Undoing Health System Monopolies May Be a Lost Cause
by Elizabeth Rosenthal - - July 27, 2023
When Mark Finney moved to southwestern Virginia with his young family a decade ago, there were different hospital systems and a range of independent doctors to choose from.
But when his knee started aching in late 2020, he discovered that Ballad Health was the only game in town: He went to his longtime primary care doctor, now employed by Ballad, who sent him to an orthopedist’s office that had been purchased by Ballad. That doctor sent him to get an X-ray at a Ballad-owned facility and then he was referred to a physical therapy center called Mountain States Rehab that was now owned by Ballad as well.
Though none of the interventions took place in an actual hospital, all came with a hospital “facility fee.” When the price of P.T. doubled overnight — to nearly $200 for approximately 30 minutes — there was nowhere else to go, because Ballad Health effectively had a monopoly on care in 29 counties of the Appalachian Highlands in northeastern Tennessee, southwestern Virginia, northwestern North Carolina and southeastern Kentucky.
“I was stuck,” said Mr. Finney, a college professor. “My wife now drives 50 miles to see a doctor that’s not part of Ballad, and I don’t have a doctor anymore.”
Biden administration regulators have unleashed a blizzard of antitrust activity and have broadened the definition of the types of unfair competition they can target. Regulators blocked a merger between the publishing giants Penguin Random House and Simon & Schuster, saying it could have decreased author compensation and diminished the “diversity of our stories and ideas.” Regulators have filed suit to block JetBlue’s acquisition of Spirit Airlines on the grounds that the existence of the lower-cost Spirit kept fare increases by other carriers in check.
But while hospital mergers and creeping consolidation have arguably proved more traumatic and costly for countless Americans like Mr. Finney, they may prove harder to curtail.
After decades of unchecked mergers, health care is the land of giants, with one or two huge medical systems monopolizing care top-to-bottom in many cities, states and even whole regions of the country. Reams of economic research show that the level of hospital consolidation today — 75 percent of markets are now considered highly consolidated — decreases patient choice, impedes innovation, erodes quality and raises prices.
Ballad has generously contributed to performing arts and athletic centers as well as school bands. But, critics say, it has skimped on health care — closing I.C.U.s and reducing the number of nurses per ward — and demanded higher prices from insurers and patients. It has a habit of suing patients for unpaid bills. Its chief executive was paid about $4 million last year.
For many years in the last century the Federal Trade Commission made little effort to go to court to block hospital mergers because judges tended to rule that as nonprofit entities, hospitals were unlikely to use monopoly power to pursue abusive business practices. How wrong they were.
In 2021 President Biden ordered the F.T.C. to be more aggressive about hospital mergers and even to review those that had already occurred. But it is unclear if the agency has the tools to do much. “Regulators are 10 to 15 years behind and don’t have the resources — so that’s where we are,” said James Capretta, a senior fellow at the American Enterprise Institute.
The normal procedure for blocking proposed hospital mergers is cumbersome: often lengthy analysis to prove the effects on a particular market, warning letters, negotiations and finally challenges in court.
With its staff of about 40 focused on hospitals, the F.T.C. has prevented seven mergers in the past two years, said Rahul Rao, the deputy director of the agency’s bureau of competition, who called the problem a “top priority.” But there were 53 hospital mergers and acquisitions in 2022 and have been more than 90 per year in recent years.
“Its job is like shooting fish in a barrel. It’s really hard to show that a prospective transaction is anticompetitive,” said Leemore Dafny, a Harvard economist who worked at the F.T.C. about a decade ago. “I saw how hard it was for government to prove its case, even when it seemed obvious.”
In one market, two hospitals might be enough to ensure competition, in another, four. Even if the price goes up, that may not be considered anti-competitive if quality improves.
The F.T.C. has an even harder time evaluating the vertical merger, which is far more common: when a big hospital system buys up a much smaller hospital or some doctors’ practices and independent surgery or radiology centers — or when it merges with a local insurer.
Many such mergers are never vetted at all, since transactions under $111 million do not have to be reported to the agency. “It’s a visibility problem,” Mr. Rao said. “We hear about it from news reports or from a state attorney general” who is more in touch with activity on the ground. Many of today’s behemoth systems — such as Northwell Health in New York, Sutter in California and University of Pittsburgh Medical Center in Pennsylvania — grew often by buying one small hospital, physician practice or surgicenter at a time, below the threshold where they would attract federal regulators’ scrutiny or merit use of their limited resources.
When hospitals buy doctors’ practices, research shows, rates for visits tend to go up as they did for Mr. Finney. Some purchases are essentially catch-and-kill operations: Buy a nearby independent outpatient cardiac center, for example, in order to eliminate cheaper competition.
