The Senate Health, Education, Labor and Pensions (HELP) Committee voted 20-3 Wednesday to send a multi-tentacled package aimed at lowering U.S. health care costs, including those for prescription drugs, to the Senate floor with a do-pass recommendation.

"The Lower Health Care Costs Act will reduce what Americans pay out of their pockets for health care in three major ways," HELP Chair Lamar Alexander (R-Tenn.) said following the vote. The bill, S. 1895, will end surprise medical bills, create more transparency throughout the health care spectrum and increase prescription drug competition.

Since last week's HELP hearing on the bipartisan bill, S. 1895 has grown from nearly three dozen proposals to 54 and now also includes the CREATES Act, which establishes a legal path for would-be competitors to get the brand samples necessary to develop generics and biosimilars. (See BioWorld, June 19, 2019.)

The package likely will be even larger by the time it comes up for a vote before the full Senate, something Alexander is working to make happen by late next month.

Both the Senate Judiciary and Finance Committees are working on their own bills to tackle the cost of prescription drugs and other health care. Alexander said provisions in those bills may be combined with the HELP package before the Senate votes on it.

The Judiciary Committee is scheduled to mark up four bills Thursday. The Prescription Pricing for the People Act, S. 1227, would require the Federal Trade Commission (FTC) to study the role of intermediaries in the drug supply chain and then make recommendations to Congress on fixing the system.

The second bill, the PACED Act, S. 440, would prohibit patent-holders from using tribal or foreign government sovereign immunity as a defense in proceedings before the U.S. Patent Office, the courts and the International Trade Commission. The bill reinforces last year's ruling by the U.S. Court of Appeals for the Federal Circuit, which struck down tribal sovereign immunity in patent proceedings. The court expanded on that ruling last week when it determined states also do not have sovereign immunity from patent proceedings. (See BioWorld, July 24, 2018, and June 18, 2019.)

The other two bills Judiciary is considering are the Stop STALLING Act, S. 1224, and the Affordable Prescriptions for Patients Act, S. 1416. The bipartisan STALLING Act would give the FTC the authority to deter the use of sham citizen petitions to delay generic or biosimilar competition. S. 1416 is intended to curb the anticompetitive use of patents by codifying definitions of "product hopping" and "patent thicketing" within the FTC Act and empowering the FTC to bring antitrust suits against companies that abuse the patent system.

Senate Finance Committee leaders Chuck Grassley (R-Iowa) and Ron Wyden (D-Ore.) are still working on their legislative package to address drug prices. It's expected to be introduced next month.

HELP amendments

Even without the contributions from the other Senate committees yet, the Lower Health Care Costs Act got a little weightier when the HELP Committee voted 17-6 Wednesday to adopt an amendment that added the FAIR Drug Pricing Act to the legislative package. The provisions of that bill would require drug manufacturers to disclose and provide information about certain planned price increases.

Alexander voted against the amendment out of concern about the unintended consequences of some of the reporting requirements. He said he will work with Sen. Tammy Baldwin (D-Wis.) and other sponsors of the bill to iron out those concerns before the Senate vote.

Sen. Rand Paul (R-Ky.), who was one of the three HELP members to vote against the Lower Health Care Costs Act, proposed a number of amendments, including one that would ensure reimbursement codes didn't lump generic drugs in with the brand drug. Paul's amendments were tabled because they fell under the jurisdiction of the Finance Committee.

(The other two no votes were from Sens. Bernie Sanders [I-Vt.] and Elizabeth Warren [D-Mass.], who didn't attend the markup but voted by proxy.)

In opening Wednesday's meeting, Alexander said the months of work on the Lower Health Care Costs Act has shifted the focus from attempting to shore up/attack the controversial Affordable Care Act (ACA) to reducing health care costs. While lawmakers may disagree on the ACA, they can agree on the need to lower costs, he said, as he encouraged committee members not to conflate the two by trying to add ACA-related amendments to the package.

"You don't have to preach the entire Bible in one sermon," Alexander said, urging his colleagues to focus on reducing costs.

"We can work together and find common ground on legislation that helps families in this country," agreed Ranking Member Patty Murray (D-Wash.), who cosponsored the package with Alexander. S. 1895 "takes valuable steps in the right direction," she added.

However, "while all these steps are good, they are absolutely not enough," Murray said. "Repairing the train can only get you so far if you're pulling up the track at the same time."

Referencing the administration's part in an ongoing legal challenge to the ACA, Murray warned of the "health care apocalypse" that could occur if the law is struck down, as many Americans would no longer have insurance to cover their medical bills and prescriptions.

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