Plaintiff Cannot Cure Defective Malpractice Opinion Letter with an Affidavit
Connecticut law requires that a plaintiff in a medical malpractice action demonstrate the existence of his or her good faith by obtaining a written opinion of a “similar health care provider” that there appears to be evidence of a breach of the applicable standard of care (Connecticut General Statutes (“CGS”) §52-190a(a)). The law sets forth one definition of “similar health care provider” if the defendant is not certified as being a specialist (or is not trained and experienced in a medical specialty or does not hold himself out as a specialist) (CGS §52-184c(b)) and another definition of “similar health care provider” if the defendant is certified as being a specialist (or is trained and experienced in a medical specialty or holds himself out as a specialist) (CGS §52-184c(c)).
In Carpenter v. Daar, 199 Conn. App. 367, the Appellate Court of Connecticut held, as a matter of first impression, that the plaintiff in a medical malpractice action cannot file an affidavit to cure a defect in the statutorily-required opinion letter of a similar health care provider—even if the affidavit is filed within the statute of limitations. Instead, the plaintiff must amend the pleadings to correct any deficiencies.
The plaintiff in this case brought a medical malpractice action against a dentist and his practice claiming that during a root canal procedure, the dentist failed to diagnose and treat an infection in the plaintiff’s tooth and as a result the plaintiff required surgery and other follow-up care. The plaintiff claimed that the dentist was a specialist in the field of endodontics and obtained an opinion letter from a board-certified endodontist.
The dentist filed a motion to dismiss, arguing that he practiced general dentistry and performed root canals in the course of his general practice and that the author of the opinion letter, therefore, was not a similar health care provider because it was written by an endodontic specialist. In response to the motion to dismiss, the plaintiff submitted a supplemental affidavit executed by the same endodontist which included some support for the opinion writer’s work in the area of general dentistry. The trial court determined that, despite the allegations in the complaint, the dentist was a non-specialist, general dentist but found that the information in the supplemental affidavit was insufficient to establish the opinion writer as a general dentist and granted the defendants’ motion to dismiss.
The Appellate Court affirmed the trial court’s decision, but on a different basis. The court discussed prior opinions of the Connecticut Supreme Court which found that the statutory requirements of service of process (that is, the process by which a plaintiff gives formal notice of a claim to the defendant) in a medical malpractice action include the attachment of a proper opinion letter to the plaintiff’s complaint and that a plaintiff’s failure to attach a proper opinion letter renders the action subject to a motion to dismiss by the defendant on the basis of lack of personal jurisdiction. Although the court acknowledged that the Connecticut Practice Book (which contains the state laws governing civil actions) allows for the filing of affidavits by the parties to a civil action in some circumstances, it found that because opinion letters are part of the summons and complaint process, they cannot “merely” be added to the record to rectify defects. Since the supplemental affidavit attempted to demonstrate that the dentist was practicing general dentistry, the court found that the plaintiff should have filed an amendment to the complaint to allege that the dentist was either engaged in the practice of general dentistry or, alternatively, that he was holding himself out to be a specialist. The additional, alternative credentialing information in the supplemental affidavit could not be used to correct the deficient opinion letter that was attached to the complaint.
Following Connecticut Supreme Court precedent, the Appellate Court determined that the defective opinion letter amounted to a defect in process that could not be ameliorated by the filing of a supplemental affidavit. The court held that the trial court should not have considered the supplemental affidavit at all, but it affirmed the trial court’s decision to dismiss the claim because the opinion letter, in the absence of the supplemental affidavit, did not establish that the opinion writer was a “similar health care provider” under either definition.
The Connecticut Supreme Court has granted certiorari in this case. We hope that the Supreme Court’s decision will provide additional clarity on the issues involved with opinions rendered by similar health care providers in medical malpractice actions.
Medicare Beneficiaries Have a Right to Challenge Hospital’s Decision to Reclassify Them as Observation Patients, But HHS Files Appeal
The decision about whether a Medicare beneficiary should be admitted to a hospital as an inpatient (for which services are covered by Medicare Part A) or placed on observation status (for which services are covered by Medicare Part B) can have significant financial consequences for the patient. For example, post-hospital care at a skilled nursing facility is a covered benefit only if the individual was classified as an inpatient at the hospital for a period crossing at least two midnights. Official Medicare policy leaves the inpatient/observation status decision to the discretion of the treating physician but the decision is not necessarily final, however, because hospitals are compelled by statute to have both a utilization review (“UR”) committee as well as a UR plan that provides, among other things, for review of inpatient admissions and the duration of stays for medical necessity. In addition, the Centers for Medicare and Medicaid Services (“CMS”) requires that a hospital act through its UR process when it changes a patient's status for billing purposes. The question of how much control the federal government actually exerts over the inpatient/observation status decision has been the subject of debate for a decade.
