Overnight Healthcare

Overnight Health Care: Supreme Court nomination reignites abortion fight in states | Trump urges Sessions to sue opioid makers | FDA approves first generic version of EpiPen

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Welcome to Thursday’s Overnight Health Care. The Senate returned for votes last night, and then promptly left town again this afternoon. Light work after a two-week break.

We also have more on an important change Health and Human Services Secretary Alex Azar is bringing to Medicare Advantage plans…. but first:


Supreme Court nomination reignites abortion fights in states

The possibility of another Trump nominee ascending to the Supreme Court bench has created a sense of urgency among abortion supporters in the states, where activists are pushing to safeguard access to the procedure.

Supporters of abortion rights worry that Judge Brett Kavanaugh’s confirmation could lead to the weakening of Roe v. Wade, the landmark Supreme Court decision that cemented a woman’s right to abortion.

They’re encouraging state lawmakers to scrub unenforced laws banning or restricting abortion off the books, should the Supreme Court throw the decision on whether abortion should be legal back to the states.

“We’re seeing more states take a look at their codes and do a little bit of cleaning up old, archaic language that might be problematic in terms of getting abortion care,” said Agata Pelka, state legislative counsel with the Center for Reproductive Rights.

We explain here.


Trump administration cracking down on production of opioids

The Justice Department and Drug Enforcement Agency proposed an average 10-percent decrease in the production quotas for six frequently misused opioids.

The proposed quotas for 2019 would decrease manufacturing for oxycodone, hydrocodone, oxymorphone, hydromorphone, morphine and fentanyl.

Context: The Justice Department sets quotas every year for Schedule I and II drugs. But a recently finalized rule gave the department the power to consider a drug’s potential for abuse when setting production limits. Before the rule was finalized, the agency could only consider factors like past sales and estimated demand.

Why it matters: Experts say the overproduction of opioids has contributed significantly to the ongoing opioid epidemic in the U.S.

What’s next: The proposed quotas will go through a 30-day comment period before being finalized.
Read more here.


In other news on the opioid front… President Trump wants Sessions to sue opioid manufacturers

Speaking during a Cabinet meeting, the president asked Attorney General Jeff Sessions to bring a federal lawsuit against drugmakers that manufacture opioids.

Several states have already filed lawsuits, which the Justice Department has backed, against drug companies that manufacture opioid painkillers.

A separate federal suit would escalate the government’s efforts to combat the drugs and risk a tense standoff with major pharmaceutical companies. Trump already has a difficult relationship with the industry because of his attacks on drug prices.

Lawsuit history: Opioid makers and distributors have been hit with hundreds of lawsuits by states, counties and cities accusing them of using deceptive marketing to sell painkillers.

Purdue Pharmaceuticals, the manufacturer of OxyContin, is facing lawsuits in 27 states for its alleged role in the opioid crisis.

International targets: The president also asked his embattled attorney general to look at opioid drugs coming into the country from China and Mexico, saying those countries were “sending their garbage and killing our people.”

“It’s almost a form of warfare,” Trump told Sessions.

When the attorney general agreed, the president responded: “I’d be very, very firm on that. It’s a disgrace, and we can stop it.”

Read more on the exchange here.


FDA approves the first generic EpiPen

Just in time for back-to-school season, the FDA approved the first-ever generic version of the EpiPen. The approval potentially sets the stage for more competition that will lower the price.

The EpiPen is meant to inject epinephrine into patients to stop a potentially fatal allergic reaction. Consumers and lawmakers have been clamoring for a generic version of the EpiPen ever since its manufacturer, Mylan, drastically hiked the price more than 400 percent in less than a decade.

The price has risen from less than $100 in 2007 for a pack of two injectors to just over $600.

The new version: It’s manufactured by Israeli company Teva Pharmaceuticals. Teva did not respond to questions about how much its generic version will cost, or when it will become available.

“We’re applying our full resources to this important launch in the coming months and eager to begin supplying the market,” Teva said in a statement.

Read more on the approval here.


Upcoming event:

Join The Hill on Wednesday, Sept. 12 for “A Healthy Start: Infant and Early Childhood Nutrition,” featuring Reps. Nanette Barragán (D-Calif.) and Bobby Scott (D-Va.), and Administrator of the Food and Nutrition Service Brandon Lipps. Editor in Chief Bob Cusack will sit down with the headliners to discuss maternal, infant, and early childhood nutrition, and what steps can be taken to establish healthier eating patterns across all communities. RSVP Here.


HHS chief Alex Azar met with stakeholder groups Wednesday to discuss the administration’s new policy of allowing some Medicare Advantage plans to use “step therapy,” in which insurers require patients to use cheaper drugs before moving on to more expensive ones.

Azar met with groups that have been critical of the policy, including the American Cancer Society’s Cancer Action Network and the American College of Rheumatology.

“Representatives offered their individual views on the new policy, … [including] concerns about the complexity and challenges their organizations’ members have faced in prescribing drugs for patients covered by plans that use prior authorization or step therapy,” an HHS spokesperson wrote in a statement released Thursday.

Secretary Azar “shared his openness to solutions that may alleviate the burden that could be imposed on physicians by the new negotiation tools,” the spokesperson said.

Context: The administration argues this policy, which takes effect Jan. 1, will give insurers more leverage in negotiations with drug companies. If an insurer can require a patient to use a cheaper drug instead of a more expensive one, companies might be compelled to drop their prices more.

Some patient groups worry this could create delays for patients in getting necessary treatment. Patients who are already receiving drugs through Part B won’t see a change to those prescriptions.

David Daikh, President of the American College of Rheumatology, said he is “encouraged” by the administration’s willingness to accept input on the policy, but is still concerned about the burden on providers.

The American Cancer Society’s Cancer Action Network also isn’t backing down on its opposition.

“We understand the policy rationale of asking a patient to start treatment with a lower cost drug that may be as effective as a higher cost treatment,” said President Chris Hansen.

“However, we want to make sure that policies don’t impede cancer patients getting the right treatment at the right time.  “We look forward to continued conversations with the administration to find ways to bring down the costs of lifesaving treatment without compromising access to the right treatments at the right time for patients who need them.” 


In ObamaCare news today:

  • A vulnerable Senate Democrat is targeting her Republican opponent over ObamaCare in a new ad released Thursday. Sen. Heidi Heitkamp (D-N.D.), who is running for reelection in a state won by Donald Trump in 2016, released an ad highlighting GOP Rep. Kevin Cramer’s votes to repeal ObamaCare.
  • New Jersey got a green light from CMS on Thursday for a reinsurance program. The waiver is expected to lower premiums by up to 15 percent in 2019, the state said. The program was approved through a section of ObamaCare called an “innovation” waiver, and is being partly funded through New Jersey’s new individual mandate penalty. So it was an interesting twist to see CMS Administrator Seema Verma applaud the approval of an ObamaCare policy, and then blame the “failures” of ObamaCare for making the policy necessary.


What we’re reading

Johns Hopkins panel creates guidelines for opioid prescribing (Baltimore Sun)

Officials remove special rules for gene therapy experiments (Associated Press)

The agonizingly slow progress against the cancer that killed Aretha Franklin (Forbes)


State by state

Number of overdoses linked to suspected bad batch of synthetic marijuana rises in New Haven, Conn. (cbsnews.com)

Ohio Medicaid drug audit calls for increased transparency (Associated Press)


From The Hill’s opinion page:

CDC opioid guideline is causing harm to people in chronic pain

To combat the opioid epidemic, focus on the forgotten addict

Tags Bobby Scott Donald Trump Heidi Heitkamp Jeff Sessions Kevin Cramer
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