Topic: Regulatory

OIG proposes to eliminate safe harbor protection for drug manufacturer rebates to PBMs; proposes two new safe harbors

By Carol Poindexter (US) and Savannah Wiseman (US) on February 5, 2019 Posted in Regulatory

On January 31, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a proposed new rule that, if finalized, would eliminate existing protection under the Anti-Kickback Statute (AKS) “discount” safe harbor (42 C.F.R. 1001.952(h)) for drug manufacturers’ rebates to plan sponsors or pharmacy benefit managers (PBMs) acting under contract with plan … Continue reading

Hospital alert: CMS hospital transparency requirements in effect January 1, 2019

By Yvonne Puig (US) and Jeff Wurzburg (US) on December 31, 2018 Posted in Regulatory

On January 1, 2019, all hospitals are required to make public a list of their standard charges. As a reminder, Section 2718(e) of the Public Health Service Act, as enacted by the Affordable Care Act, requires: “each hospital operating within the United States” to “make public (in accordance with guidelines developed by the Secretary) a … Continue reading

CMS publishes CY 2019 physician fee schedule final rule

By Jeff Wurzburg (US) on November 6, 2018 Posted in Regulatory

On November 2, 2018, CMS published its CY 2019 physician fee schedule final rule. The final rule implements a number of significant changes to the way practitioners receive reimbursement for items and services provided to Medicare beneficiaries, including: Eliminating the requirement for a practitioner to document the medical necessity of a home visit in lieu … Continue reading

OIG considers new safe harbors and other incentives to promote coordinated care

By Elise LeGros (US) on September 5, 2018 Posted in Regulatory

As part of the Health and Human Services Department’s (“HHS”) “Regulatory Sprint to Coordinated Care” efforts aimed at alleviating unnecessary regulatory barriers to coordinated care while protecting against fraud and abuse, the Office of Inspector General (“OIG”) issued a Request for Information (“RFI”) on August 27, 2018, requesting public input on the following items: Care … Continue reading

CMS proposes to expand payment for telehealth services

By Ashley Francois (US) and Lisa Genecov (US) on August 28, 2018 Posted in Regulatory

On July 12, 2018, CMS included three proposed changes to telehealth reimbursements within the CY 2019 Physician Fee Schedule (the “Proposed Rule”). Currently, subject to certain exceptions, Medicare reimbursements for certain telehealth services are statutorily limited by the type of health care professional providing the service, and the geographic location of the patient (namely, the … Continue reading

CMS further crystalizes Stark liberalizations

By Ashley Francois (US), Joseph Keillor (US) and Debbi Johnstone (US) on August 21, 2018 Posted in Regulatory

On July 12, 2018, CMS included within the CY 2019 Physician Fee Schedule (the “Proposed Rule”) two revisions to Stark Law regulations aimed at further clarifying any actual or perceived differences between current regulations and the recently enacted Bipartisan Budget Act of 2018 (“2018 BBA”). As we previously reported, Section 50404 of the 2018 BBA … Continue reading

CMS issues Pathway to Success ACO proposed rule

By Jeff Wurzburg (US) on August 10, 2018 Posted in Regulatory

On August 9, 2018, CMS published the long-awaited Pathways to Success proposed rule. CMS Administrator Seema Verma published a related article on the Health Affairs Blog. The proposed rule would usher in significant changes for Accountable Care Organizations (ACOs). Groups of providers, such as doctors and hospitals, can join together to form an ACO and … Continue reading

The US Departments of HHS, Labor, and Treasury finalize expanded access to short-term, limited duration insurance

By Jeff Wurzburg (US) on August 1, 2018 Posted in Regulatory

On August 1 the Departments of Treasury, Labor, and Health and Human Services (the Departments) published a final rule that will expand the availability of short-term limited duration insurance (STLDI). A Health Law Pulse summary of the proposed rule may be read here. STLDI is not required to comply with the Affordable Care Act (ACA) … Continue reading

