A new line of business build is the work of standing up the operating program for a regulated healthcare service an organization has not offered before: identifying every license, enrollment, certification and accreditation the service needs, then drafting the program, policies, workflows and forms it will run on. It is for organizations adding a regulated service line. Integral Healthcare Solutions (IHS) drafts the requirements map and the operating program; your clinical leaders approve clinical content, and your organization files its own applications.

Last reviewed: October 2026.

What is a new line of business build?

The governing text depends on the line, so the build starts by naming the line and the texts that govern it. The state license, accreditor standard or program rule for a specific line is scoped in each engagement from the documents your organization and its counsel hold. Three federal rules show the kind of entry requirements a new line can carry:

• Medicare provider and supplier enrollment, 42 CFR 424.510. "Providers and suppliers must submit enrollment information on the applicable enrollment application. Once the provider or supplier successfully completes the enrollment process, including, if applicable, a State survey and certification or accreditation process, CMS enrolls the provider or supplier into the Medicare program" (42 CFR 424.510(a)(1)). Also: "A provider or supplier must submit a complete enrollment application and supporting documentation to the designated Medicare fee-for-service contractor" (42 CFR 424.510(d)(1)).
• Medicaid enrollment and screening, 42 CFR 455.410. "The State Medicaid agency must require all enrolled providers to be screened under to this subpart" (42 CFR 455.410(a), as published).
• Medicare Advantage contracting, 42 CFR 422.503(b). "Any entity seeking to contract as an MA organization must: (1) Complete an application as described in § 422.501. (2) Be licensed by the State as a risk bearing entity in each State in which it seeks to offer an MA plan as defined in § 422.2" (42 CFR 422.503(b)). The same section requires the entity to "Adopt and implement an effective compliance program, which must include measures that prevent, detect, and correct non-compliance with CMS' program requirements as well as measures that prevent, detect, and correct fraud, waste, and abuse" (42 CFR 422.503(b)(4)(vi)).

Some lines have their own IHS build pages: RPM and telehealth, utilization management and case management, and specialty pharmacy start-up. This page covers the build for any regulated line.

Who needs it and what triggers it

The buyers are organizations adding a regulated service line. Common triggers:

• A decision to offer a service that requires Medicare enrollment, where enrollment completes only after any applicable state survey and certification or accreditation process (42 CFR 424.510(a)(1)).
• A plan to bill Medicaid for the new service, where the state must screen enrolled providers (42 CFR 455.410(a)).
• A decision to contract as a Medicare Advantage organization, which requires an application, state licensure as a risk-bearing entity and an effective compliance program (42 CFR 422.503(b)).
• A new service that has to fit into existing quality, compliance and policy programs without a second, parallel set of documents.

How IHS helps

IHS works through a fixed process against the texts that govern the line:

1. Gap assessment and requirements map. IHS drafts a map naming each license, enrollment, certification and accreditation the line needs, with its sequence and owner, for your organization and its counsel to confirm.
2. Document and evidence mapping: a crosswalk from each requirement to the document that meets it.
3. Drafting. IHS drafts a program description; policies and procedures for the new service, fitted into your existing policy architecture; workflows; forms; staffing and training plans; and a launch work plan. IHS drafts the program, policies and clinical content for your clinicians to review and approve.
4. Mock review of the drafted program against the governing texts for the line.
5. Readiness support: drafted application and correspondence text, marked open items for decisions only your organization can make, and the launch work plan. Your organization's named contact submits; IHS drafts the text.

What your organization supplies: the service design, sites, staffing, payer strategy, current policies and access to your counsel.

The limit: IHS does not file applications, obtain licenses, or advise on reimbursement or corporate structure. State law and payer contracts are scoped in each engagement. Your clinical leaders approve clinical content; your executives decide the business case, sites and staffing.

For the policy set the new line fits into, see Policy and Procedure Architecture. Related: Program Development and Accreditation Consulting.

What to have ready

Each item below ties to a federal rule quoted on this page, as linked, or to the line-specific texts your organization holds.

• A written description of the new service: what it is, where it will be delivered and to whom.
• The state licensing rules, accreditor standards or program rules your organization or counsel has identified for the line.
• Whether you will enroll in Medicare for the service, and the applicable enrollment application (42 CFR 424.510(a)(1)).
• Whether the line needs a state survey and certification or accreditation before Medicare enrollment can complete (42 CFR 424.510(a)(1)).
• The supporting documentation list for the Medicare enrollment application (42 CFR 424.510(d)(1)).
• Your state's Medicaid enrollment and screening requirements for the provider type (42 CFR 455.410(a)).
• If you plan to contract as a Medicare Advantage organization, your state licensure status as a risk-bearing entity and your compliance program documents (42 CFR 422.503(b)).
• Your current policies, quality program and compliance program, which the new line has to fit into.
• Planned sites, staffing and payer strategy.

When the list is together, the introductory call is the place to start.

How it compares

Organizations adding a line usually weigh these routes. They can be combined.

What it costs

Licensing, enrollment and accreditation fees depend on the line, the state and the body involved, so verify current fees with each body. IHS scopes each engagement after a free introductory call.

What this is not

• This page is not legal advice. IHS does not advise on reimbursement or corporate structure; your counsel does.
• IHS does not file applications or obtain licenses, and does not guarantee any licensing, enrollment or accreditation decision. Your organization's named contact submits; IHS drafts the text.
• This is not accreditation readiness. Building the line and getting it accredited are separate pieces of work.

Frequently asked questions

We want to add a new regulated service; what do we need before we open it?

That depends on the line. IHS starts with a requirements map naming each license, enrollment, certification and accreditation the line needs, with its sequence and owner, for your organization and counsel to confirm. The operating program is then drafted against that map.

How do we find every license, enrollment, certification and accreditation the new line requires?

IHS drafts the requirements map from the texts that govern the line and the documents your organization and counsel hold. State law and payer contracts are scoped in each engagement, and your counsel confirms the map.

Does Medicare enrollment for our new service require a state survey or accreditation first?

It can. Under 42 CFR 424.510(a)(1), CMS enrolls a provider or supplier once it completes the enrollment process, including, if applicable, a state survey and certification or accreditation process. Whether one applies depends on the provider or supplier type.

Which comes first: state license, Medicare or Medicaid enrollment, or accreditation?

The order depends on the line and the state. For Medicare, 42 CFR 424.510(a)(1) places any applicable state survey and certification or accreditation process inside the enrollment process. The requirements map sets out the sequence for your line for counsel to confirm.

What does it take to contract as a Medicare Advantage organization?

Under 42 CFR 422.503(b), the entity must complete an application, be licensed by the state as a risk-bearing entity in each state where it seeks to offer an MA plan, and adopt and implement an effective compliance program, among other conditions in that section.

What policies and procedures does the new line need on day one?

The governing texts for the line set that, so the crosswalk maps each requirement to the document that meets it. IHS drafts the policies and procedures for the new service and fits them into your existing policy architecture.

Who has to approve the new program's clinical content?

Your clinical leaders approve clinical content. IHS drafts with approval lines for them. Your executives decide the business case, sites and staffing.

What does a launch work plan for a new service line include?

In an IHS build, the launch work plan sits alongside the requirements map, program description, policies, workflows, forms, staffing and training plans. It tracks each item, its owner and its open questions so your team can see what remains before opening.

What is the difference between building the line and getting it accredited?

Building the line produces the operating program the service runs on. Accreditation, where the line needs it, is a decision by the accreditor after its own process. IHS drafts the program and any application text; your organization applies and the accreditor decides.