As hospital systems have grown — and become major employers — their sway with state legislatures has created new obstacles to curbing consolidation. Sympathetic state lawmakers have passed so-called Certificate of Public Advantage laws to shield hospitals from both federal and state antitrust action. Such certificates in Tennessee and Virginia allowed the formation of Ballad from two competing systems in 2018, over the F.T.C.’s objections. Just recently the North Carolina Senate gave the UNC Health system the green light to expand, regardless of regulators’ thoughts.
The newest challenge is how to handle the growing number of cross-market mergers, where huge health systems in different parts of a state or of the country join forces. While the hospitals are not competing for the same patients, emerging research shows that these moves result in higher prices, in part because the increased negotiating clout of the enormous health system forces companies that cover employees in both markets to pay more in what previously was the cheaper region.
There are attempts and proposals to reinject a modicum of competition or restraint into the health system: The F.T.C. has sought to ban noncompete clauses in job contracts that prevent doctors and nurses from moving from one hospital to another within a certain time, for example.
But many economists on both the left and the right have concluded that, at this point, meaningful competition may be difficult to restore in many markets. Barak Richman, a professor of law and business administration at Duke University, said, “It’s depressing for economists who live and breathe by competition to say maybe we just need price regulation.”
Indeed, a number of states — red and blue — are now gingerly floating moves to directly rein in prices. This year the Indiana legislature, for example, banned hospitals from charging facility fees for visits outside of the hospital. The lawmakers even considered fining hospitals whose prices were more than 260 of percent the Medicare rate — though they deferred that move for two years in the hope that the threat would encourage better behavior.
With the F.T.C. becoming more aggressive and legislatures considering such measures, perhaps hospital systems will heed the warnings and behave more like the care providers they’re meant to be and less like monopoly businesses.
https://www.nytimes.com/2023/07/25/opinion/health/health-system-hospital-monopolies.html
How a Drug Maker Profited by Slow-Walking a Promising H.I.V. Therapy
Gilead delayed a new version of a drug, allowing it to extend the patent life of a blockbuster line of medications, internal documents show.
Rebecca Robbins and
In 2004, Gilead Sciences decided to stop pursuing a new H.I.V. drug. The public explanation was that it wasn’t sufficiently different from an existing treatment to warrant further development.
In private, though, something else was at play. Gilead had devised a plan to delay the new drug’s release to maximize profits, even though executives had reason to believe it might turn out to be safer for patients, according to a trove of internal documents made public in litigation against the company.
Gilead, one of the world’s largest drugmakers, appeared to be embracing a well-worn industry tactic: gaming the U.S. patent system to protect lucrative monopolies on best-selling drugs.
At the time, Gilead already had a pair of blockbuster H.I.V. treatments, both of which were underpinned by a version of a drug called tenofovir. The first of those treatments was set to lose patent protection in 2017, at which point competitors would be free to introduce cheaper alternatives.
The promising drug, then in the early stages of testing, was an updated version of tenofovir. Gilead executives knew it had the potential to be less toxic to patients’ kidneys and bones than the earlier iteration, according to internal memos unearthed by lawyers who are suing Gilead on behalf of patients.
Despite those possible benefits, executives concluded that the new version risked competing with the company’s existing, patent-protected formulation. If they delayed the new product’s release until shortly before the existing patents expired, the company could substantially increase the period of time in which at least one of its H.I.V. treatments remained protected by patents.
The “patent extension strategy,” as the Gilead documents repeatedly called it, would allow the company to keep prices high for its tenofovir-based drugs. Gilead could switch patients to its new drug just before cheap generics hit the market. By putting tenofovir on a path to remain a moneymaking juggernaut for decades, the strategy was potentially worth billions of dollars.
Gilead ended up introducing a version of the new treatment in 2015, nearly a decade after it might have become available if the company had not paused development in 2004. Its patents now extend until at least 2031.
The delayed release of the new treatment is now the subject of state and federal lawsuits in which some 26,000 patients who took Gilead’s older H.I.V. drugs claim that the company unnecessarily exposed them to kidney and bone problems.
In court filings, Gilead’s lawyers said that the allegations were meritless. They denied that the company halted the drug’s development to increase profits. They cited a 2004 internal memo that estimated Gilead could increase its revenue by $1 billion over six years if it released the new version in 2008.
“Had Gilead been motivated by profit alone, as plaintiffs contend, the logical decision would have been to expedite” the new version’s development, the lawyers wrote.
Gilead’s top lawyer, Deborah Telman said in a statement that the company’s “research and development decisions have always been, and continue to be, guided by our focus on delivering safe and effective medicines for the people who prescribe and use them.”
Today, a generation of expensive Gilead drugs containing the new iteration of tenofovir account for half of the market for H.I.V. treatment and prevention, according to IQVIA, an industry data provider. One widely used product, Descovy, has a sticker price of $26,000 annually. Generic versions of its predecessor, Truvada, whose patents have expired, now cost less than $400 a year.
If Gilead had moved ahead with its development of the updated iteration of the drug back in 2004, its patents either would have expired by now or would soon do so.
