In the newsletter you will find NAMD response to HCBS RFI and CMS final rules on managed ae pass-through payments, SUD, home health agencies, and 340B drug discount program. Other issues covered are prescription drug access, family planning, MPEC, State Access Monitoring Review Plans, opioids, MACPAC CHIP recommendations, Kaiser survey of Medicaid Eligibility and Enrollment.
On January 9, NAMD submitted a response to a CMS Request for Information (RFI) on the future of Medicaid home and community-based services (HCBS). In the RFI, NAMD calls for CMS to reassess the federal-state partnership in HCBS program administration and provide more predictable, streamlined oversight and approval processes that prioritize positive beneficiary outcomes. Additionally, NAMD notes that the HCBS landscape is undergoing significant change, in part driven by CMS’s HCBS settings rule, and this evolution must be carefully considered in any future rulemaking.
In responding to the RFI’s specific questions, NAMD recommends CMS consider additional flexibilities under waiver authorities, including 1115 demonstration waivers and 1915(c) HCBS waivers, to support targeted programs aimed at further rebalancing Medicaid long-term services and supports (LTSS) towards the community. NAMD expresses concern with additional federal rules or requirements around provider conditions of participation, mandatory reporting requirements across all state HCBS programs, or other measures that are not sensitive to the specific, highly variable structures of state HCBS programs. Additionally, NAMD cautions against more stringent federal approval processes for HCBS rates.
On January 5, NAMD held the first monthly All-Director call for 2017. Less than two weeks from the inauguration, most of the discussion focused on the imminent presidential transition. Members discussed NAMD’s role in engaging policymakers and the Trump administration’s transition team.
Other issues discussed during the All-Director call included Medicaid home and community-based services, IT systems issues, and risk corridors in expansion states.
CMS Issues Final Rule on Medicaid Managed Care Pass-Through Payments
On January 17, CMS published a final rule which caps pass-through payments in Medicaid managed care programs to the amount permitted under such arrangements in approved contracts and rate certifications on or before July 5, 2016. The rule also finalizes a “lesser of” methodology to calculate the maximum amount of permissible pass-through payments, with particular application for the phase-down of such payments made to hospitals. The final rule is unchanged from the rule as proposed in November 2016.
SAMHSA Releases Substance Use Disorder Privacy Rule, Supplemental NPRM
Late last week, the Substance Abuse and Mental Health Services Administration (SAMHSA) issued a long-awaited final rule that updates the regulations on the confidentiality of substance abuse disorder (SUD) records, or 42 CFR Part 2. In conjunction with the final rule, SAMHSA also issued a Supplemental Notice of Proposed Rulemaking to seek additional comment on the role of contractors, subcontractors and legal representatives in the healthcare system as it relates to Part 2.
Key provisions of the final rule include:
Consent. A patient can now include a general designation to individuals and/or entities (i.e., “my treating providers) in the “To Whom” section of the Part 2 consent form. When using this general designation, patients have the right to obtain a list of entities to which their information has been disclosed. The rule does not finalize changes to the “From Whom” section of the consent form.
Applicability of Part 2. The Part 2 regulations will continue to apply to programs that are federally assisted and hold themselves out as providing substance use disorder diagnosis, treatment, or referral for treatment. SAMHSA did not finalize its proposed change to the definition of program to include “general medical facilities” as well as “general medical practices.”
Research. Lawful holders of patient identifying information can disclose Part 2 patient identifying information to qualified personnel for purposes of research. Also, SAMHSA revised the proposed rule to permit researchers to link to federal and non-federal data repositories if certain conditions are met.
The final rule becomes effective 30 days after the formal publication of the rule in the Federal Register. Signed consent forms already in place will be valid until they expire, and consents obtained after the effective date will need to comply with the final rule.
CMS IB Outlines Approaches to Improve Prescription Drug Access
On January 17, CMS issued an Informational Bulletin (IB) detailing flexibilities states may leverage to expand pharmacy scope of practice to support timely beneficiary access to specific drug therapies. The IB discusses how states may, through statute or regulation, modify a pharmacist’s scope of practice to allow:
Independent prescribing for specific diseases, conditions, or drugs;
Enter into collaborative practice agreements by which the pharmacist operates under the authority delegated by a licensed practitioner with prescribing authority;
Create state “standing orders” for pharmacists; or
Utilize other state-authorized protocols.
