Health IT Easter egg in Part D rule

With help from Arthur Allen (@arthurallen202) and Darius Tahir (@dariustahir)

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PART D PROPOSAL PUSHES REAL-TIME PRICING DATA: Health IT wonks eagerly awaiting interoperability rulings from CMS and ONC were disappointed Monday when the Trump administration kicked out a Medicare Part D rule instead, though there were a few data-related tidbits after all, Morning eHealth’s Darius Tahir reports.

In its proposal, CMS suggests requiring Part D insurance plans to provide real-time access to drug pricing data by Jan. 1 2020. The widget providing access — called a real-time benefit tool — would connect with doctors’ EHRs or e-prescription software and allow consumers to determine the price for a given drug and various alternatives.

The agency believes such information will allow patients and their doctors to choose the most appropriate drug, thereby saving both the government and consumers money — as well as, potentially, improving medication adherence.

Still, Darius notes, it’s not clear how much the tool will actually help. An American Medical Association report says the experience of such real-time drug pricing information is “mixed,” though the doctors’ trade group supports price transparency. CMS itself concedes that it doesn’t have data on savings and says the cost of implementing software might outweigh the benefits. Pros can read the rest of Darius’ story here.

... For those still hoping the interoperability rules will drop before ONC’s annual meeting, there’s still time before the Thursday kick-off. Lawmakers and HHS officials will convene at the gathering. Sen. Lamar Alexander’s office tells Morning eHealth that he plans to discuss EHRs and ways the HELP committee he chairs can improve health IT, and the implementation of the 21st Century Cures Law. Sen. Tammy Baldwin will talk about using EHRs to “empower patients and their providers, and improve health care efficiency and the quality of care,” her staff says.

WATCHDOG TO PROBE MAR-A-LAGO TROIKA’S INFLUENCE: Speaking of EHRs, the Veterans Affairs Department’s beleaguered attempts to modernize its own record system will soon be under increased scrutiny. The Government Accountability Office is planning to investigate whether members of Mar-a-Lago, President Donald Trump’s private club in Palm Beach, Fla., improperly influenced the VA and a $10 billion contract to modernize veterans’ health records, our colleague Lorraine Woellert reports.

Sens. Elizabeth Warren (D-Mass.) and Brian Schatz (D-Hawaii) had requested an investigation in August following reports that Trump confidant Ike Perlmutter, chairman of Marvel Entertainment, and Bruce Moskowitz, a West Palm Beach doctor, used their access to the club — and the president — to delay and shape a plan to overhaul digital health records at the VA.

Warren and Schatz asked the VA inspector general and the GAO to probe a trio of Mar-a-Lago-linked men, which also includes lawyer Marc Sherman. The GAO said it would coordinate with the VA inspector general’s office.

“Membership in President Trump’s private club, alone, is not sufficient to have an informed opinion on the best way to deliver care and benefits to our nation’s veterans,” Warren and Schatz wrote when they requested the investigation in August.

Moskowitz, an internist, objected to the VA contract with Cerner Corp. because he didn’t like the company’s software in use at two Florida hospitals, POLITICO reported in April. He and Perlmutter began attending conference calls with the contracting team in charge of implementing the project, and Moskowitz’s concerns effectively delayed the agreement for months.

ProPublica reported in August that the trio was exerting “sweeping influence” at the VA, including shaping personnel decisions. Pros can read the rest of the story here.

eHealth Tweet of the day: Razib Khan @razibkhan twitter is going to come and go. crispr is here to stay

And this perspective from a former ONC deputy national coordinator: Genevieve Morris @HITpolicywonk Come on people. When has an ONC rule ever actually worked out to be released before their annual meeting? It’s called the Office of No Christmas for a reason. :)

Full Disclosure: I have no real information about when the rule will drop....just speculating like everyone else.

It’s TUESDAY at Morning eHealth where your author is enthralled by the CRISPR baby Twitter frenzy. Takes and news tips go to [email protected]. Reach the rest of the team at @arthurallen202, @dariustahir, @ravindranize, @POLITICOPro and @Morning_eHealth.