CMS proposes significant Medicare OPPS and ASC payment system changes for 2019

By Thomas Dowdell (US) and Jeff Wurzburg (US) on July 26, 2018 Posted in Regulatory

On July 25, 2018, the Centers for Medicare & Medicaid Services published its 2019 Medicare hospital outpatient prospective payment system (OPPS) and ambulatory surgical center (ASC) payment system proposed rule. A fact sheet describing the proposed rule is available here. The proposed rule can be accessed here. CMS proposes to update hospital OPPS payment rates … Continue reading

CMS issues CY 2019 home health proposed rule

By Thomas Dowdell (US) on July 26, 2018 Posted in Regulatory

On July 12, 2018, the Centers for Medicare & Medicaid Services (CMS) published its calendar year (CY) 2019 proposed rule for Medicare payment updates and proposed quality reporting changes for home health agencies (HHA) under the home health prospective payment system (HH PPS). CMS proposes certain changes to Medicare payment and quality reporting standards for … Continue reading

CMS issues final rule to adopt risk adjustment methodology for 2017

By Jeff Wurzburg (US) on July 25, 2018 Posted in Regulatory

CMS has issued a Final Rule to adopt the risk adjustment methodology for the 2017 benefit year. The rule was issued without a notice and comment period and will become effective upon publication in the federal register. The risk adjustment program is a premium stabilization program established by Congress in section 1343 of the Affordable … Continue reading

CMS solicits comments for easing Stark Law burdens

By Benjamin Wallfisch (US) on June 25, 2018 Posted in Regulatory

Last week, the U.S. Centers for Medicare & Medicaid Services (“CMS”) released a Request for Information (“RFI”) that seeks feedback from stakeholders in the healthcare industry on possible regulatory changes to the Stark Law. CMS has expressed concern that the Stark Law may have a negative effect on alternative payment models, integrated delivery models, and … Continue reading

Department of Labor publishes final rule to expand access to Association Health Plans

By Jeff Wurzburg (US) on June 25, 2018 Posted in Regulatory

The United States Department of Labor (DOL) published a final rule on June 19 that relaxes the regulation of, and expands access to, association health plans (AHPs). President Donald J. Trump’s October 12, 2017 Executive Order instructed the DOL to consider expanding access to association health plans and the Department released a proposed rule on … Continue reading

HHS requests comments on healthcare innovation and investment workgroup

By Jeff Wurzburg (US) on June 11, 2018 Posted in Regulatory

A Request for Information (RFI) published in the June 7 Federal Register seeks comments on the structure of a workgroup to increase innovation and investment in the healthcare industry. The Immediate Office of the Secretary of HHS seeks comments on how to structure the workgroup in order to “spur investment, increase competition, accelerate innovation and … Continue reading

Joint Commission issues advisory on continuity of operations planning

By Jeff Wurzburg (US) and Yvonne Puig (US) on June 6, 2018 Posted in Regulatory

On May 22, 2018, the Joint Commission released an advisory addressing the importance of continuity of operations planning (COOP). When an emergency strikes, an ill-prepared health care organization can put patients at risk. The goal of an COOP is “to protect the organization’s physical plant, information technology systems, business and financial operations, and other infrastructure … Continue reading

OCR proposes to share HIPAA data breach settlements with victims

By Robert Kantrowitz (US) on May 22, 2018 Posted in Regulatory

The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) plans to issue an advance notice of proposed rulemaking this November on potentially sharing HIPAA breach settlements with victims. The notice would solicit public opinion on creating a process for sharing a percentage of any penalty or settlement with those harmed … Continue reading

CMS FY 2019 IPPS and LTCH PPS proposed rule targets interoperability, transparency and burden reductions

By Wendy Wright (US) and Jeff Wurzburg (US) on April 27, 2018 Posted in Regulatory

On April 24, the Centers for Medicare & Medicaid Services (CMS) released its fiscal year (FY) 2019 inpatient prospective payment system (IPPS) and long-term care hospital prospective payment system (LTCH PPS) proposed rule. CMS proposes to reduce regulatory burdens for inpatient hospitals and increase price transparency and better data sharing between hospitals and other providers … Continue reading

NIST releases latest version of its Cybersecurity Framework

By Robert Kantrowitz (US) on April 19, 2018 Posted in Regulatory

On April 16, 2018, the National Institute of Standards and Technology (NIST) unveiled Version 1.1 of its widely known Cybersecurity Framework, which incorporates changes based on feedback collected through comments, questions, and workshops held in 2016 and 2017. The Cybersecurity Framework aims to focus on industries vital to national and economic security, including energy, banking, … Continue reading

Recent effort to regulate pharmaceutical pricing deemed unconstitutional by Fourth Circuit

By Robin Adelstein (US) and Krishna Kavi (US) on April 17, 2018 Posted in Enforcement, FDA & Food Safety, News from DC, Regulatory

In the absence of federal action, states have attempted to rein in high pharmaceutical pricing by enacting laws aimed at regulating drug pricing. Following what now has become a trend, on March 13, 2018, Oregon became the newest state to enact such legislation, The Prescription Drug Price Transparency Act, H.B. 4005. But many of these … Continue reading

CMS publishes annual exchange final rule for 2019

By Jeff Wurzburg (US) on April 16, 2018 Posted in Regulatory

On April 9, 2018, the Centers for Medicare and Medicaid Services (CMS) published the Notice of Benefit and Payment Parameters for 2019 final rule (Payment Notice) and related guidance affecting the health insurance markets, including: key dates for calendar year 2018; the final 2019 Letter to Issuers in the Federally-facilitated Exchanges; guidance extending the transitional … Continue reading

Centers for Medicare & Medicaid Services finalizes policies and updates to Medicare Advantage and Part D programs for 2019

By Jeff Wurzburg (US) on April 10, 2018 Posted in Regulatory

On April 2, 2018, CMS released the 2019 Rate Announcement and Final Call Letter (Call Letter) and published an expansive final rule containing updates to policies for Medicare Advantage (MA) and the Medicare Part D Prescription Drug Program (Part D). A Health Law Pulse summary of the proposed Annual Notice and Draft Call Letter may … Continue reading

Healthcare-related exception in FCC TCPA order upheld

By Susan Ross (US) and Robert Kantrowitz (US) on March 19, 2018 Posted in Regulatory

On March 16, 2018, the U.S. Court of Appeals for the District of Columbia Circuit issued its decision on the Federal Communications Commission (FCC) omnibus order of 2015, relating to challenges to the FCC’s determination on healthcare calls and three other rulings relating to cell phones. The appellate court upheld an exception for certain “emergency” … Continue reading

Amended Colorado bill aims to enhance data privacy laws

By Robert Kantrowitz (US) on February 21, 2018 Posted in Regulatory

As Health Law Pulse posted on January 29, 2018, lawmakers in Colorado are considering legislation that, if enacted, would significantly strengthen Colorado’s data privacy protections. On Wednesday, February 14, 2018, an amended bill passed unanimously in Colorado’s House Committee on State, Veterans and Military Affairs. The proposed bill overlaps with the Health Insurance Portability and … Continue reading

The US Departments of HHS, Labor, and Treasury propose expanded access to short-term, limited duration insurance

By Jeff Wurzburg (US) on February 21, 2018 Posted in Regulatory

On February 20, 2018, the Departments of Health and Human Services, Labor, and Treasury (the Departments) published a proposed rule to expand the availability of short-term, limited-duration insurance (STLDI) in order to “provide more affordable consumer choice for health coverage.” The proposed rule follows President Trump’s October 12, 2017 Executive Order directing the Departments to … Continue reading