Day Pitney | Healthcare Law Blog
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Day Pitney LLP - Healthcare Law Blog - healthcare law, healthcare law articles, healthcare regulations with offices in Boston, Connecticut, New Jersey, New York, and Washington D.C.
Day Pitney | Healthcare Law Blog
4y ago
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
Day Pitney | Healthcare Law Blog
4y ago
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
Day Pitney | Healthcare Law Blog
4y ago
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
Day Pitney | Healthcare Law Blog
4y ago
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
Day Pitney | Healthcare Law Blog
4y ago
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
Day Pitney | Healthcare Law Blog
4y ago
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
Day Pitney | Healthcare Law Blog
4y ago
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
Day Pitney | Healthcare Law Blog
4y ago
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
Day Pitney | Healthcare Law Blog
4y ago
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
Day Pitney | Healthcare Law Blog
4y ago
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