Most recently, the CMS and the Office of the National Coordinator for Health Information Technology issued two proposed rules on Feb. 11 to spur interoperability and counter information-blocking.
Among the rule’s provisions is to post a list online of healthcare clinicians and hospitals that block the transfer of patient information, with the goal of getting providers to curb the practice.
The rules also took a less obvious swipe at electronic health record system vendors, who after years of effort have yet to achieve full interoperability. The proposed rule would require that vendors make patient information available in a standard, easily manipulated format. That would allow app vendors to collect health records and patients to manage their health, with the potential of achieving effective interoperability without EHR vendors.
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The strategy of naming bad actors already has been used in the administration’s efforts to curb high drug prices. The CMS and the Food and Drug Administration have both sought to name drug companies that raise prices too high on Medicare or engage in anti-competitive tactics to deter generic-drug competition. In addition, pharmacy benefit managers are a target for increased disclosure of fees they are paid for drug management.
CMS Administrator Seema Verma didn’t rule out similar tactics when asked if such “name and shame” tactics are going to be applied to other types of regulations.
“I think last year at HIMSS it was clear we are going to use every lever that we have to drive patients getting access” to their records, she said at a news briefing Feb. 12. “It is important that our system has interoperability and patients have access to their records and we will do everything we can to make that a reality.”
Some hospital executives say the rules, regardless of the approach, could lead to change if the various pieces fall into place. “There are a couple of things that have to happen,” said Aaron Martin, executive vice president and chief digital officer at Providence St. Joseph Health and managing general partner of Providence Ventures.
“One is it’s going to be very powerful once we can get an efficient combination between claims data and clinical data, so that the patient has full control and can view not only what was billed for, but what was actually done. Both pieces of information carry value, but they’re both incomplete,” Martin said. He said there also is consumer-generated data that patients need to willingly contribute to the discussion as well. That information is provided by Fitbit and other technology.
“The key thing is the combination of these data sets really matter,” he said.
The 21st Century Cures Act defined information-blocking and created possible penalties and disincentives for those doing it.
Under the proposed rule, a healthcare provider participating in the Quality Payment Program must say “yes” or “no” to three statements that detail whether they block information. Any provider that says “yes” to any of the statements and admits it is blocking information will be listed on the Physician Compare website managed by the CMS.
The agency will provide clinicians and hospitals with a 30-day preview period for information posted on the website.
Some experts question if doctors are going to honestly attest to blocking information or if they even know they’re blocking information.
“A provider might just say I will say no to these things because I don’t want it to be known,” Golder said. “What does CMS do in those cases? Is that a legally binding attestation, and will they prosecute folks who falsely attest?”
Another concern is how a doctor can get off the list. “We all know that once information is online it tends to live forever,” Golder said. “I would like for some way for CMS to ensure that if this is reported once and a provider remedies that situation and once it is removed then the reputational impact is remedied.”
The CMS did not return a request for comment on how attestation will work.
If any of the statements are left blank, the result will not be listed on Physician Compare, according to the proposed rule.
Others in the spotlight
In the rule, HHS proposed that a PBM disclose any services it provides to drug companies. Each year, a PBM must write to each health plan it contracts with to disclose the services and the associated costs, the rule states. “The department believes that PBMs are agents of the health plans with which they contract,” according to the rule. It added the new transparency requirement to ensure any deals with a drug company don’t conflict with services a PBM provides to a health plan.
HHS also wants to ask for additional information on the fee arrangements between drugmakers and PBMs upon request. The agency is also considering requiring PBMs to disclose such services and fees to HHS in order to get safe harbor protection. And in May, the CMS unveiled a “Drug Spending Dashboard” that highlights year-over-year price hikes in Medicare and Medicaid to coincide with the Trump administration’s drug-pricing blueprint.
That same month the FDA adopted a similar tactic to name bad actors as part of its initiative to increase generic-drug competition. It released the names of brand-name drugmakers accused of blocking generic-drug companies from getting samples of the brand product. A generic-drug company needs up to 5,000 samples of a brand-name drug to conduct the testing required to gain FDA approval.
The agency created a webpage of more than 50 brand-name drug companies that limit distribution of samples from a variety of means. For instance, sometimes a drug could not be available through standard distribution like a wholesaler. A brand-name company would instead use a central distributor or small group of pharmacies that would then not provide samples to the generic-drug company.
A safety program called Risk Evaluation and Mitigation Strategy that the FDA applies to high-risk drugs sometimes means a drug has a limited distribution strategy for safety reasons.
But a brand-name company will cite REMS as a reason to not provide samples to a generic-drug maker.
A page on the FDA’s website lists the number of complaints that generic-drug companies make to the agency and lists the products that are the subject of the complaint. When the agency first released the list in May, it included complaints for 51 drug products. In a new release last month, that figure increased to 54.
The FDA said that it doesn’t use the term “name and shame” for these programs, but instead wants to alert the industry to anti-competitive tactics. The Trump administration has targeted generic-drug competition as a key avenue to lower drug prices.
But the generic industry hasn’t been too happy with the results of “name and shame.” The lobbying group Association for Accessible Medicines noted that among three new products added to the list is the anti-malarial drug Daraprim. The drug sparked a major public outcry in 2015 when former CEO Martin Shkreli jacked up the price of the drug by more than 5,000% overnight.
“The data speaks for itself,” spokeswoman Rachel Schwartz told Modern Healthcare. “If anything, the fact that Daraprim is on this list shows that ‘name and shame’ only gets you so far.”