“We should all take a step back and ask: How did we allow this to happen?” said James Krellenstein, a longtime AIDS activist who has advised lawyers suing Gilead. He added, “This is what happens when a company intentionally delays the development of an H.I.V. drug for monopolistic purposes.”
Gilead’s apparent maneuver with tenofovir is so common in the pharmaceutical industry that it has a name: product hopping. Companies ride out their monopoly on a medication and then, shortly before the arrival of generic competition, they switch — or “hop” — patients over to a more recently patented version of the drug to prolong the monopoly.
The drug maker Merck, for example, is developing a version of its blockbuster cancer drug Keytruda that can be injected under the skin and is likely to extend the company’s revenue streams for years after the infused version of the drug faces its first competition from other companies in 2028. (Julie Cunningham, a spokeswoman for Merck, denied that it is engaged in product hopping and said the new version is “a novel innovation aimed at providing a greater level of convenience for patients and their families.”)
Christopher Morten, an expert in pharmaceutical patent law at Columbia University, said the Gilead case shows how the U.S. patent system creates incentives for companies to decelerate innovation.
“There’s something profoundly wrong that happened here,” said Mr. Morten, who provides pro bono legal services to an H.I.V. advocacy group that in 2019 unsuccessfully challenged Gilead’s efforts to extend the life of its patents. “The patent system actually encouraged Gilead to delay the development and launch of a new product.”
David Swisher, who lives in Central Florida, is one of the plaintiffs suing Gilead in federal court. He took Truvada for 12 years, starting in 2004, and developed kidney disease and osteoporosis. Four years ago, when he was 62, he said, his doctor told him he had “the bones of a 90-year-old woman.”
It was not until 2016, when Descovy was finally on the market, that Mr. Swisher switched off Truvada, which he believed was harming him. By that time, he said, he had grown too sick to work and had retired from his job as an airline operations manager.
“I feel like that whole time was taken away from me,” he said.
First synthesized in the 1980s by researchers in what was then Czechoslovakia, tenofovir was the springboard for Gilead’s dominance in the market for treating and preventing H.I.V.
In 2001, the Food and Drug Administration for the first time approved a product containing Gilead’s first iteration of tenofovir. Four more would follow. The drugs prevent the replication of H.I.V., the virus that causes AIDS.
Those became game-changers in the fight against AIDS, credited with saving millions of lives worldwide. The drugs came to be used not only as a treatment but also as a prophylactic for those at risk of getting infected.
But a small percentage of patients who were taking the drug to treat H.I.V. developed kidney and bone problems. It proved especially risky when combined with booster drugs to enhance its effectiveness — a practice that was once common but has since fallen out of favor. The World Health Organization and the U.S. National Institutes of Health discourage the use of the original version of tenofovir in people with brittle bones or kidney disease.
The newer version doesn’t cause those problems, but it can cause weight gain and elevated cholesterol levels. For most people, experts say, the two tenofovir-based drugs — the first known as T.D.F., the second called T.A.F. — offer roughly equal risks and benefits.
The internal company records from the early 2000s show that Gilead executives at times wrestled with whether to rush the new formulation to market. At some points, the documents cast the two iterations of tenofovir as similar from a safety standpoint.
But other memos indicate that the company believed the updated formula was less toxic, based on studies in laboratories and on animals. Those studies showed that the newer formulation had two advantages that could reduce side effects. It was much better than the original at delivering tenofovir to its target cells, meaning that much less of it leaked into the bloodstream, where it could travel to kidneys and bones. And it could be given at a lower dose.
The new version “may translate into a better side effect profile and less drug-related toxicity,” read an internal memo in 2002.
That same year, the first human clinical trial of the newer version got underway. A Gilead employee mapped out a development timeline that would have brought the newer formulation to market in 2006.
But in 2003, Gilead executives began to sour on rushing it forward. They worried that doing so would “ultimately cannibalize” the growing market for the older version of tenofovir, according to minutes from an internal meeting. Gilead’s head of research at the time, Norbert Bischofberger, instructed company analysts to explore the new formulation’s potential as an intellectual property “extension strategy,” according to a colleague’s email.
That analysis resulted in a September 2003 memo that described how Gilead would develop the newer formulation to “replace” the original, with development “timed such that it is launched in 2015.” In a best-case scenario, company analysts calculated, their strategy would generate more than $1 billion in annual profits between 2018 and 2020.
Gilead moved to resurrect the newer formulation in 2010, putting it on track for its 2015 release. John Milligan, Gilead’s president and future chief executive, told investors that it would be a “kinder, gentler version” of tenofovir.
After winning regulatory approvals, the company embarked on a successful marketing campaign, aimed at doctors, that promoted its new iteration as safer for kidneys and bones than the original.
