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Lauren Moldawer is an Associate in the firm’s Washington, DC office. She counsels health care providers, PBMs, and managed care organizations on regulatory issues. Lauren is admitted to practice in New Jersey and is practicing under the supervision and guidance of Members in the DC office. Before joining Mintz Levin, Lauren was with the Centers for Medicare & Medicaid Services in the Medicare-Medicaid Coordination Office, where she worked with states and health plans implementing the Financial Alignment Demonstration.

Our colleagues on the Employment Matters blog recently analyzed a budget proposal by the Massachusetts Senate that would authorize the Governor to collect additional funds from employers to offset increasing MassHealth costs.  MassHealth, Massachusetts’s Medicaid program, offers low-cost, benefit rich coverage to low-income individuals.   Eligible individuals sometimes forgo employer coverage in lieu of MassHealth coverage, a trend that is unsustainable for the Commonwealth.

In Governor Baker’s fiscal year 2018 budget, he called on Massachusetts employers to help pay for the increasing Medicaid costs.  To support this initiative, the Senate recently introduced a proposal that would allow the Governor to select from two options to offset these rising costs: (1) a “play-or-pay” option that would impose a per employee assessment on companies that do not offer their workers health plans, or (2) an across the board increase in the Employer Medical Assistance Contribution (or “EMAC”).  The Employment Matters post analyzes how the increase in the EMAC may be more administratively feasible for the Commonwealth, while the “pay-or-play” option is potentially preempted by the Employee Retirement Income Security Act of 1974 (ERISA).

Check out their full analysis here.

Patient assistance programs have been a staple within the health care industry for over a decade.  These programs, operated by 503(c)(3) charities, may receive funding from pharmaceutical manufacturers or other providers to offer assistance to low-income patients in affording their medications, copayments, deductibles, premiums, or other related services.   The Office of the Inspector General (OIG) and the Centers of Medicare & Medicare Services (CMS) have acknowledged the role of provider- and manufacturer-supported charitable premium assistance and have established parameters for these charities to operate in compliance with the Anti-Kickback Statute.

Over the last two years, however, government scrutiny and enforcement related to charitable patient assistance programs has increased.   During this time, nearly a dozen pharmaceutical manufacturers and providers have publicly disclosed receipt of government subpoenas investigating their contributions to patient assistance charities.

These new investigations raise a number of questions when it comes to structuring relationships with patient assistance programs.  On May 16th, we will be holding a webinar to review these current investigations and outline what providers, payors, pharmacy benefit managers (PBMs), and pharmacies working with manufacturers and patient assistance programs need to know in light of these investigations.

We hope you join us!  For more information and to register for this webinar, please click here.

6350-Pharma-Summit-blog-buttonMintz Levin and ML Strategies will be hosting the 2nd Annual Pharmacy Industry Summit on April 5th and 6th! The Summit will bring together stakeholders and thought leaders from across the industry to discuss legal and policy challenges facing manufacturers, PBMs, payors, pharmacies, and providers.

With a new administration and state legislatures taking aim at the pharmacy industry, manufacturers, PBMs, payors, and pharmacies face a number of unknowns and questions:

  • What is the fate of FDA User Fees?
  • Will Senator Wyden’s Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act gain traction?
  • What are state legislatures proposing to address drug pricing?
  • Will the Republicans take another shot at the Affordable Care Act?
  • What is President Trump’s “new system” for competition in the drug industry referenced in his March 7th tweet?
  • What’s new in value-based contracting and what does the future hold for innovative contracting arrangements?

With sessions focusing on the Affordable Care Act developments, drug pricing, state law developments, value-based contracting, and the FDA impact on the supply chain, among others, we plan to discuss these and many other issues impacting the pharmacy industry.

For additional information on the Summit, including an agenda and registration information, please visit our event website.

As the healthcare industry moves towards value-based purchasing, pay-for-performance, and other payment reform models, industry leaders have identified federal fraud and abuse laws as a barrier to full implementation of such models.  Last month, the Health Care Leadership Council released a White Paper entitled “Health System Transformation: Revisiting the Federal Anti-Kickback Statute and Physician Self-Referral (“Stark”) Law to Foster Integrated Care Delivery and Payment Models” (“HCL White Paper”), identifying current fraud and abuse laws as impeding transformation of the healthcare system.  Pharmaceutical and device manufacturers have also taken advantage of the OIG’s Solicitation of New Safe Harbors and Special Fraud Alerts (“OIG Solicitation”) to advocate for more flexible fraud and abuse laws with respect to value-based arrangements. Continue Reading Pharmaceutical Manufacturers and Healthcare Leaders cite Fraud and Abuse Laws as Obstacle to Value-Based Arrangements

Earlier this month, the Centers for Medicare & Medicaid Services (CMS) released its 2018 Medicare Advantage and Part D Advance Notice and Draft Call Letter (“Draft Call Letter”).  For the majority of the letter’s provisions, CMS is proposing to continue its current course of action and is refraining from introducing new policies.  With that said, however, CMS is proposing several notable updates, including updates to the use of encounter data for risk adjustment and the 2018 Star Ratings.  This blog is to highlight some key provisions and changes as MA and Part D plans prepare and finalize comments.

Continue Reading CMS’s Draft 2018 Call Letter: Minor Updates, but Largely a Continuation of Current Policies

Next Tuesday, January 12th, Mintz Levin and ML Strategies will host the first installment of our three-part series focusing on the 21st Century Cures Act (“Cures Act”).  The Cures Act represents significant legislation that will have overarching implications on medical research, product development, and drug and biologic manufacturing.

