Physicians who want to contest potential payment penalties associated with the 2018 Physician Quality Reporting System (PQRS) and/or the Value Modifier (VM) have until Dec. 1, 2017, to request an informal review of their data. The penalties in question stem from policies in effect prior to enactment of the Medicare Access and CHIP Reauthorization Act (MACRA). However, CMS has proposed some revisions intended to lessen the impact of prior policies and has based its calculation of related payment adjustments on these more lenient proposals.

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Revisions in the prior VM and PQRS policies were laid out in the 2018 Medicare Physician Fee Schedule proposed rule issued last summer, and came about as the result of advocacy from the AMA and other medical organizations. They will reduce the number of PQRS and VM penalties as well as the severity of VM penalties that would otherwise have occurred in 2018 based on performance in 2016.

If the proposals are finalized, a 2 percent PQRS penalty and a VM penalty could be avoided by having reported six measures in 2016, rather than complying with the previous reporting requirements of nine measures that crossed at least three domains and included one cross-cutting measure. The proposal would also halve VM penalties and bonuses, with penalties falling from a maximum of 4 percent to 2 percent for groups of 10 or more and from a maximum of 2 percent to 1 percent for smaller practices. In the unexpected event that these more lenient policies are overturned in the final Fee Schedule rule, penalties will be recalculated based on the prior policies.

Physicians can determine whether they will be subject to PQRS and/or VM adjustments on their 2018 Medicare fee-for-service claims by examining their 2016 PQRS feedback reports for PQRS adjustments and their 2016 Quality and Resource Use Reports (QRURs) for VM adjustments. They will also receive letters stating whether they will or will not receive a 2 percent PQRS penalty in 2018. CMS has no plans to send a separate letter about the VM. Therefore, the AMA highly encourages practices to download and review their QRURs and PQRS feedback reports to determine whether they are subject to potential PQRS and/or VM payment adjustments and ensure that such adjustments are based on the reduced requirements and penalties before filing for an Informal Review with CMS.

Those who have questions, even if they are uncertain about penalty status, are urged to submit a request for an informal review. CMS has said that it cannot guarantee that filing for an informal review in either PQRS or VM will automatically trigger an informal review in the other. Therefore, the safest course is to file requests for review of both PQRS and VM data.

Filing an informal review and/or accessing PQRS reports and QRURs requires an Enterprise Identify Management Account (EIDM) with the appropriate role. Consequently, it will also be necessary to determine whether someone within the practice has such an account and to set one up if it does not already exist. CMS offers information on how to obtain a QRUR and request a PQRS Informal Review.

If you have not already done so, 2016 PQRS feedback reports can be accessed on the CMS Enterprise Portal using an Enterprise Identity Management (EIDM) account. See PQRS Analysis and Payment webpage for more information.

For additional questions regarding the informal review process, contact the QualityNet Help Desk at 866-288-8912 (TTY 877-715-6222) or [email protected]. The help desk takes calls Monday–Friday, 7 a.m.–7 p.m. CDT. To avoid security violations, do not include personal identifying information, such as Social Security Number or TIN, in email inquiries to the QualityNet Help Desk.

For information on how to file a VM Informal Review, see the 2018 Value Modifier Informal Review Request Quick Reference Guide (PDF).

To review your QRUR, see the 2016 QRUR and 2018 Value Modifier webpage. CMS is also hosting a call to discuss these reports Oct. 19, 1:30 p.m. EDT. Register.

For additional questions regarding EIDM, contact the QualityNet Help Desk at [email protected] or 866-288-8912 (TTY 877-715- 6222); For QRURs or the Value Modifier, contact the Physician Value Help Desk at [email protected] or 888-734-6433 (select option 3).

