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Years Before Heading Offshore, Herpes Researcher Experimented On People In U.S.

Three years before launching an offshore herpes vaccine trial, an American researcher vaccinated patients in U.S. hotel rooms in brazen violation of U.S. law, a Kaiser Health News investigation has found.

Southern Illinois University associate professor William Halford administered the shots himself at a Holiday Inn Express and a Crowne Plaza Hotel that were a 15-minute drive from the researcher’s SIU lab. Halford injected at least eight herpes patients on four separate occasions in the summer and fall of 2013 with a virus that he created, according to emails from seven participants and interviews with one participant.

The 2013 experiments raise further questions of misconduct by Halford, who pursued a herpes vaccine for years while working at Southern Illinois University, which claims to have been unaware of his unorthodox research practices.

Halford, who died this summer from cancer, ran a clinical trial out of a house on St. Kitts in 2016 to test the experimental vaccine and did not alert U.S. or St. Kitts and Nevis authorities.

Following a KHN report that Halford completed the 2016 trial with no independent safety oversight, the Department of Health and Human Services demanded the university account for the research.

SIU, in an initial response to U.S. authorities, said the university’s institutional review board found “serious noncompliance with regulatory requirements and institutional policies and procedures.”

SIU, like many universities receiving federal research funds, pledged to follow U.S. standards for all clinical trials.

In 2013, Halford, who was a microbiologist not a physician, noted a need for secrecy in one email to a participant, writing that it would be “suicide” if he became too public about how he was conducting his research.

Many email exchanges with participants in 2013 — asking them to send photographs of rashes, blisters and other reactions — were sent from Halford’s university email account. He used the university phone for communication and he referred to a graduate student as assisting in the experiment and to using the lab.

“Furtive unregulated live virus vaccine injections in a Holiday Inn? This is really, really out there,” said Jonathan Zenilman, a doctor and an expert on sexually transmitted diseases at Johns Hopkins University. “Someone in the university had to know that this stuff was going on. If they didn’t, they should have.”

According to the emails between Halford and the patients and extensive interviews with the participant, Halford did not procure written informed consent as required by federal law when testing a live virus on humans. Medical researchers, such as Halford, may not inject patients without oversight by a physician or a nurse practitioner, Zenilman said.

SIU refused to comment on revelations about Halford’s 2013 experiments.

It has previously said it had no role or responsibility for Halford’s work in 2016 in the Caribbean. The university has maintained it didn’t know about the offshore trial because he pursued that through Rational Vaccines, a company the professor co-founded in 2015.

But criticism has been raised about the university’s ties to Halford’s commercial venture.

SIU, based in Springfield, Ill., shared in a patent on the prospective vaccine with Rational Vaccines, which was formed to market and research the product. The university promoted Halford’s vaccine research on its website. And when a company owned by Peter Thiel, a supporter of President Donald Trump’s, invested millions of dollars into the research this April, SIU publicly trumpeted Halford and Rational Vaccines.

The Food and Drug Administration, which oversees the safety of vaccine research in the U.S., declined to comment on the 2013 experiments. It previously declined comment on the 2016 trial.

Since Halford’s death in June, several participants who received the vaccine in 2013 and 2016 have told KHN they have informed the university about what they fear may be side effects from the vaccine.

One participant who says he received the injections in Illinois fears that the vaccine, which contains a live virus, may have given him a new and different type of herpes he did not have, a scenario that experts who reviewed his medical details for KHN said was possible.

In recent weeks, that participant from Texas and a woman from Colorado who took part in the St. Kitts trial have separately electronically reported to the FDA their possible side effects, also known as “adverse events.”

They said SIU and the FDA have not adequately addressed their inquiries.

“It makes me angry that Halford went ahead with the offshore trial anyway,” said the man from Texas who did not want to be publicly identified because of the sensitive nature of his disease. “I hope more people weren’t hurt.”

Rational Vaccines has vowed to proceed with the research. The company, founded by Halford and Hollywood filmmaker Agustín Fernández III, has said it considers the 2016 trial a success — though it is unclear what data it used to support that claim. In a statement, Rational Vaccines said that Fernández was not involved with Halford’s work before the company was formed but that Fernández was aware of “individuals who experienced positive outcomes from the vaccine.”

“Their stories are what sparked Mr. [Fernández’] future involvement,” the company stated. It did not address specific questions from KHN about the 2013 injections.

A representative for billionaire PayPal co-founder Thiel did not respond to questions about his investment in the vaccine. Thiel and other backers share libertarian political views that are critical of the FDA’s regulations.

