Pennsylvania Act 112 of 2019: Opioid Treatment Agreements

Posted by Danielle Sapega on December 03, 2019
Uncategorized / No Comments

As another mark of progress in the fight against opioid addiction, Governor Wolf signed Senate Bill 572 (the “Act”) into law on November 27, 2019, requiring prescribing providers (referred to as “Prescribers”) to take several additional steps before issuing a prescription for an opioid in certain treatment situations. Specifically, the Act’s requirements kick in before a Prescriber can issue a patient the first prescription in a single course of treatment for chronic pain with a controlled substance containing an opioid.  

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Google Partners with Ascension To Store and Analyze Millions of Patient Health Records

Posted by Gregory M. Fliszar on November 19, 2019
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Google has confirmed that it is working with Ascension, one of the nation’s largest health systems in a project that will involve the health data of millions of Americans.  Google and Ascension have partnered in a project to store and analyze patient data with the intended goal of using Google’s artificial intelligence tools to enhance patient care and medical decision making.  As a result of this partnership, it has been estimated that over 100 Google employees may have access to sensitive patient data such as name, birth date, diagnoses and treatments.  Such access by Google to millions of patient’s health data has resulted in some concern over how the data will be protected, including a recently announced inquiry into the relationship by the U.S. Department of Health and Human Services’ Office of Civil Rights (“OCR”).  OCR has stated that it “would like to learn more information about this mass collection of individuals’ medical records with respect to the implication for patient privacy under HIPAA.”  Ascension has said that the project with Google has complied with the law and followed the healthcare organization’s “strict requirements for data handling.” 

We will continue to follow this important story.  Several other tech companies continue to try to gain a bigger share of America’s health care market, which will all have to be balanced with patient data privacy and security concerns.

Hospital Price Transparency Requirements

Posted by Danielle Sapega on November 19, 2019
CMS / No Comments

CMS finalized the Outpatient Prospective Payment System hospital price transparency rules on November 15, 2019. As of January 1, 2021, hospitals will have to publicly post (and update annually) two sets of data: first, a comprehensive list of standard charges for items services offered by the hospital, and second, a consumer-friendly list of 300 “shoppable” services, including 70 selected by the Centers for Medicare and Medicaid Services (“CMS”).

The first transparency requirement states that each hospital operating within the United States must establish and make public a list of the hospital’s standard charges for items and services provided by the hospital, including diagnosis-related groups (DRGs). Standard charge is defined as “the regular rate established by the hospital for an item or service provided to a specific group of paying patients. This includes: (i) gross charge, (ii) payer-specific negotiated charge, (iii) de-identified minimum negotiated charge, (iv) de-identified maximum negotiated charge, and (v) discounted cash price.” Items and services is defined as “all items and services, including individual items and services and service packages, that could be provided by a hospital to a patient in connection with an inpatient admission or an outpatient department visit for which the hospital has established a standard charge.” Examples include supplies and procedures and room and board.

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Price Transparency Rules are Here

Posted by Robert A. Chu on November 15, 2019
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CMS today issued its Price Transparency Requirements for Hospitals Final Rule, which will go into effect on January 1, 2021. (CMS had initially proposed that it go into effect January 1, 2020, but agreed that that deadline was too “challenging”).  Hospitals will be required to post on a public website, among other things, the “payer-specific negotiated charges” for each payer and plan.  These negotiated rates have typically been subject to lock and key treatment through confidentiality agreements.  Noncompliance with the rules may result in corrective action plans (CAPs), civil monetary penalties (CMPs) of $300 per day (indexed to an inflation factor), and a public notice of the CMP on a CMS website. Under the rules, CMS can issue “subsequent” CMPs for continued noncompliance. A link to the Final Rule is here: https://www.hhs.gov/sites/default/files/cms-1717-f2.pdf.

The Trump Administration has also issued a proposed “Transparency in Coverage” rule that would require plans to give consumers access to a tool providing an estimate of their cost-sharing liability for all covered healthcare items and services.  It would also require plans to list on a website their negotiated rates for in-network providers and the allowed amounts paid for out-of-network providers.  A link to the Proposed Rule is here: https://www.hhs.gov/sites/default/files/cms-9915-p.pdf

We will continue to analyze and monitor these rules.  Stay tuned.

CMS Guidance on “Shared Space” – Comment Period Closing July 2, 2019

Posted by Danielle Sapega on June 24, 2019
CMS / No Comments

CMS recently issued long-awaited draft guidance on hospital co-location with other hospitals or healthcare facilities, providing some potential insight on the otherwise ambiguous prohibition on “shared space.” This prohibition loosely stems from the requirement that a Medicare participating hospital is evaluated “as a whole” for compliance with the Conditions of Participation (“CoP”), among other state and federal regulatory requirements. Previously, it was believed that the provider based regulations at 42 C.F.R. § 413.65 governed this prohibition (this section was cited in a 2016 memorandum from the Pennsylvania Department of Health), but the CMS guidance did not cite this particular section.

