The “what will Congress do” news leads can now stop. The Supreme Court issued its decision in King v. Burwell and Congress does not need to fix anything because, by a vote of 6-3 in an opinion written by Chief Justice John Roberts, the Supreme Court held that the subsidy provisions of the ACA are not broken, and that individuals who purchase insurance through the Federal Exchange are eligible for ACA subsidies. In a nutshell, the Court held that the most reasonable reading of the ACA provision making credits available to individuals who purchased insurance on an exchange “established by the State” makes tax credits available to individuals who purchased insurance through the Federal Exchange. The decision delves deeply into health insurance policy concepts as well as the dark-art of statutory interpretation and the underlying chaotic legislative process to find, ultimately, that it was “implausible” that Congress intended to limit tax credits to individuals who purchased insurance through a State Exchange. See King, 576 U.S. __ (2015), slip op. at 17.

At the policy level, the Court clearly understood that the three main pieces of the ACA are “interlocking.” Id. at 1. Community rating and guaranteed issuance by insurers, and mandated purchase by individuals, are underpinned by subsidies for individuals who cannot afford what they have been told they must purchase. The Court discussed the health reform precedents in states like Massachusetts and New York at length, and even used the term “death spiral,” to make clear that it understood the carrot and stick approach embodied in the ACA. Id. at 15. Taking away the “carrot” – tax credits – that makes insurance affordable for large swathes of the population will make the scheme completely untenable in states that have not created an exchange, because too many people will fall out of the mandated purchase category by qualifying for an exemption where premiums would constitute too high a percentage of their income. This, in fact, was the premise of the lawsuit brought by challengers, who reside in Virginia, a state that has not created a State Exchange. Without access to the ACA’s tax credits, their income would be low enough that they would no longer be subject to the ACA’s mandated purchase provisions, which is what they sought.Continue Reading Context Matters: Supreme Court Rules in Favor of ACA Subsidies

On June 17, 2015, the Health Resources and Services Administration (HRSA) published a Proposed Rule revising regulations governing the 340B Drug Pricing Program (340B Program) found in 42 C.F.R. Part 10. The Proposed Rule applies to all drug manufacturers that are required to make their drugs available to covered entities under the 340B Program. Notably, it sets forth the calculation of the ceiling price and application of civil monetary penalties. The Proposed Rule does not address concerns that have been expressed by manufacturers about the recent expansion of entities able to be covered entities and the expansion of pharmacy outlets serving those patients. These revisions may indicate HRSA’s interest in more stringent compliance by manufacturers of drugs that are eligible for 340B Program pricing. Comments to the Proposed Rule are due August 17, 2015.

340B CEILING PRICE

The Proposed Rule provides that a manufacturer must calculate the ceiling price for all of its covered outpatient drugs on a quarterly basis. The ceiling price is calculated by subtracting the unit rebate amount (URA) from the average manufacturer price (AMP) for the smallest unit of measure and will be calculated using six decimal places. The number is then multiplied by the drug’s package size and case package.

PENNY PRICING AND DISTRIBUTION

To address the situation where the URA equals the AMP, resulting in a $0.00 per unit of measure 340B ceiling price, HRSA proposes that a manufacturer charge $0.01 per unit of measure for a drug with a ceiling price below $0.01. For those 340B drugs whose calculated price is less than $0.01, the effective ceiling price will be $0.01 per unit of measure. Prices for 340B products must be based on the immediately preceding calendar quarter pricing data.Continue Reading HRSA Proposes Rule on 340B Ceiling Pricing, Removes Orphan Drug Regulations and Sets Forth Civil Monetary Penalties

On February 17, 2015, the largest health care provider in Massachusetts, the non-profit Partners Healthcare System, Inc. (Partners), dropped its bid to acquire South Shore Hospital based in South Weymouth, and the Commonwealth of Massachusetts dropped its antitrust suit that had challenged the acquisition.[1] Whether state or federal regulators will permit Partners’s proposed acquisition of Hallmark Health Corp. (Hallmark)’s two acute care hospital remains to be seen.

