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Growing health care crisis in Puerto Rico

Puerto Rico’s Medicaid funding crisis is deepening, adding yet another issue for Congress to deal with in what is sure to be a hectic December.

Hurricane Maria caused serious damage to Puerto Rico’s health-care system, and none of the federal disaster relief money to date has been earmarked for the Medicaid program.

A $44 billion supplemental payment request from the White House on Friday said the administration was “aware” that Puerto Rico needed Medicaid assistance, but it put the onus on Congress to act.

Efforts to provide the money through legislation have failed so far. Advocates and lawmakers are now eying the upcoming year-end spending bill as a solution, given that the bill may become a “Christmas tree” loaded up with policy provisions.

But there’s no guarantee that the Medicaid money will make it in, as lawmakers are grappling with several hot-button issues heading into December, including immigration, Trump’s proposed border wall, ObamaCare payments to insurers, and an extension of the Children’s Health Insurance Program.

Advocates are worried Puerto Rico could get left behind in the legislative frenzy to come.

“This could be the mother of all appropriations bill,” said Edwin Park, vice president for health policy at the Center on Budget and Policy Priorities (CBPP).

“And if the Senate is focused on taxes when they get back from Thanksgiving … are they going to be able to get to all of these? Puerto Rico and the Virgin Islands could fall through the cracks,” Park said.

Some lawmakers blasted the Trump administration’s disaster request on Friday, saying $44 billion is not nearly enough.

In a joint statement, House Energy and Commerce Committee ranking members Frank Pallone Jr. (D-N.J) and Senate Finance Committee ranking member Ron Wyden (D-Ore.) called on the administration to “immediately provide additional funding and extend a one-hundred percent funding match for Medicaid in Puerto Rico and the U.S. Virgin Islands just as we did in the aftermath of Hurricane Katrina.”

The territory has grappled with funding shortfalls. Before the storm, the island had enough Medicaid money to last until April 2018.

Now, experts predict that unless Congress acts, federal funding will be exhausted in a matter of months. If that happens, Puerto Rico — already cash-strapped — will be responsible for covering all its Medicaid costs going forward.

The Puerto Rican government has asked Congress and the Trump administration for help staving off the crisis. In late October, Gov. Ricardo Rosello requested $1.6 billion a year over the next five years.

“The total devastation brought on by these natural disasters has vastly exacerbated the situation and effectively brought the island’s healthcare system to the brink of collapse,” Rosello wrote in a letter to congressional leaders.

Lara Merling, a research assistant at the Center for Economic and Policy Research, said the governor is asking for only a fraction of what’s really needed.

“It’s the bare minimum to keep the system afloat,” Merling said. The program cost almost $2.5 billion in 2016, so the reimbursement would only cover about 60 percent of the cost.

The House earlier this month passed legislation reauthorizing CHIP that would also give Puerto Rico $1 billion a year for the next two years, specifically aimed at shoring up the island’s Medicaid program.

Rosello said he supported using CHIP because he didn’t want lawmakers to be distracted with other issues.

Addressing the shortfall as part of CHIP “would also remove this matter from consideration in the year-end appropriations package where Congress will need to focus its energies on addressing Puerto Rico’s recovery and long-term reconstruction needs,” Rosello said in the letter.

Despite the progress in the House on CHIP, the Senate has not moved forward with its version of the legislation.

Sen. Marco Rubio (R-Fla.) has expressed general support in recent months for helping to mitigate Puerto Rico’s Medicaid woes, but has not endorsed any specific proposals.

The Senate Finance Committee passed a CHIP bill without Puerto Rico funding, and ever since, the upper chamber has been focused on ObamaCare repeal and tax reform.

Congressional aides and outside lobbyists acknowledge that CHIP will likely only pass as part of the spending bill.

A senior Senate Democratic aide said Democrats would be pushing to include Rosello’s full request in the bill. But Democrats are also demanding a series of concessions for Republicans to get their votes, presenting the opportunity for gridlock.

If Puerto Rico doesn’t get the $8 billion Rosello has asked for, CBPP’s Park said it’s not clear when or how the funding gap could be addressed.

There will likely be future disaster supplemental funding bills, but conservatives are likely to demand that the costs of those bills be offset, he said.

“So then offsets get problematic, it gets bogged down over time … does that make it harder to include Medicaid money in the future?” Park said.

If Puerto Rico’s federal Medicaid funding runs out, up to 900,000 people would likely be cut from Medicaid — more than half of total enrollment, according to federal estimates.


Mount Sinai researchers identify new therapeutic target for ER+ breast cancer

Researchers at the Icahn School of Medicine at Mount Sinai have identified a protein that can be targeted to suppress growth of a common type of breast cancer known as “estrogen receptor positive” (ER+), including ER+ cancers that are resistant to standard treatments.