The 2013 emails and interview with a participant show Halford began unregulated human experiments while working as an associate professor in the medical school’s department of microbiology.

The Texas patient said he first learned of Halford’s work through a members-only Facebook account. According to the emails, one woman helped Halford recruit patients and organize injections. This woman identified herself to KHN in an email as a herpes patient who was injected with Halford’s vaccine. She claims she was cured as a result.

KHN attempted to contact the other participants who received injections in 2013. They either declined to comment or did not respond.

In the emails, Halford describes some of his methods, including that he was varying the doses — as well as the number of shots. He communicated regularly with participants using a familiar tone.

“Just wanted to pass along that I immunized someone with the higher dose of the HSV-2 vaccine on Monday, and I attach the photos of the injection site at 48 hours to give you and everyone else an idea of what to expect …” he wrote on Sept. 19, 2013. “This individual requested that I give him two immunizations to double the effect … one immunization per leg.”

“Everyone’s vaccines contained ~150 million infectious units of the HSV-2 vaccine strain …” Halford wrote four days later, on Sept. 23, saying the first injection of the group represented about a thirty- to fortyfold increase over what others had received in August 2013.

In the same email, Halford said he believed the experiments were important to demonstrating that his vaccine worked.

“Saturday Sept. 21 definitely represents a milestone in my career,” he wrote. “Don’t know how it will turn out, but I undoubtedly feel like this was a real test of the (a) safety / tolerability of the HSV-2 vaccine and (b) an opportunity to see if it has any therapeutic potential.

“I am indebted to all of you.”

Halford also refers to using his university’s resources in the emails.

“My lab currently consists of myself and 1 graduate student and anything I do with you guys or your blood is extra and on top of what I get paid to do …,” he wrote in a Nov. 3, 2013 email. “If my graduate student gets to it before I do, I will pass along the results.” Attempts by KHN to reach the graduate student, who was not named in the email, were unsuccessful.

When discussing the possible effects of the vaccine in emails dated Oct. 2, 2013, Halford openly speculated about possible results, calling his analysis “nothing more than an educated guess.”

“The proof is in the pudding … let’s see if your problems with outbreaks dial back or not.”

The participants treated Halford with deference and were eager to receive the injections, the emails show.

The Texas man said he did not know how the trial was financially supported, adding that Halford wouldn’t accept money from participants because, as he told them, “it would get him in more trouble if he was ever caught.”

But Halford told participants they could donate money to SIU for his research, the Texas man said. SIU has confirmed that it set up a business account for donations to Halford, but the university has refused to say how the money was used.

When Halford invited them for dinner and drinks at his house, they agreed.  “I’ll do whatever he wants,” the Dallas man wrote about the dinner.

In the emails, the participants, who ranged in age from their 20s to 50s, were enthusiastic about the potential for the vaccine and freedom from often excruciating chronic symptoms. “I do believe [it’s] safe,” the Texas man wrote Halford on Sept. 15.

But months later, on Feb. 24, 2014, he said, he was frightened by a reaction to the vaccine, after his second shot. “I got a large rash on my leg and it burned and swelled,” he wrote to Halford. “… then a blister popped up.”

The Texas man has HSV-1, which usually emerges in sores on the face. Halford’s vaccine was a weakened version of HSV-2, which is genital herpes, according to descriptions he uses in the emails. “I did not think the HSV-2 vaccine strain would be capable of reactivation, but perhaps I will have to reconsider that,” Halford wrote in response in an email.

Anna Wald, a leading herpes expert at the University of Washington, said Halford should have informed the Texas man before testing that he was vulnerable to having side effects because he had a different herpes virus type than the vaccine Halford prepared.

Wald said Halford’s research — without oversight — jeopardized the patients.

“We’re not allowed to do this to guinea pigs in this country let alone human subjects,” Wald said.

But Wald said she could understand the participants’ desire for a chance at a cure. “People underestimate how desperate people with genital HSV are,” she said. “This is what drives even the possibility of a study such as Halford’s.”

SIU continues to be under scrutiny. Jerry Kruse, the dean of SIU’s medical school, responded to the HHS inquiry into the 2016 trial on Oct. 6 and indicated that the university has more to discover.

In his letter, obtained by KHN under the Freedom of Information Act, the dean said “if deemed necessary, SIU will develop an effective corrective action plan.” Some of the letter is redacted.

Several participants from both trials told KHN they have asked SIU for help.

