WASHINGTON — Congress members debated whether fetal tissue is still needed for medical research, and a committee that vets payment models under Medicare recommended a new way to pay oncologists.
House Members Wrangle Over Fetal Tissue Research
Open-mindedness was in short supply at Thursday’s House hearing on alternatives to fetal tissue research, as committee members stated positions that appeared to have been solidified before hearing any testimony.
The House Oversight & Government Reform Committee hearing — which was organized by two different subcommittees — began with committee members from both sides of the aisle laying out their positions. “We want to make sure what is addressed today is sound science along with a moral code that most Americans believe and support,” said Rep. Mark Meadows (R-N.C.), chairman of the committee’s Subcommittee on Government Operations. “There are a lot of falsehoods out there on what this will do or won’t do. As someone who is proudly pro-life and who believes in the sanctity of life, it’s critically important that we look at all of these issues.”
Ranking member Raja Krishnamoorthi (D-Ill.) had a different take. “I come to this hearing from the perspective of improving the practice of medicine,” he said. “The International Society for Stem Cell Research (ISSCR) calls fetal tissue an essential gold standard resource in biomedical research… Fetal tissue research has helped contribute to vaccines for polio, rubella, chickenpox, shingles… [vaccines] responsible for saving thousands of lives.”
He added that fetal tissue research, which the federal government has funded since the 1950s, “is protected by law. HHS has set stringent ethical and legal guidelines [covering] transportation, research, and informed consent.”
The hearing occurred in the wake of the Trump administration’s efforts to halt government-funded fetal tissue research. In September, the administration told the National Institutes of Health to stop acquiring new fetal tissue for research, disrupting an ongoing study on the AIDS virus, according to Science.
PTAC OKs New Payment Model for Community Oncology
An oncology care model that proposes to decrease overall Medicare spending, while bettering quality of care, won the approval of an HHS advisory committee.
The Physician-Focused Payment Model Technical Advisory Committee (PTAC) voted Monday (7-0; one abstention) to recommend implementation of the Making Accountable Sustainable Oncology Networks (MASON) model, submitted by Innovative Oncology Business Solutions (IOBS) of Albuquerque. The company’s chief executive is Barbara McAneny, MD, who is also currently president of the American Medical Association.
“We’ve noticed for a long time that there are certain clusters of patients who cost more than other patients with the same clinical criteria, so clearly we’re missing some of those criteria,” McAneny told MedPage Today after the meeting. “What we’re attempting to do is look for those naturally occurring clusters of cost, and then look at what are the clinical criteria that come from the practice’s electronic health records that caused those differences.”
MASON is adopted from the Community Oncology Medical Home (COME HOME) model that aims to have cancer care administered across clinic and hospital settings. COME HOME was developed as part of a Center for Medicare & Medicaid Innovation (CMMI) grant.
Lack of Progress on Interoperability Frustrates House Members
Tuesday’s House hearing on the progress of health information technology (IT) interoperability was marked by bipartisan frustration from members of Congress about how little has gotten done.
Michael Burgess, MD (R-Texas), chair of the House Energy & Commerce Health Subcommittee, which held the hearing, set the tone with his opening statement. He noted that a rule prohibiting “information blocking” — the practice of electronic health record (EHR) vendors blocking access to patient records as a way to stifle competition — had yet to be released.
“I am extremely disappointed that 2 years after the passage of the [21st Century Cures Act], we still do not have the regulations necessary to implement these [anti-information-blocking] provisions,” Burgess said. “It is hard to explain to people that Congress provided the tools necessary for doctors and patients to better coordinate their care through the sharing of patient data, and nothing has changed.”
“I would think that we would be farther along than we are in these areas,” said Rep. Diana DeGette (D-Colo.). She asked the hearing’s lone witness, Donald Rucker, MD, the National Coordinator for Health Information Technology, to talk about the biggest impediments to greater interoperability.
FDA: Duodenoscope Cleaning Still a Problem
Aggressive efforts by the FDA and manufacturers of duodenoscopes in recent years have not succeeded in eliminating bacterial contamination problems with the devices after reprocessing, the agency said in a Safety Communication issued late Monday.
Following revelations in 2015 that scores of patients had developed abdominal infections following endoscopic retrograde cholangiopancreatography (ERCP) procedures using reprocessed duodenoscopes, the FDA ordered manufacturers including Olympus, Fuji, and Pentax to upgrade their recommendations for post-procedural cleaning and to conduct regular testing to determine how well the procedures are working.
“Interim results from these studies indicate higher-than-expected contamination rates after reprocessing, with up to 3% of properly collected samples testing positive for enough low concern organisms to indicate a reprocessing failure and up to 3% of properly collected samples testing positive for high concern organisms,” the agency said in the Monday statement. “High concern organisms” include E. coli, Pseudomonas aeruginosa, and others associated with disease, the FDA explained.
An FDA advisory committee meeting in 2015 agreed that duodenoscopes for ERCP procedures cannot be completely sterilized in every case — they contain hinged parts such as elevators at the working tip where organisms may lodge and evade removal or killing. Small cracks and other forms of damage can also occur with repeated use, which can also complicate thorough cleaning. But members also said the devices must remain in use because there are no good alternatives.
On Tuesday and Wednesday the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and its Drug Safety and Risk Management Advisory Committee will discuss “strategies to increase the availability of naloxone products intended for use in the community.”