Tagged Medicare

Trump Administration Tells States To Scale Back Their Certificate-Of-Need Laws And Scope Of Practice Rules

And the White House called on the Justice Department and the Federal Trade Commission to “monitor the competitive landscape” of providers to “prevent anti-competitive behavior.” In other hospital news: CMS star ratings, community benefit reporting, ER violations, and more.

Feds Order More Weekend Inspections Of Nursing Homes To Catch Understaffing

The federal government announced plans Friday to crack down on nursing homes with abnormally low weekend staffing by requiring more surprise inspections be done on Saturdays and Sundays.

The federal Centers for Medicare & Medicaid Services said it will identify nursing homes for which payroll records indicate low weekend staffing or that they operate without a registered nurse. Medicare will instruct state inspectors to focus on those potential violations during visits.

“Since nurse staffing is directly related to the quality of care that residents experience, CMS is very concerned about the risk to resident health and safety that these situations may present,” the agency said in a notification to state inspection offices.

The directive comes after a Kaiser Health News analysis found there are 11 percent fewer nurses providing direct care on weekends on average, and 8 percent fewer aides.

Residents and their families frequently complain the residents have trouble getting basic help — such as assistance going to the bathroom — on weekends. One nursing home resident in upstate New York compared his facility to a weekend “ghost town” because of the paucity of workers.

Richard Mollot, executive director of the Long Term Care Community Coalition, an advocacy group in Manhattan, welcomed the new edict but said it was only necessary because state inspectors have not been properly enforcing the rules already on the books.

“The basic problem is the states don’t take this seriously,” Mollot said. “How many studies do we have to have, year after year, decade after decade, saying it all comes down to staffing, and there are very few citations for inadequate staffing and virtually all of them are identified as not causing any resident harm?”

CMS said it will identify potential violators by analyzing payroll records that nursing homes are now required to submit. Those records, which became public this year, showed lower staffing than what facilities had previously told inspectors during their visits, according to the KHN analysis.

“CMS takes very seriously our responsibility to protect the safety and quality of care for our beneficiaries,” CMS Administrator Seema Verma said in a statement.

The nursing home industry criticized the heightened scrutiny.

“Unfortunately, today’s action by CMS will enforce policies that makes it even more difficult to meet regulatory requirements and hire staff,” said Dr. David Gifford, senior vice president of quality and regulatory affairs at the American Health Care Association, an industry trade group, in a written statement. “Rather than taking proactive steps to address the national workforce shortage long-term care facilities are facing, CMS seems to be focusing on a punitive approach that will penalize providers and make it harder to hire staff to meet the shared goal of increasing staffing.”

Currently, a tenth of inspections must occur during “off hours,” which can be either a weekend, or during a weekday before 8 a.m. or after 6 p.m. But for facilities that Medicare identifies as having lower weekend staffing, half of those off-hour inspections—or 5 percent of the total — must be performed on Saturdays or Sundays.

Medicare requires nursing homes to have a registered nurse on site for at least eight hours every day, but according to the payroll records, a quarter of nursing homes reported no registered nurses available at least one day during a three-month period. Since July, Medicare’s Nursing Home Compare website for consumers has highlighted homes that lack sufficient registered nurses and lowered their star ratings. Nursing Home Compare has downgraded ratings for 1,402 of 15,600 facilities for gaps in registered nurse staffing, records show.

The new directive instructs inspectors to more thoroughly evaluate staffing at facilities Medicare flags. The edict does not mean a flurry of sudden inspections. Instead, Medicare wants heightened focus on those nursing homes when inspectors come for their standard reviews, which take place roughly once a year for most facilities.

But what may appear to be staffing scarcities in payroll records may instead be clerical problems in which nurse hours are not properly recorded, say some nursing home officials.

Katie Smith Sloan, president of LeadingAge, an association of nonprofit providers of aging services, said in a statement that some homes are still struggling to adapt to the new data collection rules.

“We’ve been voicing our concerns to CMS and will continue to do so,” she said.


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The SCAN Foundation

Podcast: KHN’s ‘What The Health?’ Reading The Tea Leaves In Blue Wave’s Wake

This week, “What the Health?” panelists discuss, among other things, how the House Democrats’ leadership battle could affect the congressional health policy agenda.

The panelists are Mary Agnes Carey of Kaiser Health News, Margot Sanger-Katz of The New York Times, Alice Ollstein of Politico and Anna Edney of Bloomberg News.

As the post-election dust settles on Capitol Hill, the Democrats — soon to be in control of the House of Representatives — have begun the process of choosing their leadership team. How this shakes out will have a lot to do with how health policy agenda takes shape in the lower chamber.

House Democrats nominated Rep. Nancy Pelosi (D-Calif.) to retake the speaker’s gavel, but she still needs to win over more of her colleagues to secure the speaker post in January.

But all the action this week wasn’t focused on Congress. Food and Drug Administration Commissioner Scott Gottlieb unveiled a proposed overhaul of the FDA’s decades-old medical device approval process, and the Trump administration announced proposals it said would reduce Medicare prescription drug costs. Critics fear those changes could mean that some people with chronic diseases like AIDS or cancer might not have access to the drugs they need.

