Life Science Compliance Update

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May 19, 2014

Connecticut Requires Pharmaceutical and Device Companies to Report Payments and Transfers of Value Made To Nurse Practitioners and other APRNs

For the first time in five years a state has passed legislation aimed at reporting payments from pharmaceutical and device manufacturers to healthcare providers. Starting October 2014, Connecticut will require pharmaceutical and device manufacturers to report payments and transfers of value to advance practice registered nurses (APRNs). This group includes nurse practitioners, clinical nurse specialists, nurse anesthetists, and nurse midwives. APRNs are excluded from the reporting obligations under the Federal Physician Payments Sunshine Act. The disclosure requirement is part of a new law in Connecticut that allows APRNs to practice independent of physicians.

The approved legislation, Senate Bill 36An Act Concerning the Governor's Recommendations to Improve Access to Health Care, upholds existing requirements for APRNs to maintain a collaborative practice agreement with a physician during his or her first three years of practice.  After three years, the APRNs would be authorized to practice alone or in collaboration with a physician or other health care provider and may perform acts of diagnoses and treatments, and prescribe, dispense and administer medical therapeutics, corrective measures and drugs. On April 28th, the House voted 110 to 35 to pass the bill. The bill previously cleared the Senate 25 to 11.

Disclosure Law

While most of the discussion around the Bill focused on the merits of allowing nurses to practice independent of doctors, almost no one discussed the fact that this law requires manufacturers now have to go above and beyond the Physician Payment Sunshine Act in their aggregate spend reporting requirements. The Bill was pitched by Governor Malloy without the disclosure provision (here is the original Governor's Bill), and he did not mention it when he spoke about the benefits of the law a few weeks ago.

Section 501 of the Bill includes the disclosure amendment, and it is tacked on at the end of the legislation. The Section was offered by Senator Martin M. Looney, the Majority Leader and Senator Gerratana, the Majority Whip in February 2014. The high ranking state Senate members likely received no pushback on Section 501.

Many believed that divergent state disclosure laws would fade as the Federal law took off. Connecticut, apparently, is looking to add to the requirements.

Connecticut Sunshine Table1

Connecticut Sunshine Table2

Divergent State Reporting Requirements

We recently published an article on Massachusetts Code of Conduct. Massachusetts releases company transfers of value to nurses as well (APRNs, below). We noted that APRN payments made up less than 1% of the total spend in Massachusetts. The amount of effort involved in collecting the data hardly seemed worth it.

Total Massachusetts APRN Payments

 

Nurse Anesthetist (RN/NA)

$7,723

42

Nurse Midwife (RN/NM)

$3,990

61

Nurse Practitioner

$508

3

Nurse Practitioner (RN/NP)

$316,738

1317

Psych. Clinical Nurse Specialist (RN/PC)

$192,507

262

     

Total APRN

$521,467

1685

% of Total HCP Payments

0.94%

3.77%

Massachusetts does not allow APRN's full autonomy, so it will be interesting to see whether payments increase now that some nurses are able to prescribe drugs independently of doctors in Connecticut.

Click here for our list of other divergent state requirements: State requirements chart.

APRN Independence

According to Medscape, with passage of the main bill, Connecticut became the 18th state to allow APRNs the right to practice independently. New York is set to join this category next year.

The level of oversight or independence of APRNs has been an issue across the country for many years. Disagreements center on differences between doctors and nurse practitioner level of experience and education, patient safety, and the need for more healthcare professionals across underserved populations.

Many doctors point out that physicians have more extensive training. They say doctors are better equipped to treat patients with complex health needs and to differentiate between routine issues and bigger problems. Supporters of the Bill say the measure could expand access to primary care because APRN's could work in areas that have typically been underserved, such as poor or rural communities.

The Connecticut Hospital Association offered its support: "During the Scope of Practice Review Committee process, numerous studies demonstrating that Nurse Practitioners provide safe, high-quality care were reviewed. More importantly, evidence provided by other states indicates that the removal of the required collaborative agreement creates an environment in which APRN's are able to expand current practice and explore other options for delivering primary care services."

The Connecticut State Medical Society was not happy. They argue that they law provides "little if any detail about the structure of the three-year collaboration, educational requirements, or oversight in establishing independent practice APRN's." Michael Saffir, MD, President of the Connecticut State Medical Society stated: "It is fundamentally an issue of patient safety and health care transparency." He also noted: "Studies have shown that the team-based model, where physicians and APRN's collaborated to provide coordinated patient care, is the most effective approach to quality patient care. This bill moves in the opposite direction, by removing collaboration and fragmenting the care team. It is difficult to see how this change will improve patient care, and it does nothing to address the need for healthcare transparency in Connecticut."

The bill also requires APRNs, when applying for their annual license renewal, to attest in writing that they have earned at least 50 contact hours of continuing education (CE) in the previous 24 months.

Analysis

This is the first time that a state requires:

  • Reporting only on APRNs
  • Reporting of transfers of value to healthcare providers as opposed to direct payments
  • Added medical supplies to the reporting entities
  • Quarterly reporting on all payments and transfers of value
  • No minimum payment amount and no exemptions to reporting other than not knowing the name of the recipient

Because APRNs make up less than 1% of the total payments to healthcare providers in neighboring Massachusetts and there are only 3,424 APRNs in Connecticut – about half as many as in Massachusetts – the collection expenses and potential fines are significantly larger than the potential payments themselves.

In Connecticut, applicable manufacturers may avoid bringing important clinical information to APRNs in their newly established offices rather than facing mounds of paperwork and potential fines. This disincentive has several implications, including the fact that APRNs may be less informed about cutting edge drugs and therapies than their physician counterparts, making them less competitive. Furthermore, don't be surprised to see signs at medical conventions asking Connecticut APRNs not to attend events, or drink coffee at exhibit halls.

For continuing education (CE), this law will require reporting for APRN's faculty payments to APRNs who practice in Connecticut but not participant data which is typically not shared with supporters.

For detailers and medical affairs departments, transfers of value—including reprints, meals, and patient materials—may have to be reported.

It is not clear if the quarterly data will be made public or simply gathered at the Department of Public Health for their purposes.

There was no mention of debate on the payment disclosure issue in the legislative hearings. According to the committee records, the debate focuses solely on whether or not to allow APRN's to operate independently.

The law now moves to the Connecticut Department of Public Health to create a rule sometime this summer.

 

Thanks to Polaris Management Partners for bringing this to our attention. 

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