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ICYMI — MORE ON CRISPR: The scientist responsible for creating gene-edited babies is now under investigation for potentially violating Chinese regulations, reports MIT Technology Review’s Antonio Regalado, who first broke the news Sunday that the Southern University of Science and Technology was recruiting couples for this project. Regalado also reported that one of CRISPR’s inventors subsequently specifically called for a ban on using that technology for gene-editing babies. “Given the current state of the technology, I am in favor of a moratorium on implantation of edited embryos,” Feng Zhang stated to the Technology Review.

WHAT APPLE V. PEPPER MEANS FOR APP PRICES: The Supreme Court heard arguments Monday in Apple v. Pepper, a long-running class-action lawsuit brought against Apple by consumers who allege the company’s App Store holds monopolistic power, our colleague Ashley Gold reports.

David Frederick, representing Robert Pepper and other purchasers of iPhone apps, had argued consumers would be able to purchase apps for a lower price if Apple’s “monopoly app store” did not exist.

But the court subsequently seized on perceived weaknesses in Frederick’s arguments. Justice Samuel Alito questioned why Frederick focused on the claim that the App Store is a monopoly, rather than on the 30 percent cut Apple takes on app sales. Apple attorney Daniel Wall and Justice Department Solicitor General Noel Francisco, supporting Apple, had argued that app developers alone decide whether to raise prices to cover Apple’s fees.

Epstein Becker Green’s John Steren tells Morning eHealth that justices’ main challenge is assessing whether consumers have the right to sue Apple for damages, even though the apps themselves may have been developed by third parties. Based on the Supreme Court’s discussion Monday, Steren says it appears that most justices think the consumer does have that right. To safeguard against future lawsuits and having to pay damages, he said, Apple might raise app prices across the board.

Morgan Reed of ACT | The App Association said the group was “disappointed” when Justice Elena Kagan suggested that apps are purchased directly from Apple, instead of from developers who are using Apple’s app store as a selling platform.

FDA is planning to modernize the most commonly used medical device approval pathway to ensure that new devices account for advances in technology while relying on modern safety and performance criteria, our colleague Sarah Karlin-Smith reports.

The proposed changes to the 510(k) pathway, which was established back in 1976, would affect just over 80 percent of the devices reviewed by FDA. Low-to-moderate-risk devices can gain FDA approval through this pathway by showing they are substantially equivalent to a medical device already on the market — what’s known as a predicate device. More than 3,000 devices were approved via this approach in 2017.

FDA is looking at major changes to what companies can rely on as predicate devices — and the agency aims to eventually replace the predicate system altogether.

… FDA also granted accelerated approval for an oncology drug that targets a specific genetic driver of cancer instead of a type of tumor, the agency announced Monday. It’s the second such drug to receive approval.

RSNA RECAP: A few AI-related announcements emanated from the Radiological Society of North America conference this week: RSNA and chip maker Nvidia created a course for radiologists to learn more about AI, Ohio State University partnered with that company to build an AI marketplace for radiologists, and tech company Infervision launched an AI system that can detect conditions from chest scans.

MEANINGFUL USE LINKED TO EARLIER DISCHARGE: The hospitals meeting the meaningful use standards for EHR implementation have shorter average patient stays than their counterparts who haven’t met those federal standards, according to new research from Case Western Reserve University.

In their examination of four years of data, researchers found that the duration of patient stays was about four hours shorter for hospitals abiding by meaningful use standards, compared to hospitals that partially adopted or fully adopted but didn’t meet the meaningful use standards.

Lead researcher and Weatherhead School of Management Dean Manoj Malhotra says the meaningful use requirements push providers to access more features of EHRs that “generate right treatment pathways” and help them better communicate with other providers.

— Li Yuan writes in The New York Times about China’s AI workforce

— ICYMI: Kaiser Health News’ Judith Graham reports on errors in EHRs

— A piece in EHR Intelligence by Kate Monica covers the recent ransomware attack on Ohio hospitals that resulted in EHR downtime

— Illinois Policy’s Amy Korte reports on a series of class action lawsuits in Illinois related to biometric privacy law