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Capitol Checkup: Conservatives' repeal revival; GOP jeopardy; court snubs Amgen


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Capitol Checkup: Conservatives' repeal revival; GOP jeopardy; court snubs Amgen

Conservative Republicans in the House are seeking to renew efforts to pass a bill to repeal the Affordable Care Act, or ACA, but not replace it for two years.

The House Freedom Caucus — a group of some of the most conservative lawmakers on Capitol Hill — filed a discharge petition Aug. 11 to force a vote on a repeal-only bill that was adopted by both chambers in 2015 but was subsequently vetoed by then-President Barack Obama.

The Senate tried, and failed, in July to pass a similar measure — dubbed the Obamacare Repeal Reconciliation Act — after Republican Majority Leader Mitch McConnell of Kentucky fell short in getting enough members of his party on board to adopt his more comprehensive repeal-and-replace legislation, the Better Care Reconciliation Act.

The Senate in July also rejected McConnell's proposal to pass a "skinny repeal" bill, the Health Care Freedom Act, which would have ended the ACA's requirements for eligible Americans to buy healthcare insurance or pay a tax penalty and put other temporary provisions in place.

The three failed Senate bills were intended to be substitutes for the American Health Care Act, which was passed by a slim margin of 217-213 in the House in May.

While McConnell had the House-adopted bill returned to the Senate calendar for potential consideration later, the Freedom Caucus said it wanted to instead try again with the repeal-only legislation and filed the petition, which needs 218 signatures to force a floor vote.

Rep. Jim Jordan of Ohio, who reintroduced the repeal-only bill in July, was joined by fellow House Republican Reps. Tom Garrett of Virginia and Scott Perry of Pennsylvania in being the first ones to sign the petition.

"Now is the time for members of Congress to put on the record whether they're truly for repeal of Obamacare," Jordan said in an Aug. 11 statement.

He said lawmakers have made the job of repealing the ACA "too difficult."

"We cannot drag this process out any longer," said Freedom Caucus Chairman Mark Meadows, R-N.C.

"Doing nothing isn't an option," Perry added.

Rep. Mark Walker of North Carolina, who leads the Republican Study Committee — the largest conservative caucus in the House — threw his support behind the Freedom Caucus' effort, declaring the only thing that has changed since both chambers sent the 2015 legislation to the White House is the man who runs it.

Under Trump, "this bill would actually be signed into law," Walker said in a statement.

The conservative lobbying group Club for Growth said it would be keeping score of who signed the Freedom Caucus' petition.

"It's time to hold all House members accountable. It's time to force a vote," the group said in statement.

It insisted the House-adopted bill was not the full repeal conservative Americans had wanted, but was diluted "precisely because too many Republicans no longer support repeal."

A recent survey of 1,211 U.S. adults by the nonpartisan nonprofit Kaiser Family Foundation showed that a majority of Americans want Republicans to work with Democrats to fix the ACA, and they said the Senate's failure to repeal the law was a "good thing."

Just over half of the Republicans and Trump supporters surveyed said it was better to repair the ACA rather than see it fail.

Some Republicans in the Senate and House, including the Freedom Caucus' Meadows, have been working on proposals with Democrats aimed at stabilizing the ACA marketplace. The Senate Health, Education, Labor and Pensions Committee plans to convene its first hearing on those efforts next month.

Among measures being discussed is taking the authority for taking the cost-sharing reduction payments out of the administration's hands and bringing the funds under Congress' control, making them mandatory.

The payments help cover deductibles and copayments for about 7 million low-income Americans enrolled in ACA plans offered by private insurers through the government-run marketplace.

Trump, whose administration has been making the payments on a month-by-month basis, has threatened to end them unless Congress passes an ACA repeal bill.

The nonpartisan Congressional Budget Office is expected to soon release an analysis outlining the effects if Trump follows through on that threat.

McConnell safe, but GOP may be in trouble without repeal

Even though Trump blamed McConnell for the Senate's failure to pass an ACA repeal bill, the majority leader's job is safe, Sen. Lindsey Graham, R-S.C., told "Fox News Sunday" Aug. 13.

But if Republicans fail to soon deliver on their repeal-and-replace promise, the future of the party is in jeopardy, Graham said.

"All of us," including Trump, "are in trouble as Republicans for promising for seven years we'd repeal and replace Obamacare and failing miserably," he said.

After Trump sent out multiple tweets criticizing McConnell and told reporters he was "very disappointed" in him, numerous Republicans defended the Senate leader in their own tweets and remarks, including Sens. John Cornyn of Texas, Orrin Hatch of Utah, Lamar Alexander and Bob Corker of Tennessee, Cory Gardner of Colorado, Thom Tillis of North Carolina, Johnny Isakson of Georgia, Jeff Flake of Arizona and Pat Roberts of Kansas. Even Sen. Susan Collins of Maine, who voted against McConnell's healthcare bills, was among the Republicans who voiced their support for the Senate leader on Twitter.

"Mitch McConnell is not in any trouble in terms of his members," Graham said. "We all like Mitch. We believe he's a good solid leader."

But he said the Senate could not simply move on to other legislation, like tax reform or infrastructure, and ignore healthcare.

"I think it would be a disaster to move on," he said.

Amgen snubbed in federal biosimilar discovery case

While the Capitol Hill fight rages on over repealing the ACA, another portion of the law, which lawmakers are not seeking to dismantle, continues to be battled over in the courts — the Biologics Price Competition and Innovation Act, or BPCIA. It is a complex law that gave the U.S. Food and Drug Administration the authority to approve biosimilars, products intended to be lower-cost versions of biologic medicines.

The BPCIA, described by one federal judge as a "riddle wrapped in a mystery inside an enigma," also established the process for resolving patent disputes between innovators of brand-name biologics and biosimilar makers.

In the latest BPCIA case, the U.S. Court of Appeals for the Federal Circuit on Aug. 10 rejected Amgen Inc.'s appeal seeking to compel discovery from Pfizer Inc. unit Hospira involving a biosimilar of Epogen, a drug used to boost red-blood cells in anemic patients with chronic kidney disease, HIV and cancer and to reduce transfusions from donors to patients undergoing elective, noncardiac, nonvascular surgery.

Amgen markets Epogen, but Pfizer is seeking to sell a biosimilar version of the drug in the U.S. — a proposal that was backed by an FDA advisory committee, but rejected by the agency itself because of problems at the latter company's manufacturing site.

Amgen asserted that Hospira had failed to comply with the BPCIA's disclosure requirements by not divulging the specific composition of the cell-culture medium used in the manufacture of its biosimilar.

Amgen said it could not assess the reasonableness of asserting claims for infringement on two of its patents, even though neither was a cell-culture patent.

A district court had concluded that Amgen's motion to compel on the ground that the composition of Hospira's cell-culture media was of no relevance to the patents that were asserted — a ruling the Federal Circuit said was correct.

"Amgen has not established a clear and indisputable right to discovery of the information it seeks," the appeals court judges said. "It therefore has not established the prerequisites for this court to issue a writ of mandamus."

The Federal Circuit dismissed Amgen's appeal for lack of jurisdiction and denied the company's petition for a writ of mandamus.

The Supreme Court recently addressed questions about the BPCIA's disclosure requirements in Amgen's lawsuit against rival Novartis AG unit Sandoz.

But the issue of compelling discovery had remained an open question.