The protein, tyrosine kinase 6 (PTK6), is an enzyme molecule that is highly expressed in multiple tumor types, including prostate, ovarian, and breast cancers. It can promote cancer cell survival and growth of ER+ breast cancer cells. The study, titled “PTK6 regulates growth and survival of endocrine therapy-resistant ER+ breast cancer cells,” was published in an online study today in NPJ Breast Cancer.

“Never before has PTK6 inhibition been shown to inhibit growth and induce cell death of ER+ breast cancer cells, including those resistant to standard treatments for this subtype such as tamoxifen,” said Hanna Irie, MD, PhD, Assistant Professor of Medicine (Hematology and Medical Oncology) and Oncological Sciences at The Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, and senior author of the study. “We are excited and gratified by these remarkable results, which could lead to a new way to treat these drug resistant metastases of ER+ breast cancers and/or prevent their metastases in the first place.”

According to Dr. Irie, the research is especially important because it supports the potential therapeutic value of targeting PTK6 in ER+ breast cancers, which constitute the most common subtype of breast cancer. Approximately 65 percent of all breast cancers express the estrogen receptor (ER +) and/or the progesterone receptor (PR+). One in eight women in the United States has a chance of being diagnosed with breast cancer and an estimated 250,000 new cases of invasive breast cancer are expected to be diagnosed in 2017.

Standard treatments for ER+ breast cancer are endocrine therapies such as tamoxifen and aromatase inhibitors. “Endocrine therapies are still the most effective medical therapy for this subtype of breast cancer, and the end goal is to inhibit growth and/or kill ER+ breast cancer cells,” said Dr. Irie. “However, some breast cancer patients still develop metastatic ER+ disease despite these common endocrine therapies, so newer treatments are very important and necessary to kill endocrine therapy-resistant cancers.”

“This is a truly exciting discovery for the field of breast cancer,” said Ramon Parsons, MD, PhD, Director of The Tisch Cancer Institute. “This breakthrough could lead to more effective therapies for women with this very common subtype of breast cancer and be the therapeutic target that the drug companies have been waiting for.”

Finding possible therapeutic fix for autism, intellectual disability

A breakthrough in finding the mechanism and a possible therapeutic fix for autism and intellectual disability has been made by a University of Nebraska Medical Center researcher and his team at the Munroe-Meyer Institute (MMI).

Woo-Yang Kim, Ph.D., associate professor, developmental neuroscience, led a team of researchers from UNMC and Creighton University into a deeper exploration of a genetic mutation that reduces the function of certain neurons in the brain.

Dr. Kim’s findings were published in this week’s online issue of Nature Neuroscience.

“This is an exciting development because we have identified the pathological mechanism for a certain type of autism and intellectual disability,” Dr. Kim said.

Recent studies have shown that the disorder occurs when a first-time mutation causes only one copy of the human AT-rich interactive domain 1B (ARID1B) gene to remain functional, but it was unknown how it led to abnormal cognitive and social behaviors.

Autism spectrum disorder (ASD) impairs the ability of individuals to communicate and interact with others. About 75 percent of individuals with ASD also have intellectual disability, which is characterized by significant limitations in cognitive functions and adaptive behaviors.

There are no drugs or genetic treatments to prevent ASD or intellectual disability; the only treatment options focus on behavioral management and educational and physical therapies.

The team created and analyzed a genetically modified mouse and found that a mutated Arid1b gene impairs GABA neurons, the ‘downer’ neurotransmitter, leading to an imbalance of communication in the brain.

GABA blocks impulses between nerve cells in the brain. Low levels of GABA may be linked to anxiety or mood disorders, epilepsy and chronic pain. It counters glutamate (the upper neurotransmitter), as the two mediate brain activation in a Yin and Yang manner. People take GABA supplements for anxiety.

“In normal behavior, the brain is balanced between excitation and inhibition,” Dr. Kim said. “But when the inhibition is decreased, the balance is broken and the brain becomes more excited causing abnormal behavior.

“We showed that cognitive and social deficits induced by an Arid1b mutation in mice are reversed by pharmacological treatment with a GABA receptor modulating drug. And, now we have a designer mouse that can be used for future studies.”

Next steps for Dr. Kim and his team are to even further refine the specific mechanism for autism and intellectual disability and to identify which of the many GABA neurons are specifically involved.


HHS official downplays concerns over contraceptive rule changes

Worries that big corporations are going to roll back their contraceptive coverage benefits now that the Supreme Court has ruled they can do so are unfounded, Roger Severino, director of the Office for Civil Rights at the Department of Health and Human Services (HHS), said Thursday.