The IB notes that these approaches can assist in addressing the opioid epidemic by allowing more widespread prescribing of the opioid overdose reversal drug naloxone. States could also use these methods to improve access to tobacco cessation treatments, vaccinations, and other prescription drug therapies that may further state public health objectives.
On January 12, CMS published a Frequently Asked Questions (FAQ) document exploring health service initiatives (HSIs), which are a state option under Title 21 of the Social Security Act to improve the health of Medicaid or CHIP-eligible children aged 19 or younger. The FAQ discusses the types of HSIs approved to date, how an HSIs could be leveraged to promote lead poisoning prevention, how HSIs are funded, and other matters.
On January 11, CMS issued a FAQ which provides additional information and address questions raised from previous guidance regarding the delivery of family planning services and supplies to Medicaid beneficiaries. The guidance touches on several issues, including drug coverage for sexually transmitted diseases (STDs)/sexually transmitted infections (STIs), coding for family planning services and supplies, informed consent and patient choice, and dual eligibles.
CMS Issues Final Rule on Home Health Agency Conditions of Participation
On January 13, CMS published a final rule updating the Medicare and Medicaid conditions of participation for home health agencies (HHAs). The rule requires a series of changes, such as:
A comprehensive patient rights condition of participation that clearly enumerates the rights of home health agency patients and the steps that must be taken to assure those rights.
An expanded comprehensive patient assessment requirement.
A requirement that assures that patients and caregivers have written information about upcoming visits, medication instructions, treatments administered, instructions for care that the patient and caregivers perform, and the name and contact information of a home health agency clinical manager.
A requirement for an integrated communication system that ensures that patient needs are identified and addressed, care is coordinated among all disciplines, and that there is active communication between the home health agency and the patient’s physician(s).
A requirement for a data-driven, agency-wide quality assessment and performance improvement (QAPI) program.
A new infection prevention and control requirement that focuses on the use of standard infection control practices.
A streamlined skilled professional services requirement that focuses on appropriate patient care activities and supervision across all disciplines.
An expanded patient care coordination requirement that makes a licensed clinician responsible for all patient care services.
Revisions to simplify the organizational structure of home health agencies while continuing to allow parent agencies and their branches.
New personnel qualifications for home health agency administrators and clinical managers.
On January 4, 2017, an updated Medicaid Provider Enrollment Compendium (MPEC) was released and posted at Medicaid.gov. Building upon previous iterations, this MPEC:
Describes how screening requirements apply to network providers;
Provides for Federal Financial Participation (FFP) for limited out-of-state claims when a furnishing provider or ordering/referring physician or other professional (ORP) is not enrolled in the reimbursing state’s Medicaid plan;
Formalizes the existing process for state Medicaid agencies to report discrepancies in ownership for organizational providers that are dually enrolled in Medicare and Medicaid;
Provides guidance concerning enrolled providers’ payment eligibility for retroactive dates of service;
Revamps the “For Cause Termination” section, splitting for cause termination types into mandatory and discretionary; and
Updates “Medicaid Termination Reporting” section, clearly identifies all required data points for Medicaid termination reporting, and provides additional guidance regarding reporting time frames.
The MPEC also sets out to resolve areas of confusion, adding a “definitions” section as well as clarifying the requirement that furnishing providers must enroll in Medicaid. In limited circumstances, the Compendium also now permits an attending NPI to appear on institutional claims in lieu of the ORP.
CMS Blog Addresses Comprehensive Primary Care Model
In this blog, CMS explores the Comprehensive Primary Care initiative (CPC), in which CMS convened payers in seven regions to test whether delivering comprehensive primary care at each CPC practice site could achieve better care, smarter spending, and healthier people. In three of these regions – Colorado, the greater Tulsa region of Oklahoma, and the Cincinnati-Dayton region of Ohio and Kentucky – CMS and payers collaborated to consolidate privacy-protected patient-level health data from multiple payers into a single report given to participating primary care practices. CMS notes that practices in the three regions have been able to better identify gaps in patient care and improve care delivery.
