May 28, 2021
Policy Analyst, Office of Family Health Services
Virginia Department of Health
109 Governor Street
Richmond, Virginia 23219
RE: Public Comment for Periodic Review of 12 VAC 5-71 Newborn Screening Regulations
Dear Ms. Buskey,
Thank you for the opportunity to comment on the Virginia Board of Health periodic review and small business impact review of 12 VAC 5-71, Regulations Governing Virginia Newborn Screening Services (the “Newborn Screening Regulations”). As discussed in greater detail below, the Virginia Hospital & Healthcare Association (VHHA) submits that this regulation should be retained and has provided suggestions for how the regulation could be further improved.
The Newborn Screening Regulations adopted by the Virginia Department of Health (the “Department”) establish the Virginia Newborn Screening System, which includes the Virginia Newborn Screening Program, the Virginia Early Hearing Detection and Intervention Program, and the Virginia Critical Congenital Heart Disease Screening. The stated mission of the Newborn Screening Program is to prevent intellectual disability, permanent disability, or death through early identification and treatment of infants who are affected by those heritable disorders and genetic diseases. The Newborn Screening Regulations are critical to public health, safety, and welfare and for the economic performance of important governmental functions as outlined below.
The Newborn Screening Regulations are necessary for the economical performance of important governmental functions and to protect the public health and safety in several ways, such as:
In the absence of the Newborn Screening Regulations to establish these requirements for conducting of tests for these heritable disorders and genetic diseases, it is possible that there would be wide variation in testing practices across the state, the lack of a centralized laboratory for collection and reporting of test results, variation in reporting of results, and ultimately a less effective approach to prevent intellectual disability, permanent disability, or death through early identification and treatment of infants who are affected by heritable disorders and genetic diseases. Appropriate screening for treatable conditions is an important function that saves infants from a lifetime of preventable impairment.
We do, however, recommend the following modifications to the Newborn Screening Regulations aimed at further improving the Newborn Screening Program in terms of its protection of the public health, safety, and welfare, and economical performance:
Virginia Code § 32.1-65 and 12VAC5-71-30.A require that the disorders included in the Newborn Screening Program be “consistent with[,] but not necessarily identical to” the RUSP. Disorders on the RUSP are chosen based on evidence that supports the potential net benefit of screening, the ability of states to screen for the disorder, and the availability of effective treatments. Once listed on the RUSP the disorders are part of the comprehensive preventive health guidelines infants and children under section 2713 of the Public Health Service Act, which requires coverage of screenings without charging a co-payment, co-insurance, or deductible.
From time to time, there is legislation or requests from the public seeking to require various disorders that are not included on the RUSP to be included in the Newborn Screening Program or to require the Department to review various disorders to be included in the Newborn Screening Program. While well intended, such measures circumvent the well-established and comprehensive process that HHS has developed for evaluating disorders to be included in newborn screening programs. Operating outside the RUSP also raises the possibility that disorders could be added in misalignment with coverage requirement and availability of effective treatments potentially exposing patients to financial instability in a manner that outweighs the potential benefits of the disorder being included.
In order to properly ensure that disorders are included in the Newborn Screening Program based on evidence that supports the potential net benefit of screening, the ability of states to screen for the disorder, and the availability of effective treatments, it is appropriate to modify the Newborn Screening Regulations to require listing on the RUSP as a pre-requisite for including in in the Newborn Screening Program. Under this approach, the Department would still retain the ability to decline to add a disorder listed on the RUSP in the Newborn Screening Program, taking a may be less than, but no greater than, approach to the RUSP.
It is important to note that legislators, policy makers, health care providers, and patient advocates would continue to have available to them the ability to nominate disorders for consideration by the Committee for the Recommended Uniform Screening Panel if there are disorders that are believed to be appropriate for inclusion in newborn screening. The Committee encourages individuals and organizations to submit nominations for conditions to be considered for inclusion on the RUSP.
If listing on the RUSP is not established as a pre-requisite for inclusion in the Newborn Screening Program, the Newborn Screening Regulations should at a minimum specify conditions under which a disorder not listed on the RUSP could be considered, including demonstration of the potential net benefit of screening, the ability to screen for the disorder, the availability of effective treatments and other considerations and establish a process for nominations similar to that required for listing a condition on the RUSP.
12VAC5-71-30.C provides that the “Virginia Genetics Advisory Committee may be consulted and provide advice to the commissioner on proposed changes to the core panel of heritable disorders and genetic diseases for which newborn dried-blood-spot screening tests are conducted.” The Virginia Genetics Advisory Committee is a multi-disciplinary panel of medical, science, research, health care, and public health experts similar to the Committee for the Recommended Uniform Screening Panel at the federal level. The Virginia Genetics Advisory Committee plays a critical role in advising the Commissioner and the Department on the efficacy of the Newborn Screening Program. Given the importance of decisions to add or remove disorders from the Newborn Screening Program and the highly technical nature of newborn screening generally, it is appropriate to require that the Virginia Genetics Advisory Committee shall be consulted for recommendations on proposed changes to the core panel of heritable disorders and genetic diseases for which newborn dried-blood-spot screening is conducted.
