Tag: CMS

Service Spotlight: Engaging in Regulatory Comments to Protect Company Operations & Margins

Posted on May 29, 2019 by - Government Affairs

Proposed regulations are something that are underutilized by healthcare and life sciences supply chain entities. While legislation captures all the excitement with lobbying and either amending or passing new laws, when it comes to healthcare, the gaps legislation oftentimes leaves open-ended are left to an agency to do the details of filling in the gaps. For example, specifics on reimbursement or licensing changes are usually done by the likes of CMS, FDA, HRSA or state departments of insurance.

Changes are done via rulemaking, which are found in the federal or state register. Through proposed rules, agencies give stakeholders an opportunity to comment on a rule change, which starts a certain timed process.

Participation in agency rulemakings are key because these rules affect the finer points of your operation. Additionally, not knowing about a change in these critical rules can oftentimes result in adverse action from an agency like a fine or a warning letter if your compliance is not up to date.

Frier Levitt Government Affairs (FLGA) guides healthcare and life sciences stakeholders through the regulatory comment process. FLGA looks at your business model, monitors for proposals that will impact you, and counsels you on strategic next steps. Additionally, healthcare and life sciences stakeholders will get the benefit of working with boutique healthcare law firm Frier Levitt, LLC, who will help ensure that your company stays compliant with any news rules that are promulgated.

FLGA offers a hybrid service flexible with an organization’s changing needs. We monitor and forecast regulatory issues of importance in a concise, easy to understand and time friendly format. Our monitoring and forecasting services allow stakeholders to stay educated and engaged on new developments before the trends become mainstream.

With regulations changing all the time, it is imperative for healthcare and life sciences stakeholders and organizations to be proactive instead of reactive. Contact Frier Levitt Government Affairs today to get “in the know” and finally be prepared for regulatory changes ahead.

Industry Monitoring Alert: CMS Delays CAR T-Cell National Coverage Determination

Posted on May 21, 2019 by - Government Affairs

On May 17, 2019, CMS announced a delay in its final national coverage determination for Chimeric Antigen Receptor (CAR) T-cell therapy. Using a patient’s own immune system to attack cancer cells, CAR T-cell therapy has been getting more and more recognition as the potential next step for oncology over the last year.

According to CMS’s announcement, CAR T-cell therapy is a precision cancer treatment wherein each treatment dose is individually manufactured for the patient using their own T-cells, a type of white blood cell known as a lymphocyte. CAR T-cell therapy is a rapidly emerging adoptive cell transfer immunotherapy for select patients with relapsed or refractory cancers. Treatment protocols vary, but may be summarized in five steps:

     1. lymphocyte harvesting from the patient with cancer;

     2. creation of cancer-targeting lymphocytes in vitro using various immune modulators;

     3. selection of lymphocytes with reactivity to cancer antigens using enzyme-linked immuno-assay;

     4. depletion of the patient’s remaining lymphocytes using immunosuppressive agents;

     5. transfusion of the cancer-targeting lymphocytes back into the patient with cancer-this transfusion represents one treatment.

Frier Levitt Government Affairs (FLGA) has been monitoring developments in this sector since early 2018 and continues to follow the latest news.

FLGA’s forecasting and monitoring services help keep healthcare and life sciences stakeholders “in the know” regarding pending policy and marketplace changes. Forecasting and monitoring helps stakeholders make better strategic decisions so that they no longer just “reacting” to outside changes. Contact FLGA today for tailored forecasting and monitoring services for you and your organization.

New CMS Proposed Rule Targeting Change of Ownership Requirements for Accediting Organizations

Posted on May 20, 2019 by - Government Affairs

The Centers for Medicare and Medicaid Services (CMS) has released a proposed rule targeting accrediting organizations titled: Medicare Program; Accrediting Organizations-Changes to Change of Ownership.

This proposed rule would add requirements and a specified process to address changes of ownership as they relate to the sale, transfer, and/or purchase of assets of Accrediting Organizations (AOs) with the Centers for Medicare & Medicaid Services (CMS)-approved accreditation programs. This change is intended to provide CMS the ability to receive notice when an AO is contemplating undergoing or negotiating a change of ownership and the ability to review the AO’s capability to perform its tasks after a change of ownership has occurred. This is in order to insure the ongoing effectiveness of the approved accreditation program(s) and to minimize risk to patient safety.

The deadline to submit comments to HHS July 1, 2019.