The blog notes that many CPC practices are taking the important skills and lessons learned into the newest CMS Innovation Center primary care model, Comprehensive Primary Care Plus (CPC+). Built on the foundation of CPC, CPC+ began this month on January 1, 2017, supporting primary care practices located in 14 regions across the country, with over 50 commercial payers and state Medicaid agencies partnering with CMS.
State Access Monitoring Review Plans are now available at Medicaid.gov. These plans evaluate whether there is sufficient access for primary care services (including those provided by a physician, FQHC, clinic, or dental care); physician specialist services; behavioral health services, including mental health and substance use disorder; pre- and post-natal obstetric services, including labor and delivery; and home health services. They also include information regarding proposals to reduce rates or restructure payments in ways that may harm access to care and describe procedures to monitor access over three years once the reductions are approved. Going forward, CMS will update the plans as states amend them for purposes of analyzing and monitoring services subject to rate reductions.
CMS Issues Bulletin on Duals and Durable Medical Equipment
In this joint bulletin, the Center for Medicaid and CHIP Services and the Medicare-Medicaid Coordination Office provide examples of how states can support access to durable medical equipment, orthotics and supplies (DMEPOS) for dually eligible beneficiaries. Since both Medicare and Medicaid cover DMEPOS, it seeks to clarify Medicaid’s obligation to provide DMEPOS as a payer of last resort. Some of the strategies for doing so include:
Allowing suppliers to request Medicaid prior authorization of DMEPOS for duals;
Assessing claims for DMEPOS against Medicaid’s broader criteria, not against Medicare’s more limited coverage of medical supplies; and
Ensuring the state only requires a Medicare non-affirmed prior authorization for the limited set of items where such a Medicare prior authorization is required.
Finally, the CMS guidance encourages states to incorporate the above strategies into its managed care contracts, as appropriate.
Recently, CMS published its state-specific and cross-state comparison Medicaid Drug Utilization Review (DUR) reports for FFY 2015. These reports analyze Medicaid fee-for-service prescription drug utilization patterns, cost savings associated with DUR activities, and any new or innovative DUR practices the states are employing.
The state-specific reports are available on CMS’s website here, and the cross-state report is available here.
CMMI Approves Pennsylvania Rural Health Model
On January 12, CMS and Pennsylvania announced the Pennsylvania Rural Health Model, a new initiative approved by the CMS Center for Medicare and Medicaid Innovation (CMMI). The Model seeks to increase rural Pennsylvanians’ access to high-quality care and improve their health, while also reducing the growth of hospital expenditures across payers and increasing the financial viability of the state’s rural hospitals. Under this Model, participating rural hospitals (including critical access and acute care hospitals) will receive all-payer global budgets to cover the inpatient and outpatient services they provide.
Federal District Court Issues Injunction on Certain Provisions of ACA Section 1557 Nondiscrimination Rule
On December 31, 2016, Judge Reed O’Connor of the United States District Court for the Northern District of Texas granted a nationwide injunction in Franciscan Alliance v. Burwell, barring the U.S. Department of Health and Human Services (HHS) from enforcing its nondiscrimination rule promulgated under ACA section 1557 insofar as the rule prohibits discrimination on the basis of gender identity or termination of pregnancy. The case was initially filed last August by the Franciscan Alliance (a Catholic hospital system), a Catholic medical group, a Christian medical association, and five states. Together, the plaintiffs argued that Section 1557 of the ACA’s prohibition of discrimination on the basis of pregnancy terminations or gender transition services interfered with the federal Administrative Procedures Act, in addition to constitutional and statutory provisions protecting religious liberty, freedom of expression, and association. Judge O’Connor maintained that the plaintiffs should not have to defend administrative enforcement actions to defend their rights. The text of the injunction can be reviewed here.
The remaining provisions of Section 1557 of the ACA-prohibiting discrimination on the basis of disability, race, color, age, national origin, or sex other than gender identity-took effect as scheduled on January 1, 2017.
