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Lab Groups Worry Congressional Disarray Could Dim Chances of SALSA Passage


NEW YORK – While the lab industry continues to push to modify the 2014 Protecting Access to Medicare Act (PAMA) via the Saving Access to Laboratory Services Act (SALSA), disarray in Congress as well the bill's price tag presents challenges to its passage.

SALSA, which failed to pass Congress last year, was reintroduced in March by bipartisan groups of legislators in both the House of Representatives and the Senate, but with the calendar winding down and the House currently without a speaker, the bill could stall again this year.

If it doesn't pass, price cuts and reporting requirements scheduled under PAMA will go into effect at the start of 2024. While Congress could, as it has the last several years, pass a one-year delay, the ongoing House leadership drama makes this a less certain proposition than it has been in the past, suggested some industry observers.

SALSA would institute a sampling-based approach to collecting lab testing pricing data that proponents say would both alleviate the administrative burden on labs and ensure that price data is collected from a more representative slice of the industry. Additionally, the bill would cap the amount a test's price could fall or rise under PAMA to 5 percent a year. It would also stop price cuts scheduled to go into effect at the start of next year and extend the time between price reporting periods from three years to four.

As a relatively small piece of legislation, SALSA is most likely to pass as part of a larger package of bills, but with much congressional business stalled until the House is able to choose a new speaker, there may be few opportunities between now and the end of the year.

"There may be a smaller number of legislative opportunities than we have seen in years past," said Susan Van Meter, president of the American Clinical Laboratory Association, which is a strong supporter of the bill. "We have to adjust for that. Every [legislative] vehicle, we think, is an opportunity."

"We're afraid that SALSA is caught up in kind of the quagmire of chaos that is going on in Congress," said Donald Karcher, president of the College of American Pathologists, noting that this "probably lessens the likelihood that it might go forward."

"We're always hopeful, but not super optimistic at this point," he said.

Matthew Schulze, director of government relations at the American Society for Clinical Pathology, likewise, observed that the situation in the House made legislating difficult but said that the relevant committees were still working behind the scenes to move the bill toward passage. Last week, the House Energy and Commerce Committee held a hearing on a number of healthcare-related bills, including SALSA.

"I think, regardless, that this bill would have a little while to go [before passage] … and while it would obviously be good to have a speaker, I don't think that is something that is really adversely affecting SALSA today," he said. "It will be interesting to see what happens as we get closer to dealing with all the spending bills, the omnibus, to continue funding for the federal government."

SALSA advocates last year tried but failed to get the bill included as part of the end-of-year omnibus package. One issue was its price tag. A preliminary score from the Congressional Budget Office (CBO) projected that it would cost $6 billion over 10 years, which meant legislators would have to make cuts elsewhere to fit it into the spending package. At the same time, the CBO analysis projected that simply delaying the scheduled PAMA cuts by one year would save $730 million over 10 years, making that a potentially attractive option for lawmakers.

The same dynamic is likely to prove a challenge this year. Van Meter said, however, that ACLA has done its own analysis that puts the cost of SALSA at less than $3 billion over 10 years.

She said the difference between ACLA's score and the preliminary CBO score from last year was due to ACLA's use of a more current, "more robust" lab price dataset.

"CBO has had very little access to commercial market data," she said, noting that much of the data used in the CBO analysis came from a Medicare Payment Advisory Commission (MedPAC) report that is now several years old.

Van Meter said that ACLA has met with the CBO as well as congressional committee staff and bill sponsors to talk about its analysis and is "hopeful that [CBO] will take our analysis into consideration."

She added that ACLA is now pushing for a "full, formal 10-year score" of the bill from the CBO.

Erin Morton, a partner at lobbying firm CRD Associates, which represents the National Independent Laboratory Association (also a SALSA advocate), said she thought the ACLA analysis "does a good job painting a realistic picture of the impact of SALSA because they used data that was not included in the CBO analysis."

"From my perspective, it's a top priority to get CBO to do a formal score, and our hope is that they would use some of the data from the ACLA analysis," Morton said.

If SALSA doesn't pass, the lab industry will likely have to settle for another one-year delay, though this is not a sure thing, either.

"We're a little bit worried that getting an end-of-year omnibus bill that takes care of a lot of things may be a little more difficult" than in past years, said CAP's Karcher.

Morton said that if Congress continues to fund the government through short-term temporary spending bills, it could make passage of either SALSA or even a one-year delay challenging. SALSA, she noted, will most likely need to be attached to an end-of-year omnibus given that temporary spending bills, commonly known as continuing resolutions, don't typically deal with larger, comprehensive bills. She said that even a one-year delay could have trouble making it into a continuing resolution depending on how hurried that process ends up being.

Morton cited the recent continuing resolution passed by Congress on Sept. 30, which provided funding to keep the federal government operating through Nov. 17.

"Any new thing you put on [a continuing resolution], you risk losing support," she said. "When you're at risk of a government shutdown, you've got to just fund the government, and so, that is really what this last [continuing resolution] became."

During Quest Diagnostics' Q3 earnings call this week, President and CEO Jim Davis sounded a note of pessimism regarding SALSA's passage but one of optimism with regard to a one-year delay.

While SALSA is expected to cost money, a new CBO score of a one-year delay found that it would provide "a significant cost savings," bolstering its chances, Davis said. "We're confident that something will get done there."