By 2021, according to Ipsos, a market research firm, nearly half a million H.I.V. patients in the United States were taking Gilead products containing the new version of tenofovir.
https://www.nytimes.com/2023/07/22/business/gilead-hiv-drug-tenofovir.html
Drugmakers Are ‘Throwing the Kitchen Sink’ to Halt Medicare Price Negotiations
The government will soon announce the first 10 medications that will be subject to price negotiations with Medicare under a new law. Drugmakers are fighting the measure in court.
The pharmaceutical industry, which suffered a stinging defeat last year when President Biden signed a law authorizing Medicare to negotiate the price of some prescription medicines, is now waging a broad-based assault on the measure — just as the negotiations are about to begin.
The law, the Inflation Reduction Act, is a signature legislative achievement for Mr. Biden, who has boasted that he took on the drug industry and won. Medicare is the federal health insurance program for older and disabled people; the provisions allowing it to negotiate prices are expected to save the government an estimated $98.5 billion over a decade while lowering insurance premiums and out-of-pocket costs for many older Americans.
On Tuesday, Johnson & Johnson became the latest drugmaker to take the Biden administration to federal court in an attempt to put a halt to the drug pricing program. Three other drug companies — Merck, Bristol Myers Squibb and Astellas Pharma — have filed their own lawsuits, as have the industry’s main trade group and the U.S. Chamber of Commerce.
The suits make similar and overlapping claims that the drug pricing provisions are unconstitutional. They are scattered in federal courts around the country — a tactic that experts say gives the industry a better chance of obtaining conflicting rulings that will put the legal challenges on a fast track to a business-friendly Supreme Court.
The legal push comes just weeks before the Centers for Medicare & Medicaid Services is scheduled to publish a long-awaited list of the first 10 drugs that will be subject to negotiations. The list is due out by Sept. 1; the makers of the selected drugs have until Oct. 1 to declare whether they will participate in negotiations — or face steep financial penalties for not doing so. The lower prices will not take effect until 2026.
Earlier this month, the chamber asked a federal judge in Ohio to issue an injunction that would block any negotiations while its case is being heard.
Lawrence O. Gostin, an expert in public health law at Georgetown University, said the Supreme Court might be sympathetic to some of the industry’s arguments. In particular, he pointed to a claim by drugmakers that by requiring them to negotiate or pay a fine, the law violates the Fifth Amendment’s prohibition on the taking of private property for public use without just compensation.
“The Supreme Court is openly hostile to any perceived violation of the Fifth Amendment,” Mr. Gostin said, adding, “It would not surprise me at all to see these cases go up to the Supreme Court and have them strike it down.”
For Mr. Biden and his fellow Democrats, that would be a painful blow. The president and Democrats have long campaigned on reducing drug prices and plan to make it a central theme of their 2024 campaigns. The White House press secretary, Karine Jean-Pierre, said in a statement that Mr. Biden was confident the administration would win in court.
“For decades, the pharma lobby has blocked efforts to let Medicare negotiate lower drug costs,” she said. “President Biden is proud to be the first president who beat them.”
Republicans opposed the drug pricing provisions, which they regard as a form of government price control. But the politics of the issue are treacherous for them. Because so many Americans are concerned about high drug prices, it is hard for Republicans to come to the industry’s defense, said Joel White, a Republican strategist with expertise in health policy.
Instead, Republicans are focused on another priority of the drug industry: scrutinizing the practices of pharmacy benefit managers, which negotiate prices with drug companies on behalf of health plans. The drug companies say that by taking a middleman’s cut, the pharmacy benefit managers are contributing to the high cost of prescription medicines.
For drugmakers, the stakes of the legal challenges are bigger than just their business with Medicare, their biggest customer. The industry fears that Medicare will, in effect, set the bar for all payers, and that once the government’s lower prices are made public, pharmacy benefit managers negotiating on behalf of the privately insured will have more leverage to demand deeper discounts.
In conjunction with its legal campaign, the pharmaceutical industry is waging a public relations offensive. The industry trade group that filed one of the lawsuits, the Pharmaceutical Research and Manufacturers of America, known as PhRMA, is running advertisements targeting pharmacy benefit managers, and industry executives are publicly arguing that the drug pricing provisions will lead to fewer cures. The implication is clear: Lower prices will mean a dent in revenues, which will discourage companies from developing certain drugs.
“You can’t take hundreds of billions of dollars out of the pharmaceutical industry and not expect that it’s going to have a real impact on the industry’s ability to develop new treatments and cures for patients,” said Robert Zirkelbach, an executive vice president at PhRMA. He cited an analysis funded by the drugmaker Gilead Sciences that asserted the industry would lose $455 billion over seven years if companies negotiated with Medicare.
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A study released last month that was funded by the Biotechnology Innovation Organization, another trade group, warned that the pricing provisions would discourage innovation, resulting in as many as 139 fewer drug approvals over the next 10 years.
But that assessment is at odds with an analysis by the Congressional Budget Office, which estimated that the law would result in only one fewer drug approval over a decade and about 13 fewer drugs over the next 30 years.