The AMA sent a letter (PDF) on Sept. 25 to Sens. Lindsey Graham (R-N.C.) and Richard Durbin (D-Ill.) in support of their legislation, the "Development, Relief, and Education for Alien Minors (DREAM) Act of 2017" (S. 1615). This bill would provide an opportunity to earn lawful, permanent residence status for undocumented children and young adults who have been protected under the Deferred Action for Childhood Arrivals (DACA).

More specifically, the legislation would establish an eight-year conditional permanent residency status that can later be converted into a permanent residency status for individuals who meet educational requirements and prove that they have not committed a serious crime or pose a threat to national security and public safety. The DREAM Act has bipartisan support and has been referred to the Senate Judiciary Committee.

Read more at AMA Wire.

The AMA recently urged President Donald Trump to take three steps as part of an emergency declaration to reverse the nation's opioid epidemic. First, the AMA urged the president to waive Medicaid's 16-bed federal limit to treat patients with a substance use disorder. The AMA strongly supports the president's commission recommendation to "rapidly increase treatment capacity" and to "grant waiver approvals for all 50 states to quickly eliminate barriers to treatment resulting from the federal Institutes for Mental Diseases (IMD) exclusion within the Medicaid program."

Second, the AMA encouraged the president to suspend federal regulatory and other barriers to providing buprenorphine. The AMA supports eliminating the requirement for obtaining a special federal waiver to prescribe buprenorphine for the treatment of opioid use disorder. Even though the regulatory approach has eased somewhat over the past year, there still are considerable barriers in place. Removing the federal waiver requirement will give many more patients new access to treatment from physicians and other qualified health care professionals.

Third, the AMA urged that the president direct Attorney General Jeff Sessions to enforce existing substance use disorder parity laws. The AMA strongly agreed with the president's commission recommendation to "enforce the Mental Health Parity and Addiction Equity Act." This can be done at both the state and federal levels, but America's patients need additional help to encourage health insurance companies and pharmacy benefit managers to end the type of prior authorization, step therapy, and fail-first protocols that serve as barriers to medication-assisted treatment and multimodal pain care.

On Oct. 4, the Senate Finance Committee and the House Energy and Commerce Committees marked up their respective versions of legislation to reauthorize the Children's Health Insurance Program (CHIP). The Finance Committee passed a reauthorization bill, the "Keeping Kids' Insurance Dependable and Secure (KIDS) Act" (S. 1827), which was introduced by Committee Chairman Orrin Hatch, R-Utah, and Ranking Member Ron Wyden, D-Ore.

This bill would reauthorize CHIP for five years through fiscal year 2022 and return CHIP funding to traditional matching levels in 2021. The Energy and Commerce draft legislation, the "Helping Ensure Access for Little Ones, Toddlers, and Hopeful Youth by Keeping Insurance Delivery Stable (HEALTHY KIDS) Act of 2017" phases out the higher ACA match rate over the same time period as the Senate bill.

The Energy and Commerce Committee also considered legislation on Oct. 4 (commonly known as "Health Care Extenders") that would extend funding for community health centers, the Special Diabetes Programs, the National Health Service Corps, and Teaching Health Center Graduate Medical Education. It is expected that the House and Senate will act to extend authorization and funding for these and other health care programs before the end of the year.

Separately, the House and Senate approved short-term reauthorization legislation for the Federal Aviation Administration (FAA) (H.R. 3823) last week that included a three-month extension of funding for the Teaching Health Center Graduate Medical Education Program, which would receive $15 million over the next three months, and for the Special Diabetes Program for Indians, which would receive $37.5 million over that period.

Last week, Senate Republican leadership elected to not vote on the Graham-Cassidy health reform legislation, which would have repealed portions of the Affordable Care Act (ACA) and replaced it with a system of state-based grants and significant Medicaid program changes. Three Republican senators publicly opposed the proposal, depriving it of the requisite votes for passage.

