Stuart M. Gerson, Member of the Firm in the Litigation and Health Care & Life Sciences practices, in the firm’s Washington, DC, and New York offices, was quoted in the Report on Medicare Compliance, in “Outlook 2020: Integrity Rule, Inpatient Audits Will Stir Things Up; Privacy Is ‘Huge Focus,’” by Nina Youngstrom.
Following is an excerpt:
Welcome to 2020, the year that may be a turning point for data privacy and security. For starters, new state laws take effect in California and New York state and apply both to companies in those states and that have consumers there, while the HHS Office for Civil Rights (OCR) pushes ahead with its Right-of-Access Initiative. …
That’s just one inflection point for compliance and enforcement. There are other developments that will test health care organizations, including a regulation that went into effect Jan. 1 on patient discharge planning and a program integrity rule that will be phased in. Others that go live next year—on Medicare documentation and price transparency—require compliance preparation this year, compliance experts say.
Meanwhile, Medicare beneficiaries continue to flock to Medicare Advantage, which worries physician advisers because they say more arbitrary denials will follow. Compliance experts predict a resurgence this year of audits of short stays and other areas with high error rates on the 2019 Medicare fee-for-service improper payment rate report. Enforcement of the False Claims Act will continue, powered by whistleblowers, but there will be some ripple effects because of the Supreme Court decision in Azar v. Allina Health Services, et al. and the interplay between the Granston memo and the Supreme Court decision in Universal Health Services vs. United States ex rel. Escobar in 2016. …
Allina Case Will Complicate Enforcement
It’s possible FCA lawsuits will hit drug pricing. “I can envision any number of ways there could be litigation, including FCA cases, with regard to actual costs and prices paid” at different levels of the pharmaceutical food chain “and the actual, rather than ostensible, value of what is sought to actually be billed to the government,” says attorney Stuart Gerson, with Epstein Becker Green in Washington, D.C. Whatever the target, DOJ will face new challenges as it pursues FCA lawsuits in the wake of the 2019 Supreme Court decision in the Allina case, Gerson says. The Supreme Court ruled that CMS is required to use the rulemaking process, with its notice and comment period, to make “substantive” changes to policies that affect payment. “The Supreme Court has shown a willingness not to defer to agency interpretations, and that will only continue,” Gerson says. “CMS and FDA will have less leeway to interpret statutes and will have to rely on arguments based on literal readings of statutes.” That makes it harder to pursue enforcement actions when providers deviate from guidance rather than laws or regulations.