On October 9, HHS released two proposed rules aimed at modernizing the Stark Law and Anti-kickback Statute (AKS), particularly as they apply to value-based arrangements. These proposed rules are part of HHS’ Regulatory Sprint to Coordinated Care. The AKS proposed rule, among other things, would add new AKS safe harbors: Care Coordination Arrangements to Improve Quality, Health Outcomes, and Efficiency (§ 1001.952(ee)); Value-Based Arrangements With Substantial Downside Financial Risk (§ 1001.952(ff)); Value-Based Arrangements With Full Financial Risk (§ 1001.952(gg)); Certain tools ..read more

On October 3, President Trump issued the “Executive Order on Protecting and Improving Medicare for Our Nation’s Seniors” (the “Order”).  While the Order initially focuses on the President’s opposition to the “Medicare for All” proposals, it sets a one year deadline for  the Department of Health and Human Services (“HHS”) to  implement a series of steps to  provide Medicare beneficiaries with more diverse and affordable plans. The Order encourages fee-for-service Medicare to adopt market-based approaches seen in Medicare Advantage Plans and directs HHS to encourage Medicare Advantage plans to o ..read more

On September 26, Centers for Medicare & Medicaid Services (CMS) released new rules reducing what CMS views as unnecessary burden for health care providers. As explained in the CMS press release, “the Omnibus Burden Reduction (Conditions of Participation) Final Rule strengthens patient safety by removing unnecessary, obsolete, or excessively burdensome health regulations on hospitals and other healthcare providers.” The new rules allow health systems to share quality assessment staff among hospitals in the health system. Prior to these rules, each hospital was required to have its own st ..read more

On September 25, Centers for Medicare and Medicaid Services (CMS) released a final rule that requires acute-care and critical access hospitals to have an antibiotic stewardship program. As a condition of participation in Medicare or Medicaid, all acute-care and critical access hospitals must now have an antibiotic stewardship program in order to be reimbursed by CMS. According to a 2018 CDC study, 20-50% of all antibiotics prescribed in U.S. acute care hospitals are either unnecessary or inappropriate. Antibiotic stewardship programs are hospital-based programs that aim to promote the appropri ..read more

In the largest settlement pertaining to children’s privacy, Google LLC and its subsidiary YouTube LLC on September 4 agreed to pay $170 million to settle charges by the Federal Trade Commission (FTC) and the New York Attorney General (NYAG) for illegally collecting personal data from children without their parents’ consent and serving them with targeted advertising in violation of the Children’s Online Privacy Protection Act, 1998 (COPPA). COPPA requires websites and online services directed to children under the age of 13 years to provide notice of their information practices and obtain p ..read more

The New York Times (8/13, Hoffman) reports the US Preventive Services Task Force (USPSTF) issued draft recommendations Tuesday that all adult patients be screened “for illicit drug use, including improper use of prescription medications.” The USPSTF did not extend this recommendation to teens, citing lack of research on adolescent screening benefits. Though USPSTF “guidelines are not binding…a provision in the Affordable Care Act says that services recommended by the task force must be covered by insurance with minimal or no co-payment.” The Wall Street Journal (8/13, Burton, Subscription Publ ..read more

On July 29, the Centers for Medicare & Medicaid Services (CMS) published the CY 2020 Medicare Physician Fee Schedule Proposed Rule. Buried amongst the fee schedule provisions, the proposed rule includes key changes to the Stark Law advisory opinion regulations. Previously, CMS had requested  public comment on how to address unnecessary burden created by the Stark Law. The proposed rule, among other things, would give CMS more discretion to determine if an advisory opinion request is accepted. The rule would also shorten the timeframe for reviewing most advisory opinions. Additionally, t ..read more

On August 27, just in time for Medicare enrollment season (October 15, 2019 through December 7, 2019), the Centers for Medicare & Medicaid Services (CMS) launched a modernized and redesigned Medicare Plan Finder online tool. As explained in the CMS press release, the redesigned Medicare Plan Finder will make it easier for beneficiaries to: •Compare pricing between Original Medicare, Medicare prescription drug plans, Medicare Advantage plans, and Medicare Supplement Insurance (Medigap) policies; •Compare coverage options on their smartphones and tablets; •Compare up to three ..read more

On August 15, the Centers for Medicare & Medicaid Services (CMS) announced that HealthCare.gov and state health exchanges will require “the display of the five-star Quality Rating System (or star ratings) available nationwide for health plans … beginning with the 2020 Open Enrollment Period.” For the first time consumers will be able to compare health coverage options using the CMS five-star rating for each plan to compare the quality, along with the price, of health plans on Exchange websites, including HealthCare.gov. It is important to note that star ratings may not be available in all ..read more

The US Environmental Protection Agency’s (EPA) final rule prohibiting healthcare facilities and reverse distributors from disposing of unused hazardous waste pharmaceuticals into the sewer system took effect on August 21.  Such disposal was previously acceptable under the domestic sewage exclusion in the Resource Conservation and Recovery Act (RCRA). In addition, the final rule eliminates the dual regulation of hazardous waste pharmaceuticals that are also classified as controlled substances by the Drug Enforcement Administration (DEA) and such drugs are now regulated solely by the DEA, eli ..read more