Join my Mintz Levin and ML Strategies colleagues Tom CraneEllen Janos, and Rodney Whitlock, and moderator Bethany Hills, as they provide an introduction to the Cures Act.  Specific topics for this first webinar will include:

  • The political path taken to accomplish the Act, the compromises made, and the key implementation issues facing the Trump administration
  • Health information policies related to Electronic Health Records
  • Medicare delivery reform, coverage/payment changes, and OIG authorities
  • Mental health parity and new funding opportunities for substance use disorder prevention and improved mental health access and services
  • The “sense of Congress” on telehealth expansion and changes to HIPAA

Click here to register!  For more information on the Cures Act check out our prior blog posts covering provisions related to: (i) the role of Real World Evidence; (ii) the accelerated approval pathway for regenerative medicine; and (iii) drug and biologic manufacturers’ ability to promote their products to payors and health plans through well-developed “health care economic information.

The Centers for Medicare & Medicaid Services (CMS) has withdrawn its controversial rule implementing the Medicare Part B payment demonstration. The agency stated that after consideration of the comments, it will not move forward with the demo.

The demonstration was intended to test new reimbursement methods for Medicare Part B drugs and to promote value-based and cost-effective drug purchasing.  Despite its intentions, major patient, pharmaceutical, and physician groups criticized the scope of the rule and the speed in which CMS was implementing it.  Many worried it would restrict or limit access to certain drugs.  It also drew sharp criticism from several members of Congress, including President-elect’s nominee for the Secretary of Health and Human Services, Rep. Tom Price. Continue Reading The Medicare Part B Demo May be Dead, but Drug Pricing Concerns Still Linger

There has been much controversy over the Medicare Part B payment demonstration proposed by the Center for Medicare and Medicaid Innovation (CMMI) in March 2016.  As we await the release of the final rule, the fate of this demonstration will be in the hands of a Republican-held Congress and President-Elect Trump.  To move forward, not only will CMMI need to finalize the implementing regulations, but the Part B payment demonstration will also need to survive review under the Congressional Review Act (CRA). Continue Reading The Future of the Medicare Part B Payment Demo under a Republican-held Congress

The Affordable Care Act (ACA) and the Medicare and CHIP Reauthorization Act (MACRA) provided the Centers for Medicare & Medicaid Services (CMS) and the newly created Center for Medicare and Medicaid Innovation (CMMI) tremendous authority.  With Republicans set to take control of both the White House and Congress, the future of that authority is very much in question.

The ACA created CMMI to test innovative payment and service delivery models to reduce program expenditures and improve care.  To carry out this goal, the ACA allows CMMI to waive any Medicare provision of the Social Security Act, as well as select Medicaid provisions, that may be necessary to carry out and evaluate demonstration policies.  If the demonstrations prove effective, CMS may implement the program nationally.

Over the past few years, CMS has implemented numerous demonstration projects under CMMI’s authority.  These include delivery reform demonstrations such as the Medicare Shared Savings Program and Pioneer ACO program, as well as the Financial Alignment Initiative, which integrates care for dual-eligible individuals in select states. Demonstrations such as the Medicare Advantage Value-Based Insurance Design Model have focused on encouraging the use of high-value clinical services, while others, such as the Diabetes Prevention Program, have focused on preventive service models.  In July of this year, CMS proposed expanding the Diabetes Prevention Program nationally.

While there have been successes, CMS’s use of this authority has not been without controversy and criticism.  Continue Reading Will Republicans Embrace CMMI’s Authority?

CMS issued its Audit Protocols and Data Requests for Medicare Advantage and Part D plans on November 4, 2016 (the “Protocols”).  The Protocols have been updated based on the over 500 comments CMS received in response to the draft released in June.  The Protocols are open for comments until December 5, 2016.

A review of the crosswalk detailing the changes made to 2016’s Audit Protocols and Data Requests shows that CMS largely retained the same elements as in years past and made a few notable changes.

  • CMS is no longer asking for “self-identified issues.”  Self-identified issues were issues that had been discovered by the plan but not reported to CMS prior to the audit.  Practically speaking, this now means that plans only receive “credit” for reporting issues to CMS, whereas previously plans received some favorable treatment for reporting self-identified issues through the audit.
  • CMS added language to provide plans more instruction regarding what documentation and detail expected for tracer cases.
  • The Protocols added more emphasis on fraud, waste, and abuse policies and operations as applied to a plan’s first tier, downstream and related entities (“FDR”).
  • The Protocols asked plans in multiple areas to identify whether they classify actions as compliance or FWA.
  • CMS modified (edited, deleted, and added) many questions that appear in the Protocols questionnaires.  Some changes include:
    • Providing more detail to plans about what should be produced when conducting a formal audit under the plan’s compliance program.
    • Asking for examples of issues the plan had to deal with that involved an FDR and impacted a significant number of enrollees.
    • Asking for an example of when communicating compliance issues to the senior management/governing body was challenging.
    • Asking for a plan to share best practices.

All plans should carefully review the Protocols, consider how they would perform under the updated structure, and consider how they would update their internal audit and monitoring activities to reflect changes that CMS is considering.  As all plans know, undergoing a CMS audit requires an enormous amount of time and resources and CMS’s audit findings can greatly impact plans in many ways, including how a plan performs in the Star ratings system.