Month: October, 2018

Patient-to-Nurse Ballot Measure Could Have a Big Impact on Massachusetts Providers

As election season comes to a head, Massachusetts Health Care Providers should be learning all they can about ballot measure Question 1, the “Initiative Petition for A Law Relative to Patient Safety and Hospital Transparency” (the “Initiative”).  The Initiative sets maximum patient-to-nurse assignment limits, creates new patient assessment requirements, and conveys enforcement authority for regulating the great majority of hospitals and acute care facilities in the Commonwealth. The measure applies to hospitals licensed under M.G.L. c. 111 § 51, “the teaching hospitals of the University of Massachusetts medical school, any licensed private or state owned and state-operated general acute care hospital, acute psychiatric hospitals, and any acute care unit within a state operated health care facility.” Rehabilitation and long-term care facilities fall outside the scope of the measure.

PROPOSED REQUIREMENTS

If adopted, the Initiative would set the following patient-to-nurse assignment limits:

  • Step-Down Intermediate Care—Patients requiring intermediate level of care between the intensive care unit and general medical surgical unit—three (3) patients per nurse.
  • Post Anesthesia Care (PACU) — One (1) patient under anesthesia per nurse; Two (2) patients post-anesthesia per nurse.
  • Operating Room (OR) Units—One (1) patient under anesthesia per nurse; Two (2) patients post-anesthesia per nurse.
  • Emergency Services Departments:
    • One (1) critical or intensive care patient per nurse. (RNs may accept a second patient if initial patient is assessed as “stable”.)
    • Three (3) urgent stable patients per nurse.
    • Five (5) non-urgent stable patients per nurse.
  • Maternal Child Care Patients:
    • One (1) patient in active labor, with intermittent auscultation, or obstetrical complication per nurse.
    • During Birth and Two Hours Post Partum: One (1) Mother per nurse whose sole responsibility is the mother AND (1) baby per nurse whose sole responsibility is the baby.
    • After mother and child are stable and critical elements are met, one nurse may be assigned to mother and baby.
    • Uncomplicated Postpartum Mother/Baby: Six (6) total individual patients / three (3) couplets.
    • Intermediate or Continuing Care Babies: Two (2) babies per nurse.
    • Well-baby patients: Six (6) per nurse.
  • Pediatric Patients—Four (4) pediatric patients per nurse.
  • Psychiatric Patients—Five (5) psychiatric patients per nurse.
  • Medical, Surgical, Telemetry Patients—Four (4) patients per nurse.
  • Observational/Outpatient Treatments—Four (4) patients per nurse.
  • Rehabilitation Patients—Five (5) patients per nurse.
  • Other Unspecified Units—Four (4) patients per nurse.

In addition to staffing requirements, the Initiative requires facilities to develop a compliant “Patient Acuity Tool” designed to improve care quality in conjunction with a RN’s assessment and clinical judgment. This tool must be developed by a committee with a majority membership of staff nurses.  The tool will be utilized by nurses to determine whether a lower nurse-to-patient ratio should be applied to a particular patient. The Patient Acuity Tool must be certified by the Massachusetts Health Policy Commission (“HPC”) based on a proscribed criteria and providers should expect the HPC to promulgate regulations governing the tool’s content and implementation. The Initiative also compels the HPC to develop a notice regarding these requirements that must be placed on display in each unit, patient room, or waiting area.

The Initiative empowers the HPC to enforce the foregoing through facility inspections and the imposition of fines up to $25,000 for each initial violation and up to $25,000 per day following notification. Failure to properly post notice may result in a civil penalty between $250 and $2,500.

Proponents of the Initiative argue that patient-to-nurse limits improve nursing outcomes by preventing burnout and increasing job satisfaction. This is believed to translate to systemic improvements in patient outcomes and safety.  However, the Initiative specifically states that the new staffing requirements must be implemented without reducing other health care workforce staffing levels. That means that providers will either need to limit services to preserve profitability or grow their workforce to maintain current levels of operation, and those strategic decisions come at a cost.

PROJECTED FISCAL IMPACT

According to a detailed presentation before the Market Oversight and Transparency Committee on October 3, 2018, the HPC estimates that the Initiative will require an infusion of between 2,286 and 3,101 additional RNs into the workforce, which will drive up demand for qualified nurses resulting in increased RN earnings over time. The HPC’s research also indicates that once these standards are fully implemented, maintaining staffing ratios and the new compliance infrastructure may result in annual increased costs between $676 and $949 million. The HPC cautions that its projections are “conservative” because they do not take certain known costs into account such as implementation into emergency departments, observation units, outpatient departments, or one-time costs. For example, the HPC estimates that acute care hospitals will incur a collective one-time cost as high as $57.9 million just to develop the Patient Acuity Tool. The HPC advises that the measure could result in reductions in hospital margins or assets, reduced capital investments, closure of unprofitable service lines, and reductions in non-health care staffing. The Massachusetts Nurses Association has vehemently challenged the HPC’s cost projections as inflated and misleading.