In recent years, CMS has started to crack down on provider based hospital departments that physically share space with non licensed or separately owned hospital facilities, generally prohibiting shared staff, waiting rooms, check-in desks, patient bathrooms, and other similar items and costs. Although the prohibition was not absolute (CMS had permitted certain things to be shared, such as staff lounges and shared main lobbies), hospitals that sought to attain and maintain compliance struggled with the lack of clear guidance from CMS, and had to rely largely on word of mouth, occasional information distributed by State Survey Agencies, or even citations received if the hospital was caught with prohibited shared space or staffing. This was especially troubling in light of the fact that remediation potentially involved large scale, expensive construction and a hiring and staffing model revamp, among other mandatory modifications.

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New Pennsylvania Laws: Is Your Organization Compliant?

Posted by Danielle Sapega on June 07, 2019
Pennsylvania / No Comments

In 2018, Governor Tom Wolf signed a multitude of bills into law that significantly impact Pennsylvania health care providers. Compliance deadlines for these new laws vary. Implementing any new policies or procedures often takes longer than anticipated, so we strongly recommend taking steps to determine whether your organization is out of compliance. While not all-encompassing, the following laws represent those of particular significance:

Act 90 – Anatomical Gifts: this act represents a significant update to Pennsylvania’s anatomical gift law. Additions include a new section addressing specific requirements around vascularized composite allograft donation, an update to the statutory list of designated health care representative decision makers, and new medical record documentation requirements.

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Court Orders Stay of Order Declaring Individual Mandate Unconstitutional and Inseverable

Posted by Robert A. Chu on January 03, 2019
ACA / No Comments

affordable care actWe previously reported that District Court Judge Reed O’Connor of the Northern District of Texas declared on December 14, 2018 (1) that the Affordable Care Act’s (ACA) individual mandate is unconstitutional and (2) that the remaining provisions of the ACA are “inseverable” and therefore invalid.

Following the Order, commenters largely believed that the Order had no immediate effect.  Supporting this view, the U.S. Department of Health and Human Services (HHS) said that the Order does not have any impact on 2019 enrollment or coverage and that the Order does not have any immediate effect on its enforcement of any portion of the ACA.  Continue reading…

Federal Court Enjoins Medicare Recoupment

Posted by Robert A. Chu on December 31, 2018
Medicare / No Comments

Health insurance application form with money and stethoscopeA Houston federal judge preliminarily enjoined the government from recouping alleged Medicare overpayments made to an ambulance service company facing bankruptcy.  See Adams EMS, Inc. v. Azar, No. H-18-1443, 2018 BL 391263 (S.D. Tex. 2018).

As you may be aware, there is a massive backlog in the Medicare appeals process for alleged overpayments.  The government can begin recouping at step 3 of the arduous 4-step administrative appeal process for overpayment demands.  In a nutshell, the process involves: (1) seeking a redetermination from the Medicare Administrative Contractor (MAC), (2) asking for reconsideration from a Qualified Independent Contractor, (3) requesting a hearing before an administrative law judge (ALJ) of the Office of Medicare Hearings and Appeals, and (4) appealing to the Medicare Appeals Council.  The law requires a decision on Step 3 within 90 days, but there is currently a 3-5 year backlog. Continue reading…

CMS Releases Final ACO Regulations

Posted by Chris Raphaely on December 21, 2018
CMS / No Comments

This morning CMS released a final rule regarding its most popular program for accountable care organizations (ACOs), the Medicare Shared Savings Programs. The final rule is based on the proposed rule for the program that was published in August.  The final rule adopts the major structural overhaul contained in the proposed rule, the reduction of the program to two tracks, Basic and Enhanced, the 1 year limitation for most established (ACOs) to remain in an “upside only” risk model and the 2 year limitation for most new ACOs to remain in an “upside only” risk model. The final rule increased the percentage of savings that will be shared with an ACO in an “upside only” model from 25% as proposed to 40%.  The rule also gives approved ACOs the ability to operate patient incentive programs which include cash payments up to $20 from certain ACO professionals and federally qualified health centers for qualifying primary care services,  provides some ACOs with more flexibility with respect to reimbursement for telehealth services, and includes numerous other detailed changes to the program’s operations. Continue reading…

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“A Slow Game of Jenga:” Has a Federal Judge Toppled the Affordable Care Act?

Posted by Robert A. Chu on December 18, 2018
ACA / No Comments

wood blocks gameLast Friday, in Texas v. United States, Judge Reed O’Connor of the Northern District of Texas (1) declared the Affordable Care Act’s (ACA) individual mandate to be unconstitutional.  In so doing, the Judge, a President George W. Bush appointee, also (2) declared the remaining provisions of the ACA to be “inseverable” and therefore invalid.

Individual Mandate.  As you might recall, the Supreme Court’s 2012 NFIB v. Sebelius decision held that the individual mandate and the shared-responsibility penalty (when viewed as a whole) were constitutional because they fell within Congress’ power to tax.  The provision at the time was found to be a “tax” because, among other things, it produced revenue for the government.  (Under the shared responsibility penalty, non-exempt individuals without health insurance had to pay this tax.).  The Tax Cuts and Jobs Act of 2017 subsequently amended the ACA by reducing the shared-responsibility payment to zero, starting in 2019.  According to the District Judge, when the shared-responsibility payment becomes zero, the individual mandate and the shared-responsibility payment together can no longer be classified as a “tax” and therefore lacks a constitutional hook. Continue reading…