Do you notice any rule changes in Washington? You can thank COVID
Some changes to federal health regulations due to the COVID-19 pandemic are unlikely to go away once it is over, several speakers said Tuesday in an online session at the annual meeting of the COVID-19. Healthcare Information and Management Systems Society (HIMSS).
The pandemic has forced CMS “to follow paths that CMS, frankly, has never done before and they must have gone really fast,” said Kim Brandt, partner at consultancy firm Tarplin, Downs & Young and former senior deputy administrator for operations. and politics at CMS. “They had to offer unprecedented flexibilities to allow people to be able to set up practice areas in things like parking lots or … unused offices; they had to come up with a ‘home hospital’ model to allow certain types of services to be available. potentially perform at home.
In addition, “CMS has in fact issued over 150 waivers to our traditional requirements” to cover telehealth when it would normally only have issued a dozen, usually for a hurricane or other type of national emergency, Brandt said. “The bottom line, however, is that for telehealth in particular, it has opened up a Pandora’s Box, which is not going to turn back… because so many people have become so dependent” on this technology, which is also less expensive.
“It’s something that I think has [potential] transforming the way we work as a healthcare payer at CMS, but it’s also really exciting for patients as it enables many new and innovative approaches, which will be beneficial for everyone, ”he said. she adds.
Changes at the FDA
The FDA also had to adopt certain regulatory flexibilities during the pandemic, according to Amy Abernethy, president of clinical research platforms at Verily and former senior deputy commissioner of food and drugs at the FDA. “This has allowed the FDA to approve products more quickly and put in place emergency public health guidelines for the industry,” Abernethy said. “It allowed the whole industry to do pressure testing: what does it look like when the FDA and the rest of the government are working more nimbly?”
The FDA has taken several steps “that have allowed us to be more flexible when it comes to digital health solutions and how we use them in our daily lives,” she continued. “For example, in the context of clinical trials, the public health emergency guidelines allow companies to use real-world data to populate clinical trial datasets when a patient would otherwise not be able to make it. to the clinic for a clinical trial visit. now, this creates a space where, in the future, we can assess, what does the marriage of real-world data and clinical trial data do in terms of creating new mechanisms for trials clinics for the future? “
In the short term, “regulators are required to go back to basically what they were before, but we are not unlearning,” she added. “And so the point would be to stop and say what has been learned and what should continue in the future?” Examples could include examining “what enables the continued development of evidence while maintaining patient safety and data integrity, and how can we ensure that we are moving towards more patient-centered care. patient and clinician who lighten the burden on system physicians and enable patients to get what they need faster and smarter. “
Health confidentiality issues
Privacy and health security was another area where flexibility was key, said Deven McGraw, chief regulatory officer at Ciitizen, a company aimed at allowing everyone in the world to access their medical records. . “The HHS Office for Civil Rights (OCR), which has jurisdiction over HIPAA, has issued a number of guidelines… to enable healthcare providers, hospitals and physicians to be able to use standard telemedicine solutions and deploy them. very quickly, ”she said.
“Security and privacy don’t necessarily take a break during a national emergency, and hackers are keenly aware of the circumstances under which people might let their guard down because it’s an opportunity for them. But at the same time, there was a need for entities that were not using telemedicine to do so very quickly, and standard tools that may or may not be HIPAA compliant would have made a lot of sense in the short term, ”he said. she added.
Public health reporting rules have also been relaxed during the pandemic, McGraw said. “We have these health information exchange entities that are business partners who typically have their ability to report directly to public health is limited by the agreements they have signed with their participants – the healthcare providers – and yet they have a lot of data, “So it was essential to make it easier for them to report,” she said.
“I think it’s a little uncertain whether you can continue to somehow, not give up on safety concerns, but put them on the back burner in the absence of a public health emergency,” McGraw added. “But I will say that part of the reporting to public health is something that I think people have learned could be done and should be done… and could be kind of a candidate for some kind of lasting rule change, but we’ll ‘I’ll see how OCR handles this long term.’
New rule on “revolutionary” devices
Panelists were also asked about a final rule released by HHS in January on so-called “breakthrough” medical devices; the rule says that once these devices are approved under the FDA’s pre-market authorization process, they will also have 4-year guaranteed Medicare coverage. The rule was originally scheduled to go into effect on March 15, but has been delayed until at least December 15 as part of the usual “regulatory freeze” that occurs with a change in administration.
If and when the rule goes into effect, “I think that will have a very big impact because it will allow Medicare beneficiaries to access products much faster than they could have before, and that’s huge. from a patient perspective in terms of being able to treat their conditions, ”Brandt said. “I think part of the challenge is that CMS and FDA still have some regulatory hurdles to overcome on the CMS side.”
“Part of what CMS realized pretty quickly was that there were a lot more of these breakthrough devices and products than they had anticipated, and it was going to be a lot more workload and have a much bigger impact on the Medicare program than I initially thought, ”she added. “So that’s something that has great potential, but I think there’s still a very close dance to be worked out between the FDA and CMS, about how this is all going to work and how it’s going to work. before.”