CVS-Aetna merger approved, subject to divestiture of PDP business

The federal district court in the District of Columbia has concluded that the proposed consent judgment allowing the merger of CVS Health Corporation and Aetna, Inc. is in the public interest. The merger may go forward under the condition that CVS divest Aetna’s individual Medicare prescription drug plan (PDP) business to WellCare Health Plans, Inc. The court considered objections to the merger raised by industry, consumers, and states, and concluded that the divestiture will effectively remedy the harm to the PDP market and will not be rendered ineffective due to the proposed judgment’s failure to address effects in markets adjacent to the PDP market (U.S. v. CVS Health Corporation, September 4, 2019, Leon, R.).

In response to the proposed merger between CVS and Aetna, the United States simultaneously filed a complaint and a proposed consent judgment in 2018. Under the terms of the proposed consent judgment, CVS would divest Aetna’s individual Medicare prescription drug plan (PDP) business to WellCare Health Plans, Inc. A number of parties including members of industry, consumer groups, and state regulatory bodies (amici) opposed the proposed consent judgment and filed briefs stating their concerns. As part of its review under the Tunney Act, the court conducted a hearing with witnesses from parties and amici.

The court concluded that the proposed consent judgment is in the public interest, although it did reject the government’s assertion that the court may only consider harms alleged in the complaint. The amici briefs raised three primary objections to the merger. First, that Aetna’s divestiture to WellCare will not effectively remedy the harm to the PDP market, because the divestiture leaves the PDP market overly concentrated and WellCare will not be as strong a competitor in the PDP market as Aetna was. On this point, the court found the evidence from CVS and the Government to be more persuasive. That evidence included testimony that the PDP market is already highly competitive, because plans can be easily compared, and the market is only moderately concentrated. The moderate concentration in the PDP market has neither prevented WellCare from competing in the market, nor prevented price competition from driving premium prices down, in recent years.

Amici also argued that the proposed final judgment’s failure to address effects in markets adjacent to the PDP market will undercut the effectiveness of the divestiture remedy and harm the public. For example, CVS could raise the price of its pharmacy benefit manager (PBM) services when selling the services to health insurance competitors. Such an action could threaten the success of the proposed divestiture remedy because WellCare, which both competes against CVS in the PDP market and contracts with CVS for PBM services, would be vulnerable to such a tactic. But CVS presented more persuasive evidence that substantially undermines this theory. Rival PBMs try to underbid CVS and CVS’s PBM oftentimes competes against its own customers because health insurance companies can move PBM services in house if they consider CVS’s price for contract services too high. That evidence strongly suggests that, if CVS were to raise its PBM prices, customers like WellCare could simply switch to a less expensive PBM or stop contracting for those PBM services altogether.

Finally, amici argued that the proposed final judgment without modification will harm HIV and AIDS patients in need of affordable, quality healthcare. But the court concluded that the record did not establish that the judgment will likely result in CVS gaining the ability to steer patients away from their current healthcare providers (such as the AIDS Healthcare Foundation). The Foundation uses a different PBM and maintains its own pharmacies, therefore it is unlikely that CVS will be likely to steer patients away from the Foundation.

In the Department of Justice press release announcing the settlement, Assistant Attorney General Makan Delrahim of the Antitrust Division expressed pleasure with the decision, noting that the judgment provides a “comprehensive remedy” that “protects seniors and other vulnerable customers of individual PDPs from the anticompetitive effects that would have occurred if CVS and Aetna had merged their individual PDP businesses.”

American Antitrust Institute (AAI) statement. “AAI strongly disagrees with the merits of the court’s opinion,” said AAI President Diana Moss. “On most points, the court simply accepted piecemeal evidence introduced by the DOJ and CVS. The opinion discounts the showing by amici that the remedy will fail to preserve competition in PDP markets and that the merger raises significant vertical concerns ignored by the DOJ in its complaint. The opinion’s statement that ‘[N]otwithstanding CVS’s significant market share, the evidence showed that CVS must compete vigorously to retain its PBM customers’ is divorced from sound economics.”

National review of Medicaid opioid prescribing not yet feasible

The Office of Inspector General (OIG) has determined that limitations of the national Medicaid claims database, the Transformed Medicaid Statistical Information System (T-MSIS), makes a national review of opioid prescribing in Medicaid unfeasible. The system cannot yet identify all at-risk beneficiaries and providers, the OIG reported (OIG Report, No. OEI-05-18-00480, August 2019).