In Alexander v. Azar (Docket No. 3:11-cv-1703 (MPS)) the plaintiffs are a nationwide class of Medicare beneficiaries who were placed on observation status after entering the hospital. Some were placed on observation status at the outset and remained so throughout their stay, while others were initially designated as inpatients by the treating physician but were later placed on observation status after the hospital’s UR staff reviewed their cases. The plaintiffs brought suit against the U.S. Department of Health and Human Services (“HHS”) in 2011, arguing that they had a constitutional right to Medicare Part A coverage and that their placement on observation status without an opportunity to appeal violated the Due Process Clause of the Fifth Amendment to the U.S. Constitution.
The District Court of Connecticut (Shea, J.) examined at some length the “significant efforts” that CMS engages in to educate hospital staff on the inpatient rules and how the review and audit activities of CMS contractors, the Department of Justice and the Office of the Inspector General put “substantial pressure” on hospitals to apply CMS’s inpatient admission criteria “rigorously, uniformly, and in the same manner as CMS.” The court determined that, for beneficiaries whose status changed from inpatient to observation, there was enough involvement by the government in the deprivation of Part A coverage to constitute “state action,” which is a required element of a due process claim. These patients are, therefore, entitled to challenge the decision that deprived them of their Part A benefits.
In contrast, the court determined that patients whose physicians placed them on observation status at the outset and who were never admitted as inpatients do not have the same right to challenge their placement because there was no state action involved in these decisions. Unlike the decisions of a URC, a physician’s decision regarding inpatient or observation status is typically based on his/her professional judgment and not on CMS’s mandatory review standards.
The court modified the class and ordered HHS to establish a procedure that will allow the following Medicare beneficiaries to challenge decisions by hospitals to place them on observation status, namely:
“All Medicare beneficiaries who, on or after January 1, 2009: (1) have been or will have been formally admitted as a hospital inpatient, (2) have been or will have been subsequently reclassified as an outpatient receiving “observation services”; (3) have received or will have received an initial determination or Medicare Outpatient Observation Notice (MOON) indicating that the observation services are not covered under Medicare Part A; and (4) either (a) were not enrolled in Part B coverage at the time of their hospitalization; or (b) stayed at the hospital for three or more consecutive days but were designated as inpatients for fewer than three days, unless more than 30 days has passed after the hospital stay without the beneficiary's having been admitted to a skilled nursing facility. Medicare beneficiaries who meet the requirements of the foregoing sentence but who pursued an administrative appeal and received a final decision of the Secretary before September 4, 2011, are excluded from this definition.”
HHS has appealed this decision.
Note the blanket waivers issued by CMS for the duration of the COVID-19 public health emergency include a waiver of the Utilization Review Conditions of Participation. The blanket waivers also include a suspension of the requirement that a Medicare beneficiary have a three-day prior inpatient hospitalization for coverage of a skilled nursing facility stay.
Claims by Beneficiary of Self-Funded Plan against Insurer
The U.S. District Court for Connecticut (Meyer, J.) granted an insurance company’s motion to dismiss two counts of a complaint filed by an insured under his employer’s self-funded group health plan which was administered by the insurance company. The plaintiff brought his claims on behalf of a sub-class of plaintiffs who had substantially similar health plans. (For purposes of this summary, the sub-class will be referred to as the “plaintiff”).
In Negron v. Cigna Health and Life Ins. Co. (Docket No. 3:16-cv-01702 (August 31, 2020)), the plaintiff received prescription drug benefits through his employer’s self-funded group health plan. The employer in turn contracted with Cigna Health and Life Insurance Company (“Cigna”) to administer these benefits. The plaintiff alleged that Cigna conspired with its pharmacy benefits manager to require pharmacies to overcharge beneficiaries for their prescription drugs and to pay the excess back to Cigna, and that if the pharmacies did not comply they would be removed from the Cigna network.
The plaintiff claimed that Cigna’s alleged clawbacks breached the express terms of his health plan because he was charged more for his prescription drugs than the amount of the copayments and deductibles set forth in the health plan. The court granted Cigna’s motion to dismiss, citing the lack of a contractual relationship between the plaintiff and Cigna and the lack of any evidence that Cigna had agreed to assume any obligations to the plaintiff under either the health plan or the administrative services agreement that it entered into with the employer.
Because the court found no breach by Cigna of any express contract provisions, it also dismissed the plaintiff’s claim that Cigna breached the implied covenant of good faith and fair dealing. Without a breach of an express covenant, the court reasoned, there can be no breach of an implied covenant.
This case involved a sub-class of plaintiffs in a larger suit alleging numerous additional claims against Cigna and its pharmacy benefits managers, including violations of the Racketeer Influenced and Corrupt Organizations Act. The court has yet to rule on the merits of these other claims.
Statutory Developments from 2020
Despite the 2020 Connecticut General Assembly’s abbreviated term due to the COVID-19 public health emergency, two significant statutes affecting health care were enacted last year.
Public Act 20-2 (July Special Session): An Act Concerning Telehealth (as amended by Section 37 of Public Act 20-4 (July Special Session))
The July Special Session of the Connecticut General Assembly amended the existing state statute that governs the provision of telehealth services (CGS §19a-906) and added new provisions regarding payment for telehealth services. Some of the amended provisions are already the subject of executive orders issued by Governor Lamont that are currently set to expire on April 20, 2021. Importantly, these new telehealth provisions are in effect for only a limited period of time, from July 31, 2020 through March 15, 2021.