Accrediting organizations that transfer, purchase, or sell assets, it is pertinent to participate in this proposed rule to alert CMS about your abilities to perform your tasks once a change in ownership has occurred.

Frier Levitt Government Affairs works with Accrediting Organizations to participate in the comment period several different ways. Contact FLGA for help in having your voice heard.

CMS Issues New Guidance on Medicaid Spread Pricing to Attain Fairness Against PBMs

Posted on May 16, 2019 by - Government Affairs

CMS has issued guidance for Medicaid Managed Care and CHIP health plans which clarify how current regulations require “spread pricing” to be accounted in the calculation of Medical Loss Ratios (MLRs), which according to CMS represents the percent of premium revenue that goes towards actual claims and activities that improve healthcare quality.

The guidance states, “CMS regulations require Medicaid and CHIP managed care plans to report an MLR and use an MLR target of 85 percent in developing rates. The 85 percent target means that only 15 percent of the revenue for the managed care plan can be for administrative costs and profits. CMS is concerned that some managed care plans are not accurately reporting pharmacy benefit spread pricing when they calculate and report MLRs.”

Spread pricing has been a negative PBM business practice against pharmacy reimbursement, primarily regarding generic prescription drugs. Several states, through auditor reports and legislative actions, are starting to see that pharmacy generic reimbursement is based on lower benchmarks that those used for Medicaid and CHIP managed care plans for the same medications.

CMS’ guidance states, “Spread pricing occurs when health plans contract with pharmacy benefit managers (PBMs) to manage their prescription drug benefits, and PBMs keep a portion of the amount paid to them by the health plans for prescription drugs instead of passing the full payments on to pharmacies. Thus, there is a spread between the amount that the health plan pays the PBM and the amount that the PBM reimburses the pharmacy for a beneficiary’s prescription. If spread pricing is not appropriately monitored and accounted for, a PBM can profit from charging health plans an excess amount above the amount paid to the pharmacy dispensing a drug, which increases Medicaid costs for taxpayers.”

Expect to see more regulation on spread pricing in the future. Louisiana’s Act 483 and Arkansas’ Act 994 have started to go after PBM spread pricing on their own, while there are many other pharmacies in other states that have not yet had legislative relief from spread pricing.

Frier Levitt Government Affairs, LLC (FLGA), working hand in hand with Frier Levitt, LLC, provides pharmacies with the appropriate legal recourse against unfair PBM business practices. FLGA can provide the strategic advice on how to get spread pricing legislation enacted into law in your state, while also offering you the lobbying tools to get it done. Contact Frier Levitt Government Affairs to get your voice heard.

HHS’ Final Rule Requiring Drug Prices in TV Advertising Presents an Opportunity for Manufacturers

Posted on May 14, 2019 by - Government Affairs

Earlier this month, Health & Human Services (HHS) Secretary Azar announced a final rule from the Centers for Medicare & Medicaid Services (CMS) requiring direct-to-consumer television advertisements for prescription pharmaceuticals covered by Medicare or Medicaid to include the list price – the Wholesale Acquisition Cost – if that price is equal to or greater than $35 for a month’s supply or the usual course of therapy. This policy comes from the American Patients First Blueprint to reduce drug costs.

Lately, the culprit behind higher drug prices has been sharply debated. Some in the manufacturing community point to two issues: better science and rebate pressure. Improved patient outcomes due to scientific advances justifies higher prices, especially since near curative prescription drugs lead to a possible decrease in future healthcare costs. Additionally, manufacturers have rightly been pointing to the pressures by PBMs to increase rebates or face the potential of having certain drugs either removed from the formulary or in the alternative, subjected to increased formulary competition.

While the life sciences industry understands the complexities surrounding drug prices, many state and federal policymakers do not. Hence, there have varied and sometimes disproportionate responses to higher drug prices, which may not solve the problem.

There are many opportunities for manufacturers on the state and federal level to help alleviate policymaker concerns about drug prices, while also helping to provide a grounded response to ensure a stable market that promotes patient access.

Frier Levitt Government Affairs is active on the state and federal level, including both legislative and regulatory developments concerning drug prices. If you are a manufacturer, contact Frier Levitt Government Affairs today for help maximizing your existing resources to get control of the growing drug pricing issue.

CMS Makes Proposed Copay Accumulator Rule Final

Posted on April 30, 2019 by - Government Affairs

In January 2019, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule titled, “Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2020,” targeting Accountable Care Organizations (ACOs), payers and Affordable Care Act (ACA) exchange stakeholders, with one component of the proposed rule focusing on copay accumulators. CMS has now finalized this proposed rule, allowing payers to implement copay accumulator programs to prevent the application of manufacturer coupons from applying to patient out of pocket costs.