The Initiative will come to a vote on November 6, 2018. In the intervening period, the HPC will hold Health Care Cost Trends Hearings on October 16 and October 17. Providers with questions about the details of the Initiative and/or plans for future compliance should reach out to a qualified legal professional.

Bipartisan Legislation Aims to Limit Surprise Medical Bills

On September 18, 2018, a bipartisan group of Senators unveiled a draft measure to limit patients’ exposure to surprise medical bills. The draft bill is sponsored by Senator Bill Cassidy (R-LA) and has received support from Senators Tom Carper (D-DE), Todd Young (R-IN), Claire McCaskill (D-MO), Chuck Grassley (R-IA) and Michael Bennett (D-CO).

The bill is intended to limit balance billing to patients in the following three circumstances:

  1. Emergency services provided by an out-of-network provider in an out-of-network facility: The draft bill would limit a patient’s financial exposure when receiving emergency services at an out-of-network facility to the cost sharing amount provided by their health insurance plan for the same services provided by an in-network provider at an in-network facility. Providers would be prohibited from billing the patient any additional amount. Rather, amounts in excess of the cost sharing amounts would be paid by the insurer in accordance with state law. If state law does not establish the applicable amount, the health insurer would pay the greater of: (a) the median in-network amount for services charged by a provider in the same specialty and area; or (b) 125% of the average amount allowed by insurers for the service for a provider in the same specialty and area.
  2. Non-Emergency services following an emergency service at an out-of-network facility: When a patient has received emergency services from an out-of-network provider and requires additional non-emergency services after being stabilized, the draft bill requires the facility to notify the patient in writing that they may be required to pay higher cost-sharing than if they received services at an in-network facility and provide the patient with the option to transfer to an in-network facility. The patient must sign an acknowledgement that they received such notification. If the patient elects to remain in the out-of-network facility, the draft bill does not limit the amount the facility can charge for the additional services provided.
  3. Non-Emergency services performed by an out-of-network provider at an in-network facility: The draft bill would also prohibit an out-of-network provider, who provides non-emergency services at an in-network facility, from billing the patient beyond the amount of their in-network cost sharing. Rather the excess amount would be paid by the insurer at an amount determined in the same manner as for emergency services provided by an out-of-network provider.

 

The bill remains a draft and is not scheduled for vote. However, the bipartisan support for the bill suggests it may gain significant traction or at least jumpstart additional discussions in Congress about how to limit the use of balance billing.

Transparency and the Avoidance of Corruption: Revisions to New Jersey’s Ban on Gifts From Pharmaceutical Companies

In October 2017, we had a post about a proposed regulation promulgated by the New Jersey Division of Consumer Affairs that would place limitations on payments from pharmaceutical companies to health care providers. The rule did not provide for enforcement or penalties to be assessed against manufacturers, but rather prohibited providers from “accepting” such payments.  The affected licensees were physicians, podiatrists, physician assistants, advanced practice nurses, dentists, and optometrists.  The proposed regulation became effective as of January 16, 2018 and is codified at N.J.A.C. 13:45J-1 et seq. The regulation was one of several initiatives taken by then Attorney General Christopher Porrino to combat the opioid epidemic.  Under the regulation, a New Jersey prescriber may not accept, directly or indirectly, any of the following from a pharmaceutical manufacturer or a manufacturer’s agent:

  • Any financial benefit or benefit-in-kind, including, but not limited to, gifts, payments, stock, stock options, grants, scholarships, subsidies, and charitable contributions, except as specifically permitted by the regulation.
  • Any entertainment or recreational items (e.g., tickets to theater or sporting events, or leisure or vacation trips).
  • Items of value that do not advance disease or treatment education, including, but not limited to:

Pens, note pads, clipboards, mugs, or other items with a company or product logo;

Items intended for the personal benefit of the prescriber or staff, such as floral arrangements, sporting equipment, or artwork;

Any payment in cash or a cash equivalent; or

Any payment or direct subsidy to a non-faculty prescriber to support attendance at, as remuneration for time spent attending, or for the costs of travel, lodging, or other personal expenses associated with attending, any education event or a promotional activity.

  • Any meals unless permitted as described in the regulation with a cap in the amount of $15.

