Lobbying groups tell ONC to start over on info blocking rule

With help from Arthur Allen (@arthurallen202), Darius Tahir (@dariustahir) and Dan Diamond (@ddiamond)

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Quick Fix

— Lobbyists tell ONC to start over on info blocking rule: Trade group leaders had harsh feedback for ONC and CMS on their dual information and interoperability proposals ahead of Monday’s deadline for public comments.

— Don’t lean too much on PDMPs, federal task force says: The HHS-led interagency task force pointed out that the prescription drug monitoring programs aren’t error proof.

— More on dwindling abortion access: Women in vast swaths of the country have the right to abortion in name only.

eHealth tweet of the day, on HHS’ Office of Civil Rights’ guidance this week on business associate agreements under HIPAA, which we noted Wednesday: Farzad Mostashari @Farzad_MD, “This new @HHSOCR clarification shows need for 21C regs.

OCR lacks authority to enforce the “reasonable, cost-based fee” limitation in 45CFR§164.524(c)(4) against business associates [eg med records vendors]- can take action against only the covered entity hhs.gov/hipaa/for-prof…

Ergo: ’48 hospitals that had costs of release (as much as $541.50 for a 200-pg record) above the federal recommendation of $6.50 for electronically maintained records..1 hosp unable to disclose costs of release, b/c costs are determined by an outside party jamanetwork.com/journals/jaman…"

Deven McGraw @HealthPrivacy, “Agree! OCR can enforce the fee limits on the covered entities who hire business associates (BA) to get records to patients - even if the fees are set by the BA. But BAs who take on this role should be accountable.”

IT’S FRIDAY at Morning eHealth. If you’re still frantically scribbling down responses to ONC and CMS’ proposed rulemaking this weekend, your author wishes you happy writing. Send letters and tips to [email protected]. Tweet the team at @arthurallen202, @dariustahir, @ravindranize, @POLITICOPro and @Morning_eHealth.

Driving the Day

TOO BROAD, TOO PRICEY, TOO SOON — As Monday’s public comment deadline nears for HHS’ dual proposals on health data sharing, a coalition of health IT groups are urging ONC and CMS to make major changes, or even issue an interim rule instead of a final version.

“A a core level, the rules do not work,” Joel White said during a press call that his lobbying group, the Health Innovation Alliance, organized Thursday. “ONC and CMS ought to go back to the drawing board.”

White and other trade group leaders on the call argued the proposed rules — designed to make patient data more sharable and accessible — were too broad, would curb innovation, and would be too costly to implement.

ONC’s proposal outlines “reasonable and necessary” activities that are exempt from the 21st Century Cures Act’s ban on information blocking; it also proposes requiring certified EHRs to use the FHIR standard for APIs to make data sharing easier. CMS’ proposal, released at the same time, would also require payers in federal programs to adopt those same API standards. In response to demand from trade groups, the two agencies extended the comment period to June 3.

One of the seven “reasonable and necessary” exemptions ONC outlines would let health groups turn down health information exchange requests if the request is infeasible. But that’s too broad, according to Doug Peddicord, executive director of the Association of Clinical Research Organizations. ”Anyone can find a reason to fit” into that exemption, he said on Thursday’s call.

Pros can read the rest of the story here.

Opioids

EASE UP ON PDMPS, TASK FORCE SAYS — A federal interagency task force led by HHS recommended that prescription drug monitoring programs — the state databases storing patient prescription data — shouldn’t be used to cut patients off opioids without consultations with clinicians, our colleague Arthur Allen reports.

Clinicians “should consider checking PDMPs” before starting opioid therapy with patients, but they shouldn’t be required to check them too often without good reason, the task force recommended. More research is needed to understand how the systems should be used in inpatient and outpatient settings.

“PDMP data alone are not error proof and should not be used to dismiss patients from clinical practices,” the report says. Pros can read more here.

...Also on opioids, the American Medical Association’s opioid task force updated its recommendations on managing the crisis this week. One suggestion was to remove prior authorization requirements and “administrative burdens or barriers that delay or deny care for FDA-approved medications” used in medication-assisted treatment for opioid use disorder.

“We need help from policymakers to ensure that more people have access to treatment,” AMA President-elect Patrice Harris, who also chairs the task force, said in a news release. Physicians are seeing a dip in opioid prescriptions and a spike in PDMPs, but “we cannot enforce parity laws, or eliminate administrative barriers without the help of state and federal authorities, and that’s what is limiting treatment now.”

