C&M Health Law

C&M Health Law

Analysis, commentary, and the latest developments in health care law and policy

The Freight Train Gathers Steam: An Update on the Federal Response to the Opioid Crisis

Posted in FDA, Medicaid, Medicare
Ashley N. SoutherlandPayal NanavatiJodi G. DanielTraci Vitek

Despite the Trump Administration’s declaration of a state of emergency on October 26, 2017, the federal response to the opioid crisis largely languished on the back burner—much to the chagrin of states in the trenches of the opioid epidemic. However, based on the flurry of activity over the past several weeks, the federal government response now seems to be gathering substantive momentum, with various agencies and government actors launching attacks on all fronts—administrative, legislative, and enforcement alike. The federal government’s recent efforts present opportunities for health care organizations, life sciences companies, and health tech companies to get involved at the ground level to help influence opioid policy and provide needed products, services, and support to reduce the incidence of opioid abuse and address the health care needs of patients. Continue Reading

CMS Signals Future Patient Access Requirements for Medicare Advantage Plans

Posted in Health IT, Medicare
A. Xavier BakerJodi G. DanielMaya Uppaluru

Building on momentum from Administrator Seema Verma’s announcement of the MyHealtheData initiative at HIMSS 2018, CMS has published more clues as to future action to liberate health information for patients.

In the CY 2019 call letter to Medicare Advantage organizations and Part D programs, CMS describes the Blue Button 2.0 project and its use of the interoperable application programming interface (API) standard Fast Healthcare Interoperability Resources (FHIR). CMS encourages Medicare Advantage plans to adopt “data release platforms” that either meet or exceed the capabilities of Blue Button 2.0, and makes it clear that the agency intends to pursue rulemaking requiring such adoption for 2020.

The FHIR standard is also discussed, although not required, in the 2015 Edition Health IT Certification Criteria for API access, regulations promulgated by the Office of the National Coordinator for Health IT (ONC) that set the rules for functionality and interoperability of electronic health record systems. It seems likely that ONC further promote FHIR for API-based patient access in their upcoming rulemaking updating the certification program, expected this summer.

This move from CMS arrives alongside increased Congressional interest in patient access to information about the cost of healthcare services. This includes a recent Senate price transparency initiative led by Senator Bill Cassidy. Almost 1000 pages of feedback have already been received by Senate staffers, describing why and how payers and providers can make healthcare price and cost information more accessible for individual patients.

Health plans that wish to get ahead of the future regulatory action can check out the developer resources for Blue Button 2.0 to see how CMS envisions API access working for payer data. Plans can also participate in an ongoing ONC Tech Lab project to learn more about on how these standard resources can be used for health plan-specific information and influence standards development.

Health Care Fraud and Abuse Control Program FY 2017: Insights from Our Enforcement Team

Posted in Fraud, Waste & Abuse
Christopher Flynn

The Health Care Group’s newest partners, William S.W. Chang and Laura M. Kidd Cordova, along with Counsel Stephanie D. Willis, have authored an Alert about the 21st Health Care Fraud and Abuse Control Program (HCFAC) annual report released last Friday.  The HCFAC report is a joint effort of the U.S. Department of Justice (DOJ) and the U.S. Department of Health and Human Services (HHS) that describes the expenditures, results, and enforcement actions of the previous fiscal year.  The authors note that compared to FY 2016, other than expanded efforts to combat the opioid crisis, enforcement remained more or less consistent with prior trends.  In monetary terms, HCFAC spending slightly increased, while overall monetary recovery and returns on investment in fraud prevention efforts significantly decreased.  Interestingly, however, the proportion of overall recoveries resulting from HHS auditing activities considerably increased.

Read the rest of the Alert’s analysis of the HCFAC report and register for our webinar next Tuesday, April 17th.  During the webinar, listeners will hear Will and Stephanie, who were attorneys employed by DOJ and the HHS Office of the Inspector General (HHS-OIG), respectively, give their insights about the significance of the report for health care companies and the health care industry.

 

Iowa Enacts Legislation to Broaden Access to Association Health Plans

Posted in ERISA, Exchanges, Health Care Reform & ACA
A. Xavier BakerJoseph Records

Iowa has enacted legislation to permit the offering of certain health benefit plans that would not be subject to the restrictions of the Affordable Care Act (ACA).

