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Barbara H. Ryland is a senior counsel in the Washington office of Crowell & Moring's Health Care Group. Ms. Ryland brings more than 20 years of experience navigating the complex health care regulatory environment in working with health care clients in counseling, litigation and internal investigations. Ms. Ryland has worked with health plans to investigate and resolve False Claims Act disputes arising out of government health care programs. Ms. Ryland has also represented health plans in administrative disputes before CMS, involving Medicare Advantage and Part D plans, and in disputes with state agencies involving Medicaid managed care plans.

The final rule implementing “Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs” is now available for review, and set for publication in the May 9, 2022 Federal Register.   The final rule adopts the proposed change that requires initial and service area expansion applicants to submit their

On April 4, 2022, in Pharmaceutical Care Management Association (PCMA) v. Mulready, Case No. CIV-19-977-J (W.D. Okla. 2022), the U.S. District Court for the Western District of Oklahoma ruled on PCMA’s claim that Oklahoma’s Patient’s Right to Pharmacy Choice Act (Act), Okla. Stat. tit. 36, § 6958, et seq., was preempted under ERISA and Medicare Part D.
Continue Reading State PBM Regulation: The Struggle Continues – Oklahoma District Court Latest to Rule on ERISA, Part D Preemption

Payers, Providers, and Patients – Oh My! Is Crowell & Moring’s biweekly health care podcast, discussing legal and regulatory issues that affect health care entities’ in-house counsel, executives, and investors. In this “deep dive” episode, hosts Payal Nanavati and Joe Records talk to Barbara Ryland about benefits under Medicare Part C.

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Last week, Tennessee proposed to the Centers of Medicare and Medicaid Services (“CMS”) the first of its kind Medicaid block grant program, which would constitute a fundamental restructuring of the Tennessee Medicaid program. The proposal is intended to implement Tennessee House Bill 1280, enacted in May of 2019, which directed the governor to request CMS to approve the block grant through a Section 1115 waiver amendment.

Tennessee currently operates its Medicaid program (“TennCare”) through a Section 1115 waiver approved by CMS. Under the proposed amendment, the state would receive a block grant in an amount calculated using the federal government’s projections for the state’s Medicaid program costs, calculated as if the state were not currently participating under a 1115 demonstration waiver. In years in which the state spends less than the block grant, the state and the federal government would evenly share in the resulting savings.

As part of the proposal, Tennessee has asked for significant exemptions from federal Medicaid managed care laws. Among other things, the state has asked for flexibility to spend block grant funds on items and services not otherwise covered under Medicaid; to adopt a commercial-style closed formulary; to make changes to its benefit packages without CMS approval; to vary benefit packages for members based on medical factors or other considerations; and to be relieved from compliance with Part 438 of Title 42 of the Code of Federal Regulations, including provisions requiring federal approval for pursuit of healthcare delivery system reform initiatives, managed care contracts, and actuarially certified capitation rates paid to managed care contractors. The state believes that the proposal would “appropriately recognize[] the state’s efforts to contain costs and improve program quality, while providing a meaningful incentive to continue building on those efforts to make TennCare a stronger and more effective program.”
Continue Reading Tennessee Proposes First of Its Kind Block Grant Program for Medicaid

Nearly 20,000 comments have been submitted in response to the Department of Health and Human Services January 31, 2019 notice of proposed rulemaking eliminating discount safe harbor protection for reductions in price to prescription pharmaceutical products (or rebates) provided by manufacturers to plan sponsors under Medicare Part D and Medicaid managed care organizations (MCOs), whether negotiated by the plan or by pharmacy benefit managers (PBM) or paid through a PBM to the plan or Medicaid MCO. Most of the comments appear to be relatively short, text box comments submitted by individuals through patient or business advocacy groups.  The following is a very high level summary of the several hundred comments posted (so far) from health plans, manufacturers, pharmacies, their respective associations, and policy oriented groups:
Continue Reading Highlights from the Comments on the Proposed Elimination of Discount Safe Harbors for Rebates

In its recent notice of proposed rulemaking setting policy for Medicare Advantage (MA) and the Prescription Drug Program (PDP) for calendar year 2020, CMS announced that it would establish extrapolation as a method to be used in risk adjustment validation (RADV) audits, and further, that it would not make any adjustments to account for errors in Medicare fee for service data in determining recovery amounts.

CMS uses a risk adjustment process to modify MA plan payments to better reflect the relative risk of each plan’s enrollees. Payments to each MA plan are adjusted based on risk scores that reflect enrollees’ health status (categorized into Hierarchical Condition Categories (HCCs)) and demographic characteristics derived from member claims data. To counteract incentives that a plan might have to over-report enrollee diagnoses, CMS emphasizes that all diagnoses submitted to enhance risk must be documented in a medical record, and uses RADV audits to ensure that medical record documentation exists, and thus, that payments to MAOs accurately reflect the level of risk assumed.
Continue Reading CMS Announces and Solicits Comments on Expanded RADV Audit Methodology

In the most recent technical changes made to Part C and Part D plans for 2019, CMS codified the star ratings methodology in regulations. Now, CMS is proposing changes to these regulations, such as new definitions to clarify the meaning of terminology used in describing the star ratings methodology. In addition, CMS is proposing several changes to improve program quality and accessibility of the Medicare Advantage (MA) and Part D Prescription Drug Program (PDP) Plan Quality Rating for measures other than Consumer Assessment of Healthcare Providers and Systems (CAHPS).

Continue Reading MA/PDP Star Ratings: Proposed Technical Changes for 2020

On October 15, 2018, the Centers for Medicare & Medicare Services (“CMS”) in the Department for Health and Human Services proposed a rule to require prescription drug manufacturers to post the Wholesale Acquisition Cost (“WAC”) for drugs and biological products covered by Medicare or Medicaid in direct-to-consumer television advertisements. The WAC reflects the manufacturer’s list price for a drug to direct purchasers, not inclusive of any discounts or rebates. CMS is proposing this rule in the context of broadcast advertisements, an area in which the Supreme Court has recognized that the government may take special steps to help ensure that viewers receive appropriate information.[1]

CMS stated that 47 percent of Americans have high-deductible health plans and that many patients may pay the list price of the drug until they meet their deductible. The proposed rule aims to provide greater transparency into the prices charged by prescription drug manufacturers. The theory is that markets operate more efficiently with greater transparency, and that increased exposure of the list price will also provide a moderating force to discourage price increases. While wholesale prices do not equate to the patient’s out-of-pocket obligation, CMS asserts that benefit designs are impacted by WACs, and patients in high-deductible plans may pay the full list price until meeting their deductible – thus, the WAC may still be relevant to many patient and impact their decisions and market dynamics. The price required to be posted would be for a typical course of treatment for an acute medication like an antibiotic, or a thirty day supply of medication for a chronic condition that is taken every month. The posting would take the form of a legible textual statement at the end of the ad and would not apply where the list price for a thirty day supply or typical course of treatment of a prescription drug was less than $35.
Continue Reading CMS PROPOSES RULE TO REQUIRE PRESCRIPTION DRUG MANUFACTURERS TO DISCLOSE DRUG PRICES IN TV ADS

On August 24, 2016, Judge Edgardo Ramos of the Southern District of New York approved a settlement in which Mount Sinai Health System (Mount Sinai) will pay $2.95 million to New York and the federal government to resolve allegations that it violated the False Claims Act (FCA) by withholding Medicare and Medicaid overpayments in contravention

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