-onset disorder that affects consciousness and attention — POCD can involve subtle, difficult-to-recognize symptoms that develop days to weeks after surgery.

Most of the time, POCD is transient and patients get better in several months. But sometimes — how often hasn’t been determined — this condition lasts up to a year or longer.

Dr. Roderic Eckenhoff, vice chair for research and a professor of anesthesiology at the Perelman School of Medicine at the University of Pennsylvania, told of an email he received recently from a 69-year-old man who had read about his research.

“This guy — a very articulate man — said he was the intellectual equal of his wife before a surgery 10 years ago, a significant operation involving general anesthesia. Since then, he’s had difficulty with cognitively demanding tasks at work, such as detailed question-and-answer sessions with his colleagues,” Eckenhoff said. “He noticed these changes immediately after the surgery and claims he did not get better.”

There are many unanswered questions about POCD. How should it best be measured? Is it truly a stand-alone condition or part of a continuum of brain disorders after surgery? Can it be prevented or treated? Can it be distinguished in the long term from the deterioration in cognitive function that can accompany illness and advanced aging?

Some clarity should come in June, when a major paper outlining standard definitions for POCD is set to publish simultaneously in six scientific journals and scientists will discuss the latest developments at a two-day POCD summit, according to Eckenhoff.

Here’s what scientists currently know about POCD:

Background. POCD first began to be studied systematically about 20 years ago. But reports of patients who appeared cognitively compromised after surgery date back about 100 years, Eckenhoff said.

An influential 1955 report in The Lancet noted common complaints by family or friends after someone dear to them had surgery: “He’s become so forgetful. … She’s lost all interest in the family. … He can’t concentrate on anything. … He’s just not the same person since.”

How to recognize the condition. There is no short, simple test for POCD. Typically, a series of neuropsychological tests are administered before and after surgery — a time-consuming process. Often, tests are given one week and again three months after surgery. But the tests used and time frames differ in various studies. Studies also define POCD differently, using varying criteria to assess the kind and extent of cognitive impairment that patients experience.

How common is it? The first international study of older adults with POCD (those age 60 and older) in 1999 suggested that 25.8 percent of patients had this condition one week after a major non-cardiac surgery, such as a hip replacement, while 9.9 percent had it three months after surgery.

Two years later, a study by researchers at Duke University Medical Center, published in the New England Journal of Medicine, found that 53 percent of adults who had heart bypass surgery showed significant evidence of cognitive decline when they were discharged from the hospital; 36 percent were affected at six weeks; 24 percent, at six months; and 42 percent, five years after their operations.

Another Duke study of older adults who had knee and hip replacements found that 59 percent had cognitive dysfunction immediately after surgery; 34 percent, at three months; and 42 percent, at two years.

Other studies have produced different estimates. A current research project examining adults 55 and older who have major non-cardiac surgeries is finding that “upwards of 30 percent of patients are testing significantly worse than their baseline 3 months later,” according to its lead researcher, Dr. Stacie Deiner, vice chair for research and associate professor of anesthesiology, geriatrics and palliative care, and neurosurgery at the Icahn School of Medicine at Mount Sinai in New York City.

Vulnerabilities. The risk of experiencing POCD after surgery is enhanced in those who are older, have low levels of education or have cognitive concerns that predate surgery. Adults age 60 and older are twice as likely to develop POCD as are younger adults — a development that increases the risk of dying or having a poor quality of life after surgery.

“People who are older, with some unrecognized brain pathology, or people who have some trajectory of cognitive decline at baseline, those are the patients who you’re going to see some change in one, two or three years out,” said Charles Hugh Brown IV, assistant professor of anesthesiology and critical care medicine at Johns Hopkins Medicine.

Researchers have examined whether the type of anesthetic used during surgery or the depth of anesthesia — the degree to which a patient is put under — affects the risk of developing POCD. So far, results have been inconclusive. Also under investigation are techniques to optimize blood flow to the brain during surgery.

Mechanisms at work. What’s responsible for POCD? The drugs administered during anesthesia or the surgery itself? Currently, the evidence implicates the stress of surgery rather than the anesthesia.

“Most surgery causes peripheral inflammation,” Eckenhoff explained. “In young people, the brain remains largely isolated from that inflammation, but with older people, our blood-brain barrier becomes kind of leaky. That contributes to neuroinflammation, which activates a whole cascade of events in the brain that can accelerate the ongoing aging process.”