The decision by Partners comes a month after a Judge rejected a consent judgment that Partners and former Attorney General of Massachusetts Martha Coakley proposed regarding Partners’s agreement to acquire three acute care hospitals in the greater Boston area.[2] Less than a year ago, on June 24, 2014, the Attorney General of Massachusetts had simultaneously filed a complaint and a proposed consent judgment with Partners regarding Partners’s acquisition of South Shore and two hospitals operated by Hallmark.Continue Reading Partners Halt Acquisition of Boston Area Hospital After Court’s Rejection of Consent Judgment

This week, the U.S. Office of Personnel Management (“OPM”) published three notices of proposed rulemaking (“NPRMs”) regarding the administration of the Federal Employees Health Benefits (“FEHB”) Program. The FEHB Program provides for coverage of federal employees and annuitants and their dependents. 5 U.S.C. § 8901, et seq. These three NPRMs address subrogation and reimbursement recovery, enrollment after termination of a plan or plan option, and rate setting for community-rated plans.

Subrogation and Reimbursement Recovery

OPM’s proposed rule on subrogation and reimbursement recovery would ensure that FEHB Program carriers may seek reimbursement or subrogation recoveries in all states. 80 Fed. Reg. 931 (Jan. 7, 2015) (available here). The supplementary materials to this regulation reiterate the position the government has consistently taken—“that a covered individual’s entitlement to FEHB benefits and benefit payments is conditioned upon, and limited by, a carrier’s entitlement to subrogation and reimbursement recoveries pursuant to a subrogation or reimbursement clause in the FEHB contract.” 80 Fed. Reg. at 931.

These regulations would add a new section, 5 C.F.R. § 890.106, to FEHB Act implementing regulations. Section 890.106 would do the following:

  • Require that all FEHB contracts provide for subrogation and reimbursement by carriers;
  • Condition Program benefits and benefit payments to covered individuals on the carriers’ rights to subrogation and reimbursement, and require FEHB brochures (official statements of benefits) to explain this condition;
  • Set forth the two requisite circumstances that trigger a carrier’s right to subrogation or reimbursement: receipt of benefits or benefit payments by a covered individual as a result of an illness or injury, and the individual’s recovery or right to recovery from a third party based on the same illness or injury;
  • State that a carrier’s claim for subrogation or reimbursement is not subject to OPM’s administrative disputed claims process outlined at 5 C.F.R. § 890.105; and
  • Establishes procedural rules for carriers’ recoveries.

Continue Reading OPM Proposes New FEHB Rules on Subrogation, Post Termination Enrollment, and Rate Setting for Community-Rated Plans

President Obama announced on November 14 that the Administration will allow health insurers to continue certain coverage in the individual and small group market which would have not otherwise met the market reform requirements of the Affordable Care Act (ACA). This change raises significant questions and operational problems for issuers, providers, employer sponsors of health plans, and other organizations operating in the health care industry. In conjunction with the President’s announcement, the Centers for Medicare & Medicaid Services of the Department of Health and Human Services (CMS) has issued a letter to state insurance commissioners (CMS Letter) detailing the Administration’s new “transitional policy” in regard to this issue. The CMS Letter provides some guidance regarding health insurance policies that now may be continued, and specifies the necessary conditions under which these policies may be continued. However, there remains much uncertainty as to whether issuers will be able to continue to offer these policies, as well as the overall impact on the insurance market.
Continue Reading The Obama Administration’s ‘Fix’ for Insurance Cancellations: Five Things Worth Taking into Account

In Advisory Opinion 13-09, the HHS-Office of Inspector General (OIG) determined that a company’s offer of equity to members of its subsidiary group purchasing organization (GPO), partially in exchange for certain commitments to purchase through the GPO, could constitute a violation of the federal anti-kickback statute, 42 U.S.C. § 1320a–7b(b) (the “AKS”). While Advisory Opinion 13-09 is significant for GPOs, it also resonates more broadly, as to the AKS’s discount safe harbor, as well as any instance where the acquisition of equity is connected to items or services reimbursable under a federal health care program.

Background

The opinion’s Requestor was a company providing financial and performance improvement technology-based products and services. The GPO at issue was wholly-owned by the Requestor, and contributed approximately 60 percent of the Requestor’s revenue. On behalf of its members, the largest of which were hospital systems and integrated delivery systems, the GPO negotiated discounts and other contractual terms with vendors. Continue Reading OIG Issues Unfavorable Opinion on Proposed Offer of Equity Interest to GPO Members