Among the takeaways from this week’s podcast:

  • House Democrats nominated Rep. Nancy Pelosi (D-Calif.) to retake the speaker’s gavel this week along with the rest of its leadership slate, Reps. Steny Hoyer of Maryland and Jim Clyburn of South Carolina. This is only the first step, though. The leadership positions will not be filled officially until January, when they are voted on by the full House. Although Pelosi is still wrangling for the support needed to earn her the required 218 votes, most insiders expect the Democrat’s leadership team to look much as it did the last time Democrats ruled the House chamber in 2010, when the Affordable Care Act became law. That means the House will likely be laser-focused on the necessary steps to protect the ACA. There may also be hearings on single-payer health insurance — a concept that is increasingly gaining interest and support within the caucus, and especially among some of its newest members.
  • In the background, the Texas lawsuit that could overturn the ACA’s protections for people with preexisting conditions is still pending. That decision could come any day. Keep in mind, though, that whatever the court rules, it is likely to be appealed immediately and move up the legal ladder. And, in the interim, House Democrats may still move forward with legislation to strengthen those ACA safeguards. Such a measure could get some GOP support because many Republicans seeking re-election this year said they wanted to ensure that patients with preexisting medical conditions would not lose coverage.
  • The FDA unveiled a proposed overhaul of its decades-old medical device approval system. Among its provisions, the plan includes steps to ensure that new medical devices reflect current safety and effectiveness features. Critics of the current system say it has failed to detect problems with some implants — like hip replacements that failed prematurely or surgical mesh that has been linked to pain and bleeding. The changes, if approved, could take years to implement and some might require congressional approval.
  • The Trump administration proposed a series of changes to reduce the number of prescription drugs that all Medicare drug plans must cover. The proposal focuses on drugs in six “protected classes” and involves medications such as antidepressants, antipsychotic medicines, cancer drugs and antiretrovirals to treat HIV/AIDS. Administration officials have said the proposal could cut costs for Medicare, but patient advocacy groups say it could reduce patients’ access for much-needed treatments. The proposed changes would not occur until 2020, and Congress could intervene to stop them.

Also this week, Julie Rovner interviews KHN senior correspondent Jay Hancock, who investigated and wrote the latest “Bill of the Month” feature for Kaiser Health News and NPR. It’s about a single mother from Ohio who received a wrongful bill for her multiple sclerosis treatment. You can read the story here.

If you have a medical bill you would like NPR and KHN to investigate, you can submit it here.

Plus, for extra credit, the panelists recommend their favorite health policy stories of the week they think you should read too:

Mary Agnes Carey: The New York Times’ “This City’s Overdose Deaths Have Plunged. Can Others Learn From It?” by Abby Goodnough

Margot Sanger-Katz: NPR’s “Rethinking Bed Rest for Pregnancy,” by Alison Kodjak

Anna Edney: The Washington Post’s “Overdoses, Bedsores, Broken Bones: What Happened When a Private-Equity Firm Sought to Care for Society’s Most Vulnerable,” by Peter Whoriskey and Dan Keating

Alice Ollstein: Wired.com’s “The Science Is Clear: Dirty Farm Water Is Making Us Sick,” by Elizabeth Shogren and Susie Neilson

To hear all our podcasts, click here.

And subscribe to What the Health? on iTunesStitcher or Google Play.

Chronically Ill, Traumatically Billed: The $123,000 Medicine For MS

Shereese Hickson’s multiple sclerosis was flaring again. Spasms in her legs and other symptoms were getting worse.

She could still walk and take care of her son six years after doctors diagnosed the disease, which attacks the central nervous system. Earlier symptoms such as slurred speech and vision problems had resolved with treatment, but others lingered: she was tired and sometimes still fell.

This summer, a doctor switched her to Ocrevus, a drug approved in 2017 that delayed progression of the disease in clinical trials better than an older medicine did.

Genentech, a South San Francisco-based subsidiary of Swiss pharma giant Roche, makes Ocrevus. It is one of several drugs for multiple sclerosis delivered intravenously in a hospital or clinic. Such medicines have become increasingly expensive as a group, priced in many cases at well over $80,000 a year. Hospitals delivering the drugs often take a cut by upcharging the drug or adding hefty fees for the infusion clinic.

Hickson received her first two Ocrevus infusions as an outpatient two weeks apart in July and August. And then the bill came.

Patient: Shereese Hickson, 39, single mother who worked as a health aide and trained as a medical coder, living in Girard, Ohio. Because her MS has left her too disabled to work, she is now on Medicare; she also has Medicaid for backup.

Total Bill: $123,019 for two Ocrevus infusions taken as an outpatient. CareSource, Hickson’s Medicare managed-care plan, paid a discounted $28,960. Hickson got a bill for about $3,620, the balance calculated as her share by the hospital after the insurance reimbursement.