In addition, many new drugs “are not offering clinically meaningful benefit over existing drugs,” said Ameet Sarpatwari, an expert in pharmaceutical policy at Harvard Medical School. The Inflation Reduction Act, he said, might incentivize companies to focus more heavily on breakthrough therapies, instead of so-called me-too drugs, because the law requires the government to consider the clinical benefit of medications in determining the price Medicare will pay for them.
Until now, Medicare has been explicitly barred from negotiating prices directly with drugmakers — a condition the industry demanded in exchange for supporting the creation of Part D, the Medicare prescription drug program, which was signed into law 20 years ago by President George W. Bush.
Under the Inflation Reduction Act, the government will select an initial set of 10 drugs for price negotiations based on how much the Part D program spends on them. More drugs will be added in the coming years.
Experts expect the initial list of drugs to include oft-prescribed medicines like the blood thinners Eliquis and Xarelto; cancer drugs like Imbruvica and Xtandi; Symbicort, which treats asthma and chronic obstructive disorder; and Enbrel, for rheumatoid arthritis and other autoimmune disorders.
Medicare already pays discounted prices for those drugs. In 2021, the most recent year for which data is available, Medicare spent about $4,000 per patient for Eliquis and Xarelto, which at the time had sticker prices of $6,000 per year. The lower price reflects discounts extracted from drugmakers by pharmacy benefit managers negotiating on behalf of the private companies that contract with the government to manage Part D plans.
But those negotiations are opaque and only modestly reduce Medicare’s spending. The rationale behind the Inflation Reduction Act’s drug pricing provisions is that because Medicare covers so many people, it can use its leverage to extract even deeper discounts.
The United States spends more per person on drugs than comparable nations, in part because other countries proactively control drug pricing. Surveys show that many Americans forego taking their medicines because they cannot afford them.
Experts say the Medicare negotiation program is likely to translate into direct savings for seniors, initially in the form of reduced premiums made possible by reduced drug spending. And when lower prices take effect in 2028 for drugs administered in clinics and hospitals under another Medicare program, known as Part B, that could mean lower out-of-pocket costs for seniors covered by traditional Medicare who do not have supplemental insurance.
Backers of the Inflation Reduction Act say that in addition to saving money for the government and patients, the negotiations will inject much-needed transparency into the complicated process of determining drug prices. If a company declines to negotiate, it must either pay a hefty excise tax or withdraw all of its drugs from both Medicare and Medicaid.
“This is not a ‘negotiation,’” Merck said in its complaint. “It is tantamount to extortion.”
Taken together, the lawsuits make a variety of constitutional arguments. In addition to the assertion that the government is violating the Fifth Amendment by unjustly taking property, they include claims that the law violates the First Amendment by compelling drug companies to agree in writing that they are negotiating a “fair price.” Another argument is that the excise tax amounts to an excessive fine that is prohibited by the Eighth Amendment.
“If the government can impose price controls in this fashion on drug companies,” said Jennifer Dickey, a deputy chief counsel at the chamber’s legal arm, “it could do the same thing to any sector of our economy.”
Biden administration officials say there is nothing compulsory about the law. They argue that the companies are free not to negotiate and that they can issue news releases or make other public statements disagreeing with the negotiated price. And they note that the government routinely negotiates for the purchase of other products and that the Department of Veterans Affairs already negotiates drug prices with pharmaceutical companies.
“To me, Medicare is doing what it should do,” said Mr. Gostin, the Georgetown professor. “It’s a huge buyer of a product, and it’s basically using that clout, that bargaining power, to get the best price.”
The drug industry “is throwing the kitchen sink at the government,” he added. “They’re looking for what sticks, and their arguments are directly targeted at the Supreme Court.”
https://www.nytimes.com/2023/07/23/us/politics/medicare-drug-price-negotiations-lawsuits.html
They billed Medicare late for his anesthesia. He went to collections for a $3,000 tab
by Phil Galewitz - Kaiser Health News - July 27, 2023
Thomas Greene had been experiencing pain in his right leg, a complication from diabetes, when doctors recommended a procedure to increase blood flow to the limb.
Retired from a career as an electrician and HVAC technician, he had an outpatient procedure in April 2021 to alleviate his pain by dilating the clogged artery using a balloon snaked into his blood vessel.
Greene, who lives in Oxford, Pennsylvania, came through the procedure without any problems, and it reduced his discomfort, said his wife, Bluizer Greene. She spoke with KFF Health News on behalf of Greene, who is recovering from other health problems.
Greene is covered by Medicare and a supplemental policy through Humana and did not expect to pay anything for the care, Bluizer said.
Then the bills came.
The patient: Thomas Greene, 74, is covered by original Medicare and a Medicare supplement policy sold by Humana.
Medical service: Peripheral artery bypass surgery on Greene's right leg.