The Colorado woman from the 2016 trial who reported a possible side effect from the vaccine to the FDA said she found university officials “dismissive.”

One participant, a Californian in his 30s, said he wanted the university to continue the vaccine work with safety oversight while “taking responsibility” for any improprieties.

SIU did not adequately address his questions, and he said: “It was obvious they want nothing to do with us.”

KHN’s coverage of these topics is supported by Laura and John Arnold Foundation and Gordon and Betty Moore Foundation

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First Edition: November 21, 2017

Puertorriqueños desplazados enfrentan obstáculos para tener seguro médico

El gobierno federal otorgó a las personas afectadas por los devastadores huracanes que impactaron en los estados costeros y en Puerto Rico este verano 15 días adicionales para inscribirse y obtener cobertura médica bajo la Ley de Cuidado de Salud Asequible (ACA).

Sin embargo, los puertorriqueños que se han instalado en los Estados Unidos continental después que sus casas o negocios fueran destruidos enfrentan problemas más complejos que esa fecha límite.

Muchos de estos estadounidenses tienen preguntas complicadas sobre si su cobertura del Medicaid o Medicare de Puerto Rico puede modificarse (o incluso no funcionar) en sus nuevos hogares. Y para aquellos que buscan seguro privado, usar los mercados de ACA probablemente sea una experiencia nueva, ya que la ley federal de salud no se estableció en la isla.

Los miembros del Congreso de Florida dijeron el miércoles 15 de noviembre que les preocupa que muchos de estos recién llegados, así como las aseguradoras y los navegadores que ayudan a los consumidores con la inscripción, estén confundidos. El grupo envió una carta a Seema Verma, directora de los Centros de Servicios de Medicare y Medicaid (CMS), exigiendo que los funcionarios federales envíen una hoja informativa para “proporcionar la claridad necesaria y aliviar la confusión” entre los puertorriqueños que se han trasladado a los Estados Unidos.

Para la mayoría de las personas, el período abierto de inscripción para obtener cobertura a través de los mercados de la ley de salud termina el 15 de diciembre. Ante las dificultades causadas por las tormentas de agosto y septiembre, los residentes de las zonas más afectadas de Texas, Florida y Georgia tienen un período de gracia de 15 días extra para inscribirse, hasta el 31 de diciembre. Pero retrasar la inscripción significa que el inicio de su cobertura tendría que esperar hasta el 1 de febrero.

Muchos puertorriqueños expulsados ​​de sus hogares, sin embargo, están enfrentando un proceso más complicado. Además de aquellos que están aprendiendo cómo usar los mercados de seguros privados, algunos están aplicando para obtener una nueva cobertura del Medicare. En Puerto Rico, casi tres cuartas partes de los beneficiarios del Medicare tienen planes privados Advantage. Muchos tienen preguntas sobre si seguirán cubiertos por esos planes en el continente.

Además, el programa del Medicaid para residentes de bajos ingresos en Puerto Rico cubre casi a la mitad de los residentes de la isla, una tasa más alta que cualquier otro estado, por lo que las personas que se mudan a Estados Unidos continental pueden no calificar. Esto es especialmente cierto si su nuevo estado no expandió el Medicaid bajo ACA para todos los adultos que ganan hasta el 138 por ciento del nivel de pobreza federal (alrededor de $16,000 para un individuo). Tal es el caso de Florida.

Como mínimo, los nuevos residentes que deseen cobertura del Medicaid deberán volver a presentar una solicitud. Generalmente, la forma más efectiva de hacerlo es a través de los mercados de ACA. Ese proceso les mostrará si son elegibles para el Medicaid o tal vez para un subsidio federal con el cual podrían comprar un plan privado.

Según un memo de los CMS publicado en septiembre, los desplazados por los huracanes pueden llamar a la línea de ayuda de cuidadodesalud.gov (1-800-318-2596) y presentar una solicitud. La nota, que no proporciona detalles sobre qué documentación se necesita, también dice: “las personas pueden experimentar eventos que califican debido a un huracán que los hace elegibles para un período de inscripción especial (SEP)” para acceder a otro plan de salud. Por ejemplo, las personas que se mudaron temporalmente a Florida debido a un huracán y ahora están fuera del área de cobertura de su plan de salud podrían ser elegibles para un período especial de inscripción debido a la mudanza.

Después de las tormentas en agosto y septiembre, la Agencia Federal para el Manejo de Emergencias (FEMA) designó a todos los condados en Florida y Georgia, y 53 en Texas, para recibir “asistencia individual” o “asistencia pública”. En Puerto Rico, esta categoría fue otorgada a 31 de los 78 municipios de la isla.