At Mount Sinai, Deiner has been administering two-hour-long general anesthesia to healthy seniors and evaluating its impact, in the absence of surgery. Older adults are getting cognitive tests and brain scans before and after. While findings haven’t been published, early results show “very good and rapid cognitive recovery in older adults after anesthesia,” Deiner said. The implication is that “the surgery or the medical conditions surrounding surgery” are responsible for subsequent cognitive dysfunction, she noted.

Advice. Currently, most patients are not told of the post-surgical risk of POCD during the process of informed consent. That should change, several experts advise.

“Beyond question, patients should be informed that the ‘safety step’ of not undergoing surgery is theirs to choose,” wrote Dr. Kirk Hogan, professor of anesthesiology at the University of Wisconsin-Madison School of Medicine and Public Health, in an article published earlier this year. “Each patient must determine if the proposed benefits of a procedure outweigh the foreseeable and material risks of cognitive decline after surgery.”

“Surgery is a good thing — it improves quality of life — and most older patients do really well,” said Brown of Hopkins. “Our trick is to understand who we really need to identify as high-risk and what we can do about modifiable factors.

“If you’re older and suspect you have cognitive issues, it’s important to let your family physician as well as your surgeon and anesthesiologist know that you’re concerned about this and you don’t want to get worse. That should open up a conversation about the goals of surgery, alternatives to surgery and what can be done to optimize your condition before surgery, if that’s what you want to pursue.”

“We want people to know this does happen but not be too concerned because, typically, it does go away,” said Eckenhoff. “That said, don’t try to make cognitively demanding decisions in the first 30 days after an operation. And make sure your caregivers are prepared to help with anything from paying bills and balancing the checkbook to ensuring that you’re caring for yourself adequately and communicating well with your doctor.”

KHN launches 'Pre$cription for Power,' a groundbreaking database to expose Big Pharma's ties to patient groups.

This article first appeared April 06, 2018 on Kaiser Health News.

By Emily Kopp and Sydney Lupkin and Elizabeth Lucas

KHN staffers Vickie Connor, Julie Appleby, Melissa Bailey, Rachel Bluth, Terry Byrne, Doug Carroll and Brianna Labuskes also contributed.

Pharmaceutical companies gave at least $116 million to patient advocacy groups in a single year, reveals a new database logging 12,000 donations from large publicly traded drugmakers to such organizations.

Even as these patient groups grow in number and political influence, their funding and their relationships to drugmakers are little understood. Unlike payments to doctors and lobbying expenses, companies do not have to report payments to the groups.

The database, called “Pre$cription for Power,” shows that donations to patient advocacy groups tallied for 2015 — the most recent full year in which documents required by the Internal Revenue Service were available — dwarfed the total amount the companies spent on federal lobbying. The 14 companies that contributed $116 million to patient advocacy groups reported only about $63 million in lobbying activities that same year.

Though their primary missions are to focus attention on the needs of patients with a particular disease — such as arthritis, heart disease or various cancers — some groups effectively supplement the work lobbyists perform, providing patients to testify on Capitol Hill and organizing letter-writing and social media campaigns that are beneficial to pharmaceutical companies.

Six drugmakers, the data show, contributed a million dollars or more to individual groups that represent patients who rely on their drugs. The database identifies over 1,200 patient groups. Of those, 594 accepted money from the drugmakers in the database.

The financial ties are troubling if they cause even one patient group to act in a way that’s “not fully representing the interest of its constituents,” said Matthew McCoy, a medical ethics professor at the University of Pennsylvania who co-authored a 2017 study about patient advocacy groups’ influence and transparency.

Notably, such groups have been silent or slow to complain about high or escalating prices, a prime concern of patients.

“When so many patient organizations are being influenced in this way, it can shift our whole approach to health policy, taking away from the interests of patients and towards the interests of industry,” McCoy said. “That’s not just a problem for the patients and caregivers that particular patient organizations serve; that’s a problem for everyone.”

Bristol-Myers Squibb provides a stark example of how patient groups are valued. In 2015, it spent more than $20.5 million on patient groups, compared with $2.9 million on federal lobbying and less than $1 million on major trade associations, according to public records and company disclosures. The company said its decisions regarding lobbying and contributions to patient groups are “unrelated.”

“Bristol-Myers Squibb is focused on supporting a health care environment that rewards innovation and ensures access to medicines for patients,” said spokeswoman Laura Hortas. “The company supports patient organizations with this shared objective.”