CMS Releases Bulletin on EPSDT Services in Medicaid Managed Care
On January 5, CMS released an informational bulletin explaining the three ways states can deploy managed care to deliver some or all of the services included in the Early Pediatric Screening, Diagnostic, and Treatment (EPSDT) benefits. These three contract strategies include:
Managed care contracts should clearly identify, define, and specify the amount, duration, and scope of each service that the managed care plan is required to furnish to enrollees;
Contracts should specify a state’s decision regarding whether a plan or the state carries responsibility for informing beneficiaries of EPSDT benefits (states must inform all eligible individuals under age 21 about EPSDT benefits, provide or arrange for the provision of screening services in all cases where they are requested, and arrange for corrective treatment); and
Contracts should ensure that states have access to plan data necessary to meet the requirement that states must report EPSDT data, by age and by basis of eligibility, on child health screening services, referrals for corrective treatment, and dental services to the Secretary each fiscal year.
CMS Publishes Fact Sheet on MACRA’s Quality Payment Program
CMS recently issued a fact sheet on the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA)’s Quality Payment Program, which institutes reforms to Medicare Part B payments to help eligible clinicians to focus on the quality and efficiency of care. The fact sheet provides informative background on several elements of the Quality Payment Program, including Advanced Alternative Payment Models (APMs), the All-Payer Combination Option, the Medicaid Medical Home Model, incentive payment/MIPS exemption qualifications, data collection, and its impact on Indian Health Service (IHS) and Tribes.
The Center for Medicare and Medicaid Innovation (CMS Innovation Center) released its third report to Congress, focusing on activities between October 1, 2014 and September 30, 2016. In doing so, it discusses the nearly 40 payment and service delivery models/initiatives under section 1115A authority that CMMI has tested or announced.
The report highlights the Pioneer Accountable Care Organization Model, the Initiative to Reduce Avoidable Hospitalization among Nursing Facility Residents (Phase 1), the Diabetes Prevention Program, the Bundled Payments for Care Improvement Initiative (Model 2), and the Maryland All-Payer Model as its most exemplary and “promising” initiatives. Furthermore, the report includes updates on the Learning and Action Network, now comprised of 26 commercial health insurance plans, 23 Medicare Advantage plans, 28 Medicaid managed care plans, and two state Medicaid offices. Further, it discusses CMMI’s progress on implementing the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA).
CMS recently published a blog outlining its strategy and the array of actions underway to address the national opioid misuse epidemic. This blog builds on the Centers for Disease Control’s (CDC) new guidelines for prescribing opioids that was released earlier this year. In line with the Administration’s priority of addressing the opioid epidemic, the post describes CMS’s four priority areas in combating opioid misuse and opioid use disorder:
More effective person-centered and population-based strategies;
The expansion of naloxone availability;
The expansion of screening, diagnostic, and treatment services, especially medication-assisted treatment; and
Efforts to increase the use of evidence-based practices for acute and chronic pain management.
CMS hopes to accomplish these goals by more proactively educating beneficiaries, raising awareness of current guidelines for appropriate prescribing, promoting resources and programs that support providers, coordinating with private insurance companies to ensure policy consistency, and working with states to address substance use disorders, including opioid use disorder, among Medicaid beneficiaries.
HRSA Publishes Final Rule on 340B Ceiling Price Calculations, Civil Monetary Penalties
On January 4, the Health Resources and Services Administration (HRSA) published a final rule on the 340B drug discount program. The rule sets out a standard formula for manufacturers to estimate the 340B ceiling price of a new drug introduced to the market, with the actual price based on the general 340B formula of average manufacture price (AMP) minus unit rebate amount (URA) in effect no later than the fourth quarter following market introduction.
Additionally, the rule finalizes HRSA’s proposals to set the 340B ceiling price of a drug at one cent when the calculated price for a quarter is zero, and also finalizes the proposal to levy civil monetary penalties of up to $5,000 per instance of a manufacturer knowingly charging a 340B covered entity above the 340B ceiling price for a 340B drug.
The rule’s effective date is April 1, 2017. Read the rule here.