Aun así, Anne Packham, directora del proyecto de mercado de seguros en Covering Central Florida, una organización con sede en Orlando, dijo que la atención debe enfocarse en alentar a los consumidores a registrarse antes del 15 de diciembre, el último día en que la gente puede inscribirse para la cobertura que comienza el 1 de enero.

“Todo es ya muy confuso, y creemos que decirles a los consumidores que pueden registrarse hasta el 31 de diciembre durante un período especial es agregar confusión”, dijo. “Estas personas necesitan un seguro en este momento, el 1 de enero, no en febrero”.

Después del huracán, más de 140,000 puertorriqueños llegaron a la zona central de Florida, según la oficina del gobernador Rick Scott, para quedarse durante meses, o para establecerse y comenzar una nueva vida. Buscar seguro y atención médica ha sido arduo.

Marni Stahlman, presidenta y CEO de Shepherd’s Hope Inc., una organización con sede en Orlando que ayuda a las personas a encontrar cobertura y servicios, recordó a una pareja de puertorriqueños que la pasó mal.

“El hombre tenía Medicare, y ella, quien es maestra retirada, tiene seguro de salud a través de su sindicato. Ambos se encontraron con obstáculos”, contó Stahlman. “El plan de Medicare del esposo no era aplicable en el continente y tampoco el plan privado de la esposa. Ambos han tenido que comenzar de nuevo. Él volvió a solicitar el Medicare y ella tuvo que presentar una solicitud por primera vez en un mercado de seguros. En este momento todavía están sin cobertura, algo que nunca tuvieron que enfrentar”.

Maria Gotay y sus hijos, Edwin Rodriguez (izq.) y Cristian Rodriguez. Los tres llegaron a Orlando, Fla., dos semanas después de la tormenta y tuvieron que realizar el proceso para tener cobertura de salud. (Foto: cortesía María Gotay)

Para muchas familias, la falta de documentos y suministros complica la situación. Los huracanes no solo devastaron vidas, hogares y se llevaron la electricidad, también arrasaron con medicinas, recetas, tarjetas de seguro médico y copias de declaraciones de impuestos.

“La ayuda para todos, pero para los puertorriqueños en particular, tiene que ser integral porque estas personas solo llegan con sus pasaportes”, dijo Jean Zambrano, vicepresidenta de operaciones médicas de Shepherd’s Hope.

Entre los recién llegados a Florida, hay al menos 18,000 niños y adolescentes que necesitan atención médica inmediata, debido a que se les exige exámenes de vista y audición, y presentar sus vacunas, para asistir a la escuela. Stahlman y Zambrano dijeron que no hay un esfuerzo coordinado a nivel estatal para allanarles el camino.

La articulación de estos procesos entre los territorios y Estados Unidos continental no es un mecanismo aceitado, y la atención médica puede pasarse por alto, lo que significa que el último recurso para muchos que necesitan un doctor es la sala de emergencias.

Aquellos que llegan con sus documentos importantes tienen el éxito un poco más asegurado. María Gotay, de 51 años, llegó a Orlando desde Bayamón, Puerto Rico, con sus dos hijos, Cristian, de 17, y Edwin, de 22, 10 días después que el huracán María devastara la isla.

“Guardamos nuestros documentos en un lugar seguro”, dijo, por lo que los tuvo listos cuando solicitó cobertura de salud para sus hijos.

La navegadora Doris Allen, de Covering Central Florida, la ayudó a inscribir a su hijo menor en el Programa de Seguro de Salud Infantil (CHIP) y al mayor en un plan privado por $33 al mes después de un subsidio. Maria Gotay ya estaba cubierta por el Medicare: tiene un status de discapacidad ya que sufre de fibromialgia.

“Fuimos muy afortunados de conocer a personas que nos apoyaron”, dijo Gotay. Recordó haber llegado al centro de salud y haber caído en los brazos de Allen llorando desconsoladamente. “Nunca quise salir de Puerto Rico, nunca imaginé estar al borde de la muerte”.

“Durante el huracán, todos estábamos juntos, nuestra casa se dañó e inundó, pero resistió el ataque de María”, dijo Gotay.

La mujer trajo a sus hijos a Orlando porque sus dos hijas ya viven allí. Su esposo se quedó en la isla cuidando a su padre, que muestra signos de Alzheimer.