"There aren’t a lot of large pockets of funding outside of the pharmaceutical money. We take it where we can find it."

The first-of-its-kind database, compiled by Kaiser Health News, tallies the money from Big Pharma to patient groups. KHN examined the 20 pharmaceutical firms included in the S&P 500, 14 of which were transparent — in varying degrees — about giving money to patient groups. Pre$cription for Power is based on information contained in charitable giving reports from company websites and federal 990 regulatory filings.

It spotlights donations pharma companies made to patient groups large and small. The recipients include well-known disease groups, like the American Diabetes Association, with revenues of hundreds of millions of dollars; high-profile foundations like Susan G. Komen, a patient group focused on breast cancer; and smaller, lesser-known groups, like the Caring Ambassadors Program, which focuses on lung cancer and hepatitis C.

The data show that 15 patient groups — with annual revenues as large as $3.6 million — relied on the pharmaceutical companies for at least 20 percent of their revenue, and some relied on them for more than half of their revenue. The database explores only a slice of the pharmaceutical industry’s giving overall and will be expanded with more companies and groups over time.

“It’s clear that more transparency in this space is vitally important,” said Sen. Claire McCaskill (D-Mo.), who has been investigating the links between patient advocates and opioid manufacturers and is considering legislation to track funding. “This database is one step forward in that effort, but we also need Congress to act.”

What Drives The Money Flow

The financial ties between drugmakers and the organizations that represent those who use or prescribe their blockbuster medicines have been of growing concern as drug prices escalate. The Senate investigated conflicts of interest in the run-up to the passage of the 2010 Physician Payments Sunshine Act — a law that required payments to physicians from makers of drugs and devices to be registered on a public website — but patient groups were not addressed in the bill.

Some of the patient groups with ties to trade groups echo industry talking points in media campaigns and letters to federal agencies, and do little else. And patients, supported by pharma, are dispatched to state capitals and Washington to support research funding. Some groups send patients updates on the newest drugs and industry products.

“It’s through groups like this that patients often learn about illnesses and treatments,” said Rick Claypool, a research director for Public Citizen, a consumer advocacy group that says it does not accept pharmaceutical funding.

"It’s clear that more transparency in this space is vitally important."

For the patient group Caring Ambassadors Program, industry funds are needed to make up for a lack of public funding, said the group’s executive director, Lorren Sandt. According to IRS filings and published company reports, in 2015 the group received $413,000, the bulk of which came from one company, AbbVie, which makes a hepatitis C treatment and has been testing a new lung cancer drug, Rova-T, not yet approved. She said the money had no influence on the Caring Ambassadors Program’s priorities.

“There aren’t a lot of large pockets of funding outside of the pharmaceutical money,” Sandt said. “We take it where we can find it.”

Other patient groups such as The National Women’s Health Network, based in Washington, D.C., make sacrifices to avoid pharmaceutical funding. That includes operating with a small staff in a “modest” office building with few windows and outdated computers, according to executive director Cindy Pearson. “You can see the effect of our approach to funding as soon as you walk [in] the door.”

Pearson said it’s hard for patient groups not to be influenced by the funder, even if they proclaim independence. Patient groups “build relationships with their funders and feel in sync and have sympathy” for them. “It’s human nature. It’s not evil or weak, but it’s wrong.”

Charity As Marketing

Patients newly diagnosed with a disease often turn to patient advocacy groups for advice, but the money flow to such groups may distort patients’ knowledge and public debate over treatment options, said Dr. Adriane Fugh-Berman, the director of PharmedOut, a Georgetown University Medical Center program that is critical of some pharmaceutical marketing practices.

“[The money flow limits] their advocacy agenda to competing branded products when the best therapy might be generics, over-the-counter drugs or diet and exercise,” she said.

AbbVie — whose specialty drug Humira made up 65 percent of the company’s net revenue in 2017 and is used to treat patients with autoimmune diseases, including Crohn’s disease and certain kinds of arthritis — gave $2.7 million to the Crohn’s & Colitis Foundation and $1.6 million to the Arthritis Foundation, according to the company’s public disclosures included in the database. The list price for a month’s supply of Humira, a biologic drug, is $4,872, according to Express Scripts, a pharmacy benefits manager.

Even though Humira will face competition from near-copycat drugs called biosimilars, it is expected to remain the highest-grossing drug in the United States through 2022, according to drug industry analysts at EvaluatePharma.

