A new rule proposed by the Centers for Medicare and Medicaid Services (CMS) on October 26, 2018, would revise the way the agency validates the risk adjustment data and collects repayments from Medicare Advantage (MA) organizations. With the new methodology, CMS is expecting to return $4.5 billion in savings to the Medicare Trust Fund over 10 years, according to an October 26 CMS news release. Continue Reading CMS Issues Proposed Rule Addressing Payment Error in Medicare Advantage, Expects to Recover $4.5 Billion Over 10 Years

The Rape, Abuse and Incest National Network (“RAINN”) reports that sexual assault and abuse of people with disabilities often goes unnoticed, and, according to the National Crime Victimization Survey, people with disabilities are victimized by crime at higher rates than the rest of the population. Too often, it is the caregivers who are the perpetrators. While one with a disability may give consent to sexual activity, there can never be consent between one who is disabled and receiving care and a member of the caregiving staff. Continue Reading Sexual Abuse of People with Disabilities

In the wake of the #MeToo Movement, New York, California and a number of other jurisdictions, both local and state, have passed new laws aimed at combatting sexual harassment in the workplace.  The New York laws require written sexual harassment prevention policy, assurance that all current and new employees, and even applicants for employment, receive a copy of the policy, and mandate annual sexual harassment training for all employees.  In addition, New York law now provides that employers can be liable for sexual harassment of nonemployees in the workplace, such as contractors, vendors and subcontractors.  Recent legislation prohibits employers from using mandatory arbitration provisions in employment contracts or nondisclosure agreements except when this is the victim preference.  Let me suggest that there are some important lessons to be learned from these laws. Continue Reading Lessons From Changes to New York State’s Sexual Harassment Laws

On Wednesday, the Department of Health and Human Services (“HHS”) reversed course in its delay of implementing fines against drug manufacturers that intentionally overcharge 340B providers. In a notice of proposed rulemaking, HHS intends to advance the effective date of its final rule on the 340B drug price ceiling and civil monetary penalties to January 1, 2019, rather than July 1, 2019, as previously proposed. Continue Reading HHS proposes moving up the enforcement of 340B penalties to January 1, 2019

Anticipating open enrollment season for coverage in 2019, the Centers for Medicare and Medicaid Services (CMS) released coverage and premium information that will factor into consumer decisions about Medicare and individual commercial plans offered through exchanges. Enrollment and premium trends also inform regulatory and broader policy decisions at both federal and state levels. Continue Reading Open Enrollment Update: CMS Releases Benefit and Market Data

On September 10, 2018, the federal Food & Drug Administration (”FDA”) released its revised draft standard Memorandum of Understanding (“MOU”) between states and the FDA addressing the interstate distribution of compounded drug products.  See 83 Fed. Reg. 175, 45631 et seq. (Sept. 10, 2018). The draft is the latest in the FDA’s decades-long effort to clarify state and federal roles in investigating and responding to complaints related to compounded drug products shipped between states. Continue Reading FDA publishes revised draft MOU addressing state and federal oversight of 503A compounding pharmacies

There were several recent court decisions that have addressed the right of medical providers, acting under assignments of ERISA plan benefits from patients, to seek plan documents and summary plan descriptions, and to sue plan fiduciaries.

In one case, the district court dismissed the action, holding that the patients had not assigned their rights to sue the plan for statutory penalties. The provider attempted to obtain a retroactive assignment, but the Eleventh Circuit court of appeals held that the provider was not a participant nor a beneficiary in the plan and thus had no standing to bring a claim. Continue Reading Recent Case Law Regarding Health Plan Assignment of Benefits

A federal court decision to vacate regulations concerning “overpayments” to Medicare Advantage plans has left open questions about the way the government pays the insurers and pending cases brought by the U.S. Department of Justice. Continue Reading Court Decision on Overpayment Rule Leaves Uncertain Future for Medicare Payment Methodology and Pending Justice Department Lawsuits

This is the second article in our series on the new “Pathways” rules for Accountable Care Organizations. Our first article in the series can be found here.

The Centers for Medicare and Medicaid Services (CMS) released a report on August 27, 2018, showing Next Generation accountable care organizations (ACOs) produced net savings of $62 million in 2016 while maintaining quality of care.  CMS Administrator Seema Verma pointed to the savings as evidence that ACOs taking two-sided risk succeed, according to a CMS press release.  Continue Reading Performance Report: “Pathways” Rules Help CMS Advance Two-Sided Risk Sharing