On October 29, 2020, Governor Wolf signed House Bill 81 into law, creating new minimum education and certification requirements for central service technicians and surgical technicians working in the Commonwealth, and regulating the practice of surgical technology. The Act will take effect on December 28, 2020.
Central Service Technicians
The Act defines central service technicians (“Central Tech”)
as “an individual who provides the services of inspecting, assembling,
decontamination, preparation, packaging and sterilization of reusable medical instruments
or devices.” Under the Act, a health care facility cannot employ or otherwise
contract for the services of a Central Tech unless the individual has
successfully passed a nationally accredited central service exam for central
service technicians and holds and maintains either a certified registered
central service technician or a certified sterile processing and distribution
technician credential. Currently employed health care facility Central Techs and
contracted Central Techs are grandfathered from the requirements, but any Central
Tech that is considered a new employee must meet the minimum requirements
within 18 months from the date of hire. Techs must complete 10 hours of annual
continuing education. The Act directs the Department of Health (“DOH”) to
promulgate regulations necessary to implement the Act’s requirements, and
grants the DOH general oversight.
As we indicated in last week’s blog post , the D.C. Circuit Court’s refusal to uphold HHS’ pharmaceutical price disclosure rule (“RX Rule”) was not a predictor of how the trial court might rule in the closely watched challenge to HHS’ hospital price transparency rule (“Hospital Rule”). In a June 23, 2020 ruling on cross motions for summary judgment, American Hospital Association, et. al. v. Azar, D.C. District Court Judge, Carl Nichols, ruled that HHS did not overstep its authority under Section 2718 of the Public Health Services Act (“Section 2718”) by requiring hospitals to publish their “gross charges”, payer-specific negotiated rates, discounted cash prices, and de-identified minimum and maximum negotiated charges.
On June 16, the D.C. Circuit Court struck down the Centers for Medicare and Medicaid Services’ (“CMS”) rule issued in May 2019 requiring pharmaceutical companies to disclose the wholesale acquisition cost of drugs over $35 in their direct-to-consumer television advertisements (“RX Rule”). Similar to the RX Rule, the Hospital Price Transparency Rule, issued on November 27, 2019, requires hospitals to publish, among other information, payor-specific rates for certain services on their websites beginning on Jan 1, 2021 (“Hospital Rule”). Both rules stem from the Trump administration’s stated efforts to improve the nation’s health care quality and transparency, and both were met with swift legal opposition. The Hospital Rule litigation, American Hospital Association et al v. Azar, is currently before the U.S. District Court for the District of Columbia. While the D.C. Circuit Court’s RX Rule decision could be viewed as a predictor of the outcome of the Hospital Rule litigation, the alleged statutory authority underlying the Hospital Rule is different than the statutory authority underlying the RX Rule. Therefore, the Circuit Court’s ruling in the RX Rule litigation may not be an accurate barometer of the likely outcome in the Hospital Rule litigation.
On Friday, April 24th, President Trump signed the Paycheck Protection Program and Health Care Enhancement Act (“Act”) into law that will send an additional $75 billion to the Public Health Emergency and Social Services Fund (“Fund”) used to reimburse eligible health care providers for health care related expenses or lost revenues that are attributable to COVID-19. These funds will be in addition to the $100 billion previously appropriated to the Fund in the CARES Act. Of that $100 billion, the first $30 billion was distributed through the Health Resources and Services Administration (HRSA) to health care providers proportionally, based on the providers’ share of total 2019 Medicare payments. HHS has outlined how the remaining $70 billion of the initial $100 billion Congress dedicated to the Fund in the CARES Act would be allocated to providers, with additional payments starting April 24th. However, HHS has not published any additional guidance as to how the Act’s additional $75 billion will be allocated.
The CARES Act (“Act”) appropriates $100 billion to create a
Public Health Social Service Emergency Fund (“Fund”) to prevent, prepare for,
and respond to coronavirus domestically and internationally for necessary
expenses to reimburse, through grants or other mechanisms, eligible health care
providers enrolled in Medicare and Medicaid who provide diagnoses, testing, or
care for individuals with possible or actual cases of COVID–19, for health
care-related expenses or lost revenues that are attributable to coronavirus.
Although the Act sets forth some high level qualifying criteria, the actual
mechanism by which providers can apply for or request funds, or additional
qualifiers for eligibility, if any, have not yet been released. To date, the
Act notes that funds appropriated under this provision may be used for:
In a 2-1 decision published on December 18, 2019, a 5th Circuit panel upheld the Texas District Court’s decision ruling that the ACA individual mandate tax which, since January 2019, has had no monetary consequence, is unconstitutional. Citing the Supreme Court’s 2012 NFIB v. Sebelius opinion, the panel explained that the key feature of the individual mandate –the critical tax attributes that once saved the mandate from unconstitutionality- no longer exist, and therefore it can no longer be classed under Congress’ taxing power. Despite definitively ruling on this key issue, the panel remanded the case to the District Court to take a closer look at whether the individual mandate’s unconstitutionality is severable, or whether the entire ACA now must be struck down.
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.
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.
Posted by Danielle Sapega
on November 19, 2019
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”).
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.
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.