NQF Endorses CAHPS HCBS Measures
In late 2016, the National Quality Forum (NQF) fully endorsed the Consumer Assessment of Health Care Providers and Systems (CAHPS) home and community-based services (HCBS) measures. These 19 measures are the first NQF-endorsed measures specific to HCBS. CMS notes that these measures align with various Medicaid HCBS reporting requirements, and thus may be of use for states.
Last week, both chambers of Congress voted to advance budget resolutions charting the path towards repeal of the Affordable Care Act (ACA). The House voted 227 – 198 on Friday, following a 51 – 48 Senate vote the night before, at the end of the so-called “vote-a-rama” in which a series of amendments to the Senate resolution were introduced and voted down. The next steps are for the committees of jurisdiction in each chamber to develop budget legislation meeting the resolution’s spending targets. It remains unclear when formal legislation will be introduced or whether this legislation will be accompanied by legislation to replace elements of the ACA.
In the course of the Senate votes, a group of five Republican Senators initially sought to delay the introduction of formal budget legislation from January 27. However, they ultimately supported the legislation following assurances from Senate leaders that the January 27 date is not binding. A number of Democratic amendments, ranging from preserving the ACA’s pre-existing conditions protections to allowing adults up to age 26 to remain on their parents’ health insurance, were defeated.
On January 11, key House and Senate Committee leaders sent a letter to the Medicaid and CHIP Payment and Access Commission (MACPAC) requesting they analyze the optional Medicaid eligibility and benefit categories that states have chosen to cover. In the letter, the GOP lawmakers expressed frustration that data concerning optional benefits exist “across multiple, disaggregated sources that make meaningful review a challenge,” while information currently available from CMS “is limited to a list of mandatory and optional eligibility groups, as well as mandatory and optional benefits.”
New York Times Reports on Medicaid Cloud-based Data Storage
In this article, the New York Times highlights Nuna, a San-Francisco-based startup that has collaborated with the federal government to build a cloud-computing database of the nation’s 74 million Medicaid patients and their treatment. Requiring the extracting, cleaning and curating of data from countless computer systems, the database represents a “near historic” achievement, serving as the first “system-wide view across the program.” The article notes that the database is seen as a vital ingredient in transforming health care, especially as states work to leverage data to monitor and reward value-based care. “This kind of data,” in the words of Drew Altman, president of the Henry J. Kaiser Family Foundation, “can help move health care policy from a partisan ideological debate to one informed by knowing who the people affected are and what will likely happen to Medicaid recipients.”
Washington State Health Care Authority Reports on CMS Approval of 1115 Waiver
On January 9, Washington Gov. Jay Inslee and the Washington State Health Care Authority announced CMS approval of the next phase of its five-year State Medicaid Transformation Project. Providing up to $1.1 billion of incentives for high-quality care, the project will create partnerships with communities, address the social determinants of health, and hold down cost increases. Locally-led efforts will engage and support clients, providers, and communities through delivery system transformation strategies led by regional Accountable Communities of Health; a broader array of service options for older adults and individuals with disabilities; and key community support services for Medicaid clients with the most critical needs.
On January 17, the Medicaid and CHIP Payment and Access Commission (MACPAC) released recommendations on the future of the Children’s Health Insurance Program (CHIP). Most notably, MACPAC urges Congress to extend CHIP funding for an additional five years beyond the current expiration set for Sept. 30, 2017. MACPAC also recommends that Congress:
Continue the current CHIP maintenance-of-effort (MOE) for three more years, through FY 2022;
Establish grants for states to develop and test state-based systems of coverage for children;
End waiting periods in CHIP and eliminate premiums for children with family income below 150 percent of the FPL;
Allow states to use express lane eligibility permanently;
Provide five years of additional funding for outreach and enrollment grants, the childhood obesity research demonstration project, and pediatric quality measures program.
