{"id":31571,"date":"2020-12-07T20:13:04","date_gmt":"2020-12-07T20:13:04","guid":{"rendered":"https:\/\/dev.mtelehealth.com\/?p=31571"},"modified":"2020-12-07T20:13:04","modified_gmt":"2020-12-07T20:13:04","slug":"stark-law-changes-should-benefit-telehealth-remote-patient-monitoring","status":"publish","type":"post","link":"https:\/\/drmiltie.com\/at-home-testing\/stark-law-changes-should-benefit-telehealth-remote-patient-monitoring\/","title":{"rendered":"Stark Law Changes Should Benefit Telehealth, Remote Patient Monitoring"},"content":{"rendered":"\n\n\n

The OIG’s Final Rule on changes to the Stark Law and Anti-Kickback Statute creates several new safe harbors that will help providers create and expand telehealth platforms and remote patient monitoring programs.<\/h2>\n\n\n\n

By\u00a0Eric Wicklund<\/a><\/p>\n\n\n\n

November 24, 2020 – New safe harbors proposed for the Stark Law and Anti-Kickback Statute could help providers expand their telehealth and remote patient monitoring platforms.<\/p>\n\n\n\n

A Final Rule<\/a> issued last week by the Health and Human Services\u2019 Office of the Inspector General creates seven new safe harbors for value-based arrangements, and modifies five already in place. The new guidelines are designed to enable different groups \u2013 such as healthcare providers, telehealth and mHealth vendors and others \u2013 to collaborate on connected health services without running afoul of federal laws on fraud, waste and abuse.<\/p>\n\n\n\n

Specifically, the Stark Law, otherwise known as the physician self-referral law, prohibits referrals by a physician to another provider if the physician or his immediate family has a financial relationship with the provider. The Anti-Kickback Statute, meanwhile, bars the exchange of remuneration \u2013 which according to this law is anything of value \u2013 for referrals that are payable by a federal healthcare program like Medicare.<\/p>\n\n\n\n

The healthcare industry has long lobbied to change what it considers to be an outdated Stark Law and Anti-Kickback Statute to better align with the shift from fee-for-service to value-based care. The law is particularly troublesome in telehealth, hindering opportunities for large health systems and companies to work together and to help smaller systems and hospitals develop their own platforms or take part in a larger telemedicine network.<\/p>\n\n\n\n

Last week\u2019s Final Rule follows up on changes originally proposed in 2019<\/a>, and opens the door to more \u201cvalue-based enterprises,\u201d which are defined as two or more \u201cVBE participants\u201d working together to coordinate care, improve outcomes and reduce costs for a target population while transitioning into value-based care.<\/p>\n\n\n\n

They also reflect the changes in healthcare delivery brought about by the coronavirus pandemic, which is forcing many providers to develop virtual care programs and create hybrid models of telehealth and in-person services that challenge policies that govern care delivery<\/a>.<\/p>\n\n\n\n

According to Carrie Nixon, co-founder and managing partner of Nixon Gwilt Law, the  OIG\u2019s Final Rule \u201cgives healthcare providers and digital health companies more flexibility to enter into new business arrangements that incentivize care coordination and patient engagement as a means of improving outcomes and reducing the overall cost of care.\u201d<\/p>\n\n\n\n

\u201cThese new protections allow players in the digital health space \u2013 including Remote Patient Monitoring companies, telehealth companies, and healthcare predictive analytics platforms \u2013 to take on an unprecedented role in helping healthcare providers move the needle on patient outcomes and costs by providing in-kind and even monetary remuneration to these providers in the form of free or reduced cost items\/services or shared savings arrangements,\u201d she summarized in a recent article on her law firm\u2019s website<\/a>.<\/p>\n\n\n\n

\u201cThe value-based safe harbors do not include the traditional requirement of Fair Market Value for goods\/services or the prohibition against taking volume or value of referrals into account,\u201d she wrote \u201cFor example, under one of the new safe harbors, a remote patient monitoring company could create a VBE and enter into value-based arrangements to provide participating healthcare providers with an embedded clinical staff member at no cost to the providers to help identify, onboard and monitor patients in an RPM program.\u201d<\/p>\n\n\n\n

The new AKS safe harbors are:<\/p>\n\n\n\n