The OIG assessed the completeness of variables necessary to identify beneficiaries at risk of opioid misuse or overdose and the National Provider Identifiers (NPIs) of providers that ordered and dispensed opioids. According to the report, states were missing data necessary for a national review. Some states did not require NPI to be collected. Others included NPI in their data but incorrectly submitted the data or were unable to transmit the data to T-MSIS because of outdated systems. Without a provider NPI, it is not possible to identify all providers who may be overprescribing opioids and take appropriate action, or to identify providers for investigations of fraud, waste, or abuse, the OIG found.

Identification of beneficiaries can be impeded because a Medicaid beneficiary can have multiple IDs within a state or across states. If a beneficiary does have multiple IDs, prescriptions dispensed to the IDs would appear to be for multiple persons rather than one person. The OIG noted in the report that without a unique beneficiary ID, it is not possible to identify all at-risk beneficiaries in need of opioid-related treatment and conduct proper monitoring of services to protect beneficiaries from inadequate coordinated care.

States also have failed to report diagnoses codes for all services despite being required to do so. Without a diagnosis code, it is not possible to exclude all patients with cancer diagnoses for whom higher doses of opioids may be appropriate or to identify patients’ medical conditions to determine medical necessity for services.

The OIG noted in the report that in August 2018, CMS that all states were submitting T-MSIS data and that CMS was prioritizing T-MSIS data quality. According to the OIG, CMS indicated it would have research files available in 2019. CMS currently has been working with states to improve the quality of data submissions.

Recommendations

The OIG recommended that CMS strive to ensure that individual beneficiaries can be identified at a national level using T-MSIS. CMS should address instances in which a single beneficiary has more than one Medicaid ID within a state. CMS also should prioritize state reporting of prescriber NPIs and issue guidance to clarify the requirements for diagnosis codes.

Medicaid third-party liability changes a challenge for states

The U.S. Government Accountability Office (GAO) conducted a study to see the progress states have made in implementing the changes in third-party liability requirements since the Bipartisan Budget Act of 2018 was passed. The GAO found that the states are unclear on how to collect the required information, update their data systems, and implement the new policies. Adding to the difficulties in understanding and implementing the changes, CMS has issued inconsistent guidance and offers only outdated policy manuals that offer no assistance in implementing the changes (GAO Report, GAO-19-601, August 9, 2019).

Bipartisan Budget Act of 2018

Federal law requires states ensure that Medicaid is the payer of last resort by taking steps to identify Medicaid beneficiaries’ other potential sources of health coverage and their legal liability. The Bipartisan Budget Act of 2018 modified the required processes states must follow when paying claims with probable third-party liability for three types of services. Under the amended statute, states must apply cost avoidance procedures to claims for prenatal care services and pregnancy-related services when it is apparent that a third party is or may be liable at the time the claim is filed. Additionally, states are no longer required to pay claims for pediatric preventative services immediately and may instead require the provider to submit the claim to the third party and wait 90 days (wait-and-see period) for payment before seeking Medicaid payment. Finally, states must make payment for a child support enforcement (CSE) beneficiary’s claim if the third party has not paid the provider’s claim within a 100-day wait-and-see period.

State concerns

According to state officials, several changes to administrative tasks and the Medicaid Management Information System (MMIS) needed to be undertaken to implement the new third-party liability changes and some required research and discussion about the best methods to make these changes. Officials noted that they would need to identify the correct codes in their data systems, establish some sort of indicators in their system to identify which claims were for CSE beneficiaries or had been billed to a third party and when. Some of this additional information would require a data sharing agreement with the state entity maintaining the CSE information while other information would require providers to track down insurance information from a non-custodial parent. Some officials expressed concern that the system changes may require new hardware and system modifications and may make it difficult or impossible to implement the changes, while others discussed waiting for the new MMIS that they were already working to roll out in the future. There were also concerns that the technology changes and the increased administrative work may make the changes not cost-effective to implement.