Following Governor Phil Murphy’s election, in the Spring of 2018, the new administration assessed the operation of the rule and its dampening effect on physician participation in continuing education programs. Recognizing the purpose of the regulation as establishing uniform standard to minimize conflicts of interests between health care providers and pharmaceutical manufacturers so that patient care would be guided by the unbiased, best judgment of prescribers, Attorney General Gurbir S. Grewal proposed revisions to the regulation. These appeared in the August 6, 2018 New Jersey Register.  The changes are rather limited. They modify the definition of “modest meal” from a blanket $15 per prescriber to $15 for breakfast and lunch and $30 for dinner during the calendar year 2018 with the amount in future years tied to the consumer price index. Experience with the regulation had shown the absolute $15 limit was “unrealistic.” Another change is to remove the concept of “modest meals” and the limits when associated with educational events even where a manufacturer was the sponsor “provided the meals facilitate the educational program to maximize prescriber learning, including information about disease states and treatment approaches.” Any such meals are not counted in determining the annual cap of $10,000 on payments from pharmaceutical companies for services in connection with presentations as speakers at promotional activities, participation on advisory boards, and consulting arrangements established by the original regulation. The revisions further clarified that the regulation applied only to health care providers with active New Jersey licenses who were involved with patient care in New Jersey and would not apply to an employee of a pharmaceutical company.

The time for comment on the proposed revisions closes as of October 5, 2018.

The revisions to the New Jersey regulation are being considered when a spotlight is once more on the issue of conflicts of interest among prominent physicians and the pharmaceutical industry. On September 13, 2018, the New York Times reported the resignation of Dr. Jose Baselga, the chief medical officer of Memorial Sloan Kettering Cancer Center, for failure to disclose millions of dollars he had received from drug companies while publishing articles about these products in medical journals. The article included a comment that “Ethicists say that outside relationships with companies can shape the way studies are designed and medications are prescribed to patients, allowing bias to influence medical practice.  Reporting those ties allows the public, other scientists and doctors to evaluate their research and weigh potential conflicts.”

The same issue of the New York Times contained an Op-Ed piece by Marcia Angell, M.D. entitled “Transparency Hasn’t Stopped Drug Companies From Corrupting Medical Research.”  Dr. Angell had been the editor of the New England Journal of Medicine for over 20 years and was at the NEJM in 1984 when it became the first major journal to require authors to disclose financial ties to companies that could be affected by the publication of their research.  In her Times piece, Dr. Angell reviewed the reasons that manufacturers became financially involved with medical researchers and how financial ties could bias the work.  She concluded with these comments:

Disclosure is better than no disclosure, but it does not eliminate the conflict of interest. It’s simply a way of saying caveat emptor, and leaving it to readers to decide whether the research was biased.  But most people – even doctors and science reporters – aren’t really equipped to make those judgments, particularly when data are suppressed.

I would suggest two reforms. First, researchers at academic medical centers should not accept any payments other than research support from drug companies, and that support should have no strings attached – no control over the design, interpretation and publication of trial results.  We should go back to arm’s length grants.

Second, doctors should not accept gifts from drug companies, even small ones, and they should pay for their own meetings and continuing education, as is standard in other professions. They can afford it.

In the meantime, those of us who read these studies should remain skeptical about them until several different trials reach the same result.

These controversies have been present for a long time with various measures taken to protect patients and keep physicians focused on patient care. Some of that history was reviewed in an earlier blog post from 2014 with the commencement of the Obamacare Physician Payment Sunshine Act which encompasses more than research physicians.  In 2016, New Jersey ranked 11th in the nation for the most non-research payments to health care professionals based on the Open Payments data.[1]

The New Jersey Board of Medical Examiners has brought disciplinary proceedings against physicians for failure to make disclosures of payments received from medical product manufacturers. It has recently continued to bring disciplinary actions based on violation of its kickback rule, N.J.A.C. 13:35-6.17(c)(1), prohibiting licensees from receiving any form of compensation that “a reasonable person would recognize as having been given” to promote the prescribing of a product for patient use.[2]

The efforts of the New Jersey Attorney General to study and explore appropriate ways to deal with these conflicts of interests issues can be traced back to at least 2007 and such efforts are obviously continuing. This may be like the sound of one hand clapping or at least a voice crying in the wilderness.  But it should be noted that the Hippocratic Oath – dating back to the Fourth or Fifth Century B.C. and still administered to modern day physicians – includes a provision that “into whatever homes I go, I will enter them for the benefit of the sick, avoiding any voluntary act of impropriety or corruption.”

[1]  Helman, Farrar, Horton, Segobiano & Dingler, Physician, Feed Thyself: New Jersey’s Restriction On Pharmaceutical Payments (Jan. 24, 2018) available at https://www.navigant.com/insights/life-sciences-consulting/2018/new-jerseys-restriction-on-pharmaceutical-payments

[2]   See, e.g., In the Matter of Kenneth Sun, M.D. (Aug. 27, 2018)(between 2013 and 2015 more than $117,000 in payments) available at  https://www.njconsumeraffairs.gov/Actions/20180827_25MA06318400.pdf.