The bill combined two separate measures, each intended to expand access to association health plans (AHPs) that are exempt from many of the ACA’s protections. First, the new law would allow small employers to band together to form associations that would be eligible to offer members’ employees coverage as if they were a single large employer group, which would be subject to less burdensome regulation under the ACA. Second, a health benefit plan sponsored by a nonprofit agricultural organization domiciled in Iowa (the Iowa Farm Bureau Federation) and covered by a third-party administrator that has administered the organization’s health benefits plan for more than 10 years (Wellmark Blue Cross & Blue Shield) is exempt from the definition of insurance that is subject to regulation by the state insurance department.

Recently, AHPs have been touted by opponents of the ACA as a tool to avoid its effects for larger covered populations. Iowa’s measure follows an executive order by President Trump last fall directing the administration to, among other things, promote the use of AHPs. In response to that order, the Department of Labor proposed a rule that would expand the definition of AHP to allow employers greater access to AHP coverage. As we noted in a previous post, several states have pressed the idea through comments to that proposed rule that expanded access to AHPs would create opportunities for employers to offer more affordable coverage.

The impact of Iowa’s enactment remains to be seen. Critics of the measure have expressed concern that it will water down consumer protections by exempting coverage from ACA requirements that plans cover essential health benefits, such as maternity and mental health care. Although plans could continue to include such benefits, they would not be legally obligated to do so, and could cut costs by eliminating coverage for broad categories of health care. Continue Reading

CMS Proposed Rule Would Reduce States’ Health Care Access Monitoring Requirements

Posted in Administrative Law, Medicaid
Stephanie Willis

On March 22, 2018, the Centers for Medicare and Medicaid Services (CMS) announced a notice of proposed rulemaking (NPRM) that would, if finalized, exempt states with high rates of Medicaid beneficiaries in managed care plans from monitoring and reporting requirements related to Medicaid service access set forth in 42 C.F.R. §§ 447.203 and 447.204. The regulations currently require states to analyze and document the impact of Medicaid fee-for-service (FFS) payment amounts on beneficiary access to covered health care services in access monitoring review plans (AMRPs) submitted to CMS.

States’ AMRPs must, using a data-driven process, address the impact of Medicaid FFS payments on beneficiaries’ access to the following categories of Medicaid services: primary care services, physician specialist services, behavioral health services, pre- and post-natal obstetric services, and home health. The state must update and submit the AMRP related to these service categories to CMS at least every three years. If a state reduces Medicaid FFS rates for services outside of these categories, the state must include those additional services in the AMRP and publicly monitor the rate reductions for three years.

Since the adoption of these requirements, several states have complained that the scheme imposes an undue administrative burden and that it is not an efficient use of limited state program resources. In response, the proposed rule’s changes to the regulations would allow the following:

  • An exemption from most access monitoring requirements for states with an overall Medicaid managed care penetration rate of 85% or greater (currently, 17 States).
  • An exemption from the specific access analysis for reductions to provider payments below the “nominal payment rate change” of 4% in overall service category spending during a state fiscal year (and 6% over two consecutive years).
  • A state to submit an assurance that its baseline data “indicates current access is consistent with requirements of the Social Security Act,” rather than be required to predict the effects of proposed Medicaid FFS rate reductions or restructurings on access to care.

This NPRM aligns with the Trump Administration’s push to “cut the red tape” and to generally reduce states’ administrative burdens under federal programs. The proposed changes are also consistent with CMS’s other efforts to enable states to focus on patient outcomes rather than processes in administering their Medicaid programs, as quantified in the agency’s estimates that the proposed changes will eliminate 561 administrative hours and save a total of $1.66 million for the affected states.

Comments on the proposed rule are due to CMS no later than May 22, 2018.

Federal Employees Health Benefits Program 2018 Carrier Conference Highlights

Posted in Federal Employees Health Benefits Program (FEHB)
C&M Health LawJoseph Records

On Thursday, March 22, the U.S. Office of Personnel Management (OPM) and America’s Health Insurance Plans (AHIP) hosted the annual Federal Employees Health Benefits (FEHB) Program Carrier Conference. The conference featured OPM’s policy and contracting priorities for the FEHB Program for 2018. It followed and discussed OPM’s FEHB Program Call Letter (available here), which provides a high-level outline of its intentions for contract negotiations for plan year 2019.