“The fear that [hotel chain] Hilton is somehow going to change its policies on contraceptive coverage … I just don’t see that happening,” Severino said here at a meeting of the Federalist Society’s National Lawyers Convention. “It’s really going to be the Hobby Lobbys of the world, and those are very limited in number, and those rights should be protected.”

Severino was referring to Hobby Lobby, the arts-and-crafts store chain that was the plaintiff in the Supreme Court case successfully challenging the Affordable Care Act’s (ACA) contraceptive mandate.

The chain’s ownership maintained that it should not have to offer contraceptive coverage to its employees because doing so would conflict with the owners’ religious beliefs. Although the ACA includes an exemption to the mandate for religious organizations, it doesn’t include one for for-profit corporations whose owners object. The justices ruled that the government must include such corporations in the exemption.

Severino, who spoke as part of a panel discussion on religious liberty, said he was honored to be a member of an administration that is dedicated to religious freedom, and noted that the thesis of his talk was that “as the state tends to grow, religious liberty tends to shrink — there is a crowding-out effect.” He noted that organized religion is on the decline, with the percentage of Americans who say they do not identify with any religious tradition increasing from 2%-3% in the 1940s and 1950s to 23% today.

“Those that retain their religious beliefs — what has happened with them? We see them banding together on common ground in a way we have not seen before. And as religious believers band together on common ground, we’re seeing separation with those that do not believe.”

People of faith tend to see their religious identity integrated with their sense of self; they don’t turn it on and off like a light switch, he continued. Secularists, on the other hand, “have their own set of moral commitments but they don’t see the religious value … of those that have religious faith, and in some cases [feel that those with faith] can be seen as a threat or challenge to a vision of our common good. Some treat religious belief as with second hand smoke: you can do it in the privacy of your home, but don’t take it outside, and don’t let the children see it.”

At the same time as the attachment to organized religion is declining, there is an increase in the number of state and federal employees, and they’re in some cases displacing religious-motivated charitable activities, said Severino. “There are currently about 2 million federal bureaucrats, and the greatest growth is at the state and local level — about 18 million government workers,” with many of those jobs driven by federal grant funds.

“With both of these [trends], I contend that has led to more friction with religious institutions,” he said. And the ACA, with its loose definition of what constitutes preventive care, “really wrote a blank check to the agencies to impose its own vision of what it means to be an agency pushing the public good in the healthcare space.”

Moreover, he continued, with its specifying of which particular types of religious institutions were and were not eligible for exemptions to the mandate, it was like letting the agencies say, “These are the groups we consider religious enough [to get an exemption] and these are not … It is no surprise that there is a conflict when the federal government takes a view of the public good that differs with organizations of religious faith.”

What can be done? Agencies must rein themselves in, he said. “On the issue of religious freedom, the president in May announced a new religious freedom executive order which put the administration firmly on the side of religious freedom, directed HHS to revisit the contraceptive mandate, and issued two interim final rules protecting rights of religious institutions and organizations of moral conviction, so that burden has been finally lifted.”

He noted that Attorney General Jeff Sessions recently issued religious freedom guidance for federal agencies in rulemaking around these issues. In addition, Severino said that his own office was accepting complaints on issues related to people being able to follow their consciences and religious convictions in providing healthcare.

Newly discovered ‘molecular guardian’ keeps cholesterol in check

Harvard University researchers have identified a protein that helps keep cellular cholesterol levels under control. They call it a “molecular guardian” and it could become a target in the treatment of disorders that involve cholesterol metabolism.

“The cell must guard against any rise in cholesterol—it cannot tolerate levels that are too high or too low,” said senior author Gökhan Hotamisligil in a statement. Excess cholesterol can cause toxicity, inflammation and ultimately cell death.

While the cellular signals used to respond to low cholesterol are well known, the researchers said, it has been unclear how cells tackle high cholesterol. They looked for answers in the endoplasmic reticulum, an organelle surrounded by a membrane that is low in cholesterol and would be particularly vulnerable to a spike in cholesterol, Hotamisligil said.

The search turned up a few molecules that might be involved in cholesterol regulation, but the team zeroed in on the protein Nrf1, the levels of which increase when cellular cholesterol rises. When Nrf1 is blocked in mice, the liver “dramatically enlarged” and became inundated with cholesterol, they said.

Specifically, Nrf1 regulates high cholesterol by binding directly to it. This binding prompts a series of processes in the cell that curb inflammation and stimulate cholesterol removal. The findings are published in the journal Cell.


