President Trump has signed an Executive Order that directs the Department of Health and Human Services (HHS) to develop new nephrology policies to address reducing the number of patients developing kidney failure, increasing the number of kidneys available for transplant, and reducing the number of dialysis treatment at dialysis centers to encourage more in-home kidney dialysis. These policies will take shape in via five new CMS Center for Medicare and Medicaid Innovation payment models.
According to HHS, “the proposed required End-Stage Renal Disease (ESRD) Treatment Choices (ETC) Model would encourage greater use of home dialysis and kidney transplants for Medicare beneficiaries with ESRD in order to preserve or enhance their quality of care while reducing Medicare expenditures, and the Kidney Care First (KCF) and Comprehensive Kidney Care Contracting (CKCC) Models will test new Medicare payment options that aim to improve the quality of care for patients with kidney disease.”
Additionally, CMS announced four optional models:
The Kidney Care First (KCF) Model
The Comprehensive Kidney Care Contracting (CKCC) Graduated Model
CKCC Professional Model
The Global Model
These optional payment models are designed to help health care providers reduce the cost and improve the quality of care for patients with late-stage chronic kidney disease and ESRD. These models also aim to delay the need for dialysis and encourage kidney transplantation.
Healthcare and life sciences stakeholders can expect to continue to see policy changes for the foreseeable future so it is better to be prepared ahead of time before they happen. Frier Levitt Government Affairs (FLGA) monitors and forecasts issues of importance for healthcare and life sciences stakeholders, including state and federal legislation and regulation, all presented in a concise, easy to understand and time friendly format. FLGA’s monitoring and forecasting services allow stakeholders to stay educated and engaged on new developments before the trends become mainstream.
With laws and regulations changing all the time, it is imperative for healthcare and life sciences stakeholders and organizations to be proactive instead of reactive. Contact FLGA today to get “in the know” and finally be prepared for the changes ahead.
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.
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 HHSJuly 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 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.
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.
2018 was a key year for further shedding light on Pharmacy Benefit Manager (PBM) business practices. As state budgets continue to be squeezed and patient populations require more specialty care, state Medicaid Directors have an opportunity to pull back the curtain on PBMs and realize additional ways that your state can benefit from transparency.
An important lesson can be learned from Ohio’s 2018 successes. In a report to the Ohio Joint Medicaid Oversight Committee, the Ohio Auditor gave an overview of the audit of the state’s Medicaid program and its dealings with PBMs.
The report found:
∙ The “spread”- difference in dollar amount between what Plans pay to PBMs and what PBM pay to pharmacies- has been growing and hit its peak in the fourth quarter of 2017
∙ An overwhelming portion of PBM spread is occurring on generic drugs
∙ Spread pricing totals varied wildly from region to region
∙ There is a disconnect between the Medicaid drug spend and what PBMs reimburse to pharmacies
∙ Data confirms a high number of pharmacy closures amid reimbursement cuts
∙ Spread totals were highest on specialty drugs, which are typically dispensed at PBM-owned pharmacies
The Ohio audit report concludes that PBMs enjoyed an 8.8% spread on Medicaid beneficiary claims, yielding PBM profits in excess of $250MM—that’s just in Ohio state Medicaid. Ohio decided that it would no longer permit PBM spread pricing and now requires PBMs to have pass through model contracts.
Frier Levitt Government Affairs, LLC (FLGA) and Frier Levitt, LLC, have extensive experience working with Medicaid Directors and other stakeholders to provide money saving solutions against PBMs. For Medicaid Directors witnessing population growth, we can help unravel savings from complex PBM contracts and relationships. We can assist your state in reviewing your Medicaid contracts to determine if you are paying too high for negotiated items. We can also provide you with substantial education on the PBM business model with the goal of saving your program much needed resources. Contact us today to put an end to questions and confusion and start requiring accountability from your PBM.