Unwitting Patients, Copycat Comments Play Hidden Role In Federal Rule-Making
A proposal to sharply cut a drug discount program that many hospitals rely on drew some 1,400 comments when the Trump administration announced its plan last year. Hundreds appeared to come from patients across the country â pleas from average Americans whose treatments for diseases such as cancer depend on costly medicines.
But a review of the responses found that some individuals were not aware they apparently had become part of an organized campaign to oppose whatâs known as the â340Bâ program. Some had no memory of signing anything, much less sending their opinions about it.
Of the 1,406 comments that specifically mentioned 340B â part of several thousand comments submitted on a broad proposal to revise medical payment systems â about half included the same or similar wording and were submitted anonymously, an analysis by Kaiser Health News found. Those comments lamented âabuseâ of the drug discounts, faulted hospitals for being âgreedyâ and used phrasing such as âquality, affordable, and accessible.â
Two that were duplicated hundreds of times made the very same grammatical mistake.
They âare clearly related,â said Robert Leonard, a forensic linguistic expert at Hofstra University whose team analyzed the submissions for KHN.
In fact, the wording in the duplicate comments tracks language in a formal letter submitted to regulators by a nonprofit trade group, the Community Oncology Alliance, which receives funding from pharmaceutical companies.
Cancer survivor Janice Choiniereâs name is on a public comment saying reform of the 340B program will help âthose suffering from this insidious disease.â But when reached by phone, the 69-year-old Florida resident said she had âno ideaâ what the program is and didnât recall signing a petition.
âMy first thought is, I donât fill out and send in responses casually,â Choiniere said. âIâm hoping nobody lifted my information.â
The quarter-century-old federal program requires pharmaceutical companies to sell certain drugs at steep discounts to eligible hospitals and clinics, which donât have to share their savings with patients. Critics, including Republican lawmakers, have questioned what the facilities do with the money. Doctors in private practice, who are not eligible for the reduced rates, have warned that the programâs continued growth makes it susceptible to exploitation.
The administrationâs plan, finalized in November, reduced by $1.6 billion annually what the  pays for the targeted drugs. In late July, the agency proposed expanding those payment cuts.
As with any proposed rule, the purpose of requesting public comments is to help lawmakers and regulators consider the potential effects of their actions. But the pattern identified in the 340B comments, which were posted online by CMS, suggests the system can easily be manipulated. Patients may be especially vulnerable to being used.
âIt feels like inappropriate influence,â said Peter Ubel, a physician and behavioral scientist at Duke Universityâs Fuqua School of Business. âWhen you have a life-threatening illness, you need to know you can trust your physician to care about your interests ahead of their own.â
KHN reached 10 individuals whose names appeared in the comments â either as a signature on a personal note or on a petition also signed by others. All were patients, former patients or caregivers seen at private practices connected to the Community Oncology Alliance.
Two patients confirmed they had written notes, although they couldnât say when. Several said they must have signed or written something amid the paperwork handed to them at a doctorâs office during appointments or in follow-up correspondence. A few drew mental blanks.
The name of an 84-year-old melanoma patient shows as an online signature in an individual public comment that described the programâs reform as a matter of âlife or death.â But the Florida man, who asked not to be identified, had little recollection of writing it. His wife remembered that he signed something at his doctorâs office âout front on a clipboardâ before getting his biweekly cancer treatment.
âIf my doctor wanted me to sign something, I would sign it for him,â the man said. He âsaved my life.â
Julie Yarbrough, whose husband received treatment at New England Cancer Specialists in Maine, remembered signing a petition âat the [doctorâs] check-in areaâ about hospitals abusing 340B discounts. She was the only individual contacted who had a basic understanding of the program.
The patients reached by KHN sought care at either New England Cancer Specialists, which has three locations in Maine, or Florida Cancer Specialists, which runs nearly 100 treatment centers in that state. Data posted on the federal website  show that more than 60 percent of the 340B-specific comments originated in Florida.
âWe do a good job of educating patients and letting them know how to get involved,â said Michael Diaz, director of patient advocacy for Florida Cancer Specialists and vice president on the Community Oncology Allianceâs executive committee. âThey need to be able to contribute and give their opinion.â
Steve DâAmato, executive director of New England Cancer Specialists and an Alliance board member, mentioned patientsâ support in a  accompanying a petition posted multiple times to the government portal Oct. 10. The petition included the trade groupâs website; DâAmato noted that âpatient signatures obtained in just 2 daysâ were attached.