Virginia Genetics Advisory Committee consideration of any changes to the core panel of disorders for which newborn dried-blood-spot screening is conducted should be based on the RUSP and review of scientific evidence available, but should also take into account an assessment of the estimated costs, impact on fees, and turnaround times. In order to assist in conducting such an assessment, 12VAC5-71-30 should be modified to require the Department to provide to the Virginia Genetics Advisory Committee a fiscal impact for any changes to the core panel of disorders for which newborn dried-blood-spot screening is conducted, which should include the costs of instrumentation, validation testing, laboratory space and staff, information systems, and any other incremental fixed or variable costs likely to be incurred. The fiscal impact should also include a recommendation for funding the costs through an increase to fees charged to health care providers, state General Fund, or other available sources.
As discussed further below, fees for dried-blood-spot screening specimen collection kits have steadily increased, caused primarily by the additions to the core panel of disorders for which newborn dried-blood-spot screening is conducted. To provide greater transparency to the Commissioner, the Department, the Virginia Genetics Advisory Committee, and the public, 12VAC5-71-100 should be modified to establish a requirement for DCLS to provide to the Department information on the effectiveness of laboratory tests (e.g., for each disorder, the number of tests conducted and positive diagnoses confirmed) and costs of laboratory tests and fees charged to and collected from birthing hospitals and physicians for purchase of newborn dried-blood-spot screening specimen collection kits. This information should be updated no less frequently than annually and provided in a report that will be made available to the Commissioner, the Virginia Genetics Advisory Committee, and the public.
The Newborn Screening Regulations achieve their intended objective, but we offer the following recommendations for improving efficiency, effectiveness, and costs:
12VAC5-71-70, 12VAC5-71-100, 12VAC5-71-120, and other applicable regulations address requirements for dried-blood-spot specimen submission and notification, data collection, and information systems for data between health care providers, DCLS, and the Department. Data collection and exchange has been historically, and continues to be in some areas, a manual process and information systems can be improved to increase interoperability. Accordingly, it is recommended that 12VAC5-71-70, 12VAC5-71-100, 12VAC5-71-120, and other applicable regulations be modified to improve electronic data exchange of testing information.
12VAC5-71-100.G authorizes DCLS to set the fee charged to birthing hospitals and physicians for the purchase of newborn dried-blood-spot screening specimen collection kits in consultation with the Department. The regulation does not provide any reasonable limitations or other guidelines on how the fee is to be determined.
Currently, the Newborn Screening Program is funded by the fee that is required to be paid by birthing hospitals and other health care providers through their purchase from DCLS of dried-blood-spot screening specimen collection kits. Hospitals perform the majority of newborn screening and so bear most of the costs of the program. Cost increases generally are absorbed by hospitals because deliveries covered by a commercial third-party payer usually are paid for on a negotiated per-delivery basis, and the reimbursement rate is not adjusted to account for these screening cost increases. The same is true for Medicaid-covered deliveries, typically reimbursed at the rate lower than commercial third-party payers. Hospitals absorb the entire cost of these tests for many charity care and self-paid deliveries. Hospitals currently pay over $11 million in fees annually.
The initial cost of each dried-blood-spot screening specimen collection kit in 1992 was $10. With expansions of the screening panel since then, the current cost of each kit is $138. The current price was increased 26% from $101.20 per kit as a result of the addition of X-linked Adrenoleukodystrophy (X-ALD), Spinal Muscular Atrophy (SMA), Cytomegalovirus (cCMV), and expanded testing for Congenital Adrenal Hyperplasia (CAH) to the Newborn Screening Program, projected to result in an increase of over $2.5 million per year for hospitals. Recent discussions regarding the addition of Krabbe’s Disease would have resulted in an additional increase ranging from $18.59 to $20.07 per kit, producing an additional 13-15% increase in the fee. In total, if these changes were fully implemented, the fee would have increased by over 50% in roughly three years.
As new conditions are added to the core screening panel in Virginia, we are concerned that this approach to paying for what is a public health priority and societal benefit is unsustainable. One possible option to address this in the Newborn Screening Regulations would be to limit DCLS authorization to establish fees or implement increases to fees to include only certain incremental variable costs incurred in performing tests. For example, the costs required to purchase additional instruments or equipment needed to perform the test, additional space and related build-out costs, and software costs could not be included in the fee. Such costs would either need to be absorbed by DCLS or funded through DCLS or Department appropriation requests to the General Assembly.
Generally speaking, the Newborn Screening Regulations are concise, clearly written and easily understandable. The process is fairly complex and detail-oriented, yet the standards and criteria contained in the Newborn Screening Regulations are based on objective and well-established practices that are widely accepted in our Commonwealth and many other parts of the country. That being said, we are fully supportive of a thorough review of all definitions and other provisions of the regulations to ensure that they do in fact reflect current practices of the Department, DCLS, and health care providers and updated references to scientific information and third-party sources.
Thank you again for this opportunity to comment.
R. Brent Rawlings
Senior Vice President & General Counsel