Abortion

A RIGHT IN NAME ONLY — Several states have enacted laws that — if they take effect — would ban abortion once a fetal heartbeat can be detected. As long as Roe v. Wade stands, abortion is still legal in the United States, but that’s a right in name only for women in vast swaths of the country, writes your author with POLITICO colleagues Rachana Pradhan and Renuka Rayasam. Six states have just one abortion clinic, and Missouri may soon have none at all. Depending on where they live, women may have to travel more than 300 miles to be able to end a pregnancy.

...That’s where telemedicine comes in, as we’ve reported at eHealth. Virtual check-ins could mean that women have to travel less — and in some cases not at all — to be legally dispensed abortion medication. Abortion clinics in several states across the country offer telemedicine consultations; as other states pass more restrictive early abortion bans, those clinics could see an influx of patients. Read more here.

Veterans

MOULTON’S PLANS FOR VETS — Rep. Seth Moulton (D-Mass.), the Marine veteran running for president, introduced a plan this week to expand mental health services for veterans, Arthur writes. Earlier this week, Moulton disclosed seeking treatment for PTSD after deployments during the Iraq War. His plan would require returning combat veterans to attend a counseling session and would institute annual mental health check-ups for active duty military and veterans. He would also fill all mental health vacancies at the VA and encourage the department to offer alternative therapies, including mindfulness and cannabis.

Senate Floor

DURBIN: NO CONFIDENCE IN ACTING FDA CHIEF — The striking rebuke came after a recent meeting between Dick Durbin, the No. 2 Senate Democrat, and Ned Sharpless, who’s led FDA in an acting capacity for nearly two months. The conversation about youth use of e-cigarettes was “one of the most alarming and disappointing meetings in my time in public service,” Durbin said in a letter earlier this week. (Read more from our colleague Sarah Owermohle here.)

The Illinois Democrat — who had forged a working relationship with former FDA Commissioner Scott Gottlieb — said the agency must do more, and quickly, to get e-cigarettes out of kids’ hands.

“It is my belief that any person leading the FDA ... must, first and foremost, feel a deep sense of responsibility to protect the health and well-being of all Americans, especially our nation’s children,” Durbin wrote to Sharpless. “I do not have confidence that you are that leader.”

“Dr. Sharpless is committed to continuing to tackle the troubling epidemic of e-cigarette use among kids,” a spokesperson told POLITICO. “This includes preventing youth access to, and appeal of, flavored tobacco products like e-cigarettes and cigars, taking action against manufacturers and retailers who illegally market or sell these products to minors, and educating youth about the dangers of e-cigarettes and other tobacco products.”

HAWLEY CONTINUES CAMPAIGN AGAINST FACEBOOK — Sen. Josh Hawley this week blasted Facebook for failing to detail the information it collects from users’ encrypted messages, our POLITICO colleague Cristiano Lima reports. Earlier this month, he’d pressed Facebook CEO Mark Zuckerberg on those details; Zuckerberg recently unveiled a “privacy-focused” plan for the company.

Facebook Vice President of U.S. Public Policy Kevin Martin wrote in a letter released this week that there are “still many open questions about what metadata we will retain and how it may be used.”

“I am frankly shocked by Facebook’s response,” Hawley said in a statement. “I thought they’d swear off the creepier possibilities I raised. But instead, they doubled down.”

“My advice to consumers is simple: When Facebook tells you its messaging services are private, you can’t trust them,” Hawley noted.

ALEXANDER RECOVERING FROM LEG SURGERY — Senate HELP Chairman Lamar Alexander (R-Tenn.) underwent leg surgery for a lipoma, or a fatty lump, this week at Vanderbilt University Medical Center in Nashville, our POLITICO colleague Kimberly Hefling reports. More for Pros here.

Technology

BUZZWORD BINGO CONTRACT — General Dynamics Information Technology has a $49 million, five-year support contract with HHS to provide services related to artificial intelligence, blockchain, machine learning, natural language processing, and automation, the company announced this week.

Names in the News

Mount Sinai Health System named Andrew Kasarskis its chief data officer, a new role, Becker’s reports. ... Wei-Li Shao joins Omada Health from Eli Lilly and will serve as Omada’s chief commercial officer.

What We're Reading

— Pokémon is getting into sleep tracking, MobiHealthNews’ Dave Muoio writes.

— Jared Council writes for WSJ about IBM’s AI challenges.

— The Guardian’s Jessica Glenza reports on Femm, a fertility app funded by anti-abortion advocates.