When asked recently about patients who didnât recall signing something, DâAmato said he did not have the petition in front of him and referred all questions to the Allianceâs executive director, Ted Okon. In an interview, Okon denied that the organization had any role in soliciting patient comments.
âWe didnât do anything with patient petitions,â said Okon, although talking points and material were sent to practices nationwide for them to use when submitting comments. âThis is what we do in terms of advocating.â
Susannah Rose, scientific director of research in the Cleveland Clinicâs patient experience office, said there is âalways a worry about coercionâ when doctors make a request of patients, but more so when oncologists do the asking.
âCancer patients often feel very much in the hands of their oncologists, and they are often suffering from significant distress,â said Rose, who serves on the ethics committee of the American Society of Clinical Oncology.
The Washington-based Alliance represents private oncology practices as well as about 50Â , according to its website. Formed in 2003 when Congress approved Medicareâs prescription drug program, it was a leading critic of a controversial 2016 proposal to change how CMS paid for some drugs in Medicare. The groupâs revenue nearly quadrupled that year, to $16.3 million from $4.4 million in 2015, according to federal tax filings. The proposal never became reality.
Pharmaceutical giants Sanofi, Pfizer, Eli Lilly, Bristol-Myers Squibb and Merck each confirmed paying annual dues of $75,000 to the Alliance. The five companies also paid it nearly $1Â million between 2014 and 2017 for research papers, conferences, filming and patient education, according to corporate transparency reports.
Walgreens and PhRMA, the pharmaceutical industry trade group, also confirmed membership but did not disclose how much they pay in dues. Okon said corporate membership fees range from $25,000 to $75,000 annually while individual oncologists and their practices pay âusually on the order of a thousand dollars, two thousand dollars.â
Drug manufacturers do not influence the Allianceâs position on 340B, he said, noting in an email that âcorrelation is not causality.â
After the comment period ended, CMS slashed 340B payments to hospitals by $1.6 billion annually. Medicare had been paying hospitals 6 percent above a drugâs average sales price; it now pays them 22.5 percent less than the average sales price.
CMS Administrator Seema Verma and Eric Hargan, deputy secretary of the Health and Human Services Department, emphasized that public comments played into their decision. In the 1,133-page , they said they shared the concern that current Medicare payments âare well in excess of the overhead and acquisition costsâ for drugs bought under the program.
âWe thank the commenters for their support,â they wrote.
Kaiser Health News data correspondent Sydney Lupkin contributed to this report.
How KHN Found The Duplicated Rhetoric On 340B
Kaiser Health News data correspondent Sydney Lupkin downloaded thousands of publicly filed comments from regarding a rule that revised Medicare payments to hospitals. Lupkin found that of the 1,406 comments on the docket that explicitly mentioned â340B,â three separate comments were duplicated hundreds of times. Those three widely repeated comments made up more than half (763) of all the comments posted about the 340B drug discount program. (Note: The analysis did not review PDF attachments that were submitted as comments.)
Hofstra University professor Robert Leonard, and analysts Juliane Ford and Dakota Wing who work for his consulting firm, compared those three comment types with a letter submitted to regulators in September by Community Oncology Alliance, a nonprofit advocacy group. COAâs comment letter included 2,928 words. The three duplicated comments used 242, 260 and 306 words.
The analysts used a technique that tallies the number of N-grams, which is a set of serial words found in a string, shared in each document. They found multiple examples. One near 10-gram sequence that appeared in all 763 comments is a variation of the sentence: âThe mission of COA is to ensure that cancer patients receive quality, affordable, and accessible cancer care in their own communities.â It varied by the use of a few words, such as changing âcommunitiesâ to âcommunityâ or using the word âlocalâ instead.
Notably, the use of an Oxford comma in the same string of words â âquality, affordable, and accessibleâ â appeared in all four comments.
âIt defies imagination that three or four individual people would pick the same words in the same strain,â said Leonard, who is director of the graduate program in forensic linguistics at Hofstra University.
The frequent use of the informal word âbadâ also caught the attention of researchers. And two comments that were duplicated hundreds of times made the same grammatical mistake â using a non-standard plural âAmericanâsâ with a superfluous apostrophe.