Currently, copay accumulators are being implemented by insurance companies and Pharmacy Benefit Managers (PBMs), harming patient access. With this payor program, the value of copay assistance cards/coupons issued by manufacturers do not count towards out-of-pocket costs that are applied toward deductibles. The result has caused a cost shift onto consumers and away from employers and payers. Unfortunately, in the proposed rule, the Administration defends the use of copay accumulators.

In contrast, Arizona, Virginia, and West Virginia are leading the state legislative efforts this year to ban copay accumulator programs, although Arizona’s approach to this issue is much more measured.

CMS has stated that its final rule would apply to individual market, small, and large group and self-insured group health plans starting in 2020. The final rule is effective June 25, 2019 which will be sixty days from its April 25, 2019 publication date. There will be no further public comments taken for this rule.

States are currently trending against CMS’ position regarding copay accumulators. If you would like to target your state legislation, Frier Levitt Government Affairs (FLGA) can lobby state legislators to prohibit copay accumulator programs. Contact FLGA today to get started.

ONC and CMS Introduce Proposed Rules on Target Data Blocking

Posted on March 12, 2019 by - Government Affairs

Both the Office of the National Coordinator for Health Information Technology (ONC) and the Centers for Medicare and Medicaid Services (CMS) have introduced proposed rules on Target Data Blocking, which, if properly tailored and modified, have the potential to substantially impact Accountable Care Organizations (ACOs), Independent Physician Associations (IPAs), Clinically Integrated Networks (CINs) and other value-based care organizations (VBCOs) by greatly expanding data transparency as between payers, including Medicare Advantage Organizations (MAOs), and VBCOs.

The CMS proposed rule on target data blocking is designed to transition the industry towards interoperability, and further builds upon CMS’ goals, deriving from the 21st Century Cures Act and Executive Order 13813, to improve access to, and the quality of, information that Americans need to make informed health care decisions, including data about health care prices and outcomes, while minimizing reporting burdens on affected plans, health care providers, or payers.

According to the ONC, their proposed rule on target data blocking would implement certain provisions of the 21st Century Cures Act, including more fully and completely describing the conditions and maintenance of certification requirements for health information technology (health IT) developers under the ONC Health IT Certification Program (Program), the voluntary certification of health IT for use by pediatric health care providers, and by insulating certain reasonable and necessary IT activities that do not constitute information blocking. The implementation of these provisions would advance interoperability and support the access, exchange, and use of electronic health information. The proposed rule would also modify the 2015 Edition health IT certification criteria and Program in additional ways to advance interoperability, enhance health IT certification, and reduce burden and costs.

Why You Should Participate:

For VBCOs, expansion and clarification of the 21st Century Cures Act prohibition on “information blocking” presents a rare opportunity to create a more level playing field as between VBCOs and payers by forcing the enhancement of payer data transparency, which is critical for VBCOs to gather and/or review the data and methodologies held/employed by payers to calculate patient risk scores and to confirm the accuracy of payer-calculated accrued shared savings (or shared risk). Additionally, VBCOs, being in the unique position of having comprehensive in-house data analytics departments and proprietary healthcare data analytics methodologies or software, must be certain that the new Health IT requirements imposed by the proposed rulemakings are both clear and reasonably implementable from both a cost and technological standpoint.

Submitting targeted, concise comments to CMS and ONC expressing questions and concerns relevant to the above issues is one means of ensuring your company’s continued success in the fast-changing value-based care landscape. Indeed, even if the agencies disagree with a proposed suggestions for improving the rules, in so doing, they will have to provide reasons therefor, thereby providing you with invaluable advanced guidance for full compliance with the rules prior to their implementation.

There are multiple ways to respond to the ONC’s “21st Century Cures Act: Interoperability, Information Blocking and the ONC Health IT Certification Program” and/or CMS’ “Medicare and Medicaid Programs; Patient Protection and Affordable Care Act; Interoperability and Patient Access for Medicare Advantage Organization and Medicaid Managed Care Plans, State Medicaid Agencies, CHIP Agencies and CHIP Managed Care Entities, Issuers of Qualified Health Plans in the Federally-facilitated Exchanges and Health Care Providers” proposed rules. Contact Frier Levitt Government Affairs to have your voice heard.