Gotay dijo que vive con estrés y miedo desde el huracán, y que ha estado viendo a un psiquiatra en Orlando que la está ayudando a superarlo. A pesar de todo, regresará a Puerto Rico este mes, mientras que sus hijos se quedarán en Florida y comenzarán una nueva vida.

Esta historia fue producida por Kaiser Health News, un programa editorialmente independiente de la Kaiser Family Foundation.

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Doctor’s Rx For A Stiff Knee: A Prescription For 90 Percocet Pills

I recently hobbled to the drugstore to pick up painkillers after minor outpatient knee surgery, only to discover that the pharmacist hadn’t yet filled the prescription. My doctor’s order of 90 generic Percocet exceeded the number my insurer would approve, he said. I left a short time later with a bottle containing a smaller number.

When I got home and opened the package to take a pill, I discovered that there were 42 inside.

Talk about using a shotgun to kill a mosquito. I was stiff and sore after the orthopedist fished out a couple of loose pieces of bone and cartilage from my left knee. But on a pain scale of 0 to 10, I was a 4, tops. I probably could have gotten by with a much less potent drug than a painkiller like Percocet, which contains a combination of the opioid oxycodone and the pain reliever acetaminophen, the active ingredient found in over-the-counter Tylenol.

When I went in for my follow-up appointment a week after surgery, I asked my orthopedist about those 90 pills.

“If you had real surgery like a knee replacement you wouldn’t think it was so many,” he said, adding that the electronic prescribing system set the default at 90. So when he types in a prescription for Percocet, that’s the quantity the system orders.

Such standard orders can be overridden, but that’s an extra step for a busy physician and takes time.

As public health officials grapple with how to slow the growing opioid epidemic — which claims 91 lives each day, according to federal statistics — the over-prescription of narcotics after even minor surgery is coming under new scrutiny.

While patients are today often given opioids to manage post-operative pain, a large supply of pills may open the door to opioid misuse, either by the patients themselves or others in the family or community who get access to the leftovers.

Post-surgical prescriptions for 45, 60 or 90 pills are “incredibly common,” said Dr. Chad Brummett, an anesthesiologist and pain physician at the University of Michigan Medical School.

Last year, the Centers for Disease Control and Prevention released a general guideline saying that clinicians who prescribe opioids to treat acute pain should use the lowest effective dose and limit the duration to no longer than seven days.

But more detailed guidance is necessary, clinicians say.

“There really aren’t clear guidelines, especially for surgery and dentistry,” Dr. Brummett said. “It’s often based on what their chief resident taught them along the way, or an event in their career that made them prescribe a certain amount.” Or, as in my case, an automated program that makes prescribing more pills simpler than prescribing fewer.

Brummett is co-director of a Michigan program that has released recommendations for post-surgical opioid prescribing for a growing list of procedures.

To determine the extent to which surgery may lead to longer-term opioid use, Brummett and his colleagues examined the insurance claims of 36,177 adults who had surgery in 2013 or 2014 for which they received an opioid prescription. None of the patients had prescriptions for opioids during the prior year.

The study, published online in JAMA Surgery in June, found that three to six months after surgery, roughly 6 percent of patients were still using opioids, having filled at least one new prescription for the drug. The figures were similar whether they had major or minor surgery. By comparison, the rate of opioid use for a control group that did not have surgery was just 0.4 percent.

Some insurers and state regulators have increasingly stepped in to limit opioid prescriptions. Insurers routinely monitor doctors’ prescribing patterns and limit the quantity of pills or the dosage of opioid prescriptions, said Dania Palanker, an assistant research professor at Georgetown University’s Center on Health Insurance Reforms who co-authored a study on insurers’ response to the opioid crisis.

At least two dozen states have passed laws or rules in just the past few years aimed at regulating the use of opioids.

In my state of New York, Gov. Andrew Cuomo last year signed legislation that reduced the initial opioid prescription limit for acute pain from 30 days to no more than a seven-day supply.

As my experience demonstrated, however, a seven-day limit (those 42 pills in my case) can still result in patients receiving many more pills than they need. (For those who find themselves in a similar situation with excess pills, here is the safe and proper way to dispose of them.)

Still, some caregivers and patients worry that all this focus on overprescribing may scare physicians away from prescribing opioids at all, even when they’re appropriate.

“That’s my concern, that people are so afraid of things and taking it to such an extreme that patient care suffers,” said Dr. Edward Michna, an anesthesiologist and pain management physician at Brigham and Women’s Hospital in Boston who is on the board of the American Pain Society, a research and education group for pain management professionals. Michna has been a paid consultant to numerous pharmaceutical companies, some of which manufacture narcotics.