Medical Service: Two Ocrevus infusions, each requiring several hours at the hospital.

Service Provider: Cleveland Clinic, a nonprofit, academic medical center in Ohio.

What Gives: Hickson researched Ocrevus online after her doctor prescribed the new medicine. “I’ve seen people’s testimonies about how great it is,” on YouTube, she said. “But I don’t think they really go into what it’s like receiving the bill.”

That was particularly shocking because, covered by government insurance for her disability, she’d never received a bill for MS medicine before.

“I have a 9-year-old son and my income is $770 a month,” said Hickson. “How am I supposed to support him and then you guys are asking me for $3,000?”

Even in a world of soaring drug prices, multiple sclerosis medicines stand out. Over two decades ending in 2013, costs for MS medicines rose at annual rates five to seven times higher than those for prescription drugs generally, found a study by researchers at Oregon Health & Science University.

“There was no competition on price that was occurring,” said Daniel Hartung, the OHSU and Oregon State University professor who led the study. “It appeared to be the opposite. As newer drugs were brought to market, it promoted increased escalation in drug prices.”

With Ocrevus, Genentech did come up with a price that was slightly less than for rival drugs, but only after MS medicines were already extremely expensive. The drug launched last year at an annual list price of $65,000, about 25 percent lower than that of other MS drugs, Hartung said. MS drugs cost about $10,000 per year in the 1990s and about $30,000 a decade ago.

“We set the price of Ocrevus to reduce price as a barrier to treatment,” said Genentech spokeswoman Amanda Fallon.

It was also probably a response to bad publicity about expensive MS drugs, Hartung said. “Now companies are very aware at least of the optics of releasing drugs at higher and higher prices,” he said.

Patients starting Ocrevus get two initial infusions of 300 milligrams each and then 600 mg twice a year. Cleveland Clinic charged $117,089 for Hickson’s first two doses of Ocrevus — more than three times what hospitals typically pay for the drug, said John Hennessy, chief business development officer at WellRithms, a firm that analyzes medical bills for self-insured employers.

As is typical of government programs such as Medicare, the $28,960 reimbursement ultimately collected by the Cleveland Clinic was far less — but still substantial.

“We kind of got ourselves in a pickle here,” he said. “We’re more excited about the discount than we are about the actual price.”

Hickson’s nearly $3,620 bill represented the portion that Medicare patients often are expected to pay themselves.

Shereese Hickson, diagnosed with multiple sclerosis in 2012 and unable to work, supports herself and her son, Isaiah, on $770 a month.(Shane Wynn for KHN)

Last year, the Institute for Clinical and Economic Review, an independent nonprofit that evaluates medical treatments, completed a detailed study on MS medicines. It found that Ocrevus was one of three or four medicines that were most effective in reducing MS relapses and preventing MS from getting worse. But it also found that patient benefits from MS drugs “come at a high relative cost” to society.

At the same time, deciding which MS drug — there are about a dozen — would best suit patients is something of a shot in the dark: The science showing the comparative effectiveness of MS drugs is not as strong as it could be, researchers say.

“In general, there’s a real lack of head-to-head studies for many of these drugs,” said Hartung. The FDA has no required comparison standard for MS drugs, an agency spokeswoman said. Sometimes they’re rated against placebos. With everyone able to charge a high price, the companies have little incentive to see which works better and which worse.

Resolution: After Hickson questioned the charges over the phone, the billing office told her to apply to the hospital for financial assistance. Hickson had to print a form, provide proof of her disabled status, mail it and wait.

Hospital officials told her in October she qualified for assistance based on her income through a state program funded by hospital contributions and federal money. Cleveland Clinic wiped out the $3,620 balance.

“I’m grateful that they approved me for that, but not everybody’s situation is like that,” she said. She was worried enough about being billed again for her next Ocrevus infusion that she considered switching back to her old medicine. But her doctor wants her to give it more time to gauge its effects.

The Takeaway: Always ask about charity care or financial assistance programs. Hospitals have different policies and wide discretion about how to apply them, but often do not even tell patients such programs exist.

Because health care costs are so high, you may be eligible even if you have a decent salary. Cleveland Clinic gives free care to everybody below a certain income, said spokeswoman Heather Phillips. But it wasn’t until Hickson called that the hospital agreed to erase the charge.

While there are multiple new drugs to treat serious chronic conditions, they have often not been tested against one another. Moreover, your doctor may have no idea about their relative prices. He or she should. For newer drugs, all options may well be very expensive.

Keep in mind that drugs which must be infused often come with facility fees and infusion charges, which can leave patients with hefty copayments for outpatient treatment. Ask about oral medicines or those you can self-inject at home.

NPR produced and edited the interview with Elisabeth Rosenthal for broadcast. Marlene Harris-Taylor, from member station Ideastream in Cleveland, provided audio reporting.

Do you have an exorbitant or baffling medical bill? Join the KHN and NPR Bill-of-the-Month Club and tell us about your experience.


KHN’s coverage of women’s health care issues is supported in part by The David and Lucile Packard Foundation.