This year’s Carrier Conference included three key highlights for FEHB carriers:

  1. OPM will re-open the Indemnity Benefit Plan to contract with either a nationwide carrier or a consortium of carriers to begin offering coverage in 2020.
  2. OPM is seeking legislative changes to apply the Anti-Kickback Statute to the FEHB Program.
  3. OPM is interested in Plans improving value by offering Accountable Care Organization or other innovative models

Continue Reading

States Seek Control over Association Health Plans in Comments on DOL Proposed Rule; Iowa Senate Approves Bill Expanding Availability of Association Health Plans—Potentially to the Detriment of ACA Exchange Plans

Posted in ERISA, Health Care Reform & ACA
Christopher FlynnA. Xavier BakerSam KrauseAlice Hall-Partyka

The Department of Labor’s proposed rule on association health plans (AHPs), issued in response to an October 12, 2017 Executive Order, has received almost 900 comments, including from several states and the District of Columbia (see, e.g., comments from Alaska, Iowa, Massachusetts, Montana, Pennsylvania, and Wisconsin). States emphasized the need for clarity in the rule and affirmation of states’ long-standing authority to regulate insurance including both solvency and consumer protection issues. Iowa, for example, attributed the more than 40-year success of a multiple employer welfare arrangement (MEWA) to both the entity’s interests to serve its members and the Iowa Insurance Division’s authority to ensure that MEWAs are “adequately solvent and following fair trade practices” and argued that continued robust state insurance oversight is critical to successful AHPs.

Last week, the Iowa Senate approved two bills which, if passed by the Iowa House of Representatives, would expand the availability in the state of AHPs, a type of MEWA covered by the Employee Retirement Income Security Act of 1974 (ERISA). The legislation would allow for Wellmark Blue Cross Blue Shield to administer an AHP for the Iowa Farm Bureau Federation and could threaten the membership of Medica, the only issuer of coverage through Iowa’s exchange.

Continue Reading

Liberating Data to Transform Value-Based Care: MyHealthEData, Blue Button 2.0, and Price Transparency

Posted in Health IT
Jodi G. DanielAshley N. SoutherlandPayal Nanavati

On March 6, 2018 at the Healthcare Information and Management Systems Society (HIMSS) 2018 conference, Centers for Medicare & Medicaid Services (CMS) Administrator Seema Verma announced a new initiative furthering the current Administration’s focus on value-based care and increasing patient access to healthcare data. The initiative — called MyHealthEData — will be led by the White House Office of American Innovation, in collaboration with the Department of Health and Human Services (HHS), CMS, the Office of the National Coordinator for Health Information Technology (ONC), the National Institutes of Health (NIH), and the Department of Veterans Affairs (VA). (CMS press release here.) Continue Reading

White House Proposes Language to Congress Eliminating CSR Reimbursement for 2017

Posted in Exchanges, Health Care Reform & ACA
Alice Hall-PartykaA. Xavier Baker

On March 8, the White House encouraged Congress to pass stabilization legislation that would not authorize the reimbursement of cost-sharing reductions (CSRs) made by health plans in 2017, as reported by Modern Healthcare. This move comes almost five months after the Trump Administration’s announcement in October that it would discontinue CSR payments effective immediately. The legislation, if passed, would preclude the government from paying CSRs for the 2017 year and would allow CMS to claw back surplus money that plans have received from the federal government and applied towards CSRs. Continue Reading

Trump Administration Rejects (Nicely) Idaho’s Attempt to Skirt ACA

Posted in Exchanges, Health Care Reform & ACA
Diana HuangA. Xavier Baker

On Thursday, March 8, the Trump Administration rejected Idaho’s plan to sell health plans that do not include the consumer protections required by the Affordable Care Act (ACA). The rejection came in the form of a letter touting adherence to current law, though in many ways the letter was written by an apologetic Centers for Medicare and Medicaid Services (CMS) wanting to appease Idaho Republicans.

Earlier this year, Idaho Governor C.L. “Butch” Otter signed an executive order that allowed some Idaho health insurance plans to drop certain ACA requirements. For example, plans would not need to cover maternity care, mental illness, or other essential health benefits; insurers could charge higher premiums to those with preexisting conditions; and insurers could deny people coverage if they had failed to maintain continuous coverage. Insurers who sold such “junk” plans would be required to also sell at least one ACA-compliant option over the exchanges. Gov. Otter’s actions seemed to test just how far Alex Azar, Secretary of the U.S. Department of Health and Human Services, would go to support the “state experimentation” Mr. Azar himself advocated for under the exchanges, as discussed in our earlier post. The answer, for Idaho, is not far enough. Continue Reading