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.

Jump to Page

Privacy Preference Center

When you visit any website, it may store or retrieve information on your browser, mostly in the form of cookies. This information might be about you, your preferences or your device and is mostly used to make the site work as you expect it to. The information does not usually directly identify you, but it can give you a more personalized web experience. Because we respect your right to privacy, you can choose not to allow some types of cookies. Click on the different category headings to find out more and change our default settings. However, blocking some types of cookies may impact your experience of the site and the services we are able to offer.

Strictly Necessary Cookies

These cookies are necessary for the website to function and cannot be switched off in our systems. They are usually only set in response to actions made by you which amount to a request for services, such as setting your privacy preferences, logging in or filling in forms. You can set your browser to block or alert you about these cookies, but some parts of the site will not then work. These cookies do not store any personally identifiable information.

Performance Cookies

These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. They help us to know which pages are the most and least popular and see how visitors move around the site. All information these cookies collect is aggregated and therefore anonymous. If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance.