Mark Faccenda (US)

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COVID-19 Update: CMS Issues Wide Ranging Blanket Waivers to Assist Providers

On Monday, March 30, 2020, the Centers for Medicare & Medicaid Services (CMS) issued wide ranging blanket waivers and published an interim final rule intended to “equip the American healthcare system with maximum flexibility” to respond to COVID-19. The waivers will remain in effect until the end of the emergency declaration. CMS issued a summary … Continue reading

COVID-19 Update: Senate Unanimously Passes Emergency Stimulus Package

The United States Senate has passed a $2 trillion phase three emergency package, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act).  The Senate approved the CARES Act on a unanimous vote of 96-0, with three Senators in self-quarantine and another returning home out of an abundance of caution.  The CARES Act, assuming it … Continue reading

Update to Prior CMS Action: CMS Approves 11 New Medicaid Section 1135 Waivers; 13 States Total

On March 13, 2020, following President Trump’s declaration of a national emergency in response to the COVID-19 pandemic, CMS announced its approval of the first Section 1135 Waiver aimed at addressing the spread of COVID-19 (Coronavirus) in Florida. On March 19, CMS granted a Section 1135 Waiver to deal with the COVID-19 outbreak in Washington … Continue reading

COVID-19 Update: FDA will use enforcement discretion for limited ventilator modifications

On March 22, 2020, the FDA released guidance describing an enforcement policy that will help increase the availability of ventilators and accessories, as well as other respiratory devices, during the COVID-19 pandemic.  FDA’s guidance would permit “limited modifications to the indications, claims, functionality, or to the hardware, software, or materials of FDA-cleared devices used to … Continue reading

FDA Final Rule Amends Definition of “Biological Product”

On February 20, 2020 the U.S. Food and Drug Administration (FDA) published a final rule, revising the regulatory definition of biological products to match the definition Congress agreed to in the Further Consolidated Appropriations Act, 2020.  The changes reflect the FDA’s efforts to remove regulatory hurdles in order to create cheaper versions of biological products, … Continue reading

CMS Publishes CY 2020 OPPS & ASC Price Transparency Requirements Final Rule and Transparency in Coverage Proposed Rule

On November 15, the Centers for Medicare & Medicaid Services (CMS) published the Calendar Year (CY) 2020 Outpatient Prospective Payment System (OPPS) & Ambulatory Surgical Center (ASC) Price Transparency Requirements for Hospitals to Make Standard Changes Public final rule and the Transparency in Coverage proposed rule. CMS intends through this rulemaking to increase price transparency … Continue reading

CMS Releases Final Rule on CY 2020 Physician Fee Schedule Updates and Implements Opioid Use Disorder Treatment Programs

On November 1, 2019, the Centers for Medicare & Medicaid Services (CMS) issued a final rule that updates the Medicare Physician Fee Schedule (PFS) rates and policies for calendar year (CY) 2020 and expands Medicare coverage to opioid treatment programs (OTPs) that treat beneficiaries with opioid use disorder (OUD). In a fact sheet accompanying the … Continue reading

CY 2020 Medicare Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System Final Rule

On November 1, 2019, the Centers for Medicare & Medicaid Services (CMS) published its CY 2020 Medicare Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System final rule.  The final rule implements a number of significant changes to payment policies and rates for services furnished to Medicare beneficiaries in hospital outpatient … Continue reading

U.S. District Court Upholds Ruling that CMS Exceeded Its Statutory Authority in Reducing Medicare Payments for Clinic Visit Evaluation and Management Services Furnished in Hospital Excepted Off-Campus Provider-Based Departments

On October 21, 2019, U.S. District Judge Rosemary M. Collyer denied the government’s request to modify the Court’s previous ruling on September 17, 2019, that the Centers for Medicare & Medicaid Services (CMS) exceeded its statutory authority when it reduced Medicare payment rates for clinic visit evaluation and management (E&M) services provided to Medicare patients … Continue reading

CMS releases FY 2020 IPPS and LTCH PPS final rule

On August 2, 2019, the Centers for Medicare & Medicaid Services (CMS) published its Fiscal Year (FY) 2020 Medicare Hospital Inpatient Prospective Payment System (IPPS) and Long Term Acute Care Hospital (LTCH) Prospective Payment System (PPS) final rule (CMS-1716-F). The final rule is scheduled to be published in the Federal Register on August 16, 2019. … Continue reading

FDA publishes new 510(K) guidance

On January 22, 2019, the FDA released nonbinding guidance expanding the Abbreviated 510(k) program used to show the safety and efficacy of medical devices.  A new “safety and performance-based pathway” for certain, well understood device types, may be used by manufacturers to demonstrate substantial equivalency to devices already on the market. Under the 510(k) process, … Continue reading

CMS proposes to remove a ban on pre-dispute arbitration agreements at long-term care facilities