But other doctors say that one of the reasons doctors call in orders for lots of pills is their convenience.

“When you land on the front lines, you hear, ‘I like to write for 30 or 60 pills because that way they won’t call in the middle of the night’ ” for a refill, said Dr. Martin Makary, a professor of surgery and health policy at Johns Hopkins School of Medicine.

Makary is spearheading a consortium of Hopkins clinicians and patients that provides specific guidelines for post-surgical opioid use. The program, part of a larger effort to identify areas of overtreatment in health care, also identifies outlier prescribers nationwide to encourage them to change their prescribing habits.

The Hopkins group doesn’t have an opioid recommendation for my surgery. The closest procedure on their website is arthroscopic surgery to partially remove a torn piece of cartilage in the knee called the meniscus.  The post-surgical opioid recommendation following that surgery: 12 tablets.

Please visit khn.org/columnists to send comments or ideas for future topics for the Insuring Your Health column.

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Massachusetts Grabs Spotlight By Proposing New Twist On Medicaid Drug Coverage

In the absence of new federal policies to tame break-the-bank drug prices, Massachusetts’ state Medicaid program hopes to road-test an idea both radical and market-driven. It wants the power to negotiate discounts for the drugs it purchases and to exclude drugs with limited treatment value.

“This is a serious demonstration proposal,” said Sara Rosenbaum, a health policy expert and professor at George Washington University. “They’re not simply using [this idea] as an excuse to cut Medicaid. They’re trying to take a step toward efficiency.”

If the Department of Health and Human Services approves the Bay State’s plan, others will likely take similar action. According to the most recent federal data, Medicaid spending on prescription drugs increased about 25 percent in 2014 and nearly 14 percent in 2015.

Currently, state Medicaid programs are required to cover almost all drugs that have received Food and Drug Administration approval, including multiple drugs from different manufacturers used for the same purpose and in the same category. In exchange, manufacturers must discount those drugs — typically based on a set percentage of the list price, specified by federal law. The idea is Medicaid’s vulnerable beneficiaries get medications they need and the state doesn’t go broke paying for them.

As drug prices soar, states say, those fractional rebates no longer suffice to defray the burden of rising costs.

Take, for instance, the hepatitis C cures released in recent years. The price tags come in tens or even hundreds of thousands of dollars and — even after rebates — have cost Medicaid billions. In turn, some states tried to restrict access, so only the sickest patients could get the drugs. Advocates filed suit in response and won based on the argument that such limits violated Medicaid’s statutory drug benefit.

State officials contend that the current Medicaid rebate system may encourage drug price inflation, since a set percentage of a higher price yields a greater profit. Also, the legal requirement to cover most prescriptions leaves little wiggle room to negotiate a better price.

So, Massachusetts wants to go a different route, requesting a federal exemption known as a Section 1115 waiver, which is meant to let states test ways of improving Medicaid. It wants to pick which drugs it covers based on most beneficiaries’ medical needs and which medicines demonstrate the highest rates of cost effectiveness.

It says it will be able to negotiate better prices as a result, saving public dollars while maintaining patients’ access to needed therapies.

The federal Centers for Medicare & Medicaid Services, which will ultimately approve or reject Massachusetts’ proposal, has no deadline for its decision. A Massachusetts spokeswoman said officials are pushing for an answer by year’s end.

Already, though, the pitch is turning heads.

“This is absolutely something a lot of other states are looking very closely at,” said Matt Salo, executive director of the National Association of Medicaid Directors.

If the request is approved, agreed Jane Horvath, a senior policy fellow at the National Academy for State Health Policy, other states would follow suit “in about five minutes.”

Critics worry this change could make it harder for low-income people to get needed medications, without necessarily providing them an alternative. In the past decade, though, it has become commonplace for people with commercial insurance to have limited drug choices — meaning only those medicines listed on a plan’s formulary are covered.

The Pharmaceutical Research and Manufacturers of America (PhRMA), the drug industry’s trade group, has already lodged its displeasure, saying this would limit consumer access and is unnecessary on top of the rebates Medicaid programs receive.

“The pharmaceutical industry has a reputation for being litigious. This would be a big deal for them,” said Andy Schneider, a Medicaid expert at Georgetown University, who worked at CMS under the Obama administration. If CMS approves the waiver, analysts said, the industry would likely sue, though PhRMA wouldn’t comment on potential legal action.