Stakeholder concerns

Stakeholders were concerned that obtaining accurate information on third-party liability sources for Medicaid beneficiaries and resubmitting claims that result from incorrect or outdated information can be resource intensive and time consuming. Medicaid beneficiaries may be unaware or may not disclose other insurance policies, especially when there are multiple policies by custodial and non-custodial parents or transitions in insurance following birth. Some stakeholders were concerned that rural-based providers may not have the resources to deal with the increased administrative work and delays in payment for services that could result from the payment changes. This may lead some providers to be less willing to serve Medicaid beneficiaries, which would potentially reduce access to care or delay time-sensitive services for children and pregnant women. Some providers may also seek to identify sources of third-party liability before providing services to beneficiaries, which would also delay access to care.

Recommendations

Many states expressed the need for further guidance from CMS on how to implement some of these changes, however, the GAO noted that CMS has issued guidance that is inconsistent with the federal laws and some CMS guidance documents are out of date and not a reliable source of information for states to use in implementing the new requirements. Therefore, the GAO recommended that CMS ensure the agency’s Medicaid third-party liability guidance is consistent with federal law.

The GAO found that CMS has not taken steps to determine the extent to which state Medicaid agencies are meeting the new requirements and indicated that they expect states to comply and will not verify unless the agency is made aware of non-compliance. The GAO recommended that CMS determine the extent to which state programs are meeting federal third-party liability requirements and take actions to ensure compliance where appropriate.

State systems to track availability of psychiatric hospital beds vary

Recognizing the critical need for inpatient hospital and residential mental health and substance use disorder treatment settings, the HHS Office of the Assistant Secretary for Planning and Evaluation (ASPE) has released a report that examines how states make information on open beds available to consumers, the impact of effect that inpatient bed tracking has on patient access, and the challenges that remain with inpatient bed tracking systems. The researchers concluded that among the 17 states that track availability of psychiatric hospital beds, only five states allow for public access. In some states, systems to track the availability of psychiatric hospital beds have been challenged by the reluctance of hospitals to update information on open beds frequently enough to be useful given rapid patient turnover (ASPE Report, August 2019).

Need for inpatient bed tracking

ASPE conducted a study to examine how states make information on open beds available to consumers, the impact of effect that inpatient bed tracking had on patient access, and the challenges that remain with inpatient bed tracking systems. Inpatient hospital and residential mental health and substance use disorder (SUD) treatment settings are a critical component of behavioral health services care. Patients may require an inpatient hospital stay when they experience a psychiatric or SUD emergency, pose a threat to themselves or others, and need 24-hour medical monitoring and treatment. In the absence of a bed registry, emergency room staff, patients, or other providers must call multiple hospitals or residential settings to determine if there is a slot available that would be appropriate given the patient’s needs. This results in long waits in emergency departments.

Systems to track openings

The researchers conducted an environmental scan by identifying states that have systems to track openings in behavioral health treatment settings, such as hospital psychiatric beds and residential treatment beds. The study found among the 17 states that tracked this information, only five states allowed public access. The other 12 states kept the information about bed availability behind a firewall and only available to providers. The researchers found significant variation among states in how the registries were operating, the types of behavioral health providers they included, and perceptions of their usefulness. In some states, systems to track the availability of psychiatric hospital beds have been challenged by the reluctance of hospitals to update information on open beds frequently enough to be useful given rapid patient turnover.

Emergency department staff noted that the system does not negate the need for them to call hospitals to confirm that there is still an open bed that is appropriate for the patient’s needs and that relationships among hospitals and emergency departments and other crisis system staff may be more efficient than using the bed registries. However, some states reported that the registries were very helpful in locating open beds as well as in documenting the need for additional psychiatric beds.

Registries that post available openings in SUD residential, detoxification, and other non-hospital-based systems are less common than hospital bed registries. Connecticut has a publicly-facing registry that indicates openings in SUD treatment settings. Interviewees reported that patients with SUDs and providers like the system and find it useful. However, more effort is needed to make patients and family members aware of the system.

Future research

There have been no formal evaluations of the effect of bed registries on access to care. The report concluded that future research could help improve understanding of the characteristics and processes that make the bed registries most useful. Some avenues to explore include: (1) how financial, regulatory, contractual, and policy levers can be used to encourage participation in bed registry systems; (2) how many consumers are using the public registries and how to increase their usage; (3) whether technology can substitute for human data entry to track available treatment beds; and (4) whether registries reduce the time and effort required to locate an appropriate inpatient or residential bed.