| |  | The Lead Brief | The moves to rein in spending on expensive bandages known as skin substitutes that cost the federal government billions of dollars has triggered a massive lobbying blitz, early filed disclosures show. The influence surge reflects what’s at stake: More than $13 billion in Medicare spending that critics argue stems from years-long abuses of the system. Ballard Partners, a firm with ties to the Trump administration, earned at least $900,000 from companies and groups working on the issue during the third quarter. It’s earned more than $1.9 million so far this year from them — an uptick in work over last year. There are two main policy changes that could impact the wound care industry: A recent effort from the Trump administration to cap the amount Medicare reimburses for the skin substitutes, and a separate Biden-era move to restrict Medicare coverage to a smaller subset of products that have proven to be clinically effective. The latter policy has been delayed until the beginning of next year following fierce lobbying from the industry. That effort, and the proposed payment limits, has animated an under-the-radar advocacy campaign from the industry that argues patient access to these products could be hurt if regulators go too far. The timing element: The agency is expected to release its final rule on whether to cap reimbursements for the products — and by how much — in the coming weeks. If enacted, the looming limits could reshape the multi-billion-dollar market — and test how far the Trump administration will go to curb health spending over industry pushback. Why it matters: The issue has caught the attention of government watchdogs and policymakers. CMS Administrator Mehmet Oz told an industry conference last week that the bandages, made for hard-to-heal wounds that can be caused by diabetes or poor circulation, will cost Medicare $13 billion this year. That’s a 50-fold increase from the $256 million Medicare paid for the products just six years ago, according to the Centers for Medicare and Medicaid Services. It sounds like the industry may be open to some limits on the pricing, but not likely as far as the roughly $800 per square inch (or $125 per square cm) that’s been proposed by CMS. An investigation from the New York Times found that some of these products can cost more than $21,000 per square inch. The report calculated public data and found the average cost to Medicare was nearly $6,000 per square inch. The players: Ballard Partners has made waves on K Street, jumping up to the second-largest lobbying firm in Washington by revenue by taking in nearly $34 million in the first half of this year — bypassing longtime industry giants. Founder Brian Ballard, a prolific Florida-based GOP fundraiser, has had connections to President Donald Trump for many years. White House chief of staff Susie Wiles and Attorney General Pam Bondi are both Ballard alums. Most of the Ballard Partners’ clients working on the skin substitutes issue are tied to Tiger BioSciences, a medical technology company that has had the firm on retainer since last February: the BioCare Donor Tissue Network and BioStar Medical are divisions of the biotech company. They paid Ballard Partners $250,000 and $300,000 in the third quarter this year, respectively. The firm also represents the Diabetic Wounds Awareness PAC, which hired the firm in December and paid it $230,000 for its advocacy in the third quarter. Tiger’s chief legal officer, Larry “Buzz” Wood, is the PAC’s treasurer. A separate company, BioStem Technologies, hired Ballard Partners last fall and paid it $120,000 to lobby on its behalf from July through September of this year — an increase in spending over previous quarters. The firm declined to talk about its meetings, but the forms disclose Ballard Partners lobbyists contacting the White House and Department of Health and Human Services on these issues for clients, in addition to some congressional outreach. The companies did not respond to a request for comment on their lobbying. → The MASS Coalition, an industry group pushing back against the changes, also bolstered its spending in the third quarter, shelling out $140,000 on advocacy — a slight increase over the same time last year. → Another advanced wound care company, Organogenesis, spent $300,000 on lobbying from July through September — a 55 percent increase over the same time last year, according to disclosures. The company didn’t respond to a request for comment, but issued a statement this summer that praised the administration’s efforts to put a limit on reimbursement amounts: “We believe this new payment structure will curb abuse under the current system, and the resulting rapid escalation in Medicare spending, while ensuring a much-needed consistent payment approach across sites of care,” said Gary Gillheeney, the president and chief executive of Organogenesis. There are more filings coming in with today’s deadline, so I’ll keep an eye on the broader trend. | 
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