ACNM Policy Update - 12/12/2014

 

As noted in a previous ACNM Policy Update, CMS recently modified its policy requiring physician certifications for Medicare coverage of inpatient admissions.  In a word, the certification is now only required in cases where the inpatient stay is 20 days or longer, or when it results in outlier costs for the hospital.  To help ACNM members encourage their hospitals to revise any requirement in place that forces them to obtain physician certification of the medical necessity of their inpatient admissions, ACNM has prepared an issue brief describing the regulatory change.

On December 3, the Food and Drug Administration (FDA) published a final regulation on the Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling, referred to as the "Pregnancy and Lactation Labeling Rule" (PLLR). 

The rule requires changes to the content and format of information in prescription drug labeling to assist providers in assessing benefit versus risk and in subsequent counseling of pregnant women and nursing mothers who need to take medication.  In addition to these changes, the rule requires that drug labels be updated when information becomes outdated.

The "Pregnancy" subsection of the revised label will include information for a pregnancy exposure registry for the drug when one is available. Pregnancy exposure registries collect and maintain data on the effects of approved drugs that are prescribed to and used by pregnant women. Information about the existence of any pregnancy registries in drug labeling has been recommended but not required until now. Information in the "Pregnancy" sub-section includes a Risk Summary, Clinical considerations, and Data.  Information formerly found in the "Labor and delivery" subsection is now included in the "Pregnancy" subsection.  

The "Nursing mothers" subsection was renamed, the "Lactation" subsection and provides information about using the drug while breastfeeding, such as the amount of drug in breast milk and potential effects on the breastfed infant.

The "Females and Males of Reproductive Potential" subsection, new to the labeling, includes information, when necessary, about the need for pregnancy testing, contraception recommendations, and information about infertility as it relates to the drug.

The labeling changes go into effect on June 30, 2015. Prescription drugs and biologic products submitted after June 30, 2015, will use the new format immediately, while labeling for prescription drugs approved on or after June 30, 2001, will be phased in gradually.

Labeling for over-the-counter (OTC) medicines will not change; OTC drug products are not affected by the final rule.

Concurrently with publishing the PLLR, FDA also issued draft guidance for industry to assist drug manufacturers in complying with the new labeling content and format requirements.

On November 26, 2014 the Centers for Medicare and Medicaid Services (CMS) published a proposed regulation affecting the health insurance marketplaces.  Last year nearly 7 million people obtained coverage through the marketplace and millions more are expected to be added to those roles by the end of the open enrollment period currently running through February 15, 2015.

The proposed regulation contains a large number of provisions aimed at improving the operation of the marketplaces, the plans participating therein, and the experience of consumers.  Much of the rule focuses on financial tools meant to stabilize premiums offered through the marketplace as well as payment parameters for the federally subsidies that reduce premiums for most individuals obtaining coverage through the marketplace.

Under current rules, consumers who do not take action during the open enrollment window are generally re-enrolled in the same or similar plan they were in the previous year, even if that plan experienced significant premium increases.  Under the proposed rules, CMS considers the possibility of giving consumers the option of being defaulted into a lower cost plan rather than their current plan.

To enhance the transparency of the rate-setting process, the proposed rule includes additional provisions to facilitate public access to information about rate increases in the individual and small group markets using a uniform timeline.  It also proposes provisions to further protect against unreasonable rate increases in the individual and small group markets.

To further aid consumers in finding a health plan that best suits their needs, the rule clarifies standards for insurers to publish an up-to-date, accurate, and complete provider directory, including information on which providers are accepting new patients, in a manner that is easily accessible to the general public, including new enrollees, re-enrollees, the state, and the Marketplace.  Under these standards, the general public would be able to view all of the current providers for a plan in a provider directory on the plan's public website through a clearly identifiable link or tab without creating or accessing an account or entering a policy number.  This rule proposes that the provider directory be updated at least monthly, and CMS is considering steps to make provider directories available in standard, machine-readable formats.  This is a significant improvement.  ACNM found, in its survey of plans, that many do not list the CNMs/CMs with whom they contract in a manner that makes them easily identifiable to the public. 