Following this decision, Senate Health, Education, Labor and Pensions (HELP) Committee Chairman Lamar Alexander, R-Tenn., and Ranking Member Patty Murray, D-Wash., reignited their bipartisan discussions to stabilize the individual market. Negotiations are centered on continuing the cost-sharing reduction (CSR) payments through 2019, providing additional state flexibility under section 1332 waivers and a possible expansion of "copper plans" for catastrophic coverage. It is possible that a bipartisan agreement will be unveiled this week.

On Sept. 26, the "Creating High-Quality Results and Outcomes Necessary to Improve Chronic (CHRONIC) Care Act of 2017 (S. 807)," passed the Senate by voice vote. This AMA-supported legislation sponsored by Senate Finance Committee Chairman Hatch and Ranking Member Wyden would provide a clear pathway in the Medicare program toward new delivery models that are patient-centered and would improve health outcomes and value for patients with chronic conditions.

The CHRONIC Care Act would remove barriers to care coordination and enhance beneficiary flexibilities to be a part of an accountable care organization (ACO). Specifically, this legislation includes several provisions advocated for by the AMA, such as an extension and expansion of the Independence at Home (IAH) Demonstration Program, telehealth coverage for certain ACOs and Medicare Advantage (MA) plans, and for patients who are suffering from acute stroke. The bill also includes important patient access protections to ensure that telehealth would not be used for network adequacy determinations for MA plans. S. 807 awaits action in the House of Representatives.

On Sept. 23, CMS released proposed payment rates for clinical laboratory testing services paid on the Clinical Laboratory Fee Schedule (CLFS) for calendar year 2018. The proposed rates, the first released under a new, market-based payment system for clinical laboratory tests, show widespread cuts to reimbursement for clinical testing services, including point-of-care testing performed in physician office-based laboratories. While a significant number of tests paid on the CLFS are slated for cuts, to reduce disruption to the laboratory market these cuts will be capped at 10 percent per year over the next three years.

The AMA has been working closely with a number of physician specialty organizations, laboratory organizations, test manufacturers and other stakeholders to ensure continued access to point-of-care testing services in physician offices. Despite numerous efforts from the AMA, physician specialty and state medical societies to highlight the potential impact on patients if access to point of care testing services is lost due to reductions in reimbursement, CMS appears primed to move ahead with the new reduced rates on Jan. 1, 2018. The AMA will continue to work closely with stakeholders, CMS and Congress to mitigate the potential impacts on physician office-based laboratories. More information on the proposed rates is available on the CMS website. The agency is accepting public comment on the proposed rates until Oct. 23.

On Sept. 27, a number of physician specialty organizations joined an AMA-led letter (PDF) to the United States Pharmacopoeia (USP) urging the organization to preserve the ability of physicians to prepare sterile drug products in their offices for administration to patients. USP is in the process of revising its standards for sterile (Chapter 797) and non-sterile (Chapter 795) compounding. Initial proposed revisions of Chapter 797 would remove previous exemptions for many activities in physician offices and would subject physician practices to the full requirements of Chapter 797 if they engage in any type of mixing, combining, or altering of a sterile drug product in their office.

The AMA is working closely with other physician organizations to ensure that exemptions for low-risk physician activities are maintained. While USP standards are not enforceable on their own, they are widely adopted by state boards of pharmacy and therefore represent the law in many states. USP is expecting to release a second draft revision for public comment sometime in 2018, with the goal of the chapters becoming effective on Dec. 1, 2019. Until revised chapters 797 and 795 are finalized, the 2008 versions remain in effect for those states that have adopted them.

Separately, USP has announced that it will be delaying implementation of Chapter 800, which includes standards for the compounding of hazardous drugs. This chapter potentially affects several specialties, but is particularly of note to those in the oncology community who engage in preparation of chemotherapy products in their practices. USP has stated that the content of the Chapter, which was finalized in 2016, will not change, but that the implementation timeline is being adjusted to fall in line with implementation of revised Chapter 797. Both chapters are slated to take effect Dec. 1, 2019.

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