On June 5, 2017, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule to revise requirements established by the Reform of Requirements for Long-Term Care Facilities final rule (2016 Final Rule). Specifically, the proposed rule would remove regulations prohibiting long-term care facilities from entering into pre-dispute arbitration agreements with residents or their … Continue reading

House narrowly passes American Health Care Act; Republican Senators signal they will draft a health care bill from scratch

Following a series of thwarted efforts and delays, on May 4, 2017, the U.S. House of Representatives passed by a narrow margin of 217-213 the American Health Care Act of 2017 (H.R. 1628) (AHCA), a plan to repeal and replace the Affordable Care Act. The Congressional Budget Office and Joint Committee on Taxation first estimated … Continue reading

Vote on MacArthur Amendment delayed; Trump Administration will continue to pay subsidies to insurers for low-income individuals; CMS issues three new payment rules for FY 2018 proposing increased payments to skilled-nursing facilities, inpatient rehabilitation facilities, and hospice care

Vote on MacArthur Amendment delayed: Last week, the House delayed voting on a revised bill to repeal and replace the 2010 Affordable Care Act, thwarting White House plans to hold a vote before President Donald Trump’s 100th day in office. The revised American Health Care Act (AHCA) would include the amendment drafted by Representative Tom … Continue reading

ONDCP addresses urgent public health threat posed by illicit fentanyl

On February 23, 2017, leaders of the Committee on Energy and Commerce, in a letter to the Office of Natural Drug Control Policy (“ONDCP”), urged ONDCP to address how it and other federal agencies intend to confront the immediate public health threat posed by illicit fentanyl.  The Committee correspondence also directed ONDCP to respond to … Continue reading

Trump Administration and Republican Congressional leadership shift focus following non-vote on ACA repeal and replace legislation; States push for Medicaid expansion

Republican Congressional leadership quickly reprioritized and refocused their efforts following the Trump Administration and House Republican leadership’s failure to secure enough votes for full House passage of the American Health Care Act (“AHCA”), the bill intended to repeal and replace the Affordable Care Act (“ACA”). As previously covered, Republican House Speaker Paul Ryan pulled the … Continue reading

Joint Commission links safety culture to health care organization leadership

On March 1, 2017, the Joint Commission issued a Sentinel Event Alert warning of the link between inadequate safety cultures within health care organizations and a rise in the occurrence of adverse events, and further urging health care organization leadership to adopt a culture of safety through formal initiatives and a top-down model behavioral approach.  … Continue reading

CMS proposes rule to stabilize health insurance market

On February 15, 2017, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule to stabilize the individual and small group health insurance market by increasing incentives for individuals to maintain enrollment in health plans, decreasing incentives to enroll in coverage only after healthcare services are needed, and reducing the regulatory burdens for … Continue reading

CMS finalizes proposals to streamline the Medicare appeals process

On January 17, 2017, the Centers for Medicare & Medicaid Services (“CMS”) finalized certain changes to the Medicare appeals process, with the intent to provide increased transparency and efficiency to cure the current backlog in pending appeals. According to CMS, the number of requests for an Administrative Law Judge (“ALJ”) hearing or review pending at … Continue reading

FDA approves opioid drug Arymo ER for chronic pain management

On January 9, 2017, the US Food and Drug Administration (“FDA”) approved opioid drug Arymo ER (morphine sulfate) manufactured by Egalet US, Inc. (“Egalet”) for use in the management of pain severe enough to require long-term opioid treatment, and where alternative treatment options are inadequate. In its approval, FDA explains that typical post-marketing surveillance of adverse … Continue reading

CMS abandons plans to test new Medicare Part B drug reimbursement model

CMS announced on December 15, 2016 that it will not pursue its plans to finalize a proposed rule that would have created a pilot program to test a new Medicare Part B prescription drug reimbursement model. CMS explained that while the rule garnered some support, numerous stakeholders “expressed strong concerns” about the proposed reimbursement model. … Continue reading

CMS Reopens Hospital Appeals Settlement Process

On November 16, 2016, the Centers for Medicare & Medicaid Services (“CMS”) hosted a 2016 MLN Connects National Provider Call (“Provider Call”) for purposes of outlining the parameters of the 2016 Hospital Appeals Settlement Process, which CMS initially launched in August 2014 for certain eligible inpatient provider types. During the 2014 Hospital Appeals Settlement Process, … Continue reading

Mississippi Federal judge temporarily blocks CMS pre-dispute arbitration ban

On November 7, 2016, the U.S. District Court for the Northern District of Mississippi granted a preliminary injunction against CMS’s enforcement of the mandatory pre-dispute arbitration agreement ban, which has recently triggered a flurry of litigation. As the Order explains, in enacting the final rule promoting the pre-dispute arbitration ban, CMS relied fundamentally upon disparities in … Continue reading