Additionally, the Act modifies (with no expiration date) the requirements for pharmacies transferring unfilled electronic prescriptions for controlled substances.
Existing law defines “telehealth provider” as one of a number of licensed health care providers who provides health services through the use of telehealth within such person's scope of practice and in accordance with the standard of care applicable to the profession (CGS §19a-906(a)(12)). Until March 15, 2021, the definition of “telehealth provider” is revised to mean one who is: (1) an in-network provider for fully-insured health plans or a provider enrolled in Medicaid/HUSKY B; and also (2) one of the providers listed in CGS §19a-906(a)(12) or one of the following additional providers: art therapists, athletic trainers, behavior analysts, dentists, genetic counselors, music therapists, nurse mid-wives, and occupational and physical therapist assistants. Telehealth providers must be licensed in Connecticut or, if licensed outside of Connecticut, must meet certain additional requirements specified in Section 1(a) (13)(B)(ii) of the Act.
Other key provisions of the new law that differ from the current law (CGS §19a-906) and are set to expire on March 15, 2021 include:
- Authorization for telehealth providers to offer audio-only telehealth services;
- A modification of the requirement that telehealth services and health records comply with the Health Insurance Portability and Accountability Act (“HIPAA”), by allowing telehealth providers to use any information or communication technology in accordance with the directions or revisions made to HIPAA and the regulations promulgated under HIPAA by the Office for Civil Rights of the United States Department of Health and Human Services;
- Limitations on the amounts that telehealth providers can accept from patients for telehealth services, and a requirement that a telehealth provider who determines that a patient is unable to pay for telehealth services offer the patient financial assistance to the extent required under federal or state law;
- Provisions addressing the delivery of telehealth services by providers outside of Connecticut, as well as provisions protecting Connecticut residents who receive telehealth services from out-of-state providers; and
- A requirement that the telehealth provider determine whether the patient has health coverage that is fully insured, not fully insured or provided through Medicaid or the Children's Health Insurance Program, and whether the patient's health coverage, if any, provides coverage for the telehealth service. In addition, at the time of the first telehealth interaction with a patient, the telehealth provider must provide information to the patient regarding the limited duration of the new statute’s provisions, in addition to the information required by CGS 19a-906(b)(2).
Not all of the provisions of the Act expire on March 15, 2021. Section 2 of the Act amends the Connecticut statute governing prescription requirements (CGS §21a-249) to allow pharmacies to transfer to another pharmacy, electronically or by phone, unfilled electronic prescriptions for Schedule II-V controlled substances if the transferor pharmacy and the receiving pharmacy meet certain conditions.
NOTE: Two bills affecting telehealth have been introduced during the 2021 regular legislative session of the Connecticut General Assembly. The first, HB 5118, would extend the March 15, 2021 expiration date of some of the provisions of Public Act 20-2 to May 30, 2022. This bill would also allow health insurers to reimburse providers of telehealth services at a reduced rate compared to the rate paid for in-person care under some circumstances. The second bill, HB 5142, would amend CGS §19a-906 to allow for the provision of mental health treatment services through telehealth using audio-only telephone.
Public Act 20-4 (July Special Session): An Act Concerning Diabetes and High Deductible Health Plans
Under a new law effective January 1, 2021, pharmacists must, in certain emergency situations, immediately prescribe and dispense not more than a 30-day supply of specified diabetes-related drugs and devices to a patient if certain criteria are met and the patient pays, or has health insurance coverage, for the drug or device. For patients who do not have health insurance to cover such emergency supply or who are concerned that the drugs or devices would be unaffordable, the law requires the pharmacist to refer such patients to a federally-qualified health center. The law restricts these emergency prescriptions to once in a 12-month period and limits the amount the pharmacist may charge patients, both insured and uninsured, for such emergency drugs and devices. The law also amends the state’s electronic prescription drug monitoring program to require pharmacies, nonresident pharmacies, outpatient pharmacies in hospitals and institutions and dispensers to report to the Department of Consumer Protection the emergency diabetes drugs and devices they prescribe and dispense in a manner consistent with the manner in which they report prescriptions for controlled substances. Such reports must be made on at least a daily basis.
Beginning January 1, 2022, the law will require certain individual and group health plans to cover testing and treatment of all types of diabetes (current law requires these insurers to cover treatment for only some types of diabetes). The law will also impose a cap on the amount the patient is obligated to pay under such plans for diabetes-related drugs ($25 for a 30-day supply) and devices ($100 for a 30-day supply), including those prescribed under the emergency conditions described above.
In addition, the Commissioner of Social Services was charged with establishing a working group by November 1, 2020 to, among things, determine whether she should establish a program to refer individuals in Connecticut who have been diagnosed with diabetes to federally-qualified health centers and other covered entities for treatment, regardless of whether these individuals have health coverage. If the working group determines that the Commissioner should establish such a program it is required to develop the criteria that the Department of Social Services would apply to the program.