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Capitol Checkup: Block grant pushback; ACA suit paused; 'Right to Try' tried

Democratic lawmakers and various healthcare experts late last week immediately criticized the Trump administration's plan to go around Congress and turn Medicaid into a block-grant program and cap the amount of money the federal government provides to states.

Medicaid provides insurance coverage to about 77 million low-income Americans. It is a federal program, but is administered and jointly funded by U.S. states. The federal government matches state Medicaid spending, but those rates vary, ranging from 50% to about 75%, depending on a state's finances.

Block-granting the program would mean states would be given a fixed lump sum of federal funding they could use as they see fit.

Congressional Republicans had tried, but failed, in 2017 to pass the block-granting idea as part of their efforts to repeal and replace the Affordable Care Act. The ACA expanded Medicaid to an additional 12 million low-income Americans — a number that is growing as more states adopt the expansion.

The advocacy group Families USA has called Medicaid block grants a bad idea, saying it would result in states cutting benefits and services to their low-income residents.

When word got out on Jan. 11 that the Centers for Medicare and Medicaid Services has been working on guidelines to block grant Medicaid, Democrats immediately voiced opposition.

"It is deeply troubling that the Trump administration is reviving one of the most destructive parts of the failed Republican repeal bill that voters overwhelmingly rejected" in the November 2018 midterm elections, Rep. Frank Pallone, D-N.J., chairman of the House Energy and Commerce Committee, told S&P Global Market Intelligence in a statement. "CMS doesn't have the legal authority to block grant Medicaid. Block grants undermine the protections of the Medicaid program and put our most vulnerable citizens at risk."

On Twitter, Sen. Bob Casey, D-Pa., greeted the news, first reported by Politico, with a "Hell no," calling the administration's plan "immoral" and an "unconscionable action."

If the administration tries to "decimate Medicaid through executive action after its scheme was rejected by Congress and the American people, I will fight it with everything I have," Casey tweeted.

University of Michigan law professor Nicholas Bagley tweeted that the administration was "playing with fire here."

Federal shutdown delays ACA appeal

Meanwhile, the impacts of the ongoing partial U.S. government shutdown — now into its fourth week, the longest in U.S. history — have reached into the lawsuit challenging the constitutionality of the Affordable Care Act.

On Jan. 11, Judge Leslie Southwick of the U.S. Court of Appeals for the Fifth Circuit in New Orleans granted a request by the U.S. Department of Justice to put the case on hold in light of the shutdown.

The lawsuit against the ACA was brought by Republican attorneys general and governors from 20 states. Rather than defending the ACA, the Trump administration, represented by the Justice Department, sided with the Republican plaintiffs in the case.

The Justice Department is one of the agencies caught in the shutdown. Last week, the agency said that without an appropriation from Congress, its attorneys were prohibited from working, even on a voluntary basis, except in very limited circumstances, including emergencies involving the safety of human life or the protection of property.

On Dec. 14, 2018, Judge Reed O'Connor of the U.S. District Court for the Northern District of Texas ruled the entire 2010 healthcare law unconstitutional.

A coalition of 17 Democratic state attorneys general is appealing the ruling. The Justice Department filed its own notice of appeal last week. House Democrats are also seeking to intervene in the case.

Shutdown poses significant FDA challenges

U.S. Food and Drug Administration Commissioner Scott Gottlieb acknowledged over the weekend the shutdown and lapse in funding "represents one of the most significant operational challenges" in the agency's recent history.

"It is not business as usual at FDA. Many key functions aren't getting done," Gottlieb tweeted on Jan. 13.

The FDA furloughed more than 7,000 of its employees, or 41% of the agency, on Dec. 22, 2018, when Congress failed to fund 25% of the federal government.

In a Jan. 11 memo, Gottlieb acknowledged the "personal hardship and strain" being placed on many of his staff, particularly those going without pay.

The House last week adopted a series of spending bills that would fully open the FDA and the other affected agencies, but Senate Majority Leader Mitch McConnell, R-Ky., has so far refused to bring the measure up in his chamber.

Earlier this month, Gottlieb admitted the FDA was running out of user fee funds it collects from drugmakers to help with marketing application work and needed to reallocate some of that money to post-market surveillance activities.

On Jan. 12, the commissioner tweeted that he would provide an update this week on the remaining balances of those fees.

"We're also closely evaluating when we will cross a threshold, beyond which, we have to declare that we will not be able to meet medical product user fee goals for 2019," he wrote on Twitter.

The next day, Gottlieb said surveillance inspections focused on the highest risk products and facilities for food, drug, medical, device and pharmacy compounding had been deemed excepted, unpaid work during the shutdown.

Expanded access vs. Right to Try

During the shutdown, Gottlieb has emphasized the FDA's expanded-access program, which helps critically ill patients obtain experimental drugs, has remained operating, despite the lapse in funding.

Days before the shutdown started, the commissioner disclosed plans for the so-called "Project Facilitate" pilot program, which is intended to help expanded-access applicants more directly in obtaining unapproved medicines.

Even though Gottlieb in recent months has been highlighting the improvements to the expanded-access program, also called compassionate use, one California doctor decided to instead use the new Right to Try Act, saying it offered a "more expedited path to treatment" than the FDA's program.

It is the first known use of the federal Right to Try law.

Epitopoietic Research Corp., a small Belgian company, last week said it had initiated treatment with its experimental immunotherapy Gliovac, also known as ERC1671, in a California patient with recurrent glioblastoma, the most aggressive form of brain cancer.

ERC said it informed the FDA June 15, 2018, that intended to make Gliovac available to a U.S. patient under the new Right to Try Act. The agency acknowledged acceptance of the company's notification on July 13, 2018, ERC said in company documents.

A spokesman for Daniela Bota from the University of California Irvine School of Medicine — the doctor who administered the immunotherapy — said the physician was complying with both her state's right-to-try requirements and the federal law.

The patient had sought to participate in Bota's phase 2 trial of Gliovac, but the person did not meet the study's criteria, the physician's spokesman told S&P Global Market Intelligence. So the patient's family requested access under the state and federal right to try laws.

Right to Try critics have said the law could expose desperately ill patients to "snake oil" salesmen peddling false hopes.

Gottlieb initially opposed the Right to Try Act, sponsored by Sen. Ron Johnson, R-Wis., and publicly criticized it during an October 2017 hearing. He noted the FDA already approves 99% of the 1,000 applications it receives annually from patients for the expanded access program, also known as compassionate use.

But after President Donald Trump threw his full weight behind Johnson's bill, the commissioner backed away from his opposition and said he felt "comfortable" with the legislation, which was enacted in May 2018.

Gottlieb has not publicly commented about the Gliovac patient.

The author of the Right To Try Act, Johnson, did not respond to requests for comment about the first known use of his law.

Bota has previously used the FDA's expanded-access program for other patients, including in accessing Gliovac, her spokesman said.

The doctor, however, did not respond to questions about whether she had initially sought or discussed using the expanded-access program for the California glioblastoma patient.

While the Gliovac patient was "not the nightmare scenario" many had worried about with the Right to Try Act — "charlatan taking advantage of vulnerable" patients — it also was "still bad because it undercuts expanded access, which works and could have worked here," Holly Fernandez Lynch, an assistant professor in medical ethics and health policy at the University of Pennsylvania, wrote on Twitter.

But the fact that it took several months for the first patient to use the Right to Try Act "shows how utterly unnecessary" it is, Fernandez Lynch said.