Service provider: The operation was performed at Jennersville Hospital in West Grove, Pennsylvania, which closed in December 2021. Anesthesia services were provided by two providers who work for North American Partners in Anesthesia, which is private equity-owned and, with thousands of providers operating in 21 states, identifies itself as among the nation's largest anesthesia staffing companies.
Total bill: For the anesthesia care, North American Partners in Anesthesia billed $2,965.58: $1,334.51 for a certified nurse anesthetist and $1,631.07 for an anesthesiologist.
What gives: North American Partners in Anesthesia, or NAPA, pursued Greene to pay for his anesthesia care instead of billing Medicare on time, sending the debt to collections before the couple discovered the problem.
Medicare eventually received the claims from NAPA, months after Bluizer said they started receiving collections letters. But Medicare denied them because they were filed late — nearly 17 months after the surgery. Humana also denied the claims.
Medicare requires providers to submit claims within a year of providing their services. And Medicare supplemental policies, like Greene's plan from Humana, generally do not pay for services if Medicare doesn't cover them, whether because Medicare has not paid its part yet or because the program denied the claim.
A year after Greene's surgery, in spring 2022, the couple opened a letter from a collections agency working on behalf of the anesthesia group. It demanded Greene pay about $3,000.
"Something has to be to be wrong, because this is the first time my husband has ever been asked to pay out-of-pocket and we've had the same insurance for years," Bluizer said.
She said for several months she called NAPA and the collections agency, C.tech Collections, of Mount Sinai, New York, to determine why it was billing her husband.
Greene was also contacted by the Faloni Law Group, a second organization working on behalf of NAPA to collect the debt, and Bluizer said she followed its instructions to respond by mail, disputing the debt on the grounds that it should be billed to insurance.
But her communication attempts did not resolve the issue, and she said her husband continued to receive collections notices.
Neither debt collector responded to requests for comment.
"We were angry, and it was very upsetting because we had never had a bill put into a collection agency for any of his hospitalizations, and it was money we did not feel that we owed," Bluizer said.
She said they may have received some letters from the anesthesia group in 2021 and 2022 that they discarded without opening because they believed her husband's medical bills would be covered by insurance, as the rest of his surgery bills were.
Worried about the situation, including its potential impact on their credit, the couple reached out late last year to Harold Ting, a volunteer counselor for Pennsylvania's MEDI program, which provides free assistance to Medicare beneficiaries. Medicare generally covers anesthesia services.
"This is totally unfair that a beneficiary ends up having to pay for what should be a totally covered service, when the provider is at fault," Ting said.
Two explanation of benefits statements from Humana show the insurer received claims from NAPA in April 2021, shortly after Greene's surgery. The statements said the claims could not be considered at that time, though, because Humana had not yet received Medicare EOBs for the services.
Kelli LeGaspi, a Humana spokesperson, declined to comment on Greene's case. She said a Medicare EOB — a coverage statement generated when the program processes a claim — is required for the supplement carrier to consider a claim. Without it, a claim for secondary coverage cannot be considered and is denied, she said.
Supplement plans deny claims for benefits that are denied by Medicare, she said.
"If Original Medicare declines to pay the claim, then the Medicare supplement plan is required to decline the claim as well," she said.
In December 2022, a NAPA representative told Bluizer in an email that NAPA billed Medicare after the April 2021 surgery and that Medicare denied the claims in August 2021. The representative provided an account statement showing the claims were sent to collections that month.
But Bluizer said a Medicare representative told her in late 2021 that the program had received no claims from NAPA.
Greene's Medicare account shows NAPA filed claims in September 2022, about 17 months after his surgery and about five months after he received his first collections letter. Both claims were denied.
A quarterly summary notice said while the time limit for filing the claims had expired, Greene also could not be billed.
Meena Seshamani, director of the federal Center for Medicare, said in an email to KFF Health News that if a Medicare provider sends a claim a year or more after a service is provided, it is denied except in very rare circumstances.
There is no exception for provider error, she said.
A spokesperson for NAPA declined to be interviewed on the record, despite receiving a signed release waiving federal privacy protections.
Martine G. Brousse, a billing expert and founder of the patient advocacy firm AdviMedPRO, said Greene's Medicare notice should have reassured the couple that he did not owe anything, despite the several overdue-bill notices they received.
If the Medicare statement "shows a zero balance to the member, then the provider cannot legally go after the patient," said Brousse, who is not involved in Greene's case. "The patient has zero liability because it is not their fault" the provider billed Medicare more than a year after the surgery. "That is the end of the story."
Another mystery about the claim is why NAPA billed separately for a nurse anesthetist and an anesthesiologist. Bluizer said her husband was not told why NAPA billed individually for the two medical professionals — a practice that some insurers believe constitutes double billing.
Brousse said there could be a simple explanation, such as if the nurse anesthetist started the procedure and the anesthesiologist finished it or if the company charged for the anesthesiologist to work in a supervisory role.
But the Medicare claims document shows each provider billed for the same amount of time — a little over an hour.