The Arthritis and Crohn’s foundations have been largely silent on the cost of Humira and vocal on safety concerns about biosimilars. The Arthritis Foundation has championed state laws that could add extra steps for consumers to receive biosimilars at the pharmacy counter, potentially keeping more patients on the brand-name drug. Experts say those laws could help protect Humira’s market share from generic competitors.

A coalition of patient groups, Patients for Biologics Safety & Access, opposes the automatic substitution of a cheaper biosimilar when doctors prescribe a biologic. In 2015, members of that coalition, including the Crohn’s & Colitis Foundation, the Arthritis Foundation and the Lupus Foundation of America, accepted about $9.1 million from pharmaceutical companies in the database, according to public disclosures. They include AbbVie and Johnson & Johnson, makers of blockbuster biologics.

The Arthritis Foundation did not deny receiving the money but said the foundation represents patients, not sponsors. It is “optimistic” about biosimilars’ ability to help patients and save them money, said Anna Hyde, vice president of advocacy and access. “The Foundation supports the Food and Drug Administration’s scientific standards in evaluating the safety and efficacy of biosimilars, and we support policies that encourage innovation and foster a competitive marketplace.”

The Crohn’s & Colitis Foundation maintains “more than an arm’s-length distance” from its donors in the pharmaceutical industry, who have no say over the foundation’s strategic objectives, said president and CEO Michael Osso.

He added that the foundation’s position on biosimilars is “evolving.”

Lupus Foundation CEO Sandra Raymond said she could not explain how her group, also based in Washington, was involved in the coalition. She confirmed the Lupus Foundation received $444,000 from Pfizer in 2015 but said the money was not linked to any relationship with Patients for Biologics Safety & Access.

“I never went to a meeting,” Raymond said. “A former employee signed us up for a whole host of coalitions. I think we put our name on something or someone did.”

She said the Lupus Foundation was no longer a member of the coalition. Days after Kaiser Health News reached out to the coalition, its website was updated, excluding the Lupus Foundation.

For its part, AbbVie — which overall donated $24.7 million to patient groups in 2015, according to the new database — stipulates that its grants to nonprofits are “non-promotional” and provide no direct benefit to its business, according to a company statement. The company gives to patient groups because they serve as an “important, unbiased and independent resource for patients and caregivers.”

Insulin And Influence

The American Diabetes Association said in an email to KHN that it received $18.3 million in pharmaceutical funding in 2017, accounting for 12.3 percent of its revenue; that was down from $26.7 million in 2015. The money flowed in as insulin makers continued to hike prices in those years — up to four times per product — leading to hardships for patients.

The only “Big Three” insulin maker in the database, Eli Lilly, gave $2.9 million to the American Diabetes Association in 2015, according to disclosures from the company and its foundation. Sanofi and Novo Nordisk are the other two major insulin makers, but neither was in the S&P 500 and therefore not included in the database. Over the past 20 years, Eli Lilly has repeatedly raised prices on its bestselling insulins, Humalog and Humulin, even though the medicines have been around for decades. The drugmaker faced protests — by people demanding to know the cost of manufacturing a vial of insulin — at its Indianapolis headquarters last fall.

The ADA launched a campaign decrying “skyrocketing” insulin in late 2016 but did not call out any drugmaker in its literature. When legislators in Nevada passed a bill last year requiring insulin makers to disclose their profits to the public, the ADA did not take a public stance.

The American Diabetes Association said it doesn’t confront individual companies because it is seeking action from “all entities in the supply chain” — manufacturers, wholesalers, pharmacy benefit managers and insurers.

“As a public health organization, the ADA’s commitment and focus is on the needs of the more than 30 million people with diabetes,” said Dr. William Cefalu, its chief scientific and medical officer. “The ADA requires support from a diverse set of partners to achieve this objective.”

Eli Lilly said it contributes money to the American Diabetes Association because the two share a “common goal” of helping diabetes patients.

“We provide funding for a wide variety of educational programs and opportunities at ADA, and they design and implement those programs in ways that are aligned with their goals,” Eli Lilly said in a statement. “We’re proud to support the ADA on important work that helps millions of people living with diabetes.”

Most patient groups say that funders have little or no influence in shaping their programs and policies, but their agreements are private.

They Weren’t Always Backed By Pharma

Into the ’80s and early ’90s, patient lobbying was generally limited and self-funded with only one or two affluent patients from an organization traveling to Washington on a given day, said Diana Zuckerman, president of the nonprofit National Center for Health Research.

