Tag: centers for medicare and medicaid services

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.

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 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.