Congress moving on opioid legislation

With help from Arthur Allen (@arthurallen202) and Mohana Ravindranath (@ravindranize)

CONGRESS MOVING ON OPIOID LEGISLATION: The big opioids package lumbers on in Congress, with a lot of activity of note Tuesday. Here’s what’s important:

The House voted on a package of 25 bills addressing the opioids crisis Tuesday, part of a broader package slated for approval later this month. For eHealth purposes, Lynn Jenkins’s bill (H.R. 3331 (115)) establishing a demonstration program for incentives for behavioral health providers’ EHR adoption is probably the most notable of the batch. Legislators also approved Rep. Barbara Comstock’s Better Pain Management Through Better Data Act of 2018 (H.R. 5473 (115)), which requires HHS to issue guidance on data collection for opioid sparing.

The House by vote voice also approved Jessie’s Law, which would promote notation of a patient’s history of opioid addiction in the EHR.

Other bills approved in this tranche make tweaks to telehealth and prescription drug monitoring programs.

The Senate Finance Committee unanimously approved its big bill to address the opioid crisis. The “HEAL Substance Abuse Disorders” Act tries to improve Medicare’s and Medicaid’s response to the crisis. Overall, the bill boosts Medicare’s telehealth reimbursement for opioid treatment, among other initiatives.

eHealth tweet of the day: Jeff Dachis @jeffdachis “Medical professionals and organizations, stop using HIPAA as an excuse to not use modern forms of communication to engage with patients. You look stupid.”

WEDNESDAY: Your correspondent is always alert to eHealth tech in the wild — which is why he was tickled by a sighting in a more domestic setting: a zoo. The National Zoo’s elephants are apparently being tracked by ankle wearables; as far as your correspondent knows, no news as to whether they’re working out more because of it. Discuss pachyderms’ tech usage at [email protected]. Like an elephant, one should never forget to discuss eHealth developments socially at @ArthurAllen202, @dariustahir, @ravindranize, @POLITICOPro, @Morning_eHealth.

FDA RELEASES DRAFT PATIENT-EXPERIENCE DATA GUIDANCE: The new agency guidance regarding patient-experience data in drug development includes few details about using digital health tools as a means for collecting that information. The agency says that companies interested in using digital apps or gadgets to gather the data should consult with the agency.

Conceptually, patient-experience data is information regarding how patients react to drugs beyond traditional metrics, like mortality and morbidity, that seeks to capture other important factors how patients feel about therapies they’re taking. For example, a patient might become more active when taking a drug.

Digital health enthusiasts have long felt their gizmos could play a role here; for example, a smartphone might be able to measure the increase in steps taken during a study period. But the guidance simply says that groups interested in using those technologies for gathering the data should consult with the agency first.

Some industry observers we chatted with were puzzled by the scanty detail — described over two sentences — in the guidance. “FDA really doesn’t explain what [its] concerns might be with digital health technologies,” said Epstein, Becker and Green lawyer Bradley Merill Thompson. “It would have been much more useful if FDA articulated what [their] concerns were, rather than just saying, hey come talk to us.”

GIROIR SINGS TECH’S PRAISES: Tech has caught assistant secretary for health Brett Giroir’s eye. At a happy hour event hosted by Intel on Tuesday, Giroir offered a long list of potential tech solutions to ameliorate the opioid crisis. Giroir hit some of the typical bases, supporting telehealth as a way to deliver medication-assisted treatment as one example, and praising Project ECHO, a program connecting primary care physicians with specialists as a “big innovation” and “really remarkable.”

But Giroir also staked some new ground, musing about the possibility of wearable tech that could sense if a patient was overdosing and warn caregivers and providers that imminent treatment is needed.

Giroir also offered a hint about where policy might go next, citing Monday’s letter to state Medicaid directors on using CMS dollars to support projects boosting software installations to address the opioid crisis — like integrating prescription drug monitoring programs into EHRs. You could use “enhanced match for a variety of things,” he said.

VETS CAN GET TELECARE ANYWHERE: The VA rule that allows veterans and their providers to do telemedicine visits regardless of where they are went into effect this week, Neil Evans, chief officer for Connected Care at the VA, said Tuesday. About 12 percent of the veterans seen at the VA get care through telemedicine; there are no longer barriers to providing it across state lines and irrespective of location, Evans said. You’ll remember that former Secretary David Shulkin announced the program last August at a White House event with President Donald Trump (the initiative started during the Obama administration).

CMS MOVES TO REIMBURSE FOR SMARTPHONE-ENABLED CGMs: CMS is now covering continuous glucose monitoring devices that interface with a smartphone, the agency announced. In January 2017, the agency decided to reimburse so-called therapeutic CGMs, which replace fingerstick blood glucose monitors. But many digitally forward groups wanted a further tech upgrade, which they’ve received. This tech allows blood glucose data to flow from the monitors to a patient’s smartphone, and that data can then be shared with doctors or caregivers.

Several groups, like ACT | The App Association and JDRF, were effusive in their praise.

ADVAMED OFFERS CYBER COMMENTS TO E&C: The big medical device trade group has also offered comments to the House Energy and Commerce’s cybersecurity request for information in a letter. The association describes the industry’s support of robust digital defenses, but argues that maintaining such defenses indefinitely is prohibitively expensive, particularly as old technology ages beyond the ability of companies to support it. Among other policy suggestions, they argue manufacturers should communicate to their customers regarding when they can no longer support old technology.

AMA NAMES NEW LEADERS: The annual changing of the guard at the American Medical Association took place Tuesday. Barbara McAneny, a New Mexico oncologist, is the association’s president for the year. Patrice Harris, an Atlanta psychiatrist, will serve as president-elect. Harris has been active in the association’s opioid task force, which has made recommendations to policymakers on prescription drug monitoring programs among other ideas.

IN MEMORIAM: We’re saddened to learn of the passing of Alice Borrelli on Monday. Borrelli, Intel’s global director of global health and workforce policy and formerly an official at AT&T, was a fixture in the digital health policy world. She frequently helped reporters such as myself understand and explain policy coherently. Her memorial will be held June 21, at 10 a.m., at Vienna Presbyterian Church.

WHAT WE’RE CLICKING ON:

—A Health Affairs blog post says it’d be a mistake to cut back on non-emergency medical transportation reimbursement in Medicaid. Such transportation has been an intriguing business for many startups.

—We’re (not) sorry for losing your data, declares a New Yorker satire.

—How Apple Health Records built on the FHIR standard.

—A data audit of the highly controversial “Streams” app built by Google subsidiary DeepMind in one NHS hospital.