{"id":180329,"date":"2021-11-30T14:00:00","date_gmt":"2021-11-30T14:00:00","guid":{"rendered":"https:\/\/icrowdnewswire.com\/?p=2956194"},"modified":"2021-11-30T14:00:00","modified_gmt":"2021-11-30T14:00:00","slug":"cms-and-hhs-signal-course-correction-in-new-stark-aks-and-cmp-final-rules-and-give-the-green-light-for-value-based-care","status":"publish","type":"post","link":"https:\/\/ipsnews.net\/business\/2021\/11\/30\/cms-and-hhs-signal-course-correction-in-new-stark-aks-and-cmp-final-rules-and-give-the-green-light-for-value-based-care\/","title":{"rendered":"CMS and HHS Signal Course Correction in New Stark, AKS, and CMP Final Rules and Give the Green Light for Value-Based Care"},"content":{"rendered":"

\"Mills
\nBy Mills Fleming, HunterMaclean<\/em><\/p>\n

With a nod to the broad reach and increasing complexity of the federal health care fraud and abuse laws, while also acknowledging their detrimental impact on advancing quality care initiatives, both the Centers for Medicare and Medicaid Services (CMS) and the Department of Health and Human Services (HHS) took the unprecedented step last December of issuing corresponding final rules as part of their Regulatory Sprint to Coordinated Care initiative, aka the Sprint Project.<\/p>\n

As explained in the HHS\u2019s press release<\/a>, these historic and sweeping new rules, published on December 2, 2020, aim to \u201creduce regulatory barriers to care coordination\u201d and \u201caccelerate the transformation of the health care system into one that pays for value and promotes the delivery of coordinated care.\u201d<\/p>\n

The new rules are also designed to facilitate the market\u2019s rapid move away from fee-for-service to value-based care models with the hope that these changes will \u201cstand the test of time.\u201d As then-HHS Deputy Secretary Eric Hargan commented, \u201cToo often, \u2018sorry, Stark\u2019 or \u2018can\u2019t do it, AKS\u2019 have been watchwords in American healthcare\u2026we\u2019re finally breaking down barriers to patient-centered, value-based healthcare innovation.\u201d<\/p>\n

How We Got Here<\/em><\/strong><\/p>\n

The federal laws in question are the anti-kickback statute (AKS), the physician self-referral law known as Stark, and the civil monetary penalty (CMP) law provision prohibiting inducements to beneficiaries. They have been in effect for decades and suffered their fair share of piece-meal applications and judicial interpretations. They have also become the government\u2019s weapon of choice to punish violations\u2014even if, as reinforced in United States v. Shah<\/em>, No. 19-12319 (11th Cir. 2020), \u201cone purpose\u201d out of a multitude of many legitimate objectives is construed to induce the volume or value of impermissible referrals (under the AKS) or any<\/em> arrangement that does not fall within an applicable Stark exception.<\/p>\n

Those who have practiced in this area are all too familiar with the peril associated with these violations. Federal courts acknowledge this disparity as well, calling the Stark law in particular a \u201cbooby trap\u201d and a \u201cdeath sentence\u201d for the wary and unwary alike.<\/p>\n

Adding to this peril is the ever-widening chasm between regulatory guidance and judicial application, which has vexed the most well-intentioned attorneys and led one federal appellate judge to comment, \u201cIt is easy to see how even diligent counsel could wind up giving clients incorrect advice.\u201d<\/p>\n

And, finally, health care providers have had to navigate the treacherous impasse created by a dual regulatory environment where an arrangement could violate one law while meeting the requirements for protection under the other.<\/p>\n

Enter the Sprint Project<\/em><\/strong><\/p>\n

In 2018, HHS formally launched the Sprint Project to accelerate a transformation of the health care system, with a focus on removing \u201cunnecessary government obstacles\u201d to coordinated care and to \u201caddress any undue regulatory impact and burden\u201d caused by Stark and the AKS. Soon after the launch, both HHS and CMS published Requests for Information (RFI) to solicit public input. Subsequently, HHS\u2019s Office of Civil Rights issued a similar RFI with respect to the Health Insurance Portability and Accountability Act (HIPAA) rules.<\/p>\n

HHS and CMS collectively received over 700 responses to the RFI, and on October 9, 2019, they published their proposed respective changes to the AKS\/CMP and Stark. The final rules were published just over a year later on December 2, 2020.<\/p>\n

Overview<\/em><\/strong><\/p>\n

Overall, the AKS final rule adds new safe harbors for the following:<\/p>\n