But the power of patient-lobbyists became apparent after a successful campaign by AIDS patients led to government action and a national push to find drugs to treat the then-terminal disease. Zuckerman said she will never forget when two women visited her office and asked how breast cancer patients could be as effective as the AIDS patients.

“At the time, there were no breast cancer patients advocating for money or anything else. It’s hard to believe,” she said. “I still remember that conversation, because it was really a turning point.”

Soon after, breast cancer patients started visiting the Hill more frequently. Patients with other diseases followed. Over time, patients’ voices became a potent force, often with industry support.

"Sick consumers make for good press."

Even some wealthy, high-profile organizations take industry money: For example, $459,000 of Susan G. Komen’s $118 million in 2015 revenue came from drugmakers in the database, according to public disclosures. Asked about the pharma money, the foundation said it has institutional processes in place to ensure that “no corporate partner — pharma or otherwise — decides our mission priorities,” including a scientific advisory board — free of sponsor influence — that reviews its research program.

Today, patient advocacy groups flush with more industry dollars fly patients in for testimony and training about how to lobby for their drugs.

Some years ago, as the groups increased in number, Zuckerman said, she started getting email invitations from advocacy groups to attend so-called lobbying days explicitly sponsored by the pharmaceutical industry. The hosts often promised training and usually some kind of keynote speaker at a luncheon in Washington — plus a potential scholarship to cover travel. Now, lobbying days involving dozens of patients from a single group are part of the landscape.

Dan Boston, president of lobbying firm Health Policy Source, said, “It would be naive to think these people on a Tuesday afternoon just happen to turn up in XYZ places,” adding that the money isn’t necessarily a bad thing. Money tends to flow toward citizen groups that already have the same priorities as their funders, he said.

Marching Into The Future

Patient groups have been successful at campaigning for drug approvals, at times sparking controversy.

When scientists within the FDA advised against the approval of Exondys 51, a drug to treat Duchenne muscular dystrophy, parents of children with the rare genetic disorder and patients rallied to lobby for it in Washington. They were seen as pivotal to the FDA’s 2016 decision to grant approval for the drug, made by Sarepta Therapeutics. The decision was controversial in part because the FDA noted that clinical benefits of the drug — aimed at a subset of people with Duchenne muscular dystrophy — were not yet established.

Sarepta Therapeutics, which is not featured in the database, has taken measures to support its patient base. In March, it announced an annual scholarship program — 10 grants of up to $10,000 each for students with Duchenne muscular dystrophy to attend university or trade schools. Sarepta Therapeutics is also among the funders of Parent Project Muscular Dystrophy, a patient advocacy group at the forefront of the push for Exondys 51’s approval.

The Pre$cription for Power database will grow to include new disclosures. Not all drugmakers are willing to disclose their company giving. Eleven of the 20 companies examined — Allergan, Baxter International, Biogen, Celgene, Endo International, Gilead Sciences, Mallinckrodt, Mylan, Perrigo Co., Regeneron Pharmaceuticals and Vertex Pharmaceuticals — declined to disclose their company giving or did not respond to repeated calls.

Paul Thacker, a former investigator for Sen. Chuck Grassley (R-Iowa) who helped draft the Physician Payments Sunshine Act in 2010, said there is reason to question the flow of money to patient advocacy groups. The pharmaceutical industry has fostered relationships in every link of the drug supply chain, including payments to researchers, doctors and professional societies.

“There’s so much money out there, and they’ve created all of these allies, so nobody is clamoring for change,” Thacker said.

Since the Physician Payments Sunshine Act began requiring the industry to report its payments to physicians, the industry is more reluctant to co-opt them, so “pharma has to find other megaphones,” PharmedOut’s Fugh-Berman said.

And in times of public outrage over high drug prices and soaring insurance costs, patients are particularly sympathetic messengers, she said.

“Sick consumers make for good press,” Fugh-Berman said. “They make for good testimony before Congress. They can be very powerful spokespeople for pharmaceutical companies.”

Many plans already offer some health benefits not covered by traditional Medicare. But the new rules will expand that significantly.

This article first appeared April 03, 2018 on Kaiser Health News.

By Susan Jaffe

Air conditioners for people with asthma, healthy groceries, rides to medical appointments and home-delivered meals may be among the new benefits added to Medicare Advantage coverage when new federal rules take effect next year.

On Monday, the Centers for Medicare & Medicaid Services (CMS) expanded how it defines the "primarily health-related" benefits that insurers are allowed to include in their Medicare Advantage policies. And insurers would include these extras on top of providing the benefits traditional Medicare offers.