But federal approval is no sure thing.

On one hand, the Trump administration has encouraged states to test changes that would run Medicaid more like a private insurance plan. Through that frame, Massachusetts’ approach seems a logical fit. Though a formal strategy has not been released, President Donald Trump has said his administration intends to bring drug prices “way down.”

On the other hand, analysts said, CMS’ decision-making regarding waivers has proven unpredictable. The agency declined to comment beyond confirming it was reviewing Massachusetts’ request.

It’s clear why states are interested. On average, between 25 and 30 percent of state budgets go to Medicaid, and program directors across the country identify rising drug costs as a major contributor to spending increases, according to a recent survey by the Kaiser Family Foundation. (Kaiser Health News is an editorially independent program of the foundation.)

In Massachusetts, Medicaid accounts for about 40 percent of the state’s budget. Prescription-drug spending has in the past seven years more than doubled — from about $917 million in 2010 to about $1.94 billion last year, according to figures provided by the state health department.

If the waiver is approved, the state’s Medicaid program would cover at least one medication per therapeutic class — that is, per specific medical need.

It also would have an appeals process for people to get their off-formulary drugs covered, if they’re medically necessary.

Number crunchers say it’s hard to estimate what this would save. It depends on how the state negotiates, how industry responds and what the program covers. The potential result is significant, though.

“You’d have to be foolish not to consider this,” said Ameet Sarpatwari, an epidemiologist and lawyer at Harvard Medical School, who studies drug pricing and related legislation.

But consumer groups worry about Medicaid’s low-income beneficiaries, even as they acknowledge that rising drug costs are unsupportable for state budgets.

“The Medicaid population is different from the commercially insured — they’re more vulnerable and have a lot more going on in their lives, and are generally poorer. So they have fewer resources to try to get the services and prescription drugs they need,” said Suzanne Curry, associate director of policy and government relations at Health Care For All, a Massachusetts-based advocacy group.

Although Massachusetts, a state with a long history of innovation, has committed to making sure patients get needed medicine, “you have to ask what will real-world implementation looks like,” said Benjamin Sommers, an associate professor of health policy and economics at Harvard’s public health school. Appeals processes, he noted, can be onerous or restrictive.

And even if Massachusetts receives federal approval, it still couldn’t challenge the cost of certain expensive drugs that are the only offering in their therapeutic class. For instance, Spinraza, which treats the rare but debilitating disease of spinal muscular atrophy, has a price tag of $750,000 for an initial year of treatment. With no therapeutic equivalent, it would still have to be covered.

But states are desperate to push back in new ways and however they can. “We have seen in the past year … drugs that have almost bankrupted state budgets,” Sarpatwari said. “There will be many other states that will be interested in following this lead.”

KHN’s coverage of prescription drug development, costs and pricing is supported by the Laura and John Arnold Foundation.

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Displaced Puerto Ricans Face Obstacles Getting Health Care

The federal government has granted people affected by the devastating hurricanes that wracked coastal states and Puerto Rico 15 extra days to sign up for health coverage under the Affordable Care Act.

But Puerto Ricans who fled to the mainland after the destruction face problems well beyond timing.

Many of those Americans have complicated questions about whether the Medicaid or Medicare coverage they had in Puerto Rico will shift with them to their new locations. And for those seeking private coverage, using the ACA’s insurance marketplaces will likely be a new experience because the federal health law didn’t establish those marketplaces in the U.S. territory.

Members of Congress from Florida said Wednesday they are concerned that many of these recent arrivals, as well as insurance companies and navigators, are confused. They sent a letter to Seema Verma, the director of the Centers for Medicare & Medicaid Services (CMS), requesting that federal officials put out a fact sheet to “provide much-needed clarity and alleviate confusion” among Puerto Ricans who have relocated to the States.

Insurance enrollment on the health law’s marketplaces ends for most people Dec. 15. In a bow to the hardships caused by the August and September storms, residents living in hard-hit areas of Texas, Florida and Georgia are allowed to sign up as late as Dec. 31. But waiting until those final 15 days means that the start of their coverage is delayed until Feb. 1.

Many Puerto Ricans driven from their homes, however, are negotiating layers of red tape. In Puerto Rico, nearly three-quarters of Medicare beneficiaries are in private Advantage plans. Many have questions about whether those plans will cover them stateside.