High cholesterol has no symptoms, but it can lead to atherosclerosis, or cholesterol buildup in the arteries, which can cause chest pain, heart attack or stroke. It is usually managed with dietary changes, exercise and medications like statins or PCSK9 inhibitors.

A recent study found that a PCSK9 inhibitor may be able to immunize people against developing high cholesterol and atherosclerosis. The vaccine induces the production of antibodies that inhibit PCSK9, allowing the body to eliminate LDL, or “bad,” cholesterol.

But scientists are still looking for alternative methods for managing high cholesterol, and the Harvard scientists believe the insight from their research could advance the field. “This discovery really teaches us a lot about how cells maintain cholesterol homeostasis,” Hotamisligil said. “Now, we demonstrate that there is a molecular yin-yang—formed by NRF1 and SREBP2—that together keep cellular cholesterol within a safe, narrow range. That’s an exciting finding that could have broad, new therapeutic applications.”

Building on Cures Act, FDA plots cell therapy fast track

The FDA has created a policy framework for cellular therapies and other regenerative medicines by releasing two draft and two final guidance documents. Publication of the texts builds on the 21st Century Cures Act by setting criteria for the new Regenerative Medicine Advanced Therapy (RMAT) designation and outlining the benefits of the regulatory status.

Given two of the documents are finalized versions of existing texts and a third seeks to simplify the regulation of devices that enable regenerative treatments, the RMAT guidance (PDF) is the novel part of the framework for drug developers. In the guidance, the FDA takes the RMAT status created by the 21st Century Cures Act, contextualizes it against other regulatory designations and explains how and why companies may want to apply.

RMAT is open to investigational regenerative medicine therapies that treat, modify, reverse or cure serious conditions and have generated promising preliminary clinical evidence of efficacy. The FDA cites a single-arm, open-label study of a skin burn cell therapy and a phase 2, dose-finding trial of a heart failure regenerative medicine as examples of the types of experiments that could provide preliminary evidence of efficacy.

Candidates that receive RMAT status will receive all the benefits of the FDA’s fast track and breakthrough designation. The law that created RMAT also covers accelerated approvals and how to satisfy the subsequent post-approval requirements.

The FDA is accepting comments on the RMAT text and draft device guidance for 90 days.


While aspects of the framework are intended to ensure effective regenerative medicines reach patients as soon as possible, FDA commissioner Scott Gottlieb, M.D., also framed it as an attempt to curb the rise of cellular therapies from unscrupulous providers.

“Alongside all the promise, we’ve also seen products marketed that are dangerous and have harmed people,” Gottlieb said in a statement. “With the policy framework the FDA is announcing today, we’re adopting a risk-based and science-based approach that builds upon existing regulations to support innovative product development while clarifying the FDA’s authorities and enforcement priorities.”

The final guidance documents clarify when cell and tissue-based products are exempt from the established regulations and how the FDA interprets “minimal manipulation” and “homologous use.”

Great Migration: 168,000 people move From Puerto Rico to Florida

Following the devastating hurricanes that still have much of Puerto Rico without power, a mass exodus is underway.

The migration rivals those from New Orleans to Houston after Hurricane Katrina and from Cuba to Miami during the Mariel boatlift according to the New York Times story on the “Great Migration“.

More than 168,000 people have flown or sailed out of Puerto Rico to Florida since the hurricane, landing at airports in Orlando, Miami and Tampa, and the port in Fort Lauderdale. Nearly half are arriving in Orlando, where they are tapping their networks of family and friends. An additional 100,000 are booked on flights to Orlando through Dec. 31, county officials said.

The Puerto Rican population of Orlando has exploded from 479,000 in 2000 to well over one million this year, according to the Pew Research Center. The impact of this latest wave is likely to stretch from schools and housing to the work force and even politics.

Puerto Ricans, who are American citizens and tilt Democratic, could sway the electoral results of one of the country’s most pivotal swing states.

Bilingual Strains, Housing Strains

Educators are worried about the impacts and pressures because the kids are largely Spanish speaking.

The area’s two county school districts — Orange and Osceola — have taken in 3,280 new Puerto Rican students since the hurricane, 70 percent of the Florida total, according to district officials.

City administrators are worried about the lack of affordable housing, a problem even before the hurricane migration.

Brain Drain

The New York Times article did not mention the impact on Puerto Rico. Those with money or talent are among those most likely to leave.

On September 29, Politico reported Puerto Rico’s Exodus Begins with a Trickle.

I’ve heard an estimated 15,000 Puerto Ricans from the island will be in Central Florida by mid-October,” said Ney Rivera Garcia, a founding member of Orlando-based Puerto Rican Action Initiative.

We are now at 168,000 and counting.