In the proposal, CMS would allow states to select a new "benchmark" plan in their state that would be used to define "essential health benefits" (EHB) in that particular state.  Under the law, most small employer and individual plans are required to cover the EHB.  To define the EHB, the state would simply point to the package of benefits covered by the benchmark plan. Other plans offering coverage in these markets would need to offer benefits that are substantially equal to those of the benchmark.  If the benchmark plan did not meet specified legal requirements for coverage of 10 broad areas of coverage, the states could issue requirements for supplementing the benchmark benefit package. 

The benchmark would be selected from among the options identified under the rule that are available in 2014.  The standard set by the new benchmark would be applicable to other affected insurers as of 2017. 

This particular process is important to midwives because a review of the information provided by HHS with regard to the benchmarks selected in the first iteration of this process did not provide sufficient detail to know if the benchmark plans included CNMs/CMs in their networks or coverage of their services.  We detailed what we found with regard to those benchmarks in a presentation done for ACNM members in late 2013 (slides 27-36 here). 

ACNM will prepare comments in response to this proposal.  Comments are due December 22.

ACNM has updated a set of state fact sheets meant to be used by ACNM members in their discussions with policy makers, payers, employers or other stakeholders with whom they interact.  The documents are intended to give basic facts about midwifery in every state and include the following items:

- Number of AMCB Certified Midwives, 2014
- Number of CNM/CM Attended Births, 2012
- Percent of CNM/CM Attended Births, 2012
- Number of Birth Centers in State, 2014
- State Scope of Practice Statement
- Regulatory Environment (Autonomous Practice, Collaborative Requirement, or Supervisory)
- Medicaid Coverage Fee-for-Service payment to CNMs as a percent of payment to physicians
- Midwifery Education Programs in the state

When you download the document, it includes fact sheets for every state.  You will need to print only those pages that pertain to your specific state.  It was intentionally prepared as a single, combined document because the idea of having to update 50 separate documents any time one of these data points changed made me want to run away screaming.

Enrollment through the health insurance marketplaces during the ongoing open enrollment period is exceeding expectations.  HHS recently announced that as of December 5, more than 2.5 million individuals had submitted applications to determine eligibility for coverage through the marketplace and nearly 1.4 million had successfully selected a plan after being determined eligible.  

Analysts who have looked at the report say the pace of enrollment exceeds both that of last year and expectations for this year previously announced by HHS.  HHS predicted around 9 million enrollees at the end of the open enrollment period, but current estimates from outside analysts put the figure closer to 12 million 

For midwives, this means that a larger proportion of the women they serve will be covered under these plans.

The Centers for Disease Control and Prevention (CDC) have released the 2013 Birth Data tables.  For those of you who like to play with Excel, these tables are a very useful tool for examining trends in birth in the U.S.  Since the data are based on birth certificates, which are not 100 percent accurate, they have to be taken with a grain of salt, but they are the best, most comprehensive set of data available and they are very useful for many purposes. 

CDC's website allows users to generate their own customized tables, asking any type of question they like from the entire dataset.

Some interesting stats for 2013 include the following:

- CNMs/CMs attended 320,983 births in 2013, or 8.2 percent of the total.  In 2012, they attended only 313,846 births, or 7.9 percent of the total.
- In 2013, CNMs/CMs attended 8,454 birth center births and 7,697 home births.  Both of these numbers were up over 2012, when those numbers were 7,182 and 7,131 respectively. 
- In 18 states, CNMs/CMs attended more than 10 percent of all births. 
- For CNM/CM attended births, the top five states in 2013 were:  Alaska : 26.8 percent, New Mexico : 25 percent, Vermont : 20.9 percent, New Hampshire : 19 percent, and Oregon : 17.8 percent.

The Congress has passed H.R. 1281, the Newborn Screening Saves Lives Reauthorization Act of 2014, which reauthorizes a series of programs, including, among others:

- a grant program for screening, counseling, and other services related to heritable disorders that can be detected in newborns.
- a grant program to evaluate the effectiveness of screening, counseling, or health care services in reducing the morbidity and mortality caused by heritable disorders in newborns and children.
- the operation of the Advisory Committee on Heritable Disorders in Newborns and Children.
- the clearinghouse for newborn screening information.

At the time of this notice the President had yet to sign the final bill.

 

 

As usual, if you know any CNMs/CMs who are not currently ACNM members, please forward this Policy Update to them.  We want to be sure they know what the association is doing on their behalf and the kinds of activities that their membership would support.