"As far as I can tell, this looks like two providers billed with the same 'I did the job' Medicare procedure code," she said. "Medicare cannot accept that without an explanation."
The resolution: Unable to get answers, Ting connected Greene to the nonprofit, Pennsylvania-based Center for Advocacy for the Rights and Interests of Elders.
In March, Ariel Rabinovic, an advocate with the center, contacted NAPA on Greene's behalf and explained that federal law does not allow the group to bill Medicare patients for services Medicare does not cover. He said he was told the company would stop billing Greene.
Bluizer said the couple has not received any collections notices since then.
Rabinovic said he has seen others situations where health providers who agree to accept Medicare try to bill patients for services Medicare does not cover, which is not allowed.
"Older folks have a lot of things going on, and dealing with this can be very confusing for them," he said. "A lot of people end up paying because they don't want to deal with it."
Greene has faced several health issues and spent time in a rehabilitation hospital this winter. His wife said she was happy the billing issue had been resolved without their having to pay anything.
The takeaway: When a Medicare statement says the patient may not be billed anything for a health service, that's the bottom line. Don't write a check, but also don't ignore bills and collections notices, because they could ultimately hurt your credit.
Read your mail, the experts said. While Greene was not responsible for paying the anesthesia bill given that Medicare said he did not owe anything, the couple may have prevented the debt from being sent to collections if they had responded to the anesthesia group's communications and confirmed it had Greene's insurance information, Brousse said.
Keep copies of bills and insurance statements, especially Medicare EOB documents, or follow them on an online portal.
The couple was smart to reach out to advocates for help resolving the issue when they could not do so on their own, Rabinovic said.
"This is why people need to read their notices from Medicare even when it says 'This is not a bill,'" he said.
Also, when an anesthesia bill includes charges for both a nurse anesthetist and an anesthesiologist, question the charges. Many insurers will not pay for both.
The Centers for Medicare & Medicaid Services recommend beneficiaries call 1-800-MEDICARE with questions about their care or bills or file a complaint online.
India Is Using Technology To Give 1.4+ Billion People Access To Healthcare
India’s vast population of more than 1.4 billion people continues to grow significantly, bringing with it immense opportunity for innovation and disruption. In this regard, world leaders, corporations, regulators, and investors are slowly realizing that India’s prowess in the next 50 years will be unmatched. In fact, Goldman Sachs released a report earlier this month indicating that India is soon likely to become the world’s second largest economy.
With this growth in population, one of the paramount areas of investment which the government has focused on is embracing technology to increase access to quality healthcare.
Providing healthcare services in an affordable, effective and efficient manner is a concept that has become increasingly challenging for most nations across the globe, especially as the cost of care continues to rise and holistic population health continues to decline. India is no different, especially as it grapples with providing cost effective care to a population that is nearly 5 times the size of the U.S.— the majority of which is not even located in large, metropolitan city centers.
This initiative has been top of mind and a firm resolution for India’s latest Prime Minister Narendra Modi, who has been celebrated as one of the world’s most powerful and influential leaders in recent years. In 2018, PM Modi announced the launch of “Ayushman Bharat,” the world’s largest free healthcare program aimed at providing best-in-class universal health coverage. The program entails two aspects: first, the establishment of Health and Wellness Centers (HWCs) that focuses on the delivery of comprehensive primary and diagnostic care; and second, Pradhan Mantri Jan Arogya Yojna (PM-JAY), which provides more than 550 million people with coverage of Rs. 5 lakhs per family, per year, for secondary and tertiary care hospitalizations.
Though this initiative is a gargantuan undertaking, India is fortunate to have some of the world’s best tech talent. A significant aspect of Ayushman Bharat is the digital ecosystem being harnessed to enable its functions. This is more broadly deemed as The Ayushman Bharat Digital Mission (ABDM), which “aims to develop the backbone necessary to support the integrated digital health infrastructure of the country. It will bridge the existing gap amongst different stakeholders of Healthcare ecosystem through digital highways.” Specifically, the vision for the ABDM is “to create a national digital health ecosystem that supports universal health coverage in an efficient, accessible, inclusive, affordable, timely and safe manner, that provides a wide-range of data, information and infrastructure services, duly leveraging open, interoperable, standards-based digital systems, and ensures the security, confidentiality and privacy of health-related personal information.”
The ABDM connects key stakeholders across the healthcare landscape to enable best-in-class healthcare delivery, bringing together healthcare technology companies, government regulators, and care delivery organizations with labs, pharmacies, hospitals, and healthcare providers across multiple domains. The digital architecture has also been intricately designed to carefully link and maintain secure health records while also providing easy user interfaces to access care on a daily basis. In fact, the initiative has landed some of the country’s largest organizations as key partners, including Tata Medical and Diagnostics group and Apollo Hospital.