KFF Releases 50-State Survey of Medicaid Eligibility and Enrollment Policies in 2017
The Kaiser Family Foundation’s (KFF) annual 50-state survey provides crucial data on Medicaid and CHIP eligibility, enrollment, renewal and cost sharing policies as of January 2017. The report reveals that Medicaid and CHIP remain the central sources of coverage for low-income children and pregnant women, with 49 states covering children and 34 states covering pregnant women with incomes at or above 200% FPL as of January 2017. The report also finds that states are continuing to upgrade and streamline their eligibility and enrollment processes, as well as deploy a variety of premium and cost-sharing strategies to minimize patient financial burden. In light of continuing federal discussions on Medicaid and reauthorization of CHIP, this report aims to provide a baseline of state policies against which future policy changes could be explored.
Commonwealth Fund Analyzes Effect of Medicare ACOs on SNF Re-hospitalizations
Recently, the Commonwealth Fund published a brief titled “ACO-Affiliated Hospitals Reduced Re-hospitalizations from Skilled Nursing Facilities Faster Than Other Hospitals.” The brief analyzed Medicare hospital readmissions data from 2010 to 2013 for patients discharged to skilled nursing facilities (SNFs), and found that all hospitals saw declining readmissions. However, the data revealed that hospitals affiliated with Medicare Pioneer Accountable Care Organizations (ACOs) saw readmissions reduced by 3.1 percentage points, Medicare Shared Savings hospitals saw readmissions drop by 4 percentage points, and non-ACO hospitals saw reductions of 2.9 percentage points. The majority of readmissions occurred within the first three days of discharge.
SHVS Brief Explores Cross-Sector Accountability to Drive Population Health
Earlier this month, the Robert Wood Johnson Foundation’s State Health Value Strategies (SHVS) program published an issue brief titled “Shared Measurement and Joint Accountability Across Health Care and Non-Health Care Sectors: State Opportunities to Address Population Health Goals.” The brief outlines how health care leaders can collaborate with state policymakers to leverage cross-sector strategies to holistically address the drivers of population health. Shared measures and shared accountability which expand beyond clinical interventions are key tools to advance this work.
The brief calls out five elements to ensure successful efforts:
Ohio Medicaid Agency Reports on Expansion for State Legislature
Ohio’s Medicaid agency recently released a Group VIII Assessment, evaluating the impact of the 2014 Medicaid expansion with respect to access and utilization of health care, physical and mental health status, financial distress/hardship, and employment. The report finds that:
Medicaid expansion contributed to a large decline in the uninsured rate for low-income non-senior adults in Ohio (≤138% of the FPL) to the lowest rate ever recorded (14.1%);
Enrollee access to medical care became overwhelmingly easier with Medicaid, with nearly half of Group VIII enrollees (43.3%) reporting a decline in unmet health care needs;
Nearly half of Group VIII enrollees (47.7%) reported improvement in their overall health status since enrolling in Medicaid; and
Group VIII enrollees reported modest physical and mental health status gains, and most reported an increase in household, employment, and health security since enrolling in Medicaid.
The report also includes information on the enrollees themselves, including demographic and mental health characteristics, and modes of prior insurance.
Commonwealth Fund Assesses State Impact of ACA Repeal
A recent Commonwealth Fund report examines the state-by-state effect of Affordable Care Act repeal on employment and economic activity. Using a multistate economic forecasting model, the report predicts that repeal would result in a $140 billion loss in federal funding for health care in 2019 and the loss of 2.6 million jobs (mostly in the private sector) that year across all states. According to the Fund, states and health care providers would likely be particularly impacted by the funding cuts.
NCPDP White Paper Aims to Assist States in AAC Drug Reimbursement Under Outpatient Drug Rule
Recently, the National Council for Prescription Drug Programs (NCPDP) published a white paper titled “The Proper Use of the NCPDP Telecommunication Standard Version D.0 as it applies to the Implementation of Medicaid Reimbursement Methodologies Based on Actual Acquisition Cost (AAC) Plus a Professional Dispensing Fee.” This white paper walks through relevant NCPDP codes for processing Medicaid covered outpatient drug reimbursements, with the aim of informing Medicaid agencies and their fiscal agents with key information to ensure a smooth implementation of required changes under the covered outpatient drug rule.
Medicaid Directors may wish to make this resource available to their Pharmacy Directors and other staff. The white paper can be accessed on NCPDP’s website here.