Also, the Medicaid program for low-income residents in Puerto Rico covers nearly half of the island’s residents  — a rate higher than any state — but it’s not clear that people moving stateside will continue to qualify because they may not meet the tighter eligibility standards. That is especially true if their new home state did not expand Medicaid under the ACA to all adults earning up to 138 percent of the federal poverty level (about $16,000 for an individual).

At the very least, they will have to reapply for Medicaid coverage. Often the most effective route is through the ACA marketplaces. That process will show them whether they are eligible for Medicaid or perhaps a federal subsidy to purchase a private plan.

According to a CMS memo released in September, they can call the healthcare.gov help line (1-800-318-2596) for help. The memo, which doesn’t provide details about what documentation is needed, also says that “individuals may experience qualifying events due to a hurricane that makes them eligible for a special enrollment period (SEP)” to access another health plan. For example, individuals who temporarily relocated to Florida due to a hurricane and are now out of their health plan coverage area could be eligible for a special enrollment period because of the move.

After the storms hit, the Federal Emergency Management Agency (FEMA) designated all counties in Florida and Georgia, and 53 in Texas, to receive “individual assistance” or “public assistance.” In Puerto Rico, this category was granted to 31 of the island’s 78 municipalities.

Still, Anne Packham, director of the insurance marketplace project at Covering Central Florida, an organization based in Orlando, said the focus should be on encouraging consumers to register before Dec. 15, the last day most people can sign up for coverage that begins Jan. 1.

“Everything is already very confusing, and we think that telling consumers that they can register until Dec. 31 during a special period is adding confusion,” she said. “These people need insurance right now, on Jan. 1, not February.”

Since the storms, more than 140,000 Puerto Ricans have arrived in the central area of ​​Florida, according to Gov. Rick Scott’s office. They may stay only for a few months or settle to start a new life. Seeking insurance and medical attention has proven arduous.

Marni Stahlman, president and CEO of Shepherd’s Hope Inc., an organization based in Orlando that helps people find coverage and services, recalled one Puerto Rican couple that had a tough time.

He had Medicare and she was a retired teacher who had insurance through her union, Stahlman said. “The husband’s Medicare policy was not applicable on the mainland and the wife’s was not honored either,” she said. “Both have had to start over. He with reapplying for Medicare and she had to apply for the very first time in a marketplace. They are at this time still ‘uninsured,’ something that they have never had to encounter.”

Maria Gotay and her sons, Edwin Rodriguez (left) and Cristian Rodriguez. They came to Orlando, Fla., two weeks after Hurricane Maria hit Puerto Rico. Having important papers helped them through the process to obtain health care. (Courtesy of Maria Gotay)

Complicating the situations for many families is the lack of records and supplies. The hurricanes not only devastated lives, homes and power, but they also took medicines, prescriptions, insurance cards and copies of tax returns.

“Help for everybody, but for Puerto Ricans in particular, it has to be integral because these people only arrive with their passports,” said Jean Zambrano, vice president of medical operations at Shepherd’s Hope.

Among the newcomers to Florida, there are at least 18,000 children and adolescents who need medical attention quickly because they are required to get vision, hearing and immunization screenings to attend school. Stahlman and Zambrano said there is no coordinated effort at the state level to pave the way for them.

Maneuvering between the territories and the States is not a well-oiled machine, and health care can fall through the cracks — which means the last resort for many needing medical attention is the emergency room.

Those who arrive with their important papers help ensure success. María Gotay, 51, arrived in Orlando from Bayamón, Puerto Rico, with her two boys, Cristian, 17, and Edwin, 22, 10 days after Hurricane Maria ravaged the island.

“We keep our documents in a safe place,” she said, so she had them ready when applying for coverage for her children.

Navigator Doris Allen, from Covering Central Florida, helped sign up Gotay’s younger son for the Children’s Health Insurance Program (CHIP) and the older one in a private insurance plan for $33 a month after a subsidy. Maria Gotay was already covered by Medicare because she has a disability from fibromyalgia.

“We were very fortunate to meet such supportive people,” said Gotay. She recalled arriving at the health center and falling in Allen’s arms crying hysterically. “I never wanted to leave Puerto Rico, I never imagined being at the edge of dying.”

“During the hurricane, we were all together, our house was damaged and flooded, but it withstood Maria’s onslaught,” said Gotay.

She brought her sons to Orlando because her two daughters were already living there. Her husband stayed on the island, caring for his father who shows signs of Alzheimer’s, she said.

She said she has enormous stress and fear following the hurricane, and has been seeing a psychiatrist in Orlando to get help. However, she will return to Puerto Rico this month, while her boys stay in Florida to begin a new life.

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