In May of this year, the National Health Authority of India announced that “Over 100 health programs and digital health applications [have completed] their integration with [the] Ayushman Bharat Digital Mission [ecosystem],” signifying an important milestone for the initiative. “The growing pool of ABDM integrators signifies the collaborative efforts by the health tech innovators from Government and private sector in making healthcare service delivery more efficient, accessible and affordable for all. We look forward to expanding the ABDM partners ecosystem to take the benefits of digital healthcare delivery to the masses. As more and more companies get integrated, we will be able to achieve interoperability in true sense.”
One such program and application that has become immensely popular and widely used is eSanjeevani, the National Telemedicine Service of the Ministry of Health and Family Welfare (MoHFW) which has actually been recorded as the world’s largest telemedicine program.
The platform operates in two ways: 1) a provider-to-provider service that patients can use after walking into a health and wellness center or that physicians can use to request more specialized clinical advice from other physicians, and 2) eSanjeevani OPD, which directly connects a patient to a provider in the comfort of their own homes.
Of note, the adoption of the program has been widely successful. Since its inception in 2019, the program has already “served more than 114 million patients at over 115,000 Health & Wellness Centres (as spokes) through 15,700+ hubs; and over 1100 online OPDs serviced by more than 225,000 doctors, medical specialists, super-specialists and health workers as telemedicine practitioners.”
Undoubtedly, the Indian government’s efforts in undertaking such a large initiative must be commended, and its entire healthcare playbook is certainly something which other countries can learn from. India is often compared to other Western nations with regards to its healthcare outcomes; however, very few other countries have to reconcile with the scope and scale of a population size similar to India, let alone take into consideration very nuanced cultural, demographic, economic, and social factors. Furthermore, even if compared on a one-to-one basis with consideration of population and demographic factors, healthcare outcomes in India still surpass those of many leading Western nations, especially when taking into account the cost-of-care with regards to the value provided to patients.
Indeed, there is significant promise in India’s relentless efforts to embrace technology and digital innovation to further improve its healthcare system. Although these efforts are certainly still a work in progress and there is still a lot of work to be done, one thing is certain— India is slowly but surely succeeding in becoming a global beacon of ideal healthcare.
Where House Democrats want to go next on lowering drug prices
by Paige Winfield Cunningham - Washington Post - July 26, 2023
It’s been nearly a year since Congress passed legislation allowing the federal government — for the first time — to force lower drug prices for a limited number of medications in Medicare.
Now a trio of House Democrats are outlining how they’d like to expand the measure to Americans beyond just those in the Medicare program and to more than 20 drugs, in materials provided first to The Health 202.
Their bill is only aspirational, considering Republicans control the House. But Democrats, who have long called in vain for drug price negotiation, were emboldened by the measure in the 2022 Inflation Reduction Act which, while incremental, represented an unusual victory for them over the pharmaceutical industry.
The bill being introduced today by the leaders of the three House committees dealing with health-care issues would extend the lower drug prices that will soon be negotiated in Medicare to employer-sponsored health plans and plans offered on the state insurance marketplaces. And it would do two additional things:
- The government could negotiate lower prices for up to 50 drugs. As laid out in the Inflation Reduction Act, eligible drugs would generally need to be the highest-cost drugs and would need to meet a number of other qualifications, such as having a minimum length of time elapsed since their FDA approval and not having an “orphan drug” designation.
- Medicare drug rebates required under the IRA would also apply to private plans. Drugmakers that hiked the prices of single-source drugs and biologicals in commercial plans faster than the rate of inflation would have to pay a rebate to the U.S. Treasury.
“The Inflation Reduction Act finally granted Medicare the power to negotiate lower prescription drug prices for seniors, however, the fight is not over,” Energy and Commerce Committee ranking Democrat Frank Pallone Jr. (N.J.) said in a statement.
Pallone, along with Ways and Means ranking Democrat Richard Neal (Mass.) and Education and the Workforce ranking Democrat Bobby Scott (Va.), will announce the measure today.
“This bill delivers on our promise to build upon the historic progress made by the Inflation Reduction Act and will allow us to further lower drug prices,” Scott said in a statement.
The background
With battles over the 2010 health-care law largely in the rearview mirror, Democrats have spent the last few years focusing on the high cost of drugs. Former House speaker Nancy Pelosi invested considerable energy in trying to get her drug price negotiation bill, H.R. 3, passed and was instrumental in getting a pared-back version included in the Inflation Reduction Act. Republicans have overwhelmingly opposed the measure, calling it a “government price control” and introducing legislation in the Senate to repeal it.
Since then, the pharmaceutical industry’s lobbying group and several drug companies have filed suit over the negotiation measure, saying it stymied research and development. The Congressional Budget Office has estimated the negotiations could lead to a very modest reduction in the number of new drugs coming to market in the next 30 years, saying there would be 13 fewer new drugs out of an estimated 1,300 new drugs approved during that time period.
The next major deadline for implementing that legislation is Sept. 1, when the Centers for Medicare and Medicaid Services must announce the first 10 drugs it will negotiate over.