"Medicare Advantage beneficiaries will have more supplemental benefits making it easier for them to lead healthier, more independent lives," said CMS Administrator Seema Verma.

Of the 61 million people enrolled in Medicare last year, 20 million have opted for Medicare Advantage, a privately run alternative to the traditional government program. Advantage plans limit members to a network of providers. Similar restrictions may apply to the new benefits.

Many Medicare Advantage plans already offer some health benefits not covered by traditional Medicare, such as eyeglasses, hearing aids, dental care and gym memberships. But the new rules, which the industry sought, will expand that significantly to items and services that may not be directly considered medical treatment.

CMS said the insurers will be permitted to provide care and devices that prevent or treat illness or injuries, compensate for physical impairments, address the psychological effects of illness or injuries, or reduce emergency medical care.

Although insurers are still in the early stages of designing their 2019 policies, some companies have ideas about what they might include. In addition to transportation to doctors’ offices or better food options, some health insurance experts said additional benefits could include simple modifications in beneficiaries’ homes, such as installing grab bars in the bathroom, or aides to help with daily activities, including dressing, eating and other personal care needs.

"This will allow us to build off the existing benefits that we already have in place that are focused more on prevention of avoidable injuries or exacerbation of existing health conditions," said Alicia Kelley, director of Medicare sales for Capital District Physicians' Health Plan, a nonprofit serving 43,000 members in 24 upstate New York counties.

Even though a physician's order or prescription is not necessary, the new benefits must be "medically appropriate" and recommended by a licensed health care provider, according to the new rules.

Many beneficiaries have been attracted to Medicare Advantage because of its extra benefits and the limit on out-of-pocket expenses. However, CMS also cautioned that new supplemental benefits should not be items provided as an inducement to enroll.

The new rules "set the stage to continue to innovate and provide choice," said Cathryn Donaldson, of America's Health Insurance Plans, a trade group.

"CMS is catching up with the rest of the world in terms of its understanding of how we keep people healthy and well and living longer and independently, and those are all positive steps," said Ceci Connolly, chief executive officer of the Alliance of Community Health Plans, which represents nonprofit health insurance plans. Some offer non-emergency medical transportation, low-cost hearing aids, a mobile dental clinic and a "grocery on wheels," to make shopping more convenient, she said.

UnitedHealthcare, the largest health insurer in the U.S., also welcomes the opportunity to expand benefits, said Matt Burns, a company spokesman. “Medicare benefits should not be one-size-fits-all, and continued rate stability and greater benefit design flexibility enable health plans to provide a more personalized health care experience," he said.

But patient advocates including David Lipschutz. senior policy attorney at the Center for Medicare Advocacy, are concerned about those who may be left behind. "It's great for the people in Medicare Advantage plans, but what about the majority of the people who are in traditional Medicare?” he asked. "As we tip the scales more in favor of Medicare Advantage, it's to the detriment of people in traditional Medicare."

The details of the 2019 Medicare Advantage benefit packages must first be approved by CMS and will be released in the fall, when the annual open enrollment begins. It's very likely that all new benefits will not be available to all beneficiaries since there is "tremendous variation across the country" in what plans offer, said Gretchen Jacobson, associate director of the Kaiser Family Foundation’s Program on Medicare Policy. (Kaiser Health News is an editorially independent program of the foundation.)

Addressing a patient's health and social needs outside the doctor's exam room isn't a new concept. The Institute on Aging, for example, is a California nonprofit that offers health, social, and psychological services for seniors and adults with disabilities. It has helped people in San Francisco and Southern California move from nursing homes to their own homes and provides a variety of services to make their new lives easier, from kitchen supplies to wheelchair ramps.

"By taking a more integrated approach to address people's social and health needs, we have seen up to a 30 percent savings in health care costs compared to the costs of the same individuals before they joined our program," said Dustin Harper, the institute's vice president for strategic partnerships. The agency serves 20,000 Californians a year, including former nursing home residents, who qualify for Medicare or Medicaid, the federal-state health insurance program for low-income people, or both.

In addition to next year's changes in supplemental benefits, CMS also noted that a new federal law allows Medicare Advantage plans to offer benefits that are not primarily health-related for Medicare Advantage members with chronic illnesses. The law and the agency's changes are complementary, CMS officials said. They promised additional guidance in the coming months to help plans differentiate between the two.